Sterility testing British Pharmacopoeia

Recognizing these problems, UK food regulatory authorities have generally abandoned the use of quantitative microbial counts as enforceable standards of food quality. Despite this, the European Pharmacopoeia has introduced both quantitative and qualitative mierobial standards for non-sterile medicines, which might become enforceable in some member states. It prescribes varying maximum total microbial levels and exclusions of particular species according the routes of administration. The British Pharmacopoeia has now ineluded these tests, but suggest they should be used... 

British Pharmacopoeia (1993) Appendix XVI A Test for Sterility, A180-A184. London HMSO. (3.4) Denyer S. Baird R. (eds) (1990) Guide to Microbiological Control in Pharmaceuticals. Chichester Ellis Horwood. (3)... 

Specific details of the sterility testing of parenteral products, ophthalmic and other non-injectable preparations, catgut, surgical dressings and dusting powders will be found in the British and European pharmacopoeias. 

The British Pharmacopoeia makes an allowance for acddenlal contamination which may arise during the execution of a sterility test by aUowing the test to be repeated. Under these circumstances the following rules apply. 

Particulates are critical in sterile filtration, specifically of injectables. The USP 24 United States Pharmacopoeia) and BP British Pharmacopoeia) quote specific limits of particulate level contaminations for defined particle sizes. These limits have to be kept and, therefore, the particulate release of sterilizing grade filters has to meet these requirements. Filters are routinely tested by evaluating the filtrate with laser particle counters. Such tests are also performed with the actual product under process conditions to proove that the product, but especially process conditions, do not result in an increased level of particulates within the filtrate. 

When the Test for Sterility first appeared in the USP and in the British Pharmacopoeia (BP) in the 1930s, it was described in the same terms as any other pharmacopeial test method that is, as a method whereby a microbiologist could determine whether a single article presented for analysis was sterile. 

Sterility tests appeared in the British Pharmacopoeia for the first time in 1932 and in the United States Pharmacopeia in 1936 [59]. Currently sterility testing is a legally binding... 

Appendix XVIA, Test of sterility, British Pharmacopoeia, 1993, p. A180. 

Both the British and European pharmacopoeias indicate that it is necessaiy to conduct control tests which confirm the adequacy of the facilities by sampling of air and surfaces and carrying out control tests using samples known to be sterile. In reahty, this means... 

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