STERILITY TEST pharma无菌检查制药公司.cu.eg.pptVIP

STERILITY TEST It’s a quality control test for any sterile product, required for all articles or substances to be introduced into raw tissue (injections and ophthalmics). Sterility testing attempts to reveal the presence or absence of viable micro-organisms in a sample number of containers taken from a batch of product. Sterility test is a final control on the sterilization process (i.e. the test indicates that a sterilization process is effective or not). The test shows that samples tested were free from living bacteria and fungi but not viruses.? Methods of Sterility Test Membrane filtration Direct transfer Direct transfer method Culture media for sterility test must be: Capable of initiating and maintaining the vigorous growth of a small number of organisms. Sterile. There is no one medium which could detect both bacteria and fungi. The USP recommends two culture media for sterility testing: a) Fluid Thioglycolate Medium (FTM) for detection of both aerobic and anaerobic bacteria. b) Trypticase Soya Broth (TSB) (Fluid soya bean casein digest medium) primarily intended for the culture of both fungi and highly aerobic bacteria .  Direct transfer method Formulation of FTM Yeast extract ..........……......... nutrient (growth factor) Pancreatic digest of casein………nutrient (nitrogen source) Dextrose……...nutrient (carbon source) L-cysteine...... antioxidant, supports growth of clostridia neutralizes metal preservatives Sod. thioglycolate……...antioxidant neutralizes metal preservatives. Agar (0.075%)…… viscosity inducer to reduce oxygen diffusion Resazurin sod……... redox indicator (pink at high O2 tension in upper third of container and yellow at low O2 tension in lower 2/3 of the container). Distilled water pH after sterilization 7.1 ? 0.1 Formulation of FTM Pancreatic digest of casein.................... nutrient Papaic digest of soya bean ................... nutrient Dextrose (high %)............