Recommendations are given to ensure a virtually sterile product at the end of preparation. 展开 关键词: Corneal transplantation Microbial contamination Preparation procedure Quality control DOI: 10.1159/000027269 被引量: 1 年份: 1998 收藏 引用 批量引用 报错 分享 ...
Any antimicrobial activity of the product necessitates a modification of the test procedure (see Neutralization/Removal of Antimicrobial Activity under Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests ?61?). For a given product, if the antimicrobial activity with respect to ...
place of the test preparation. There must be no growth of microorganisms. Growth Promotion and Inhibitory Properties of the Media Test each batch of ready-prepared medium and each batch of medium prepared either from dehydrated medium or from ingredients. Verify suitable properties of relevant media...
PreparationAseptic handling is the procedure to enable sterile products to be made ready to administer using closed systems (EU Resolution CM/Res(2016)2). Microbiological monitoring (MM) and media fills are used for environmental and process control. In this study, the application of MM methods ...
(2004), was used in this study as indicative of wastewater contamination. In order to track down the points of contamination entry into the system, the tracking procedure recommended byPitt (2004)was followed by collecting upstream samples until theE. coliconcentrations fell below the threshold (...
The method for sample preparation depends on the physical characteristics of the product to be tested. If none of the procedures described below can be demonstrated to be satisfactory, a suitable alternative procedure must be developed. Water-Soluble Products—Dissolve or dilute (usually a 1 in 10...
Microbiological analysis is used to help control the growth of viruses, bacteria and microorganisms. Water requirements for this procedure are sensitive.
If self-prepared cultures are used, follow a validated procedure (such as in MicrobialEnumeration Tests 〈61〉) for preparation. Use a challenge inoculum of NMT 100 colony-forming units (cfu) for growth promotion and suitability testing.NEGATIVE CONTROLSInclude a negative control to verify the ...
A fast and reliable procedure for spore collection from anaerobic fungi: Application for RNA uptake and long-term storage of isolates Shelby Calkins, Nicole C. Elledge, Radwa A. Hanafy, Mostafa S. Elshahed, Noha Youssef Pages 206-213
PREPARATION OF THE SAMPLE The method for sample preparation depends on the physical characteristics of the product to be tested. If none of the pro- cedures described below can be demonstrated to be satisfactory, a suitable alternative procedure must be developed. Water-Soluble Products—Dissolve or...