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list of Books & Website for Capsule manufacturing Study

1. Pharmaceutical capsules . Second edition 2. Quality Assurance Guide    vol. I& II first edition 3. How to Practice GMPs by P.P.Sharma 4. Pharmaceutical Process Validation by LOFTUS and NASH 5. www.indianindustry.com 6. www.fujicapsule.com/english/system/seam.htm 7. http://pharmlabs.unc.edu/capsules/text.htm 8. www.pharmagel.it/production2.htm 9. www.rjengineering.com/process.htm 10. www.drugdeliverytech.com 11. www.jintan.com 12. www.capsugel.com 13. www.innercaps.com 14. www.intota.com 15. www.pharmaceutical-industry.info 16. www.tsrlinc.com 17. www.qualicaps.com

Batch Manufacturing Record - Capsule

M/s (Name and address of the company) __________________________________ Name of the product __________________________________________________ (Trade name, if any) (MFR No.) __________________________________________________________ (Batch No.) ____________________________________ Capsule size __________ (Batch size.) ____________________________________ Colour _______________ Date of Expiry _______________________________________________________ Date of commencement ________________________________________________        Sr.No. Ingredients Standards Q/C Report No. Label Claim Quantity Required Quantity actually used Remarks 1 2 3 4 5 6 7 8 TOTAL Raw material initially weighed and measured by _____________________...

ENCAPSULATION PROCESS:

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Globex Method: The lipophillic fill and the shell formulation are stored in separate containers, both kept warm. The fill and the shell material are pumped through a concentric double capillary, with fill in the inner one. The fill is pumped in pulses to give fill volumes between 20 to 600 mg. Here, the formation of capsule depends upon the interfacial tension between the fill and shell material. The shell material possesses a higher surface tension. In attempt to reduce the surface tension, the droplet is formed. As a result of this the seamless round soft capsules are formed. The end of the double capillary is immersed in a cooling bath containing a liquid usually liquid paraffin which is kept at about 4 ˚C  Advantages: Seamless capsules, which are tamper-evident. Free of contamination or air entrapment. Risk of leakage is minimal. Capacity: 10,000-40,000 capsules per hour. Rotary Die Process: At the same time when two fi...

Quality Control Test For Capsule

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Raw Material Testing: GELATIN             BLOOM             VISCOSITY             MOISTURE             PH             ISO IONIC POINT,PH             PARTICLE SIZE             SO2 (PPM MAX)             H2O2             CLARITY             MICROBIAL STANDARDS Water Fill material – powder                       Sem...

Capsule Packaging

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Plastic Bottle with Screw Cap  (most popular package in USA ) Clam Shell Blister (one-piece plastic blister that folds over and locks itself; no heating required) Blister Pack (heat sealed plastic blister on a cardboard ) Plastic Pail / Bucket (Economical bulk package) Plastic Pouch Zip Locked (for sale via retail stores or route trucks must be packed in outer case for shipping)

AUTOMATIC CAPSULE FILLING:

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AUTOMATIC CAPSULE FILLING TRANSFER LINE READY TO BLISTER PACK 1. EMPTY CAPSULE SORTER ELEVATOR SE-100 2. AUTOMATIC CAPSULE FILLING M/C [AF-90(T)] 3. AIR DISPLACEMENT UNIT – ADU 4. AUTOMATIC PROCDUCT CONVEYING SYSTEM –PCS – 100 5. ON LINE METAL DETECTION SYSTEM 6. ON LINE CHECK WEIGHER CW- 10 7. DEDUSTING & POLISHING MACHINSE DP – 100 8. MINI CAPSULE SORTER MCS – 100 9. EMPTY CAPSULE ELIMINATOR ECS -100

Hard Gelatin Capsule (HGC)

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HARD GELATIN CAPSULE The hard gelatin capsule consists of a base or body and a shorter cap, which fits firmly over the base of the capsule. ADVANTAGES: 1. They may be used to mask the unpleasant tastes, aromas, or appearance of a drug. 2. They allow powders to be dispensed in an uncompressed form, thus allowing for quicker dissolution and                        absorption of the drug following oral dosing (as compared with tablets). 3. They offer the pharmacist versatility to prepare any dose desired for a variety of administration routes             (e.g. oral, inhalation, rectal, or to be diluted for vaginal, rectal, oral or topical use). 4. They may be easier than tablets for some people to swallow. 5. They can be making to alter the release rate of the drug. 6. They are available ...

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