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Transmission of scrapie to sheep and goats transpired subsequent usage of a formol-inactivated vaccine from contagious agalactia, well prepared with brain and mammary gland homogenates of sheep contaminated with Mycoplasma agalactiaeEnsure personnel thoroughly understand the founded acceptance requirements for microbial counts. Supply illustrations

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  No. 21 CFR 211.113(a) calls for suitable written procedures to become set up and followed throughout manufacturing to forestall objectionable microorganisms in drug merchandise not needed to be sterile.   Also, the second paragraph of USP Common Chapter Antimicrobial Efficiency Screening reads:   Antimicrobial preservatives really should not b

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