Search results with tag "Of nonsterile products"
<62> MICROBIOLOGICAL EXAMINATION OF NONSTERILE …
triphasepharmasolutions.comMicrobiological Examination of Nonsterile Products: Microbialtained at 2° to 8° for a validated period. Enumeration Tests 〈61〉. If the product to be examined has antimicrobial activity, this is insofar as possible removed or neutralized as de-Negative Control scribed in Microbiological Examination of Nonsterile Products:
<62> Microbiological Examination Of Nonsterile Products ...
www.uspnf.combiological Examination of Nonsterile Products: Microbial Enumer-hours. As an alternative to preparing and then diluting down a fresh ation Tests 〈61〉. suspension of vegetative cells of Cl. sporogenes, a stable spore sus-If the product to be examined has antimicrobial activity, this ispension is used for test inoculation.
Microbiological Examination of Nonsterile Products ...
www.triphasepharmasolutions.commicroorganisms that may be used for nonpaper biological EXAMINATION OF NONSTERILE indicators are described in the Total Viable Spore Count section. PRODUCTS: MICROBIAL For Biological Indicators for Moist Heat, Dry Heat, and Gase-ous Modes of Sterilization, Liquid Spore Suspensions, the ENUMERATION TESTS
Module 08 USP 1115 Bioburden Control of Non-Sterile …
latam-edu.usp.orgcontamination of nonsterile products. The quality or type of water used for nonsterile product formulation and final rinse of clean equipment should be chosen based on product risk. Purified waters used in pharmaceutical manufacturing are deionized and thus do not contain chlorine to …
Microbiological Examination of Nonsterile Products ...
www.drugfuture.comNONSTERILE PHARMACEUTICALpackaging system. The testing history would include micro-bial monitoring during product development, scale-up, pro-PRODUCTS cess validation, and routine testing of sufficient marketed product lots (e.g., up to 20 lots) to ensure that the product has little or no potential for microbial contamination. Be-
<61> Microbiological Examination Of Nonsterile Products ...
www.uspnf.comWater-Soluble Products—Dissolve or dilute (usually a 1 in 10 dilution is prepared) the product to be examined in Buffered Sodium Chloride–Peptone Solution pH 7.0, Phosphate Buffer Solution pH General Considerations 7.2, or Soybean–Casein Digest Broth. If necessary, adjust to a pH of 6 to 8. Further dilutions, where necessary, are prepared ...