COMMENT A question that is frequently asked during consulting, webinars and seminars is how does one choose appropriate microbial limits, especially with non-sterile raw materials, intermediates and final products. The USP Microbiological Expert Committee has considered this issue and provided Guidance. Please read their considerations below. In determining the appropriate … [Read more...]
FDA Safety Communication: Advanced Sterilization Products (ASP) Sterrad Cyclesure 24 Biological Indicators — Revised Expiration Dates
Date Issued: July 3, 2012 Medical and Surgical Specialties: General Surgery, Surgical Technology, and any specialty that uses devices that must be sterilized at low temperatures Device: The Sterrad Cyclesure 24 Biological Indicator, manufactured by Advanced Sterilization Products (ASP), is a product used periodically to monitor and confirm the microbicidal effectiveness of the … [Read more...]
PYROGEN AND ENDOTOXIN TESTING: QUESTIONS AND ANSWERS (06/12) JUST ISSUED
The FDA just published their final Guidance for Industry Pyrogen and Endotoxin Testing: Questions and Answers. FDA has determined that previously published USP and AAMI documents describing methods and calculation of pyrogen and endotoxin testing limits provide industry with appropriate information. However, because the compendial chapters and standards do not address certain … [Read more...]
FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART II (REVISED)
The USP has recently released a Summary of Frequently Asked Questions (FAQ) for both USP <61> and <62>. The FAQ for USP <61> was previously posted in another Blog. The FAQ listed below is the second of two Parts discussing additional FAQ from USP <62>. Q. Why shall I use the shortest incubation period? A. You have to show that the worst conditions … [Read more...]
REGULATORY COMPLIANCE/EXPERT MICROBIOLOGICAL WITNESS CONSULTATION
Regulatory Compliance -- Form FDA 483/Warning Letters With the advent of only 15 calendar days to respond to regulators following a Form FDA 483 or Warning Letter, it is incumbent upon the recipients of these to use the time most productively to minimize any further regulatory actions. Understanding the Observation becomes the initial step. Unless the individuals are … [Read more...]
