Microbiology Research Associates (MRA) specializes in microbiology testing and consulting services for the Biotechnology, Healthcare, Pharmaceutical, and Medical Device industries. Our FDA regulated testing laboratory is located just outside of Boston MA, and our areas of specialization include contamination control, clean room validation, environmental monitoring, and sterile compounding.
For over 20 years MRA has served clients ranging from large pharmaceutical manufacturers, compounding pharmacies and hospitals to complex medical device developers and virtual biotech companies. MRA implements testing, validation and consulting, demonstrating customer product quality and process consistency. Our services provide the highest quality testing based on regulatory compliance and responsively meeting client deadlines.
Microbial characterization and method development. FDA submission for microbial controls.
MRA will set up protocol based media fill for TPN pumps, repeaters and compounding robots including growth promoted media in multiple type containers.
Training seminars for contamination control garbing, biological safety
Disinfecting Consulting and cleanroom contamination control
Turnaround 33 days includes interim reports at 7, 14 and 21 days.
Per USP <71> turnaround time 14 days
Membrane filtration or Direct Transfer, ISO 5 Cleanroom
With changes to USP <51> and ISO 14644, it is imperative to engage a testing company with expertise in regulatory compliance and contamination control. MRA serves clients ranging from large pharmaceutical manufacturers, complex medical device developers, to virtual biotech companies. MRA implements testing, validation and consulting to ensure customer product quality and process consistency.
We specialize in contamination control for cosmetics, specifically in verifying preservative effectiveness in products such as body lotions, shampoos, soaps, and eye care solutions. MRA provides the highest quality testing, adhering to CTFA and USP regulatory requirements while meeting strict client deadlines.
Cleanroom Validation (IQ, OQ, PQ)
MRA will validate a new or upgraded cleanroom and verify design, operational and performance specifications. Quote based on number of cleanrooms, ISO 5 PEC’s, Chemotherapy and Number of HEPAs.
Cleanroom Cleaning and Disinfection Program Implementation
MRA will setup cleaning and disinfection program including procedures for disinfectant types, preparation, contact time, frequency, rotation, equipment and schedules.
Environmental Services Pharmacy Cleanroom Disinfection
Include educational seminar, SOP review, cleaning observation, equipment compliance, disinfectant types, contact times and frequency.
USP <1112> Water Activity Testing (Aw) of Non-Sterile Pharmaceuticals (Solids/Oils/Creams) (2 days): Application of water activity for determination of potential microbial growth proliferation.
Samples can be shipped to MRA for laboratory analysis or MRA can provide qualified microbiologists to perform E/M on-site.
Enhanced Reports including graphical & Statistical Analysis can be provided per client request.
Includes growth promoted media for bacteria, yeast and mold, calibrated air samplers and particle counters for sampling. Also includes validated incubation, laboratory analysis, colony counts, Genus ID and final reports.
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