It is very brief outline for testing of sterile pharmaceutical preparations i.e parenteral. However, you people can improve the document for further use by referring to USP & BP. YOUR COMMENTS WILL BE APPRECIATED. THANKS

5. Ampoules are placed in a vacuum chamber.
Completely submerge in deeply blue coloured dye solution of about 0.5 to 1%
methylene blue.
A negative pressure is applied within the ampoule, subsequent atm pressure causes the
dye to penetrate an opening thus make visible after the ampoule has been washed.

10. • If temperature rise of any individual is 0.5 °C or more;
• Perform test on five more rabbits; and it will pass if;
• Not more tan 3 of 8 show individual rise in temperature of 0.5
• Sum of 8 individual maximum temperature rise does not exceed 3.3

15. LAL
tube
Test sample/Control Result
1 Negative control (pyrogen
free saline)
Should be negative
2 Positive control (pyrogen) Should be positive
3 Positive internal control (test
contain with endotoxins)
Should be positive
4 Test sample May be positive or negative

17. Fluid thioglycollate medium
• For aerobic and anaerobic organisms
Soya-bean casein digest medium
• For fungi and aerobes

19. MEDIUM ORGANISM FORTESTING
GENERAL testing Spores of Bacillus subtillis
Sarcina lutea (non-spore)
Candida albicans
AEROBIC AND ANAEROBIC BACTERIA
Thioglycollate medium (specific) Bacteroides vulgatus
Clostridium sporogenes
GROWTH PROMOTIONTESTS