Jan 19, 2011
By:
Scott Sutton
A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.
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The author provides a history of the information chapter USP 91211: "Sterilization and Sterility Assurance of Compendial Articles," from the early 1900s to the current version.
May 1, 2009
By:
Scott Sutton
The author provides a history of the information chapter USP ‹1211› "Sterilization and Sterility Assurance of Compendial Articles," from the early 1900s to the current version.
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The current scope of PAT limits opportunities for microbiological test improvements.
Feb 2, 2007
By:
Scott Sutton
The role of micro-biological testing in real-time release is too important to ignore.
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Dec 2, 2006
By:
Scott Sutton
The US Pharmacopeia (USP), the Japanese Pharmacopoeia, and the European Pharmacopoeia "Microbial Limits Tests" are in the final stages of harmonization. The harmonized USP chapters are slated for implementation in 2009. This article describes the harmonized USP Chapters <61> "Microbial Enumeration," <62> "Absence of Specified Microorganisms," and <1111> "Microbiological Attributes of Nonsterile Pharmaceutical Products," and suggests they will likely require some revalidation of existing methodologies. Companies should put plans in place immediately for this work and show consistent progress towards this goal.
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Apr 2, 2005
By:
Scott Sutton
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.
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Quantitative and Qualitative Assays
Apr 1, 2005
By:
Scott Sutton
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results. To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the apparent number in the sample.
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