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Flow Chart For Capsules: Approved Raw Materials & Excipients

The document outlines the standard process flow for manufacturing capsules. It involves approving raw materials and excipients, mixing and sifting powders, filling capsules, polishing and inspecting capsules, and final packing before transferring to finished goods storage and dispatch. The entire process is conducted under controlled temperature and humidity conditions.

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aparna tiwari
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100% found this document useful (2 votes)
2K views

Flow Chart For Capsules: Approved Raw Materials & Excipients

The document outlines the standard process flow for manufacturing capsules. It involves approving raw materials and excipients, mixing and sifting powders, filling capsules, polishing and inspecting capsules, and final packing before transferring to finished goods storage and dispatch. The entire process is conducted under controlled temperature and humidity conditions.

Uploaded by

aparna tiwari
Copyright
© © All Rights Reserved
Available Formats
Download as RTF, PDF, TXT or read online on Scribd
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FLOW CHART FOR CAPSULES

APPROVED RAW MATERIALS


& Control temp. & humidity
EXCIPIENTS

Check for SIFTING


Sieve size

(Time as per the Product SOP)


MIXING In-process analysis for mixed
powder

Check temp. & FILLING In-process checks


humidity (DT, Wt. Variation)

POLISHING
Sorting of breakage capsules

Analysis for filled capsules

Output READY FOR PACKING

FINAL PACKING

TRANSFER TO F.G. STORE

DISPATCH
CAPSULES :

In capsules, the drug in powder form with or with out suitable fillers after mixing are filled in pre-formed
hard gelatin capsule shells. For this use of drum mixer, manual / semi automatic capsule filling machine
is made. After filling the capsules are polished & inspected with help of capsules polishing machine.
Entire processing is done under controlled temperature humidity conditions with the help of Air
conditioners Dehumidifiers. Packing is done with help of counters or strip/blister packing machine.
FLOW CHART FOR AVALEH

APPROVED RAW MATERIALS


&
EXCIPIENTS

Check for EXTRACTION


Sieve size

pH adjustment
MIXING/VOLUME MAKING Analysis of mixed mass
BY BASE/VEHICLE TO
DESIRED MASS

In-process checks FILLING & SEALING Batch printing

Final testing

PACKING

TRANSFER TO F.G. STORE

DISPATCH
FLOW CHART FOR OINTMENTS

APPROVED RAW MATERIALS


&
EXCIPIENTS

Check for SIFTING


Sieve size

Analysis of mixed bulk


(Time as per the Product SOP) paste
MIXING

Batch coding FILLING & SEALING In process checks

Analysis of filled
tubes

PACKING

TRANSFER TO F.G. STORE

DISPATCH
PROCESS FLOW DIAGRAM OF CHURNA

RAW MATERIAL
RECEIPT

MIXING/ BLENDING OF
POWDER/GRANULES & COLOUR etc.

SIEVING

QUALITY CONTROL

ASSEMBLING IN MFG ROOM

FILLING POUCH/SEALING

FINISHED PRODUCT

QUALITY CONTROL

CARTONING/ PACKING

TRANSFER TO F.G. STORE

DISPATCH
PROCESS FLOW DIAGRAM OF ARISTA/ASAVA

RAW MATERIAL
RECEIPT

EXTRACTION OF HERBS AND


BLENDING WITH GUDA
(FERMENTATION)

FERMENTED FOR 21 DAYS

FILTERATION

FINISHED PRODUCTS

FILLING , SEALING & LABEL

PACKING IN MASTER CARTOON &


SEALING

QUALITY CHECK

QUALITY CONTROL

PACKING

TRANSFER TO F.G. STORE


DISPATCH

PROCESS FLOW DIAGRAM


OF
GHRITA

MURCHA OF GHEE (VEHICLE)

Drug Analysis of mixed suspension/


Solution/Suspension solution
Making

KWATH PREPD OF HERBS In process checks

KWATH MIXED WITH GHEE

BOILING THE MIXTURE UNTIL WATER


REMOVED

FILTER, COOLED

QUALITY CONTROL

PACKING IN GLASS CONTAINER

TRANSFER TO F.G. STORE

DISPATCH
FLOW CHART FOR OIL

APPROVED RAW MATERIALS


&
EXCIPIENTS

AQUEOUS EXTRACT PREPN. OF Testing of Distilled Water


HERBS

Vials/Ampoules EXTRACT IN OIL VEHICLE pH Adjustment &


Washing Volume make
Analysis of bulk solution

FILTERATION OF OIL EXTR

Vials/Ampoules
Sterilization in VOLUME MAKE UP BY BASE OIL In-process Checks
D.H.S. AND COLOR, FRAGRANCE

MIXING & FILTRATION

Check for Final analysis of product


Particulate matters FILL, SEAL & LABEL

FINAL PACKING

TRANSFER TO F.G. STORE

DISPATCH
FLOW CHART FOR TABLETS/ GUTIKA

Approved Raw Materials


& Excipients

Check for Sieve Size SIFTING


Approved Raw Materials & Excipients

(Time as per the product SOP)


MIXING

(Time as per the Product SOP)


KNEADING

(Time as per the Product SOP)

GRANULATION

(Time & Temp. as per the Product SOP)

DRYING

Check for Sieve Size (Time as per the product SOP)


SIZE REDUCTION

Check for material (Time as per the Product SOP) In-process analysis for Granules

addition LUBRICATION

Check the dies & punches COMPRESSION


In-process checks
(DT, Wt. Variation etc.)

Analysis for un-coated tablets


DEDUSTING & INSPECTION

Tablets free from Foreign/black particles

FILM COATING
& VISUAL INSPECTION Analysis for film-coated tablets
Output
FINAL PACKING

TRANSFER TO F.G. STORE

DISPATCH

TABLETS :

Since most of the drugs can not be compressed as such to make suitable tablets, they have to be
converted to free flowing granular form & other inert excepients have to be added to modify drug
availability characteristics. Thus use of sifter is done to screen & select suitable sized particles, Mass
mixer/Rapid mixer granulator is used for granulation/binding, tray drier & fluid bed dryers are used for
drying purpose. Granulation/ Cadmill is used for size reduction & for final mixing lubrication -Ribbon
blender is used. Mixed granules are compressed on suitable Rotary compression machines with in-
process controls. They are coated (sugar coated are film coated) if required using suitable coating &
polishing pans.
Then they are packed using Strip/Blister machine or bulk packed with counting devices if so required.
FLOW CHART FOR LIQUID
ORALS(PANAK/SYRUP/DROPS)

APPROVED RAW MATERIALS


&
EXCIPIENTS

Check for SIFTING


Sieve size

D.M.WATER
PREPARATION Testing of D.M. Water

SYRUP
PREPARATION

Bottle MIXING IN S.S.TANK pH Adjustment & Volume


Washing
Analysis of bulk solution

FILTER THE SYRUP/ SUSP. PASS


THROUGH COLLOID

Bottle Drying FILLING & SEALING In-process Checks

Checking of Final analysis of product


Glass INSPECTION
& Foreign particles
FINAL PACKING

TRANSFER TO F.G. STORE

DISPATCH

Mixing

Grinding

Bulk Testing

Gelatin melting & colouring Molding & Filling

In-process check

Cleaning/Washing

Drying

Inspection

Packing
ORAL LIQUIDS :

The manufacture of liquid orals generally involves the following steps:-

Step I : Preparation of sugar syrup :


D.M. water is added to the stainless steel tank along with the required quantity of sugar and stirred till
it is completely dissolved.
Step II : Addition of Ingredient

Various ingredients are separately dissolved and added to the sugar syrup prepared
in Step I. pH is then adjusted.
Step III : Filtration & Filtering
The solution so prepared is filtered through a filter press, the clarity of solution is
checked and then filled in bottles.

However, the method of manufacture for each dosage form will vary depending upon
the formulations and are given in pharmacopoeias. The proprietary and patent
preparations of the said dosage forms are manufactured as per the method developed by
the manufacturers and approved by the drug licensing authority.

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