The purpose of this study is to ascertain whether or not a bulk product is sterile. The procedure follows the method described in 21 CFR 610.12 and the United States Pharmacopeia USP30/NF25. The test article is filtered using a sterile filtration device and vacuum suction in a class II biological safety cabinet (Clean Room). The filter is then physically removed using sterile foreceps and cut in half with a sterile surgical blade. One half of the filter is transferred to Fluid Thioglycolate Medium and the other half is transferred into Soybean Casein Digest Medium. The two types of media are incubated at different temperatures to provide the proper conditions for the growth of bacteria, yeast and mold. The media bottles are then incubated for 14 days and macroscopically examined on days 3, 7 and 14. The results are recorded and the final reading on day 14 would determine if the test material passes the sterility test. In the event of bacterial or fungal growth, the sponsor will be notified and an investigation of the source of contamination will be carried out. The isolates will be identified to the species level.
Observations are recorded and the data is described in detail in a final report that the client receives. The studies are conducted under Non-GLP conditions and as described in the United States Pharmacopeia USP30/NF25.
The sponsor will NOT be required to review and approve a protocol prior to study initiation. Please fill out the sample submission form below in either Word or PDF format and send along with the samples.
