A

Training Report

For the partial fulfillment

Of
Sem-VII, B.Pharm, GTU

Submitted by
Prajapati Sahil A
Arihant School of Pharmacy & BRI, Gandhinagar
(202080290036)
2023 - 2024

1
 CERTIFICATE

This is to certify that “Industrial Training” was carried out by Mr. Prajapati Sahil
A (Enrollment No.: 2020802900036) studying in Bachelor of Pharmacy semester
7 at Arihant School of Pharmacy & BRI (208) for partial fulfilment of Subject :
Practice school, Subject code: BP705PP for a period supervision of 150 hours. This
work has been carried out under my guidance and supervision and it is up to my
satisfaction.

Date:

Place:

Name and Sign of Mentor: Name And Sign Of Principal:

Seal of Institute

2
INDUSTRIAL TRAINING CERTIFICATE

3
 ACKNOWLEDGEMENT

It is a matter of pleasure and happiness to make and submit this industrial training report during
course of the completion of this industrial work. Many of the persons have offered their valuable
and enormous support.
I'm thankful to all my teachers of Arihant school of pharmacy and & BRI. For their blessings and
encouragement.
I would like to express my special thanks and gratitude to West coast pharmaceutical Works and
Mr Lalit Prajapati for providing all the essential facilities which were required for this training.

Finally, I express my regards to my beloved parents who inspired me throughout my studies and
completion of this training.

(Sahil Prajapati)

4
 ABSTRACT

❖ This report represents the experience and skills gained during the Industrial training
undertaken at West-Coast Pharmaceuticals Works Limited.
❖ The report contains some of the tests carried out on the drug samples to ensure that they are
safe for consumption and the processes and methods used for the manufacturing of various
dosage forms.
❖ During this period, I acquired practical knowledge and skills in various departments majorly
the Production and Quality control department. In the field, I got knowledge of various
instruments used for manufacturing and quality study. The brief description of instruments
are given separately.
❖ This report discusses the skills gained and experience gathered during the period of training,
justifying the relevance in equipping students with needed competence to thrive in the real
world.
❖ In conclusion, this report is the summary of what I have learnt during my industrial training
programme.

5
 INDEX

SR NO TOPIC NAME PAGE NO

1 CERTIFICATE BY HEAD OF 2
DEPARTMENT

2 INDUSTRIAL TRAINING CERTIFICATE 3

3 ACKNOWLEDGEMENT 4

4 SUMMARY/ABSTRACT 5

5 INDEX 6

6 INTRODUCTION 7

7 PRODUCT LIST 10

8 OBJECTIVE 18

9 SECTION IN WEAST COAST 19

10 CONCLUSION 53

6
 INTRODUCTION

West-Coast Pharmaceuticals Works Limited is a global pharmaceutical company. It manufactures

Pharmaceutical finished formulations, Dietary Supplements & Cosmeceutical Products. The
company offers pharmaceuticals in a wide range of dosage forms, including capsules, tablets,
ointments, liquids & creams. Plant is approved by WHO-GMP, NAFDAC-Nigeria, PPB Kenya &
MOH-Zambia.

It also Manufacturer Disinfectant Products. (All hospital disinfectant products), Medicated Soaps,
Food Supplements/ Nutraceuticals products, Veterinary products, Sustained release drugs, Ready
Premix, Herbal Products, OTC category products.

It develop products as per buyers requirement. Currently covered territories are ANGOLA,
ALGERIA, BENIN, BHUTAN, BOTSWANA, CAMBODIA, DENMARK, DOMINIC
REPUBLIC, ECUADOR, ETHIOPIA, GUATEMALA, HAITI, HONG KONG, IVORY COAST,
KENYA, KUWAIT, LIBERIA, MALDOVA, MAXICO, MAYANMAR, MONGOLIA,
MOZAMBIQUE, NIGERIA, PANAMA, PAPUA NEW GUINEA, PHILIPPINES, RWANDA,
SINGAPORE, SOUTH KOREA, SRI LANKA, SUDAN, TAJIKISTAN, THAILAND,
TURKMENISTAN, UAE, UGANDA, UZBEKISTAN, VIETNAM, YEMEN, ZAMBIA.

West-Coast Pharmaceuticals, making its mark around the globe with vast range of products. West-
Coast is a crafted participant in the world of Finished Formulations of Pharmaceuticals,
Cosmeceuticals, Nutraceuticals & OTC. West-Coast was incorporated in 1965 & over the years, it
has grown into a vast organization. Its experience and dedication makes us capable of processing
all kinds of effective medicinal products.

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VISION
To be a leading organization by providing high quality products with the best service in the
industry.

MISSION
To discover, develop and market products with total customer satisfaction through state-of-the-art
technology ”

VALUES

• Quality
• Innovation
• Commitment
• Passion
• Agility

Why It?
At West-Coast, it believe that quality healthcare is a human right & it has committed to provide
best health care at affordable prices within the reach of common people.

Its Strength !
It has state of the art plant having approvals with WHO-GMP, ISO & various International
authorities. It is present in 40 plus countries across the globe & still counting. It has strong back
up of perfect documentation with complete dossiers in various format General, ACTD etc. A well
equipped QC lab along with well qualified QA personnel is an added advantage. Its F&D
Department is continuously working on New Development & further improvement in existing
formulation & Production house, with sophisticated advanced machinery. These all forms a West-
Coast what it has today.

8
It is Manufacturer of Pharmaceutical Products for various categories of products

• Anti-Cancer Tablet & Capsule.

• Hormones Tablet & Capsule.
• Î’-Lactum Table. (Coated / Uncoated)
• Î’-Lactum Capsule & Dry Syrup.
• Oral Powder (ORS, PROTEIN POWDER,)/li>
• Oral Liquid Section.
• General Tablet & Capsule.
• Disinfectant Products. (All hospital disinfectant products)
• External Liquid/Ointment/Gel/Lotion/Nasal spray
• Cosmetics products.(CREAM/ GEL/ LOTION/SOAPS/SHAMPOO/OILS)
• Medicated Soaps
• General Powder Repacking.
• Liquid Repacking.
• Dietary Supplement/Food Supplements/Nutraceutical products.

its also manufacturing following category of products.

Cosmeceutical Products (Medicated Cosmetics Mfg. Under Cosmetic Lic)
Veterinary products
Sustained release drugs
OTC category products.
Ready Premix.

Its Plant is approved by WHO GMP CERTIFICATE .(GENERAL TABLET, CAPSULE,

SYRUP, EXTERNAL)
GMP CERTIFICATE. (FOR ALL DEPARTMENT)
NAFDAC – NIGERIA
MOH-ZAMBIA
PPB- KENYA
MOH- VIETNAM
Registered products with ZAMBIA, NIGERIA, ALGERIA, ANGOLA, MOZAMBIQUE,
KENYA, PANAMA, THAILAND, VIETNAM, MONGOLIA, CAMBODIA, YEMEN,
KUWAIT, MYANMAR, SOUTH KOREA, VIETNAM, DENMARK, DOMINIC REPUBLIC,
MALDOVA, UZBEKISTAN, TURKMENISTAN, SRILANKA etc.

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 PCD PRODUCT LIST

(Effective From 01-04-2020)

N
NAME OF PRODUCT COMPOSITION PACKING
O
ANTI-BACTERIAL

1 CEFDO – 200 DT TAB Cefpodoxime Proxetil 200mg. 5X10 TAB

2 FCIN-OZ TAB Ofloxacin 200mg + Ornidazole 500mg. 10X10 TAB

3 CEFME 200 TAB Cefixime 200mg 10X10 TAB
4 DOXYSPOR CAP DOXYCYCLINE HYCLATE100MG +LACTOBACILUS 10 X10CAP
5 NITRO CAPSULES Nitrofurantoin USP 100 mg 2X10CAP
LAXATIVE/ANTI DIARROHEAL
6 WESCOLAX TAB Bisacodyl Tab 5mg. 10X10 T
7 RADOT 100DT TAB Racecadotril 100 mg 2X5X10 T
8 RADOT 10DT TAB Racecadotril 10 mg 2X5X10 T
ANTI EMETIC /PPI/ANTACID
9 OND–8 TAB Ondansetron Tablet 8mg. 2X5X10 T
ANTI ALERGIC/COLD/COUGH
10 LEET TAB Levocetirizine Mouth Desolving Tab 5mg 2X5X10TAB
11 LEET AM 2.5 SY 60ML LEVOCETRIZINE + AMBROXOL 2.5MG SYRUP. 60ML
12 LEET SYRUP LEVOCETRIZINE 5MG SYRUP 60ML

13 MONT-LC TAB Montelukast 10 mg. Levocetirizine Dihydrochloride 5 mg. 3X10 T

MONTELUKAST SODIUM & LEVOCETRIZINE

14 MONT-LC KID TAB 10 X10TAB
HYDROCHLORIDE DISPERSIBLE TABLET
VITAMINS/MINERALS/CALCIUM/PROTEIN
15 FOLCIN TAB FOLIC ACID 5MG TABLET 1X30 T
16 D-FILL DROP Vitamin D3 400 IU 30 ML
17 WESCOVITA TABLET Lycopene 500 mcg
Lutein 1 mg
Beta-carotene 5 mg
Vitamin A 1250 iu
Vitamin C 60 mg
Vitamin E 30 iu
Selenium 70 mcg
Manganese 2 mg
Chromium 120 mcg

10
 Zinc 15 mg
Vitamin B1 1.5 mg
Vitamin B2 1.7 mg
Vitamin B3 20 mg
Vitamin B5 10 mg

Vitamin B6 2 mg 10x10 T
Vitamin B12 6 mcg
Folic acid 400 mcg
Biotin 100 mcg
Vitamin K 25 mcg
Vitamin D3 200 iu
Iron 6 mg
Calcium 75 mg
Potassium 25 mg
Copper 2 mg
Magnesium 25 mg
Phosphorus 50 mg
Iodine 150 mcg
Silicon 2 mg
Boron 150 mcg
Molybdenum 75 mcg
Vanadium 10 mcg
L-lysine 50 mg
L-arginine 20 mg
L-methionine 10 mg
Vitamin A 1500 Iu
Vitamin C 15 mg
Vitamin D 400Iu
Vitamin E 5 Iu
Thiamin hydrochloride 0.5 mg
18 WESCOVITA DROP Riboflavin 0.6 mg 30 ML
Niacinamide 8 mg
Vitamin B6 0.4 mg
Vitamin B12 2 mcg
Patothenic acid 3 mg

11
 ANALGESIC / NSAID
19 ACEMOL TAB Aceclofenac & Paracetamol Tab. 2X5X10 TAB
ACECLOFENAC100MG+PARACETAMOL325MG+SERRATIO
20 ACEMOL SP TAB 10 X 10TAB
PEPTIDASE 15MG
21 PACTOL 650MG TAB PARACETAMOL 650 MG TAB 10 X 10TAB
22 BACFEN-10 MG TAB BACLOFEN 10MG TAB 10X10T
DICLOFENAC DIETHYLMONIUN + MITHYEL
23 MEDIGEL 30GM
SALYSILIC+MENTHOL GEL

Menthol I.p. 6%w/w methyl salicylate I. p. 15% w/w

24 WANGAY GEL 15 GM
Eucalypyus oil I.p. 2%w/w Turpentine oil I.p. 1.5%w/w

Dicyclomine Hydrochloride & Paracetamol

25 SPASMOL TABLET 10X5X10 T
Tab.(20mg.+500mg)

Diacerein 50 mg, Glucosamine Sulphate Sodium Chloride

26 DIFLEX TABLET 2X5X10 T
USP 500 mg Eq. to Glucosamine 314 mg
E.N.T. / DENTAL
Paradichlorobenzene 2.0% w/v Benzocaine I.P. 2.7%w/v
27 WAXNIL DROP Chlorbutol I.P. 5.0%w/v Turpentine Oil I.P. 10ml
5.0% v/v Oil base q.s.
Xylomeazoline HCL I.P. 0.1% w/v Benzalkonium Chloride
28 XYLONE ADU. N DROPS Solution I.P. 0.2% w/v (as preservative) An Aqueous 10ml
Isotonic Base q.s.
Xylomecazoline Hydrochloride IP 0.05% w/v In An
Aqueous Isotonics Solution Using Purified Water IP
29 XYLONE PED. N. DROPS 10ml
Benzalkonium Chloride Solution IP Eq To Benzalkonium
Chloride 0.011 %
30 FOROTO DROP CLOTRIMAZOLE 1% W/V, LIGNOCAINE 2% W/V EAR DROP 5ML
31 BENZOFEN ORAL GEL DICLOFENAC 3.0%+ BENZOCAINE 20.0% ORAL GEL 10 GM
PHYLLANTHUS EMBLICA FRUIT ( AMLA ) 60MG
AMNUSOPS ELENGIS BARK ( BORSALI ) 82.75MG
AZADIRACHTA INDICA BARK ( NEEMSAL) 98MG

PRONGAMIA PINNATA BARK ( KARANJSAL ) 32.50MG

32 ORAMINT HERBAL 200ML
HOARRHENA ANTIDYSENTRICA ( KUTAJSAL ) 32.50MG

GLYCYRRHIZA GLABRA ROOT ( JETHIMADH ) 55MG

OCIUM BASILICUM PAN ( TULSI ) 30MG
MENTHA VIRIDIS PAN ( FUDINA ) 20MG

12
 EUGENIA CARYOPHYLUS FLOWER BUD ( LONG ) 22.50MG

CINNAMOMUM CASSIA BARK ( TAJ ) 20MG

ACACIA KATECHA SAR ( KHADIR ) 30MG
CURCUMA LONGA RHIZOMES ( HRIDRA ) 22.50MG

BERBERIS ARISTATA RHIZOMES ( DARU HALDI ) 22.50MG

MYRICA NAGI BARK ( KAYFAL ) 30MG

BARIERIA PRIONITIS BARK ( VAJRADANTI ) 32.50MG

ZANTHOXYLUM ALTUM ROXIT BARK ( TEJBAL ) 30.50MG

TERMINALIA CHEBULA FRUIT ( HARITAKI ) 20MG

PAN ARBUS PRECATRIA FRUIT ( CHANOTHI ) 20MG
QUERCUS INFECTORIOUS FRUIT ( MAYAFAL ) 20MG

ELETTARIA CARDAMOMUM SEED ( ILAYACHI ) 20MG

ASPARAGUS RACEMOUS ROOT ( SHATAVARI ) 25MG

AQUEOUS BASE Q.S

GYNEC DIVISION/ HORMONES

FOLIC ACID 5MG + VITAMIN B12 (CYANOCOBALAMIN)
33 FOLCIN-T1 10X10T
500MCG + PYRIDOXINE 5MG
FOLIC ACID 5MG + DHA100MG + ZINC20MG+VIT B12
34 FOLCIN-T2 10X10CAP
1MCG
35 LABETOL TAB LABETOLOL TABLET 10 X 10 T
Vitamin B1 (Thiamine) 2.0 mg
Vitamin B2 (Riboflavin)2.5 mg
Vitmain B6 (Pyridoxine Hydrochloride) 0.75 mg
36 MULVIT-L SYRUP Vitamin B12 (Cyanocobalamin) 0.002 mg 200 ML
Vitamin B3 (Niacinamide) 15 mg
L-Lysine 375 mg

Ferrous ascorbate eq.to elemental iron 100 mg

Folic acid 1.5 mg
37 FERINEXT TABLET 3x10 T
Elementral zinc 22.5 mg
Cyanocobalamine (vit.B12) 15 mcg
38 FERINEXT XT SYRUP Ferrous ascorbate eq. To elemental iron 50 mg 150 ML

13
 Folic acid 750 mcg
Zinc sulphate eq. 10 mg
Vitamin B12 7.5 mcg

39 LYNA TABLET Levonorgestrel IP 0.15 mg Ethinyloestradiol IP 0.03 mg 21 T

Ethinyl Estradiol IP 0.035 mg Cyropterone Acetate BP 2

40 CYNA TABLET 21+7 T
mg
41 MEDONA – 10MG TAB Medroxyprogesterone Acetate IP 10 mg 10X10 T
42 EVYA TABLET Estradiol Valerate USP 2.0 mg 28 T
43 NYNA TABLET Norethisterone I.P. 5 mg 10X10 T
44 LEZ 2.5 TAB Letrozole USP 2.5 mg 3X10T
45 CLOMI-50 TAB Clomiphene Citrate IP 50 mg 10X5 T
46 FEMISOF INTIMATE LIQ UREGULAR VAGINAL WASH 100ML
Doxylamine Succinate USP 10 mg Pyridoxine
47 VOMEX TAB 2X5X10 T
Hydrochloride IP 10 mg Folic acid IP 2.5 mg
48 CLOMI Q 10MG TAB CLOMIFEN CITRATE 25MG + COENZYME Q10 50MG 10 X 1 X 10TAB
CARDIO – DIABETIC DIVISION
49 LIPINA – 10mg TAB Atrovastain Calcium, Atrovastain 10 mg 10X10 T
Losartan Potassium USP 25mg, Hydrochlorothiazide BP
50 LOSA – H TABLET 10X10 T
12.5mg
51 LOSA – 50 TABLET Losartan Potassium USP. 50mg 10X10 T
Glimepiride USP 1mg, Metformin Hydrochloride IP
52 MET GL – 1mg TAB 10X10 T
500mg (In sustained release form),
Glimepiride USP 2mg, Metformin Hydrochloride IP
53 MET GL – 2mg TAB 10X10 T
500mg (In sustained release form)

54 TELMI - 40 TAB Telmisartan I.P 40mg 10X10 T

55 TELMI – H TABLET Telmisartan I.P. 40mg+ Hydrochlorothiazide 12.5mg 10x10 T
Thiamine Hydrochloride 10 mg.Riboflavine 10
mg.Nicatinomide 50 mg.Pyridoxine Hydro
56 BECOVIT TABLET 15mcg.,Vitamin B12 100mg ,Calcium Pantothenate 50 10X10 T
mg.Ascorbic Acid 150 mcg. Biotin 100mcg.Folic Acid 1.5
mg.
57 DIMIDE-S TABLET FRUSEMIDE AND SPIRONOLACTON 10x10Tab
DERMA DIVISION
Clindamycin Phosphate U.S.P.Eq. to Clindamycin 1% Gel
58 ACNEGEL 15GM
base Q.S.
59 FUSIC CREAM FUSIDIC ACID CREAM IP 10 GM

14
60 FLUSON CREAM FLUTICASONE PROPINATE CREAM IP 0.05% 15GM
61 MUPICOAT OINTMENT MUPIROCIN OINTMENT IP 2% 5GM
62 TERFIN 250MG TAB TERBINAFINE TABLETS USP 250 MG 1 X 7TAB
63 TERFIN CREAM TERBINAFINE CREAM 15 GM
64 HALSOL CREAM Halobetasol Propionate 0.5mg 15GM

65 HALSOL – S CREAM Halobetasol Propionate 0.5mg Salicyclic acid IP 30mg 10GM

66 DEFLA-6 Deflazacort 6mg. 10x10 T

Mometasone Furoate USP 0.1% w/w In cream base q.s.
67 METOS CREAM Preservatioves Methyl Paraben IP 0.2% w/w Propyl 10GM
Paraben IP 0.002% w/w

68 METOS LOTION Mometasone Furoate USP 0.1% w/w Aqueous Base q.s. 15ML

Mometasone Furoate USP 0.1% w/w Fusidic Acid 2% w

69 METOS – F OINTMENT 10GM
Ointment base q.s.

Mometasone Furoate USP 0.1% w/w Terbinafine HCL BP

70 METOS – T CREAM 1% w/w Preservatives: Chlorocresol IP 0.1% w/w In 15GM
cream base q.s
71 PILENIL OINTMENT Lidocaine HCI 0.70% W/W, Zinc Oxide 6.60% W/W. 25GM
72 FAZOL 150MG TAB Composition :Fluconazole 150mg Excipients q.s. 10X1 TAB
73 OLIVERA CREAM Olive Oil with Allovera & Vita.E-CREAM 50GM
74 VERAVIT CREAM Olive Oil with Allovera & Vita.E-CREAM 50GM
75 OLIVERA LOTION Olive Oil with Allovera & Vita.E-Lotion 60ML
Chlorhexidine gluconate,
Triclosan,
Tea tree oil,
Salicylic acid,
Camphor,
Peppermint oil,
Eucalyptus oil,
76 CLEARCLIN LOTION Isopropyl alcohol 60ML

Salicylic acid
Triclosan
Tea tree oil
Chlorhexidine gluconate
Xanthan gum

15
 Chlorhexidine gluconate,
Triclosan,
Glycerin
Tea tree oil,
Salicylic acid,
Di – sodium EDTA
Menthol
Steareth – 2
77 CLEARCLIN FACE WASH PPG – 1 60ML
Propylene glycol
Sodium laureth sulfate
Distearyldimonium chloride
Cocamidopropyl betine,
Cetyl alcohol,
Steareh – 21
Stearyl ether,
Carbomer,
78 VERASOFT LOTION 50M CALAMINE+ALOVERA+VITAMIN E LOTION 50ML 50ML
79 VERASOFT LOTION 100 MCALAMINE+ALOVERA+VITAMIN E LOTION 100ML 100ML
ALOVERA EXTRACT
ZONC OXIDE
VITAMINE E
GLYCERIN
NEEM SEED OIL
Cetyl alcohol,
80 SEPLIN SOAP 75GM
CETYL ALCOHOL
CAMPHOR
TURMERIC EXTRACT
TEA TREE OIL
CHLOREXIDINE DIGLUCONATE
TRICLOSAN
CHLORHEXIDINE GLUCONATE
TRICLOSAN
GLYCERIN
TEA TREE OIL
81 CLEARCLIN SOAP SALICYLIC ACID 75GM

16
 MENTHOL
STEARETH - 2
PROPYLENE GLYCOL

SODIUM LAURETH SULFATE

DISTEARYLDIMONIUM CHLORIDE
COCAMIDOPROPYL BETINE
CETYL ALCOHOL
STEAREH - 21
SPECIAL DIABETIC CARE PRODUCTS
EFFECTIVE MOISTURIZER FOR SEVERE DRY SKIN IN
82 FRC CREAM 100GM
DIABETES
OTHER PRODUCTS
83 METH-2.5 Methotrexate Ip 2.5 mg 10 X 10 T
Olive Oil
Vitamin A
Vitamin D
Vitamin E
Avocado Oil
Aloevera Extract
SOFOIL (Baby Almond Oil
84 60ML
Massage oil) Sesame Oil
Shankhapushpi
Camphor
Liquid Paraffin
Mineral Oil
Castor Oil
Coconut Oil
85 OLIVERA SOAP ALOVERA, VITAMIN E & OLIVE OIL SOAP 75GM

86 ITRACONAZOLE CAP 100MG 10X10CAP

ITRANEED 100MG CAP
87 RABZOL-DSR CAP Rabeprazole 20mg & Domperidone 30mg Sustained Relea 10X10CAP
88 PANOP-DSR CAP Pantaprazole 40mg & Domperidone 30mg Sustained Rele a 10X10CAP

17
 Objective Of the Industrial Training

The purpose of industrial training is to expose students to real work of environment experience
and at the same time, to gain the knowledge through hands on observation and job execution.
From the industrial training the students will also develop skills in work ethics, communication,
management and others. Moreover, this practical training program allows students to relate
theoretical knowledge with its application in the manufacturing Industry.

The objectives of industrial training are:

• To provide student the opportunity to test their interest in a particular career before
permanent commitment are made.
• To develop skills in the application of theory to practical work situations.
• To develop skills and techniques directly application to their careers. Internships will increase a
student's sense of responsibility and good work habits.
• To expose students to real work environment experience gain knowledge in writing report in
technical work/projects.
• Internship students will have higher levels of academic performance.
• Internship program will increase student earning potential upon graduation
• To build the strength, teamwork spirit and self-confidence in student's life.
• To enhance the ability to improve student's creativity skills and sharing idea.
• To build a good communication skill with group of workers and to learn proper
behaviour of corporate life in industrial sector.

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 SECTIONS IN WEST COAST
➢ Raw Material Store
➢ Tablet Manufacturing Section
➢ Capsule Manufacturing Section
➢ Liquid Manufacturing Section
➢ Ointment Manufacturing Section
➢ Quality Control and Quality Assurance Section
➢ Microbiology Section
➢ Finished Goods Section

RAW MATERIAL STORE

➢ A raw material also known as a feedstock or most correctly unprocessed material, is a basic
material that is used to produce goods, finished products, energy or intermediate materials
which are feedstock for future finished products. As feedstock, the term connotes these
materials are bottleneck assets and are highly important with regards to producing other
products.
➢ Pharmaceutical raw materials comprise substrates or elements that are used for
➢ manufacturing different types of drugs e.g. endocrine disorder drugs, musculoskeletal
system drugs,
➢ anti-infective drugs viz. cephalexin, penicillin, ampicillin, cephradine, etc. Pharmaceutical
excipients
➢ and ingredients or raw materials used to manufacture drugs are extracted from
different sources.
➢ These sources could be natural or synthetic. Recently, many of the raw materials previously
derived
➢ from natural sources are being produced synthetically in part or even biotechnologically.
This is so
➢ because manufacturing them artificially is economical, safer and much quicker.
Pharmaceutical raw
➢ materials are manufactured using different types of acids, alcohols, esters, phenones,
pyridines, etc.
➢ Pharmaceutical raw materials comprise substrates or elements that are used for
manufacturing different types of drugs e.g. endocrine disorder drugs, musculoskeletal
system drugs, anti-infective drugs viz. cephalexin, penicillin, ampicillin, cephradine, etc.
Pharmaceutical excipients and ingredients or raw materials used to manufacture drugs
are extracted from different sources. These sources could be natural or synthetic. Recently,
many of the raw materials previously derived from natural sources are being produced
synthetically in part or even biotechnologically. This is so because manufacturing them
artificially is economical, safer and much quicker. Pharmaceutical raw materials are
manufactured using different types of acids, alcohols, esters, phenones, pyridines, etc.
➢ Pharmaceutical raw materials are essential to producing pharmaceutical drugs and
include active pharmaceutical ingredients (APIs) also known as bulk active are

19
 pharmaceutically active and have desired pharmacological effects on the body e.g.
alvimopan, sparfloxacin, sapropterindihydrochloride, lanreotideacetate, nicotinic aicd,
etc. In contrast pharmaceutical excipients are the pharmaceutically inert substances which
help in delivering the active ingredients e.g. anti-adherents, binders, coatings, disintegrants,
fillers, etc.

Fig.1 – Raw Material Store

➢ STEPS INVOLVE IN RM STORE
1. Receiving
2. Sampling
3. Storing
4. Dispensing

1. Receiving
o Raw material is supplied by vendors by placing order.
o After receiving the raw material check he “Observation on pack”
o Segregate the raw material according to batch number.
o Pre entry cleaning of raw material by vacuum cleaner.
o Weighing of the raw material

2. Sampling
o Before sampling get line clearance by QA person.
o OC person test the sample of raw material under LAF by different tests and fill
it in “Observation on sampling are and pack” and “Certificate of analysis”.
o Warehouse operators will paste the labels of “Approved label” and “Sampled label”.
o Next sent raw material for storing.
20
 3.Storing
o The raw material is stored at 3 different temperature zones –
o Ambient: Not more than 35 0C
o Controlled temperature room: 15 – 25 0C
o Cold roomx: 2 – 8 0C
4.Dispensing
Raw material is picked for dispensing according to “Material pick list for process
order” and dispensed according to BMR prepared by QA personnel.
o Selection of raw material is done according to “First expiry first dispense”.
o Raw material is dispensed from dispensing booth under LAF to the production area.

21
 PRODUCTION SECTION
• General Instructions and Precautions –
➢ Ensure area and equipment cleanliness before starting the manufacturing operations.
➢ Check and ensure that all manufacturing equipment and other required
accessories are clean ready for use.
➢ Wear gloves and nose mask during all manufacturing process.
➢ Counter check the weights of all ingredients before using in the batch.
➢ Get line clearance from QA for manufacturing.
➢ Air handling unit (AHU) system should be kept ON throughout the manufacturing
process.
➢ Temperature should be kept between 25 0C + 2 0C and relative humidity should be
kept between 50 + 10%.
➢ Ensure that QC approval purified water is being used for manufacturing purpose.
➢ Always transfer solution to the manufacturing vessels through 20 meshes.
➢ During the preparation of product, no other product processing should be done in the
same area.
➢ Whenever sifting through SS mesh is involved; check the mesh integrity before and
after use.
➢ All critical aspects during manufacturing like temperature, duration of mixing,
weight, etc. must be checked and recorded by the supervisor.
➢ Supervisor to ensure completion of all in-process records during various stages of
manufacturing operations till completion of the batch.
➢ Release from QA should be taken from all in-process tests mentioned in batch
manufacturing record.
➢ No over writing is allowed in batch manufacturing record. If initial data is wrong
entered, cancel the data by single stroke arrow and put initials. Record reasons
for change as footnote on the same page.
➢ All details whatever is necessary should be recorded in batch manufacturing record
(BMR).
➢ Send a test request to QC after manufacturing is completed.
➢ Check all polyethylene bags before and after material loading for black particles
and sealing.
➢ Check calibration of respective equipment/machine before use.

22
 TABLET MANUFACTURING SECTION
• Tablet Components and Additives
A. Active Ingredients: ornidazole IP, Folic acid, pantoprazole sodium, tranexemic
acid, azithromycin, cefixime, metformin, vitamin B6,etc.
B. Non-active Ingredients: six major excipient categories
a. Diluents: lactose, starch, mannitol, Sorbitol
b. Binders: Acacia, Gelatin, Tragacanth, starch.
c. Lubricants: stearic acid, magnesium stearate, calcium stearate. and talc
d. Disintegrants: Starches are the most common disintegrating agents
e. Colors: D&C and FD&C dyes and lakes, and
f. Flavors and Sweeteners: mannitol, lactose, sucrose, saccharin and dextrose

Unit Operations
There are three methods of preparing tablet granulations. Such as:
(a) Wet granulation,
(b) Dry granulation (also called "slugging"), and
(c) Direct compression.

WET GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Preparation of binder solution.
4. Mixing binder solution with powder mixture to form wet mass
.5. Coarse screening of wet mass using 6- to 12- mesh.
6. Drying moist granules.
7. Screening dry granules with lubricant and disintegrants.
8. Mixing screened granules with lubricant and disintegrants.
9. Tablet compression.

DRY GRANULATION
1. Milling of drugs and excipients.
2. Mixing of milled powders.
3. Compression into large, hard tablets called slugs.
4. Screening of slugs.
5. Mixing with lubricant and disintegrating agent.
6. Tablet compression.

DIRECT COMPRESSION
1. Milling of drugs and excipients.
2. Mixing of ingredients.
3. Tablet compression.

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EQUIPMENTS

1. SIFTER
An instrument used to sieve the ingredients of a tablet with a replaceable mess ware. In this technique,
particles of power mass are placed on a screen made of uniform aperture. The sifter is attached with a
vibrator that helps in sieving the materials through the meshwork. The mechanism of action is to
loosen the packing of the particle in contact with screen surface, permitting entrapped sub sieve
particles to the screen surface.qq

Fig 2. Sifter Fig 3. Planetary Mixer

2. Planetary Mixer :For wet granulation a planetary mixer is used. Solutions of the binding agent are
added to the mixed powders with stirring. The powder mass is wetted with the binding solution until
the mass has the consistency of damp snow. The planetary mixer can mix a material of 100kg. The
beater of the planetary mixer revolves 2-4 times for each revolution of the head, providing double
mixing action.
3. Mass Mixer:This is also mixing equipment used to mix dry as well is wet ingredients. The mixer has
blades that are alternately arranged and is allows uniform mixing. The mass mixer is emptied by
inverting it and scrapping off its ingredients. The planetary mixer can mix a material of 100kg.

4. Multi-mill ;This is a hammer mill that uses a high speed rotor to which a number of swinging hammers
are fixed. The unit is enclosed with chamber containing a grid or removable screen through which the
material can pass. The material is fed from the top and ground by impact of hammers or against the
plates around the periphery of the casing. The materials are enough pass through the screen that forms
the lower portion of the chamber. The fragments are swept downward against the screen where they
undergo additional hammering action until they are reduced to a size small enough to pass through the
openings and out. Oversize particles are hurled upwards into the chamber where they also undergo
further blows by the revolving hammers.

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5. Fluidized bed dryer
In a fluidized bed dryer, the fluidized air stream is introduced by a fan or blower mounted at the top of
the apparatus. The air is heated to the required temperature in an air heater and flows upwards through
the wet materials, which remains in a drying chamber fitted with a wire mesh supported at the bottom.
By this process, the material is suspended and agitated in a warm air stream while the granulation is
maintained in motion.

Fig 4. Fluidized Bed Dryer Fig 5. Tray Dryer

6. Tray dryer
It consists of a chamber, containing horizontal arrangements of trays on which granules are dried. The
drying process is accomplished by a gust of hot air driven by or blower through an electric heater and
heat exchange. In this method, the wet materials are placed over paper sheets and finally placed over
the trays and the drying operation is carried out. These dryers are mainly useful for materials that
contain alcoholic solutions and where slow drying for better granule characteristic is necessary.

7. Compressor
For increased production, Rotary machines offer a great advantage. A head carrying a number of sets
of punches and dies revolves continuously while the tablet granulation runs from the hopper, through
a feed frame and into the dies placed in a large, steel plate revolving under it. This method promotes a
uniform fill of the die and therefore an accurate weight for the tablet. Compression takes place as the
upper and the lower punches passes between a pair of rollers. This action produce a slow squeezing
effect on the material in the die cavity from the top and bottom and so gives a chance for the entrapped
air to escape. The punches and dies can be removed for inspection, cleaning and inserting different sets
to produce a great variety of shapes and sizes.

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TABLET PROCESS
➢ The basic unit of any tablet press is a set of tooling consisting of two punches and a die which is
called a station.
➢ The die determines the diameter or shape of the tablet; the punches, upper and lower, come
together in the die that contains the tablet formulation to form a tablet.
➢ There are two types of presses: single-punch and rotary punch.
➢ The single-punch press has a single station of one die and two punches, and is capable of producing
from 40 to 120 tablets per minute depending on the size of the tablet. It is largely used in the early
stages of tablet formulation development.
➢ The rotary press has a multiplicity of stations arranged on a rotating table in which the dies are fed
the formulation producing tablets at production rates of' from a few to many thousands per minute.
➢ There are numerous models of presses manufactured by a number of companies, ranging in size,
speed, and capacity.
Tablet presses consist of
1) Hoppers, usually one or two, for storing and feeding the formulation to be pressed
2) Feed frame(s) for distributing the formulation to the dies
3) Dies for controlling the size and shape of the tablet
4) Punches for compacting the formulation into tablets
5) Cams (on rotary presses) that act as tracks to guide the moving punches. All other parts of the
press are designed to control the operation of the above parts.

Fig 6. Rotary Tablet Press

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COATING

➢ Tablet coatings perform one or more of the following functions. They may: mask the taste of
unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate
incompatible ingredients, control the release of medicament in the gastrointestinal tract, and
provide an elegant or distinctive finish to the tablet.
➢ The materials used for coating may largely comprise sucrose (sugar coating), water soluble film
forming polymers (film coating) or substances which are soluble in the intestinal secretions but not
in those of the stomach (enteric coating).
➢ These types of coating can all be applied by the pan or fluid-bed processes; the compression coating
technique is suitable for sugar and enteric coatings, but not for film coating.
TYPES OF COATING
1) SUGAR COATING
2) FILM COATING
3) MODIFIED RELEASE COATING
1) SUGAR COATING: This traditional coating imparts a smooth, rounded, elegant appearance to the
tablet. Stephenson and Smith (1951) have given a detailed discussion on the composition of sugar
coatings.
➢ The sugarcoating process involves building up layers of coating material on the tablet cores as
they are tumbled in a revolving pan by repetitively applying a coating solution or suspension
and drying off the solvent.
➢ Before sugarcoating, the core is coated with a sealing coat of shellac, PVP*-stabilized types of
shellac, or other polymeric materials, such as cellulose acetate phthalate and polyvinyl acetate
phthalate.
➢ The next stage is to build up a subcoat that will provide a good bridge between the main coating
and the sealed core, as well as round off any sharp corners. This step is followed by smoothing
or grossing.
➢ The finishing stage is accomplished by again applying one or two layers of clear syrup. The
tablets are then left for several hours before being transferred to the polishing pan.
➢ The polish is a dilute wax solution (e.g., carnauba or beeswax in petroleum spirit) applied
sparingly until a high luster is produced.
2) FILM COATING: Film coating has increased in popularity for various reasons.
➢ The film process is simpler and, therefore, easier to automate. It is also faster than sugarcoating,
since weight gains of only 2 to 6% are involved, as opposed to more than 50% with
sugarcoating.
➢ Two major groups of film coating materials may be distinguished:
(a) Those that are non-enteric and, for the most part, cellulose derivatives, and
(b) Those that can provide an enteric effect and are commonly esters of phthalic acid.
➢ Films may contain a plasticizer that prevents the film from becoming brittle with consequent
risk of chipping.
➢ Until recently, alcohols, esters, chlorinated hydrocarbons, and ketones have been among the
most frequently used types of solvents. However, because of increasing regulatory pressures
against undesirable solvents, there has been a pronounced trend toward aqueous film coating.
➢ Modified-Release Coatings: A coating may be applied to a tablet to modify the release pattern
of the active ingredient.
➢ Two general categories, enteric coating and controlled-release coating, are distinguished.

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 ➢ The former are insoluble in the low pH environment of the stomach but dissolve readily in
the small intestine with its elevated pH.
➢ They are used to minimize irritation of the gastric mucosa by certain drugs and to protect
others that are degraded by gastric juices.

Fig 7. Tablet Coating Machine Fig 8. Automatic Coating Machine

PACKAGING AND LABELLING OF TABLETS

➢ Packaging and Labeling of tablets are done in Packaging and Labeling area.
➢ In this area concurrently three actions i.e. visual checking for contaminant or deformity, Labeling
and Packing are taking place.
➢ This room is fitted with air-conditioners and a temperature of about 27◦C is maintained.
➢ This area has an inspection table where deformity and contamination are checked against black
and white background.
➢ The minimum luminosity required in the inspection zone is 500lacs.
➢ The inspection table is fitted with stainless steel conveyors.
➢ The equipment is attached with a motor of 1 H.P. and a reduction gear box with adjustable
pulley.
➢ It is sometimes convenient to categorize packages by layer or functions –
1) Primary Packaging
2) Secondary Packaging
3) Tertiary Packaging

Primary Packaging – It is the material that first envelope the product and holds it. This usually is
the smallest unit of distribution or use and is the package which is in direct contact with the content.

Secondary Packaging – It is outside the primary packing and may be used to prevent pilferage or to
group primary packages together.

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Tertiary Packaging – These are used for bulk handling, warehouse storage and transport shipping.
The most common form of palletized unit load that packs tightly into containers.

Fig 9. Blister Packaging Machine

TYPES OF PACKAGING
1) BLISTER PACKING
2) STRIP PACKING
1) Blister Packing: This is useful for packaging of unit dose of pharmaceuticals. This packing mode
has been used extensively for several good reasons. It is a packaging configuration capable of
providing excellent environmental protection, coupled with an aesthetically pleasing and
efficacious appearance. It also provides user functionally in terms of convenience, child resistance
and now temperature resistance.
Blister packing consists of two principals components:-
1) A formed base web creating the cavity inside which the product fit.
2) The lidding foil for dispensing the product out of the pack.

2) Strip packing: The blister package is formed by heat softening a sheet of thermoplastic resin and
vacuum drawing the softened sheets of plastic into a contoured mould. After coming, the sheet is
released from the mould and proceeds to the filling station of the packaging machine. The semi-
rigid blister previously formed, is filled with the product and lidded with a heat sealable backing
material. The backing material can be either a push through or peelable type. For a push through
type of blister, the backing material is usually heat seal coated aluminum foil. The packaging of
the final product is done in paper cartons, manually, and is finally sealed using an automatic sealer.
The machine can seal cartons.

Fig 10. Blister Packaging Fig 11. Strip Packaging

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 CAPSULE MANUFACTURING SECTION
➢ Capsule is the most versatile of all dosage forms.
➢ Capsules are solid dosage forms in which one or more medicinal and inert ingredients are
enclosed in a small shell or container usually made of gelatin.
➢ The process of manufacture of capsules is known as Encapsulation.

Types of Capsules

1) Hard Gelatin Capsule

2) Soft Gelatin Capsule

➢ The hard capsule is also called “two piaece” as it consists of two pieces in the form of small
cylinders closed at one end, the shorter piece is called the “cap” which fits over the open end of
the longer piece, called the “body”.
➢ The soft gelatin capsule is also called as “one piece”. Capsules are available in many sizes to
provide dosing flexibility.
➢ Unpleasant drug tastes and odors can be masked by the tasteless gelatin shell.
➢ The administration of liquid and solid drugs enclosed in hard gelatin capsules is one of the most
frequently utilized dosage forms.
INDUSTRIAL FILLING OF HARD GELATIN CAPSULES

a) Removal of caps
b) Filling of the bodies
c) Replacement of caps
d) Ejection of filled capsules
➢ Capsules are delivered into the perforated capsule filling ring.
➢ The ring is rotated on a turntable, and a vacuum pulls the bodies into the lower half of the ring,
leaving the caps in the upper half of the ring.
➢ The top & bottom halves of the filling ring are separated manually, and the cap half of the ring is
set aside.
➢ The body half of the ring is then moved to another turntable where it is rotated mechanically
under a powder hopper.
➢ The hopper contains an auger which feeds the powder into the bodies.
➢ When the capsule bodies are filled, the cap and body rings are rejoined.
FILLING OF POWDER IN CAPSULE SHELL

Filling of powder is generally done by the different machines. The equipments used for filling of
powder in capsule shell types –
1) Hand Operated Capsule Filling Machine.
2) Semi Automatic Capsule Filling Machine.
3) Automatic Capsule Filling Machine.
1) HAND OPERATED CAPSULE FILLING MACHINE
The machine is designed for filling a wide variety of formulation suitable for all classes of
pharmaceutical industry. The machine is simple to operate with no variation. The machine is fully
made out of stainless steel 304 quality except harden and lubricant parts.

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 Fig 12. Hand Filling Capsule Machine

Features
➢ Low investment.
➢ Benefit ration simple to operate can be handled by UN skilled labor.
➢ All the loading plates are made of s.s.304 quality.
➢ Easily dismantle and reassembled even by unskilled labor.

Output
➢ 8000 Capsule per/hour from 300 holes machine.
➢ 4500 Capsule per/hour from 200 holes machine.
➢ 2000 Capsule per/hour from 100 holes machine.

Working
➢ It consist of a bed having 200-300 hole, a loading tray having 200-300 holes, a power tray, a pin
plate having 200-300 pins, a sealing plate having a rubber top, a lever, a cam handle.
➢ The empty capsules are filled in the loading tray and it is placed over the bed.
➢ The cam handle is operated to separate the capsule caps form their bodies.
➢ The power tray is placed in a proper position and filled with an accurate quantity of power with
scraper.
➢ The excess of the powder is collected on the platform of the powder tray.
➢ The pin plate is lowered and the filled powder is pressed by moving the pin downwards.
➢ After pressing the pin plate is raised and the remaining powder is filled into the bodies of the
capsules.
➢ The powered tray is removed after its complete filling.
➢ The cap holding tray is again placed in position.
➢ The plate with the rubber top is lowered and the lever is operated to lock the caps and bodies.
➢ The loading tray is then removed and filled capsules are collected.

2) SEMI AUTOMATIC CAPSULE FILLING MACHINE

The Semi-Automatic Capsule filling machine is a user-friendly machine available with advanced
features.

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Fig 13. Semi Automatic Filling Capsule Machine

Features
➢ Fill weight accuracy
➢ Formulation yields
➢ Maintenance free operation
➢ Operator ease and safety
Innovative features
➢ Automation of loading station - This eliminates the need for continuous operator attention as
solid state control circuitry provides automatic stoppage of the loading table after completion of
one cycle, each of 60 strokes.
➢ Automation of filling station - This, again, is a revolutionary feature that eliminates the need for
continuous operator attention. Motorized. swing-in and swing-back of the drug hopper after one
filling cycle results in reduced operator fatigue.
➢ Pneumatic closing station - This utilizes an electronic sensor which activates a pneumatic cylinder
to carry out the closing operation resulting in ease of operation and reduced operator fatigue.
➢ Vertical Closing - Vertical closing of filled capsules reduces reject rates and powder spillage. This
is critical for pellet filling. This is achieved by having two speeds for auger and nine speeds for
filling table operation.
➢ Modular type hopper provides easy and fast dismantling for cleaning. Change-over times
between batches are reduced.
➢ Filled capsule output capacity can be increased using our ring loading station. This allows
existing SA-9 installations to be upgraded for extra production.
Output

Capsule Size 00 0 1 to 5
No. of Holes/ Loading Ring 360 420 480
Output Per hour 21,600 25,200 48,960
With ring loading system 36,700 42,840 48,960
Output per hour

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3) AUTOMATIC CAPSULE FILLING MACHINE

➢ High Speed Automatic Capsule Filling machines are suitable for filling powders and pellets. These
are versatile machines with several outstanding features both functional and mechanical.
➢ The machines have capabilities to give an output of 40,000 capsules and 90,000 capsules per hour
with high filling accuracy and can accommodate capsule sizes.
➢ Capsule fillers are used to fill hard gelatin and non gelatin capsules with pre determined quantity
of liquids, powders, pellets, tablets.
➢ Most machines conform to the GMP guidelines with various safety features for maximum operator
protection.
➢ Capsules are normally fed into the machine, the filler then align, opens and accurately fills each
capsule and recloses.
➢ Fillers generate minimum dust with lowest level of product loss. Non-separated, double loaded
capsules and improperly inserted capsules are automatically rejected by machines to maintain the
consistency in the quality of product.
➢ Most capsule fillers are characterized with fast changeover time to accommodate a variety of
capsules in terms of shapes and size.
➢ High Quality Capsule Filling Machine requires minimal maintenance and easy to clean.
➢ Another important feature is the installation of speed adjusting equipment and automatic counters
ensuring the right quantity of capsules being filled and packed.

Fig 14. Automatic Filling Capsule Machine

Output
➢ Model - A 40 40,000 capsules per hour for powder & 30,000 capsules per hour for pellets.
➢ Model - A 90 90,000 capsules per hour for powder & 70,000 capsules per hour for pellets.

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LIQUID MANUFACTURING SECTION

➢ The Liquid Manufacturing Plants are ideal tools for the pharmaceutical industry for the
production of Oral Liquids.
➢ It is specially designed to take care of two critical factors which directly affect the quality of the
Liquids.
➢ Minimum manual handling of Liquid.
➢ Effective cleanness during manufacturing.
➢ It also provides the benefits of the effective manpower utilization.
LIQUID MANUFACTURING PLANT CONSIST THE FOLLOWING EQUIPMENTS AND
ACCESSORIES
➢ Sugar Syrup Vessel
➢ Manufacturing Vessel
➢ Storage Vessel
➢ Control Panel
➢ Product Piping
➢ Working Platform
SALIENT FEATURES OF THE LIQUID MANUFACTURING PLANT ARE AS FOLLOWS
➢ The Plant is designed to be operated only by one operator and one helper.
➢ All material transfers are done by vacuum or by transfer pumps.
➢ All the vessels are CGMP (paint free construction)
➢ The gaskets used are of silicon (food grade).
➢ All contact parts are of S.S. 304 quality material (SS316 provided on demand) & finished to class
4B (Mirror) finish and are crevice free.
➢ The entry of stirrer & high speed emulsifier are from top. In-line Emulsifier (as per customer
choice) provided on demand. (Optional)
➢ All vessels are suitable for internal pressure of 1 Kg. / Sq. cm. and hence can be sterilized.
➢ All pipes, pipe fittings and valves are of SS304 / SS316 (as per customer requirement) seamless
quality, internally electro polished, with triclover ended joints.
➢ The entire plant is equipped with CIP & SIP connections, so that customer can use this facility, if
have CIP & SIP equipment.
➢ All values of temperature & time of the plant are indicated digitally on the control panel. Ampere
indicates on Ampere meters.
➢ A micro processor based automatic operating plant can be designed as per requirement.
(Optional)
➢ All the inlet & outlet connections are provided with tri clover joints, which are very easy for
cleaning & replacement.
PROCESS CONTROL
➢ This system consists of a closed circuit manufacturing facility from feeding of Sugar / Water
Phase to loading the Volumetric Liquid Filling Machine.
➢ The Sugar and Water, are load with vacuum system or by mechanical system or manually.
➢ The Sugar Syrup Vessel is supplied with high speed stirrer & electrical heating (In small model) /
steam heating facility (In bigger size model).
➢ The sugar syrup is prepared at required temperature & is transferred to Manufacturing Vessel by
vacuum or by transfer pump.
➢ The product during emulsion formation is re-circulated through In-Line Homogenizer or Liquid
Transfer Pump.

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➢ The Pump also discharges the product in the Storage Vessel.

➢ The Storage Vessel is then taken to the filling area (if it is small capacity) and is connected to again
Liquid Transfer Pump or Storage Vessel remains fixed (In bigger size) & pump transfer the Liquids
in the float tank which is connected with filling machine.
➢ The entire Plant can be operated by centralized operating panel by one operator.
➢ The plant is equipped with an electrical control panel with digital temperature indicators /
controllers and digital timers.
➢ Minimum two batches per shift of the same product can be assured in this plant.
➢ This plant conforms to CGMP standards (Paint Free Construction).

LIQUID FILLING MACHINES

1. AUTOMATIC LIQUID FILLING MACHINE

➢ Automatic anti-pressure liquid filling machine adopting the ways of vacuum filling to fill all
several of overflow products with high accuracy and versatility ensure filling without leakage, no
foam and damaged bottle is no incorporated.
➢ Automatic speed variation adjustment makes operation more convenient and reliable.

2. SEMI AUTOMATIC VOLUMETRIC LIQUID FILLING MACHINES

➢ Semi automatic volumetric liquid filling machines is two head, table top, fully GMP model used
to fill variety of liquids.
➢ Semi automatic volumetric liquid filling machine can be used for different types of glass, Plastic,
Metal containers.
➢ Semi automatic volumetric liquid filling machine works on volumetric principle and is fitted with
two syringes on the sides.
➢ The motor and gear box are covered in a SS cabinet. The desired volume can be adjusted by
increasing or decreasing the eccentricity. Bottles are kept bellow the nozzles manually.
➢ Output bottles per minute depending on type of liquid and fill size with the help of three speed
pulley arrangement.

Fig 15. Semi Automatic Liquid Filling Machine

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3. HIGH SPEED AUTOMATIC BOTTLE FILLING & CAP SEALING MACHINE

➢ High Speed Automatic Bottle Filling & Cap Sealing Machine can be adapted to a wide variety of
bottle shapes and liquids properties and can be used in various Industries such as Pharmaceuticals,
Cosmetics, Agrochemicals, Chemicals, Etc.
➢ This unit is fully automatic unit and can be coupled with a un-scrambler to feed the bottles to the
in feed conveyor of this machine.
➢ This machine achieves the complete operation of filling the bottles automatically and accurately.
➢ The complete filling sequence for different fill sizes is programmable for the speed with the
movement of a switch, achieves complete synchronization automatically.
➢ The fill range of this machine can be adjusted from 30 ml to 1000 ml with the change of syringes.
Higher fill volumes can be achieved by taking multiple strokes of the syringes.
➢ The number of filling head can be either 4, 6 or 8 depending upon the output required from this
unit. Usually we get an output of 80-160 bottles per minute. This also depends on the fill volume
of the bottle & number of filling heads.
➢ The filling machine is further attached to a manual capping machine which is to be operated by an
operator who would carry the bottle from the filling section, place the cap on the bottles neck and
seal it with the help of the rotating head.
➢ This operation is also done automatically by connecting an online automatic bottle capping
machine.
➢ The sealed bottles are then carried towards the inspection table by means of a slat conveyor, where
the bottles are visually inspected by the operator for any particles in the filled liquid.
➢ This process is simultaneously carried out in a white & black background and thereafter the bottles
are further transferred for next operation, i.e. labeling and packaging.
4. ROTARY BOTTLE WASHING MACHINE
➢ The washing machines are ideal for washing injection bottles, infusion bottles, ampoules,
cartridges and syringes. It is designed to clean various types of glass bottles or plastic, metal
containers either round or odd shaped, subjecting it to a series of distinct processing operations.
➢ On washing machines, containers are fed individually and considerately through several stations:
flooding, washing (with or without ultrasonic support), blowing out and transfer to a downstream
sterilizing tunnel.
➢ The bottles are loaded on rotating platform where bottles are getting cleaned in a series of
operations. The bottles are placed in an inverted position in cups.
➢ The external cleaning of the bottles is done by spraying showers. Solenoid valves are provided to
enable the regulation of timings and sequence of various washing media to suit specific
requirement.
➢ Washing Sequences and positioning of washing stations can be interchanged as required for liquid
oral & injectable.
➢ Washing Machines are available with S.S. body, S.S stand and S.S. control panel as per the GMP
requirement.
➢ A vary speed drive pulley is provided for different output between 64 to 100 bottles per minute.
➢ Simple change over to different container sizes.
➢ Rotary Bottle washing machines are used for Bottle washing for pharmaceutical, food, cosmetic,
chemical etc.
➢ Bottle washing machines are suitable for different type and shape of bottle such as glass, plastic
and aluminum bottles.

5. ROPP CAP SEALING MACHINE

➢ ROPP CAP Sealing machine is ideal for continuous heavy duty operations.
➢ The machines are suitable to apply ROPP cap on round as well as flat, rectangular shaped bottles.
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 lOMoAR cPSD| 18112524

➢ The capping machines are ideal for application in pharmaceutical, liquor, food, agrochemical, edible
oil, lube oil and other packaging applications.
➢ Cap Sealing machines are equipped with hopper feeder for standard height of caps to feed the cap on
to the bottle neck for online capping.
➢ This machine is fully automatic and is complete with Rotary Cap Feeding Hopper and built-in Slat
Conveyor.
➢ The bottles are fed in a vertical position. As soon as the bottle strikes the end-chute, a cap from the
shoe of the automatic cap feeder is placed on the bottle and passed to the sealing head for sealing.
➢ The sealing head seals the bottles and later conveys them to the slat conveyor for onward transfer to
inspection machine.
➢ The guide rails and stainless steel slat conveyor can be adjusted to accommodate various shapes and
diameter of bottles.
➢ A limit switch with actuator mechanism is provided for sensing bottle-topple.
➢ The machine is provided with variable speed mechanism for speed adjustment.
6. SINGLE HEAD AUGER TYPE DRY SYRUP POWDER FILLING MACHINE
➢ Automatic Single Head Auger Type Dry Syrup Powder Filling Machine is a compact model used for
filling of Dry Syrup Powder into bottle.
➢ The incoming dry bottle (sterilized and siliconized) are fed through the infeed Turn Table with suitably
guided on the moving delrin flat conveyor belt at the required speed for feeding.
➢ Filling head is mounted on machine top plate.
➢ When bottle reaches to the filling station, it will be hold by the pneumatic bottle holder.
➢ Immediately it will be sensed by the bottle sensor as soon as it gets the signals from sensor magnetic
clutch starts to rotate which is mounted on auger shaft.
➢ It will fill the desire amount of powder to the bottle through auger, where rotation time is previously
saved in PLC control.
➢ After filling of bottle pneumatic piston goes back and releases the bottle to move on conveyor.
➢ The main advantage of this machine is Pneumatic bottle holding system is directly connected with
Auger rotation, so till bottle get filled with powder as per set value, pneumatic system will not going
to release the bottle.

7. DRY SYRUP POWDER FILLING MACHINE

➢ Automatic Monoblock Dry Syrup Powder Filling with Eight Head ROPP Cap Sealing Machine is a
Compact machine used for filling and sealing of Dry Syrup in bottles.
➢ The incoming dry container (sterilized and siliconised) are fed through the infeed Turn Table with
suitably guided on the moving delrin flat conveyor belt at the required speed for feeding to the feed
worm for correct spacing be two bottles and get enter into the infeed starwheel, which will be
transferred below funnel, 16 nos. of funnel is mounted on round plate and powder filling head is

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mounted from centre pipe, which gives the flexibility to adjust power of wheel as per requirement and
consumes less space on machine.
➢ Machine will be having a lifter assembly on base of bottom plate, when bottle come below funnel,
bottom platform will lift the bottle and insert the bottle inside funnel.
➢ The sterilized powder is stored in to powder hopper is agitated by pair of mechanical agitators for
maintaining consistency and uniform bulk density, powder wheel rotates at the pre determined speed
below the powder hopper practically no clearance.
➢ Powder wheel consist of Piston in each port and behind the powder wheel vacuum plate is provided
there is no clearance between powder wheel and vacuum plate due to back spring pressure.
➢ Volume of powder is sucked in to the port of powder wheel during vacuum according to the
piston length different fill size can be achieved.
➢ The excess powder is doctored off by a doctor blade, now doctor blades can be add from outside
also without removing powder hopper.
➢ When powder wheel indexes further and remain in the port due to the vacuum till it reaches just
vertical position.
➢ The time dose of Compressed air, sterilized low pressure Nitrogen Gas sequentially flushes out
powder from the port of powder wheel in to the funnel.
➢ Funnel will be equipped with square rod to break the solid slug of powder and powder will start
to fill inside bottle, which is moving with funnel.
➢ In this model Bottle is getting around 5 to 6 second filling time.
➢ Bottles further move with funnel and reaches to exit star wheel, which is infeed star wheel for eight
head ROPP cap sealing machine, while rotating star wheel bottle picks up the cap from exit end of
chute, ROPP caps kept in orientation unit, automatically orient caps in right direction before
entering into delivery chute.
➢ And Bottle is entering below the sealing head, consist of four rollers. Two rollers properly Skirts,
Spins and Seals the cap and simultaneously another two roller performs perfect threading
according to bottle neck diameter.
➢ After sealing operation, sealing head moves upward with cam and bottle enters into exit star wheel.
Move further on conveyor belt for next operation.

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OINTMENT MANUFACTURING SECTION

➢ Ointment Section required to handle various formulations for e.g. transdermal drug delivery system
in the form of gel and other external preparations.
➢ It is provided with fully automatic lami tube filling line inbuilt with tube cleaning, filling, sealing
and embossing stations integrated with online cartonator, online batch coding and check weighing
system.
OINTMENT MANUFACTURING PLANT
➢ Ointment Manufacturing Plants are ideal for the pharmaceutical and cosmetic industries for the
production of ointment, creams, tooth paste, lotions and other emulsions and homogenizations.
➢ To ease cleaning, efficiency of agitators, ease of maintenance
➢ The combined action of horizontal blade and specially designed anchor ensures most efficient
mixing with shearing action of homogenizer, important when working with viscous products.
➢ Ointment plant comprises components such as manufacturing vessel and agitators with flush
bottom valve, wax/water phase vessel with side mounted fast speed stirrer, flush bottom valve and
conical filter, manufacturing vessel with double speed anchor and fast speed emulsifier fitted with
mechanical seal, lifting pneumatically for manufacturing vessel, spray ball on top cover for
cleaning main vessel, monitoring of the product temperature with digital indicator on panel,
electric control panel board with all necessary controls.
➢ Ointment Manufacturing Plant is very useful for creams, lotions, gels, shampoos, tooth pastes and
such preparations.
PROCESS CONTROL
➢ All waxes and oils are dissolved in the wax phase vessel separately
➢ All aqueous phase materials are added in the water phase vessel and processed separately.
➢ Both phase vessels are jacketed and are provided with motor driven propeller type of agitators
which facilitate thorough mixing.
➢ Once the phases are ready, they are transferred to the main Ointment manufacturing vessel by
opening respective valves.
➢ This transfer takes place through filters and pipelines due to the vacuum created within the main
vessel with the aid of a pump.
➢ The Ointment Manufacturing vessel is provided with anchor type of stirrer along with Teflon
scrapper at the ends, the agitator is driven by dual speed motor.
➢ A built-in high speed emulsifier ensures proper emulsification of the ointment, The MIMIC
feature in the control panel controls the time of emulsification with the aid of timers.
➢ The finished product is transferred to storage vessels by means of the bump pump.
➢ Transfer from storage vessel to the filling hoppers is achieved by means of reciprocating
metering pumps at the required rate.
➢ Special scrappers are provided for transfer of the complete product and to avoid wastage.
MACHINES USED IN OINTMENT
1. PLANETARY MIXER
➢ Planetary Mixer is used in various applications such as Ointments, Pharmaceutical Creams,
Cosmetic Creams, Ceramics, Ink Pastes, Color Pigments, Rubber, Compounds etc.
➢ Planetary Mixer is useful for thorough mixing of ointments, creams, lotions, toothpastes etc. in
sterile or non-sterile conditions.Intimate and homogeneous mixing of products is employed by
planetary motion of beaters and centrally located homogenizer.

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➢ Product container provided with jacket to heat and cool for circulation of steam / cold water. Mixer
is also designed to operate under vacuum to remove air entrapment in product during mixing.
➢ High speed dispenser suitable for homogenizing the product with independent drive at the center
of top dish
➢ Product bowl mounted on castor wheels for easy portability, washing & transporting mixed
materials.
➢ Jacketted bowls available for heating or cooling of products during mixing.
➢ Provision to mix materials under vacuum for de-aeration purpose.
➢ Double beaters open type to cover full cross section of products in bowl.
➢ For ointments / paste / cream / lotions etc. high speed emulsifier provided for homogeneous
mixing and to produce lustrous product.
➢ Motorized drive assembly for lifting and lowering.
➢ Needs comparatively smaller area for installation.
➢ Electrical control panel with back up fuses and indicator lamps for easy process control.
2. TUBE FILLING MACHINE
➢ Automatic Tube Filling Machines fill ointment/cream in cylindrical aluminum collapsible/ lami/
coextruded plastic tubes and close it absolutely safely and symmetrically.
➢ No tube - No fill device which makes sure that filling does not take place if tube is not present at
the filling station.
➢ At the orientation station, when the tube is lifted, its presence is checked by a sensor and this signal
is relayed to the filling station. Hence if a tube is not there, the dosing action does not take place
and hence there is no fill.
➢ If the tube is not ejected out by the ejector, the machine stops in order to avoid damages.
➢ In case of any jamming on the indexing system, to avoid breakages, the load is sensed by the
variable drive through the PLC & the machine stops automatically.
➢ Blow off device and tail cutting arrangements to avoid the paste / cream touching the sealing
portion of the tube.
➢ Over load clutch to protect the indexer and all the related shafts rods etc.
➢ Solid state no tubes no fill device mechanism.
➢ Tube holders are of spring loaded type to take care of any tube diameter variation.
➢ Over load clutch to protect the indexer and all the related shafts rods etc.
➢ Audiovisual Alarm Annunciation System for any abnormal conditions of the machine.
➢ Comprehensive control panel with all protection features.
Tube Filling Process
➢ The empty tubes are first loaded in the cassette, which then travels through the guides to be held
in the feeder by vacuum.
➢ The tube is then fed into the tube holder by the feeder.
➢ The tube holders are fitted on the circular turret which intermittently takes the tube to all the
stations.
➢ The tube then passes through the centering station which presses the tube from top and lodges it
into the tube holder.
➢ It then travels to the orientation station for positioning the ‘I’ mark. Here the tube is lifted and
revolved. The moment the ‘I’ mark comes in front of the scanner, the tube stops revolving and
comes down.

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➢ It is then carried to the filling station where the dosing action of the piston in the cylinder forces out
the required volume of material through the hose pipe onto the suck back device and then from the
nozzle into the tube.
➢ The tube then travels through the individual pressing, crimping and coding stations after which it is
ejected out at the ejecting station.
➢ In case of lami/plastic tubes, after the filling station, the tube travels to the hot air blowing station
where hot air is blown onto the inside of the end of the tube by a nozzle having holes on its
periphery.
➢ The tube then goes to the sealing station where the tube is pressed and sealed. It then travels to the
dual coding & trimming station where the tube is first coded with metal stereos on the seal and the
irregular shape at the tube end is trimmed by a set of blades.
➢ It is then ejected out at the next station.

Fig 16. Tube Filling Machine

Fig 17. Tube Labeling Machine

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QUALITY CONTROL AND QUALITY ASSURANCE SECTION

Quality control is the part of GMP concerned with sampling, specification and testing and with
organization; documentation and release procedures which ensure that necessary and relevant tests are
carried out and that materials are not released for sale or supply, until their quality has been judged
satisfactory.

Quality Control (QC) laboratory ensures that the products are pure, safe and effective and are
released only after thorough analysis as per stringent specifications, methods and procedures
developed according to international guidelines viz. EU cGMP, MHRA, WHO, TGA, etc.

One of the most important elements in QC laboratory program is the quality and assurance of
the standard which are used. The standard can be broadly defined into two categories –
➢ Reference standard or primary standard
➢ Working standard or secondary standard
The working standard are those obtained from reliable source and whose purity and strength have
been optimized through test, generally compared with the reference standard. The quality control
section performs different control measure and test procedures to verify the product and material
quality. The tests are performed by the QC personnel and the results are matched with a reference
standard.

Different types of test are performed for different material. The types of test performed for each
material are as follows –
1. Size and Shape test
2. Color test
3. Hardness test
4. Friability test
5. Weight Variation test
6. Content uniformity test
7. Disintegration test
8. Dissolution test
9. HPLC
10. IR Spectroscopy
11. UV Spectrophotometer
1. Size and Shape – Thickness is + 5% of standard value control to facilitate packaging. Shaped
tablet requires slotted punches because of the non-uniformity force during compression.
2. Organoleptic Property – Color of product must be uniform. Non-uniformity of color on the
tablet is called Mottling.
3. Hardness
➢ Tablet requires a certain amount of strength or hardness and resistance to friability to withstand
mechanical shakes of handling in manufacture, packaging and shipping.
➢ Hardness generally measures the tablet crushing strength. The strength of a tablet was determined
by following ways;
(a) By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there
is a sharp snap, the tablet is an acceptable strength.

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(b) Tablet hardness can be defined as the force required breaking a tablet in a diametric
compression. In this test the tablet is placed between two anvils, force is applied to the anvils,
and the crushing strength that just causes the tablet to break is recorded.
➢ Generally used Hardness testers are:
a) Monsanto Tester
b) Strong-Cobb Tester
c) Pfizer Tester
d) Erweka Tester
e) Schleuniger Tester
➢ Hardness for compressed tablet is 5 to 8 kg.

Fig 18. Monsanto Tester Fig 19. Pfizer Tester

4. Friability
➢ Friability of a tablet can determine in laboratory by Roche friabilator.
➢ This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets through a Distance
of six inches in the friabilator, which is then operate for 100 revolutions.
➢ The tablets are reweighed. Compress tablet that lose less than 0.5 to 1.0 % of the Tablet weigh
are consider acceptable.

Fig 20. Roche Friabilator

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5. Weight Variation test (U.S.P.)

➢ Take 20 tablets and weighed individually.
➢ Calculate average weight and compare the individual tablet weight to the average.
➢ The tablet pass the U.S.P. test if no more that 2 tablets are outside the percentage limit and if no
tablet differs by more than 2 times the percentage limit.
6. Content Uniformity Test
➢ Randomly select 30 tablets. 10 of these assayed individually.
➢ The Tablet pass the test if 9 of the 10 tablets must contain not less than 85% and not more than
115% of the labeled drug content and the 10th tablet may not contain less than 75% and more than
125% of the labeled content.
➢ If these conditions are not met, remaining 20 tablets assayed individually and none may fall outside
of the 85 to 115% range.
7. Disintegration Test (U.S.P.)
➢ The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top and 10mesh
screens at the bottom end.
➢ To test for disintegration time, one tablet is placed in each tube and the basket rack is positioned in
a 1-L beaker of water, simulated gastric fluid or simulated intestinal fluid at 37 ± 2 0C such that
the tablet remain 2.5 cm below the surface of liquid on their upward movement and not closer than
2.5 cm from the bottom of the beaker in their downward movement.
➢ Move the basket containing the tablets up and down through a distance of 5-6 cm at a frequency
of 28 to 32 cycles per minute.
➢ Floating of the tablets can be prevented by placing perforated plastic discs on each tablet.
➢ According to the test the tablet must disintegrate and all particles must pass through the 10 mesh
screen in the time specified. If any residue remains, it must have a soft mass.
➢ Disintegration time: Uncoated tablet: 5-30 minutes
➢ Coated tablet: 1-2 hours

Fig 21. Disintegration Test Apparatus Fig 22. Dissolution Test Apparatus

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8. Dissolution Test (U.S.P.)

➢ A single tablet is placed in a small wire mesh basket attached to the bottom of the shaft
connected to a variable speed motor.
➢ The basket is immersed in a dissolution medium (as specified in monograph) contained in a 100
ml flask.
➢ The flask is cylindrical with a hemispherical bottom.
➢ The flask is maintained at 37±0.5 0C by a constant temperature bath.
➢ The motor is adjusted to turn at the specified speed and sample of the fluid are withdrawn at
intervals to determine the amount of drug in solutions.
9. HPLC
➢ Most widely used separation technique
➢ Broad applicability – organic & inorganic
➢ Can be very sensitive, accurate & precise
➢ Suitable for separation of nonvolatile species
Chromatography can be described as a mass transfer process involving adsorption using a non-
polar stationary phase and a mobile polar phase titrating through the column. The active component of
the column, the sorbent or the stationary phase, is typically a granular material made of solid particles
(e.g. silica, polymers, etc.), 2-50 μm in size. High performance liquid chromatography (HPLC) is a
chromatographic technique used to separate a mixture of compounds in analytical chemistry and
biochemistry with the purpose of identifying, quantifying or purifying the individual components of
the mixture. Before the invention of HPLC, chemists had column chromatography at their disposal,
and column chromatography was time consuming. To speed up a classic column chromatography,
chemists would have to use a short column for separation, however this lead to poor separation of
molecular components held within solution. The basic setup of a classic column chromatography
would include the column that varied in I.D. from 10 to 50nm and column lengths of 50-500cm. The
column was then packed with the stationary phase ranging in particle size from 150 to 200 μm thick.
Chemists realized that with the development of pressurized systems, reducing the particle size would
increase the efficiency. It was not until the late 60’s that chemists and industrial engineering process
acquired adequate technology and manufacturing techniques to develop a smaller grained stationary
phase that would be cohesive with a pressurized system.

Fig 23. HPLC

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10. FT-Infrared (IR) Spectroscopy

➢ It uses a beam of infrared light to analyze the structure of organic compounds. Whereas NMR
analyzes the atoms present, IR instead analyzes the bonds present. NMR produces a set of sharp
signals where every atom’s signal may be discerned, but IR only produces broad absorptions which
may frequently overlap. You are unlikely to be able to completely deduce a structure using only
IR. Nevertheless, IR provides a valuable tool for probing the structure of organic molecules.
➢ The infrared portion of the electromagnetic spectrum is divided into three regions; the near-mid-
and far-infrared, named for their relation to the visible spectrum. The far-infrared, approximately
400-10cm-1(1000–30μm), lying adjacent to the microwave region, has low energy and may be
used for rotational spectroscopy. The mid-infrared, approximately 4000-400cm-1(30–1.4μm) may
be used to study the fundamental vibrations and associated rotational vibrational structure. The
higher energy near-IR, approximately 14000-4000cm-1(1.4–0.8μm) can excite over tone or
harmonic vibrations. The names and classifications of these sub-regions are merely conventions.
They are neither strict division nor based on exact molecular or electromagnetic properties.

Fig 24. FT-IR

11. UV Spectrophotometer
➢ In Pharmaceutical Industry, A spectrophotometer is commonly used for the measurement of
transmittance or reflectance of solutions, transparent or opaque solids, such as polished glass.
➢ However they can also be designed to measure the diffusion any of the listed light ranges that
usually cover around 200nm-2500nm using different controls and calibrations. Within these ranges
of light, calibrations are needed on the machine using standards that very in type depending on the
wavelength of the photometric determination.
➢ The basic function of a spectrometer is to take in light, break it into its spectral components, digitize
the signal as a function of wavelength, and read it out and display it through a computer.
➢ The first step in this process is to direct light through a fiber optic cable into the spectrometer
through a narrow aperture known as an entrance slit. The slit vignettes the light assist enters the
spectrometer. In most spectrometers, the divergent light is then collimated by a concave mirror and
directed onto a grating.

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➢ The grating then disperses the spectral components of the light at slightly varying angles, which is
then focused by a second concave mirror and imaged onto the detector. Alternatively, a concave
holographic grating can be used to perform all three of these functions simultaneously. This alternative has
various advantages and disadvantages, which will be discussed in more detail later on.
➢ Once the light is imaged onto the detectors the photons are then converted into electrons which are
digitized and read out through a USB (or serial port) to a computer.
➢ The software then interpolates the signal based on the number of pixels in the detector and the
linear dispersion of the diffraction grating to create a calibration that enables the data to be plotted
as a function of wavelength over the given spectral range.

Fig 25. UV Spectrophotometer

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MICROBIOLOGY SECTION
➢ The Guide to the Inspection of Pharmaceutical Quality Control Laboratories provided very limited
guidance on the matter of inspection of microbiological laboratories.
➢ While that guide addresses many of the issues associated with the chemical aspect of laboratory
analysis of pharmaceuticals, this document will serve as a guide to the inspection of the
microbiology analytical process.
➢ As with any laboratory inspection, it is recommended that an analyst (microbiologist) who is
familiar with the tests being inspected participate in these inspections.
Following processes are carried out in microbiology laboratory:
➢ Sterility Testing
➢ Antimicrobial Efficacy Testing (AFT)
➢ Microbial Limits Testing
➢ Bioburden Determination
➢ Endotoxin (LAL) Testing
➢ Environmental Monitoring and Identification
➢ Water Analysis
Microbiological Testing of Non-sterile Products
➢ For a variety of reasons, we have seen a number of problems associated with microbiological
contamination of topical drug products, nasal solutions and inhalation products.
➢ The USP Microbiological Attributes Chapter provides little specific guidance other than “The
significance of microorganisms in non-sterile pharmaceutical products should be evaluated in
terms of the use of the product, the nature of the product and the potential hazard to the user.”
➢ The USP recommends that certain categories be routinely tested for total counts and specified
indicator microbial contaminants. For example, natural plants, animals and some mineral products
for Salmonella, oral liquids for E.coli, topical for P.aeruginosa and S. aureus and articles intended
for rectal, urethral or vaginal administration for yeasts and molds. A number of specific
monographs also nclude definitive microbial limits.
➢ Microbiological testing may include an identification of colonies found during the Total Aerobic
Plate Count test. Again, the identification should not merely be limited to the USP indicator
organisms.
➢ The importance of identifying all isolates from either or both Total Plate Count testing and
enrichment testing will depend upon the product and its intended use.
➢ Obviously, if an oral solid dosage form such as a tablet is tested, it may be acceptable to identify
isolates when testing shows high levels. However, for other products such as topical, inhalants or
nasal solutions where there is a major concern for microbiological contamination, isolates from
plate counts as well as enrichment testing should be identified.
Sterility Testing
➢ One of the most important aspects of the inspection of a sterility analytical program is to review
records of initial positive sterility test results. Request list of test failures to facilitate review of
production and control records and investigation reports.
➢ Particularly for the high risk aseptically filled product, initial positive sterility test results and
investigations should be reviewed.

➢ It is difficult for the manufacturer to justify the release of a product filled aseptically that fails an
initial sterility test without identifying specific problems associated with the controls used for the
sterility test.
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➢ Examine the use of negative controls. They are particularly important to a high quality sterility
test. Good practice for such testing includes the use of known terminally sterilized or irradiated
samples as a system control.
➢ Alternatively, vials or ampoules filled during media fills have also been used. Be especially
concerned about the case where a manufacturer of aseptically filled products has never found an
initial positive sterility test. While such situations may occur, they are rare.
➢ In one case, a manufacturer’s records showed that they had never found positive results; their
records had been falsified. Also, the absence of initial positives may indicate that the test has not
been validated to demonstrate that there is no carryover of inhibition from the product or
preservative.
Validation
➢ Confirmation through the provision of objective evidence that the requirements for a specific
intended use or application have been fulfilled.
➢ Validation is one of the important steps in achieving and maintaining the quality of the final
product. If each step of production process is validated we can assure that the final product is of
the best quality.
➢ Validation of the individual steps of the processes is called the process validation. Different dosage
forms have different validation protocols.
Process Validation – It is establishing documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product meeting its pre-determined
specifications and quality characteristics.

Types of Process Validation

➢ Prospective validation
➢ Retrospective validation
➢ Concurrent validation
➢ Revalidation

Instruments and Devices used in microbiology laboratory

➢ Analytical balance
➢ Incubator
➢ Refrigerator
➢ Laminar Air Flow/ Biosafety cabinet
➢ Magnetic stirrer
➢ Deep freezer
➢ Light microscope
➢ pH meter
➢ Autoclave
➢ Hot air oven

➢ Analytical Balance – They are used in precise weighting of small amounts of samples and
chemicals used for preparing media and stock solutions.
➢ Incubator – In the microbiology laboratories it is among the leading devices which are work at
different temperatures according to the purpose and the work load of the laboratory. It is used in
cultivating, multiplying and in the characterization tests of microorganisms. This device provides
the heat necessary for the growth of microorganisms.
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Fig 26. Incubator

➢ Biosafety Cabinet – It is used in microbial inoculation and isolation studies as well as sterile
storage of materials. In addition, it is utilized for protection of user, samples and the environment
from hazardous contamination.
➢ Refrigerator – The device is used for the storage of the stock solutions, chemicals, kits and nutrient
media that should be maintained at certain temperatures.
➢ Magnetic Stirrer – It is a device which provides mixing and keeping the chemical solutions and
mixtures at a certain time and temperature by the help of a magnetic bar. Vortex agitates the
solutions in the tube, flask and so on in certain speed and duration.
➢ Deep Freezer – It is used to store stock cultures in microbiology. It is a device used to store
materials which should be kept at low temperatures.
➢ Autoclave – The main purpose of this device is to sterilize materials and media under pressure and
steam.

Fig 27. Autoclave

➢ Inverted Phase Contrast Light Microscope – By the help of different refractive properties of the light,
Phase Contrast Light Microscope provides visibility to sub-cellular structures of microorganisms that are
examined in a liquid medium without any staining. Fluorescence attachment is used to display objects stained
with special fluorescent dyes (DAPI, FITC, Texas Red, etc.) and that cannot be displayed with normal light
microscopy techniques. It operates according to the principle of reflective light.

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Fig 28. Light Microscope Fig 29. pH Meter

➢ pH Meter- It is used to determine the pH of the media prior to experiments and to monitor pH value during
experiments. The device is used especially in the preparation of stock solutions and the culture media used for
the growth of microorganisms.

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FINISHED GOODS SECTION

➢ Finished goods are goods that have completed the manufacturing process but have not yet been
sold or distributed to the end user.
➢ A good purchased as a “Raw material” goes into the manufacture of a product.
➢ A good only partially completed during the manufacturing process is called “work in process”.
➢ When the good is completed as to manufacturing but not yet sold or distributed to the end-user, it
is called a “finished good”. This is the last stage for the processing of goods.
➢ The goods are ready to be consumed or distributed.
➢ There is no processing required in term of the goods after this stage by the seller.

Procedure
➢ Receive the finished good transfer ticket from production duly authorized by production
supervisor and checked by QA.
➢ Following are to be made in finished good transfer ticket after received from production –
o Name of product
o Batch No.
o Manufacturing Date
o Expiry Date
o Quantity
o Date of transfer tickets
➢ Verify the received goods against transfer with above details.
➢ Ensure the all details are complete as per our requirements.
➢ In case of any observation, intimate to production department and get it corrected.
➢ Enter the physically verified quantity in SAP system.

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CONCLUSION

Industrial training is very much essential for Pharmacy Students. It is also a great opportunity
to acquire practical knowledge. During training period, in the industry I acquired lots of experiences
in Pharmaceutical Production and Production management. This will help me to clarify my theory
knowledge. I hope and pray that it will help me much in future profession.

During our training period, we had seen the various instruments and apparatus in the industry.
The highly sophisticated instruments that work precisely must be operated with intense care for
optimum use. We could acquire a lot of information regarding the latest instruments and their working
procedures.

It was taught that, the CGMP guidelines are to be strictly followed in the industries in each
and every section. And the similar guideline was seen followed in west coast pharmaceutical works
limited. It helped us to acquire knowledge on punctuality, regularity and working environments in
industries.

The friendly working environment west coast pharmaceutical works limited. will remain in
our mind in near future. Hence, we can say that our goal of attending the industrial tour is fulfilled.
We acknowledge the great help “west coast pharmaceutical works limited”.

...SAHIL PRAJAPATI A.

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