Microbial Validation

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• Minimizing Risk in Sterilization Validation
  By Bill Swichtenberg, Senior Editor Sterility testing is an essential part of every sterilization validation, to rule out the presence of particulate, bacterial and fungal contamination. Personnel must wear isterile gowns that prevent microbial shedding. The result is a monotonous, careful process...
• Answer Key for Validation Quiz
  . Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations. More White Papers ... Products. Biotest Diagnostics Corp. AdvantaPure. Novasep Process. More Products ... PharmaManufacturing.com is the site for knowledge, news and analysis for manufacturing and other...
• Medical Device Link . Bioburdens and Validation John Broad , director of microbiology at NAMSA (Irvine, CA), answers questions about validating the sterilization process. Ed Arscott , manager of microbiology (NAMSA, Northwood, OH); Susanne Anderson ,
  Medical Device & Diagnostic Industry If a product supports microbiological growth, will validation be affected? Products known to support microbial growth include hydrogel-, water-, and saline-based product lines. For these items, the length of time between final packaging and processing...
• Medical Device Link . Coating Minimizes Thrombosis and Restenosis in Cardiovascular Stenting Service Bureau Uses New 3-D Printing System to Create Prototypes Validation Software Developed for Medical Device Manufacturers
  . Additional benefits include reduced platelet adhesion and activation and inhibited microbial adhesion. Advanced Surface Technology is an ISO 9001 certified company offering a variety of proprietary...
• An Interview with John Albright, Regulatory and Compliance Manager, Celsis
  A number of different rapid microbial methods are available to drug manufacturers today, and more companies are applying them. In fact, a recent NDA approved by FDA specified the use of RMM. Validation is relatively easy to achieve, and FDA is reportedly receptive to well-validated rapid methods...
• Will Pharma Ditch the Dish?
  By Agnes Shanley, Editor in Chief See the end of this article for data from our recent RMM survey, a list of vendors and their rapid method technologies, and links to related resources. The past few years have seen a wide array of rapid microbial methods (RMM) reach the market. Designed to reduce...
• How Early Communication with FDA Sped Up One RMM Implementation
  By Agnes Shanley, Editor in Chief Microbial contamination is a real and present danger for manufacturing many biologics and pharmaceuticals. Rapid Microbial Methods (RMM) systems and methodologies can help manufacturers release product faster and manage the risks of contamination while ensuring...
• Rapid Microbiological Methods for a New Generation
  that are specific for microbial target sites of interest. Examples include: rely on PCR DNA amplification, 16S rRNA typing, gene sequencing and other novel applications. Many of these systems are used for the rapid and accurate detection of a specific target microorganism or for the identification...
• GSK, Pall Speed Microbiological Contamination Detection
  the user the opportunity to adopt the technology in a broad range of applications, including pharmaceutical product release, monitoring pharmaceutical water systems, environmental contamination monitoring, testing biological indicators used e.g. for autoclave validation and qualifying microbial...
• How Early Communication with FDA Sped Up One RMM Implementation
  to supporting a strong scientific case to present to senior management. What is the most important aspect of the validation studies? Setting acceptance criteria is extremely important. With ATP Bioluminescence, a baseline must first be established, based on non-microbial ATP. A reading two times...

Engineering Web Search: Microbial Validation