GELATIN SPECIFICATION FOR SGC

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 Gelatin, a plasticizer (usually Glycerin), and other ingredients.
 Ø  Gelatin Shell raw Materials are accurately weighed and then lended with demineralized water and melted under vacuum in large stainless steel pressure tanks.
 Ø  Completed batches are then transferred to the production lines in heat controlled receiving tanks in which the gelatin mass s maintained at the            required temperature and viscosity. 



MEDICAMENT PREPARATION:


 Ø  Precise Weighments, Mixing, Homogenizing.De-aeration, sieving and preservation in accordance with the CGMP standards.
 Ø  The quality assured medicament/fill material is hand released for the encapsulation process.
 Ø  The medicine preparation area has a standard range of mixers, homogenizers and milling equipment or the preparation of the fills.
 Ø  For simple oils the material is decanted into a 200 kg Mobile vessel, positioned on a floor scale, blanketed with Nitrogen, if required, and then sealed ready for the next stage of the process. 


Ø  Blends of oils follow a similar process but a Silverson mixer is used to ensure a uniform mix is achieved.
Ø  Multi ingredient suspension products are prepared by weighing out each individual ingredient and placing them in intermediate containers.
Ø  The excipient, materials used for the suspension process, are weighed and delivered to the homogenizing unit where heat is applied to melt the fats and waxes.
Ø  Once in a molten form the actives are then added in the order dictated by the batch documentation.
Ø  The unit is closed and a vacuum applied to ensure no air gets into the fill material, and then a homogenizer is used to ensure a homogenous mix is achieved.
           After the mixing has taken place the fill is then milled and deaerated to ensure a smooth and 
                 fiber free mix and decanted into mobile medicine tanks.   


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