Disinfection Qualification Testing White Paper

Considerations for Aseptic and Cleanroom Manufacturing Environments

Obtaining the highest confidence that aseptic, cleanroom, and other critical manufacturing environments are properly cleaned, sanitized and disinfected is paramount in ensuring the production of safe and effective pharmaceutical products and/or medical devices. The microbiological safety of these products is primarily determined by the quality of raw materials, the integrity of the manufacturing process, as well as the effectiveness of cleaning and disinfection procedures performed in the facility. It is for this reason that the U.S. Food and Drug Administration (FDA) requires manufacturers of pharmaceutical and other critical products to qualify and validate the disinfection procedures used in these manufacturing environments.

With a properly designed disinfection program, manufacturers better control the risk of microbial contamination, ensuring safe products for patients. This paper is intended to provide an overview of disinfection qualification testing and the considerations that must be addressed when designing and executing these studies.

MRA White Papers- Disinfection Qualification Testing

New Bioburden Control Warnings Aimed at Preventing Microbiological Contamination

BioPharm International releases new warnings about protecting against microbiological contamination throughout the manufacturing process.

In an article posted on the Process Development Forum, BioPharm International says manufacturers need to maintain bioburden control throughout the entire manufacturing plant to minimize the risk of contaminants entering medicinal products.

Adhering to cGMP requirements is stressed to ensure quality in both the product and the process.

MRA experts, with their extensive experience, can help clients meet the rigorous cGMP standards and bioburden control requirements to protect against microbiological contamination. Contact an MRA representative to learn more.

USP to Revise General Chapter <797>, Postpone General Chapter <800>

USP says it will revise General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. General Chapter <797> will be published in the Pharmacopeial Forum 44(5) Sept./Oct. 2018 for a second round of public comment before it is official.

The revised USP General Chapter <797> is expected to be published in USP 42-NF 37 Second Supplement on June 1, 2019, and become official on Dec. 1, 2019. Some sections may have longer implementation dates to allow for adoption of the standard. While <797> is under revision, the published version remains official and enforceable.

USP also has postponed the official start date of General Chapter <800>, which deals with the compounding of hazardous drugs, to Dec. 1, 2019. This postponement will align the official date of General Chapter <800> with the official revision of General Chapter <797>.

At Microbiology Research Associates (MRA), our expertise is in DQSA 503A and 503B facilities. For more than 20 years, MRA has served clients ranging from hospitals to national compounding pharmacies to 503B outsourcing manufacturers. We have become their USP <797>, <800> and cGMP compliance experts. MRA offers full-service compliance capabilities for pharmacists who need to ensure and/or restore a state of environmental control for their products and processes. To learn more, contact an MRA representative.