(Priya) Internship Report
(Priya) Internship Report
As a part of Requirementof
B. Pharm. Program (PCI)
By
DYPatildeemedtobeUniversitySchoolofPharmacyNavi
Mumbai
2022
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
DECLARATION
I declare that I have done the industrial training and is submitted the report for partial
fulfillment of the requirements of the degree bachelor of pharmacy in D. Y. Patil
University School of Pharmacy. I wish to state thatthe work embodiedin this report
reflects the work done / learning in the organization by me. If the reportsoundsto be
fictitious, manipulativeor plagiarized,the institute has a rightnot
toacceptthereportandrejectthesame. The duration of training is from ____
2022TO 2022.
_____
NameandSignatureofTrainee
Forwardedthrough,
Sr. Preceptor Nameof Nameof ContactNo.& Signature
No. Organization Person emailID withDate
1 On-site
2 Faculty
Principal’sSignaturewithDate:
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
Data fortheMeeting withtheFacultyPreceptor
1.
2.
3.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
CERTIFICATE
ACKNOWELDGEMENT
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
OBJECTIVE OF INDUSRIAL TRAINING
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
ABOUT INDUSTRY/HOSPTIAL(NAME)
Dortmund Laboratories was established in the year 1987 for manufacturing generic formulations
in form of tablet, capsules, ointment and liquid. Dortmund has 30 years excellence in
Pharmaceutical Formulations & Healthcare products with an emphasis on manufacturing product of
international Quality. It is supported by Highly Experience Qualified Pharmaceutical team with
Quality Assurance, Quality control and Certified Production experts.
Dortmund is an institution working indefatigably to discover, develop and distribute best quality
pharmaceutical products to the needy and serve mankind with our devoted medical staff
comprising highly qualified professionals with a rich wealth of experience.
Dortmund has built a reputation for excellence and superiority on the foundations of offering
consistently high quality, constantly expanding product portfolio, timely deliveries, and to state-of-
the-art manufacturing facilities-conforming to the most stringent as well as demanding international
standards.
Focused strongly on innovation and research, the company is present in more than 30 therapeutic
category.
Our Corporate Headquarters is located in Dombivli, with 2 manufacturing units in Dombivli MIDC,
Maharashtra India.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
INDEX
2 GENERIC FORMULATION
a)Tablet
b)Capsules
c)Ointment
3) QUALITY CONTROL
4) QUALITY ASSURANCE
5) PACKAGING
6) CONCLUSION
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*EFFERVESCENT FORMULATIONS*
• EFFERVESCENT FORMULATIONS ARE PRODUCED AS
SOLIDS WITH INTENT TO TRANSFORM INTO A LIQUID
FORM JUST BEFORE ADMINISTRATION .
• IN WATER , EFFERVESCENT REACTION PRODUCES
CARBON DIOXIDE(CO2)- THE FIZZING THAT APPEALS
TO CONSUMERS ALONG WITH FLAVOURFUL
ADDITIVES PROVIDING MULTI-SENSORY EXPERIENCE
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*TYPES*
1) IMMEDIATE RELEASE TABLETS
a)DISINTEGRATING TABLETS:-
Breaking of a compressed tablet into small granules upon ingestion
(Example-Clonazepam)
b)CHEWABLE TABLETS:-
Oral dosage form intented to be chewed and then swallowed by the
patients rather than to be swallowed whole.
(Example- sodium fluoride chewable tablet)
c)EFFERVESCENT TABLETS:-
Solids with intent to transform into a liquid form just before
administration .
(Example –Calcium Carbonate)
d)SUBLINGUAL TABLETS:-
Substances diffused into the blood through tissue under the tongue
(Example-Nitroglycerine)
e)LOZENGES:-
Solid dosage form that are intended to be dissolved or disintegrated
slowly in the mouth.
(Example-Strepsil)
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*GENERIC FORMULATIONS*
*TABLET*
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
MANUFACTURING PROCEDURE:-
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*CAPSULES*
• SOLID PREPARTAIONS WITH HARD & SOFT SHELLS
OF VARIOUS SHAPES & CAPACITIES,USUALLY
CONTAINING A SINGLE DOSE OF ACTIVE
INGREDIENTS.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*INSTRUMENTS USED IN THE
MANUFACTURING OF CAPSULES*
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
CAPSULE FILLING MACHINES
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*OINTMENT*
• Ointment Section required to handle various formulations for eg.
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.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
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.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
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.
• 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.
• Needs comparatively smaller area for installation. Electrical
control panel with back up fuses and indicator lamps for easy
process control.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
2. 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. 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 section.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*QUALITY CONTROL*
• 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 havebeen 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
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
8. Dissolution test
9. HPLC
10. IR Spectroscopy
11. UV Spectrophotometer
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
b) Strong-Cobb Tester c) Pfizer Tester
d) Erweka Tester
e) Schleuniger Tester
Hardness for compressed tablet is 5 to 8 kg.
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.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
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.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
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.
• 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.
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*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 –
➢ Name of product
➢ Batch No.
➢ Manufacturing Date
➢ Expiry Date
➢ Quantity
➢ Date of transfer tickets
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
*CONCLUSION*
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai
DYPatilDeemed tobeUniversitySchoolofPharmacy,Nerul,NaviMumbai