Use of environmental isolates in the pharmaceutical microbiology laboratory has been increasing in popularity. This article discusses the current regulations andguidance documents, regulatory expectations, and expert opinions on the use of environmental isolates.
This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.
This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.
The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.
Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. This article discusses the concept of disinfectant rotation and the current mainstream industry practices.
This article looks at in-process bioburden testing and the importance of establishing accurate data and routinely monitoring the data for adverse trends.
According to section 503B of the Food Drug and Cosmetic Act, outsourcing facilities are required to comply with all cGMPs and regulations regarding insanitary conditions. Many regulatory observations are written for the failure to follow cGMPs and insanitary conditions. This article highlights some of the microbial expectations for 503B compounding pharmacies.
the regulations governing non-sterile manufacturing are not as clear or as abundant as those for sterile manufacturing. This leads many manufacturers to utilize risk assessment analysis tools to adapt portions of sterile manufacturing guidelines when developing environmental monitoring programs for non-sterile environments.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. This article will address concepts of environmental monitoring and the importance of disinfectant efficacy and proper cleaning in cleanrooms.
Humans are the primary source of contamination in cleanrooms. They are critical to the microbial regulation of the cleanroom and must be properly gowned. The primary purpose of cleanroom gowning is to protect the product and environment from contamination. When used correctly, cleanroom gowning greatly reduces the microorganisms released by personnel.
In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood.
This article explains the final three components that can be used to establish a compliant disinfectant efficacy testing package in the U.S. along with tips for assembling the package.
There are many regulations and guidance documents that discuss disinfectant efficacy testing, and establishing a compliant disinfectant efficacy testing package aids in providing clear documentation that the disinfectants employed in a facility have been analyzed as required by these regulations.