Biosafety classification is based on U.S. Public Health Service Guidelines, it is the responsibility of the customer to ensure that their facilities comply with biosafety regulations for their own country.
US Food & Drug Administration. GENERAL BIOLOGICAL PRODUCTS STANDARDS; General Provisions; Sterility Code of Federal Regulations Title 21: 21CFR610.12, Subpart B, 2005
U.S. Pharmacopeia General Chapters: <71> STERILITY TESTS. Rockville, MD:U.S. Pharmacopeia;USP USP34-NF29, 2011
Supplemental assay method for testing for preservative interference with sterility tests. :US Department of Agriculture;USDA, Center for Veterinary Biologics STSAM0903.01, 1999
Sterility test, Growth promotion test. Tokyo, Japan:Japanese Pharmacopoeia;JP JP14e.part I.54.
U.S. Pharmacopeia General Chapters:<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. Rockville, MD USP34-NF29, 2011
Nucleotide (GenBank) : DQ060365 Clostridium sporogenes RNA polymerase subunit B (rpoB) gene, partial cds
