Regulatory Aspects of Microbiology in a Non-Sterile Environment
: 10 Oct 2019
Sector: Cosmetic/Personal Care, Pharmaceutical, Veterinary, Water
Type: Training, Webinar, Seminar
Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation of non-sterile components, the environment and final product. This two hour live webinar discusses various regulations and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms.
Products that are sold as sterile, but include a non-sterile phase within their manufacturing cycle will also be reviewed since the Regulators often have concerns regarding these in-process materials. Thoughts about in-house microorganisms that may be considered as "specified" will also be discussed. Warning Letters, Recalls and USP Chapters will be used to highlight the various discussion points.
- Review the various Regulations pertaining to non-sterile raw materials, in-process materials and final product.
- Examine the various USP documents that discuss the elements associated with the concept of non-sterile manufacturing.
- Gather information regarding the impact of process hold times, preservation issues, cleaning, sanitization, and the requirements for the testing of recovered microorganism.
- Learn when recovered microorganisms require testing.
- Understand why Warning Letters and Recalls were issued for non-sterility