Microbiological operations are an integral part of pharmaceutical industry and play a significant role in the overall product life cycle such as during Drug Development: Development of new drugs - vaccines, antibiotics, Fermentation and Microbial bioconversions of drugs; during Drug Manufacturing: Aseptic processing, Sterilization, Process validation and Environmental Monitoring; during Quality Control: Microbiological Testing - Sterlity Testing or during Storage & Distribution: Preservation of drugs and Cold Chain. The microbiological attributes of pharmaceutical ingredients are often critical to final product quality. FDA expects manufacturers to measure and characterize the microbial quality of their pharmaceutical substances as well as of their final drug products. Contract microbiological testing service providers apply USP, Ph. Eur. and other international methods to a wide variety of biologics and traditional pharmaceuticals. These testing facilities should meet the demanding cleanliness and engineering requirements of microbiological testing programs. Class 100 hoods, clean rooms and isolators for microbial evaluation are important parts of their facilities. Biological and microbiological testing services include: Microbial limits tests (microbiological examination of non-sterile products); Sterility testing; Microbial contaminant identification; Antimicrobial effectiveness testing (sterile and non-sterile multi-dose forms) and microbial challenges; Mycoplasma testing; Microbiological assessment of antibiotics; Bacterial endotoxins testing; Sampling and analysis of water for pharmaceutical microbiology; Chemical disinfectant testing and cleaning studies; Environmental monitoring; Microbiological attribute studies (e.g. barrier testing for packaging, condoms and medical gloves, and hygienic and antibacterial testing for contact lenses, personal care products, and more.); Non-viable particulate testing, etc.

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Well-equipped laboratories performing comprehensive tests for the finished products, WIP, raw materials, equipment cleaning in compliance to ICH guidelines using Pharmacopoeial methods, In-house test methods and customer's requirements.

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AMRI offers market-leading expertise in cytotoxicity assays. Our scientists use cell culture assays to assess the biocompatibility of a material or extract through an in vitro reaction of mammalian cells following exposure.

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JGL's analytical laboratory is GMP certified and offers microbiology testing which includes Microbiological Limits testing; Presence/Absence of Pathogens; Sterility testing; LAL testing; Identification of microorganisms.

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After it acquired 3M’s fine chemical department, the Axyntis Group’s Pithviers location set up an over 1,000 m2 quality control laboratory as well as a microbiology laboratory.

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Our stand-alone facility is dedicated to USP <51>, USP <61> and USP <62> testing that covers raw materials through finished products.

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JGL's analytical laboratory is GMP certified and offers microbiology testing which includes Microbiological Limits testing; Presence/Absence of Pathogens; Sterility testing; LAL testing; Identification of microorganisms.

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Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

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AMRI's experts bring many years of experience in the pharmaceutical, cosmetic and consumer industries, and we have handled a diverse and vast list of products and specifications.

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AMRI performs bioburden/microbial enumeration testing on various pharma articles including raw materials and finished forms, as well as on medical devices and packages that are categorized as nonsterile, to determine the microbial load on the products

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With our long history of serving the pharmaceutical industry, Merck has pioneered & refined ground-breaking solutions, demonstrating the regulatory & technological expertise to make compliance as simple as possible, and help save your valuable resources.

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To ensure the quality of your parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection and APIs, AMRI's experts offer testing for the detection and control of endotoxins.

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AMRI performs antimicrobial effectiveness testing (AET) or preservative effectiveness testing to help evaluate your product’s ability to withstand microbial contamination during use.

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UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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We are approved by the State FDA and Central Drugs Standards Control Organisation (CDSCO) for the testing of drugs and cosmetics and can also provide reports on form 39 for pharmaceutical microbiology testing.

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Our facilities and testing methods are compliant with all Health Canada, FDA, USP and other regulatory body requirements and guidelines in order to provide effective testing services for your product.

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ACTA offers comprehensive microbiological services to support your needs. ACTA uses well-maintained and calibrated instrumentation to perform your microbiological testing.

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AMRI provides microbiological population verification services through the assessment of biological indicators per USP <55>.

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All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

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AMRI provides expert services to test disinfectant efficacy. Disinfection and cleaning of critical areas is a key component to successful control of these environments.

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Pharmatis has been conceiving and developing various recipes, processes and drugs for many years. Pharmatis offers a wide range of industrial developments.

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All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

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AMRI provides environmental monitoring services to evaluate your cleaning and disinfection programs, assessing the microbial cleanliness of your manufacturing environment per USP <1116> Microbiological Evaluation of Clean Rooms

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All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

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Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.