EVALUATE THE QUALITY OF THE INVENTORY 2 A material is declared sterile if it is free from living microorganisms, both pathogenic and nonpathogenic, both in vegetative and non-vegetative forms. Sample Taking Take samples to test their quality according to the table below Number of containers in the batch Number of sample parts Less than 100 10% or 4, whichever is more big Not less than 100, no more than 500 10 More than 500 2% or 20%, whichever is taken small For preparations sterilized in an autoclave at temperatures above 100oC, the number of samples used can be reduced to 10. If the contents of each container are 250 ml or more, the number of samples used can be reduced to 3. If the contents of each container are less than 1 ml of liquid or less than 50 mg of solid, then the number of samples used used is 3 times the amount stated in the table above. As for the sterility test, it is carried out according to the following table The amount of substance required for Amount of test substance in receptacle Test for germs Test for mold and yeast Fluid Less than 1ml All contents All contents Half full Half full Not less than 20 ml 2 ml 2 ml More than 20 ml 10% of the content 10% of the content All contents All contents No more than 200mg Half full Half full More than 200 mg 100 mg 100 mg Not less than 1 ml Not less than 4 ml Not less than 4 ml Congested Less than 50 mg Not less than 50mg The test procedure consists of (1) direct inoculation into the test medium and (2) membrane filtration technique. Sterility testing for Pharmacopeia materials, where possible using membrane filtration, is the method of choice. This procedure is especially useful for soluble liquids and powders that are bacteriostatic or fungistatic, to separate microbial contaminants from growth inhibitors. Procedures must be validated for such use. For the same reason, this method is very useful for substances such as oils, ointments, or creams that can dissolve in a non-bacteriostatic or non-fungal diluent. It is also used to test surface sterility or critical lumens of medical devices. MEDIA I. Liquid Thioglycolate Media L-cystine P 0.5g Sodium chloride P 2.5g Glucose (C6H12O6) 5.5g Agar P, granule (moisture content no More 15%) 0.75 g P yeast extract (water soluble) 5.0 g Pancreatic digestion of P casein 15.0 g Na thioglycolate P, or 0.5 ml Thioglycolic acid P 0.3 ml Dissolve Na resazurin P (1) in 100 ml) made fresh 1.0 ml Water 1000 ml pH after sterilization 7.1+ 0.2 II. Soybean-Casein Digest Medium Pancreatic digestion of P casein 17.0 g Papaik digestion of soy flour 3.0 g Glucose (C6H12O6) 2.5g Sodium chloride P 5.0 g Potassium phosphate dibasic P 2.5g Water 1000 ml pH after sterilization 7.3+ 0.2 TESTING HOW No. Processing Initials 1. Sterilize tools that will be used in the autoclave and oven 2. Prepare all the reagents needed for the preparation Sterility Test 3. Mix in a sterile petri dish 10 ml of sterile agar medium and 1 ml of liquid preparation.Perform liquid media control procedures with microbes 4. Close the media cup, then incubate at temperature 37°C for 24 hours 5. Interpretation of results