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.

Microbiology Research Associates Appoints New Director of Business Development

Acton, MA – Microbiology Research Associates (MRA) (http://www.mra-bact.com) recently announced that Kelly Hagen has joined the team to develop their growing portfolio of regional and national accounts further. Kelly Hagen comes with a wealth of knowledge and experience within the Industry. For the past five years, Kelly has been responsible for selling high-value chemistry development and manufacturing services for API, Intermediates and Raw Materials to C-Suite Level Executives and Scientists within the pharmaceutical and biotechnology industry.

Before her work in Business Development, Kelly spent ten years working in the pharmaceutical industry with positions at Sunovion, Novartis and Purdue Pharma.

Kelly holds a Bachelor of Arts in Communication Sciences Degree from the University of Connecticut.

Kelly comments “I am excited to start a new challenge with Microbiology Research Associates, the leader in the on-site environmental monitoring of hospital compounding pharmacies In the New England area and I look forward to working with the team to further develop the regional and national presence.”

Darcy Sidwell, Vice President “Kelly brings a wealth of business development experience and will be an asset to our fast-growing Microbiology Testing and Consulting Laboratory Services Company.”

Contact Information:
Microbiology Research Associates
Kelly Hagen

About Microbiology Research Associates:
Microbiology Research Associates (MRA), offers microbiology consulting, research and testing services to the pharmaceutical, cosmetic, medical device, biotechnology, and health care industries. MRA is an FDA (No# 1000148174) and DEA (No# RB0486096) registered laboratory and has state of the art ISO 5 Cleanroom with Isolator.

Microbiology Research Associates


MRA’s 3D ink program is able to detect and quantify the amount of potential microbial contamination within an ink product.  This testing also determines shelf life capabilities in order to prevent microbial proliferation within the ink.

  • Detecting and quantifying – USP <61><62> bioburden test which will determine total number of bacteria yeast and mold as well as the absence of specified pathogens.
  • Shelf life capabilities – USP <51> Antimicrobial Effectiveness Test which will determine the efficacy of the preservative characteristics of the product.

MRA’s President, Fran McAteer to be Keynote Speaker

Fran McAteer, MRA’s President, will be a keynote speaker at the Yankee Alliance GPO annual meeting on May 2nd, 2017. He will be presenting the proposed USP <797> revisions for the member audience. Fran initiated a first-in-the-nation program for USP <797> compliance assessment of third party high risk compounders.  He also introduced a compliance program for registered compounders to meet the standards of the recently passed Drug Quality & Security Act.

vials and syringe


Parenterals, high risk or proposed USP <797> Sterile Compounding, Category 2 compounds can be tested for container closure integrity to demonstrate sterility and stability. Container Closure Integrity testing for USP <1207> Sterile Product Packaging Integrity Evaluation is performed per PDA (Parenteral Drug Association) Technical Reference (TR) No. 27 Pharmaceutical Package Integrity. Testing utilizes high density microbial challenges of Brevundimonas diminuta, a very small rod shaped organism, for penetration to the container closure seal. Failure of microbial penetration into the container is the acceptance criteria for demonstration of closure integrity. This type of testing is the basis of stability verification in parenterals and also Beyond-Use-Dating (BUD) extension in Compounded Sterile Preparations (CSPs).

MRA has performed container closure integrity testing on vials, syringes, large volume parenterals and IV bags for customers nationwide. Integrity testing is protocol based and utilizes microbial immersion methodology.

For more information email us at info@mra-bact.com.

MRA announces the addition of a new, comprehensive pharmacy program for Bacillus Calmette Guerin (BCG) compounding for Bladder Cancer Therapy

This state of the art program will complement the existing USP <797> and <800> services currently offered by MRA with emphasis on:

  • TICE® / TheraCys® BCG Mycobacterium bovis specific sampling and detection for air and surfaces in addition to existing USP <797> monitoring for viable particulates.
  • Personalized education and proficiency testing specifically designed for BCG compounding pharmacy personnel which includes organism handling and storage, aseptic technique and appropriate biohazard personal protective equipment (PPE).