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Microbiological Assays of Antibiotics

Analytical >> Analytical Testing Services >> Microbiology

Cebiphar is expert in microbiological testing and handles your antibiotic assays, Ph Eur, USP, specific methods. Our assets: experience of many different formulations (human & veterinary medicines, medical devices), last generation automated systems.

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Modern Microbiological Lab

Analytical >> Analytical Testing Services >> Microbiology

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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Microbiological Examination For Non Sterile Products

Analytical >> Analytical Testing Services >> Microbiology

Our stand-alone facility is dedicated to USP <51>, USP <61> and USP <62> testing that covers raw materials through finished products. We are an FDA-regulated, DEA-licensed, ISO 17025 and ISTA-certified contract service provider to the pharmaceutical, medical device, personal and consumer product

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Microbiological Quality of Sterile Products

Analytical >> Analytical Testing Services >> Microbiology

Cebiphar and its sister company ACM Pharma undertake sterility testing (clean room, isolators, BacT/Alert®), Bacterial endotoxins/ LAL, Particulate contamination (subvisible particles), Container Closure Integrity Testing.

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Microbiological Laboratory

Analytical >> Analytical Testing Services >> Microbiology

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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Microbiological Quality of Non-Sterile Products

Analytical >> Analytical Testing Services >> Microbiology

Certain germs have a pathogenic power that justifies their research & enumeration, the main ones being P. aeruginosa, S.aureus, E.coli, Salmonella, A. brasiliensis, C.albicans. The tests are carried out in accordance to the EU and Int' standards.

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Microbial Limits Testing

Analytical >> Analytical Testing Services >> Microbiology

AMRI performs bioburden/microbial enumeration testing (MET) on various pharmaceutical 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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Bacterial & Fungal Identification

Analytical >> Analytical Testing Services >> Microbiology

Phenotypic identification/ Mass Spectrometry - Maldi TOF/ rDNA Bacterial and Fungal identification. Thanks to our center of expertise, you benefit from the combination of all these technologies to guarantee reliability and reactivity.

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Antimicrobial Effectiveness Testing (AET)

Analytical >> Analytical Testing Services >> Microbiology

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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Biocides

Analytical >> Analytical Testing Services >> Microbiology

The aim of biocide activity test is to determine the capacity of a product (antiseptic, disinfectant surface/hand) to cause a logarithmic reduction desired at a given time. The tests are conducted in accordance to the reference standards.

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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