Knowledge of Pharma

GELATIN PROPERTIES ACID OSSEIN FISH BLOOM(G)0 180-210 160-210 VISCOSITY, 6.67%,600(MPA,S) 2.7-3.2 3.0-3.5 MOISTURE (%MAX) 13.0 13.0 ASH (%MAX) 1. 1.0 PH ,1% SOLUTION 5.0-6.0 5.0-6.0 ISO IONIC POINT,PH 6.0-8.0 7.0-9.4 PARTICLE SIZE % PASSING 4 US # 100 100 SO2 (PPM MAX) 60 60 H2O2 60 60 CLARITY (45% solution in 30% glycerol) Clear no precipitate MICROBIAL STANDARDS TOTAL COUNT 500 500 E.COLI IN 10 GM Absent Absent P. AERUGINOSA IN 10 GM Absent Absent GELATIN MASS PREPARATION:  Ø   The Shell of the Soft Gelatin Capsules comprises of pure Pharmaceutical...

COMPOSITION OF SOFT GELATIN CAPSULE SHELL 1)       GELATIN           2)       PLASTICIZER                  --GLYCERIN                                                    --SORBITOL 3) WATER 4) PRESERVATIVES           --METHYL PARABEN                                                 ...

One piece hermetically sealed soft gelatin shell containing a liquid, a suspension or semisolid. Advantages Ø   Products can be encapsulated in various shapes - various sizes - various colors. Ø   Products with thick slurry type paste Medicaments to light oils and powders (with inert media) can be encapsulated. Ø   Unit doses. Ø   Lower dose of active ingredients. Ø   High accuracy in fill weights. Ø   Fewer inactive ingredients. Ø   Improved stability. Longer shelf life. Ø   Improved bioavailability. Ø   One piece Capsule - tamper proof. Ø   One piece Capsule - no problem of microbial contamination, oxidation and evaporation.            Ease of administration - oral, rectal and vaginal. Disadvantage Ø   Highly sensitive to temperature and humidity. PLANT LAYOUT Generally SGC manufacturing premise has two floor building on first floor the preparati...

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...

GENERAL REQUIREMENT: 1.1 The environment condition in which filling of hard gelatin capsule should be normally carried out is:                         Humidity:                 Not more than 35% RH                         Temperature:         Not more than 25%             These conditions should be maintain even work has stopped at the end of   working day and during                                    the week- ends. 1.2 The area around machine should be kept clean at all times. ...

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)

A. DIRECT FILLING METHOD                    1.AUGER FILLING METHOD                    2.VIBRATION ASSISTED FILLING B. INDIRECT FILLING METHOD      1. TAMP-FILLING METHOD      2. DOSATOR NOZZLE MACHINE                    3. VACUUM-FILLING METHOD LIQUID  FILLING: PELLET   FILLING: TABLET FILLING: