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Microbiology Research Associates, Inc.

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Acton, Massachusetts, US

About Microbiology Research Associates, Inc.

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... Show more »

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.

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Certifications & Qualifications

DEA Schedule II DEA Schedule III DEA Schedule IV DEA Schedule V FDA Inspected GLP ISO 9001

Our Services (27)


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IND/NDA/BLA Submission

Investigational New Drug/New Drug Application Submission
Price on request

Microbial characterization and method development. FDA submission for microbial controls.

Microbial characterization and method development. FDA submission for microbial controls.

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Process Consulting

Price on request

MRA will set up protocol based media fill for TPN pumps, repeaters and compounding robots including growth promoted media in multiple type containers.

MRA will set up protocol based media fill for TPN pumps, repeaters and compounding robots including growth promoted media in multiple type containers.

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Aseptic Processing

Price on request

Training seminars for contamination control garbing, biological safety

Training seminars for contamination control garbing, biological safety

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Cleaning Validation Services

Price on request

Disinfecting Consulting and cleanroom contamination control

Disinfecting Consulting and cleanroom contamination control

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Antimicrobial Efficacy Testing

Price on request

Turnaround 33 days includes interim reports at 7, 14 and 21 days.

Turnaround 33 days includes interim reports at 7, 14 and 21 days.

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Microbiology Consulting

Price on request
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Microbial Limit Testing

Price on request

Turnaround time 5 days includes final report

Turnaround time 5 days includes final report

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Sterility Testing

Price on request

Per USP <71> turnaround time 14 days
Membrane filtration or Direct Transfer, ISO 5 Cleanroom
Biological Indicators

Per USP <71> turnaround time 14 days
Membrane filtration or Direct Transfer, ISO 5 Cleanroom
Biological Indicators

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Endotoxin Testing

Starting at $575.00 per sample

Turnaround time - 2 days

Turnaround time - 2 days

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Medical Device Testing

Price on request

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.

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.

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Cosmetic and Personal Care Product Testing

Price on request

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.

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.

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Clean Room Validation

Price on request

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... Show more »

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.

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USP Water Testing

Price on request

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.

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.

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Facility Environmental Monitoring/Industrial Hygiene

Price on request

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... Show more »

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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Project Management

Price on request
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Product Development, Testing, and Packaging

Price on request
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Product Testing Services

Price on request
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Biology

Price on request
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Laboratory Equipment and Facility Management Services

Price on request
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Cells and Tissues

Price on request
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Medical Devices & Diagnostics

Price on request
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Regulatory Affairs Services

Price on request
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Product Quality Control

Price on request
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Testing of Cell Lines

Price on request
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Microbiology

Price on request
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Sterilization Services

Price on request
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Microbiology Assays

Price on request
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