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 grade Ge

COMPOSITION OF SOFT GELATIN CAPSULE SHELL 1)       GELATIN           2)       PLASTICIZER                  --GLYCERIN                                                    --SORBITOL 3) WATER 4) PRESERVATIVES           --METHYL PARABEN                                                              --PROPYL PARABEN 5) COLORANTS                     --F.D & C                                                              --CERTIFIED LAKES 6) OPACIFIER                       --TITANIUM DIOXIDE 7) FLAVOURING AGENT   --ETHYL VANILLIN 8) Fumaric acid is added to aid solubility and to reduce aldehyde tanning of gelatin. Steps Of Manufacturing of SGC::

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 preparation of medicament and gelatin is carried out and they are directly delivered to encap

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                       Semi solid                         Liquids-suspension, emulsion, solutions  I.P.Q.C: DURING FILLING WEIGHT VARIATION TEST MOISTURE CONTENT LOCK LENGTH Final Product Q.C :     PHARMACOPIEAL STANDARDS             UNIFORMITY OF MASS             UNIFORMITY OF CONTENT             DISINTEGRATION TEST             DISSOLUTION TEST             MICROBIAL TEST     INDUSTRIAL STANDARDS             DIMENSION             CAPSULE SHAPE                SOLUBILITY            ODOUR EQUIPMENT VALIDATION: EQUIPMENT COMPONENT INSTRUMENTED PARAMETER MEASURED ZANASI LZ64 PISTON

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. Spillage should be cleaned up promptly.        The machine must be thoroughly cleaned during the week –ends and when there is a product change –    over. 1.3 The speed gear should not be adjusted when the machine is running on power, 1.4 Operator should wear rubber gloves, nose mask and head covers when the machine is operated for filling. PRELIMINARY OPERATIONS 2.1 The RH in the room or area should be checked and recorded on manufacturing sheet. Filling should not  be started i

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: