Sterile testing
Download as PPTX, PDF5 likes1,057 views
The document outlines a testing procedure for ampoules submerged in a methylene blue dye solution within a vacuum chamber to detect temperature rises in rabbits. It specifies criteria for passing the test based on temperature measurements and includes controls for detecting pyrogens and other organisms in various growth media. Additionally, it details specific organisms used for general testing and growth promotion tests.
Sterile testing
- 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