Join MRA at April Events

Microbiology Research Associates’ priorities include staying up-to-date on the latest industry news, trends and regulations, and discussing clients’ needs in person. MRA is taking advantage of the opportunity to do both at three events in April

Interphex

MRA staff will attend Interphex, April 17-19, at New York City’s Javits Center, taking in the latest in pharmaceutical, biotech and medical device seminars and displays. If you’d like to meet with one of our representatives, contact MRA to set up an appointment.

BIOMEDevice Boston

Stop by Booth 429 to chat with MRA staff at BIOMEDevice Boston, April 18-19. Our representatives will be available to discuss MRA’s service offerings and how we can best serve your needs.

NHIA Annual Conference

If sunshine is more your thing, find MRA at Booth 344 at the NHIA annual conference in Phoenix, Ariz. MRA staff will be ready to discuss pharmacy and home infusion regulations and how MRA’s services will benefit you.

We hope to see you at these events!

Find MRA at the Reed Conference

Microbiology Research Associates strives to provide the best service to its pharmacy clients. To ensure we’re up-to-date on the most recent news in pharmacy practice and regulatory updates, MRA will attend the 78th annual Reed Conference on Thursday, March 8. We’d love to see you there. If you’d like to discuss the latest pharmacy news and testing options with us, contact MRA.

MRA Closed for Presidents Day

Microbiology Research Associates offices will be closed for the Presidents Day holiday, Feb. 19. We will reopen for normal business hours Feb. 20.

Cleanroom Classification Influences Layout

A cleanroom’s classification defines the level of cleanliness that must be met and maintained. And while it does not determine the cleanroom layout, it does influence it.

A January 2018 article from Controlled Environments Magazine details many design options and requirements for various sizes and ISO levels of cleanrooms.

Microbiology Research Associates can validate your new or upgraded cleanrooms, and can verify the design, operational and performance specifications. Once your cleanroom is validated, MRA also can set up a cleaning and disinfectant program to maintain proper cleanliness.

Contact MRA to learn how we can help you with your cleanroom validation.

MRA Adds Space to Enhance Service Offerings

Microbiology Research Associates is committed to providing the top-quality service its clients have come to expect. To that end, MRA has expanded its testing space to provide more room for its growing environmental monitoring business and new antibiotic potency testing services.

You can read more about MRA’s expansion with the Boston Real Estate Times.

 

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
203-685-7919
Email:Kelly@mra-bact.com

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
978-263-2624
info@mra-bact.com

MRA ANNOUNCES THE ADDITION OF A NEW CUSTOMIZED MICROBIAL TESTING PROGRAM FOR 3D INK PRODUCTS.

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.