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Bactimm

Pharmaceutical Microbiology

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Bactimm

Bactimm & Farmalyse are contract service providers for the pharmaceutical industry, hospitals and the medical device industry, offering a full range of laboratory investigation services, quality control testing and validation services for clean rooms, processes and disinfectants.

Bactimm is the microbiological centre of excellence in our organisation.

As a benefit of our Good Manufacturing Practice (GMP) accredited clean rooms of 500m class D-A, one of only three in the Benelux-Germany area, all our microbiological studies are performed in-house with a service range including sterility testing, endotoxin testing and mycoplasma testing.

Bactimm is accredited with relevant GMP, ISO 9001 and ISO 13485 certifications and our services are calibrated to the OECD-GLP and ICH guidelines.

Fast, high-quality laboratory services

One of the core competencies of Bactimm is to provide specific solutions that enable our clients to aptly fine-tune their business model and outsourcing needs. With over 90% retention of sponsors, we take pride in offering our clients the best of our services and continually grow with them to adapt to their requirements and needs.

Bactimm offers services in the following areas:

  • Quality control testing
  • Laboratory investigations
  • Environmental monitoring

With over 12 years of experience in the industry, we serve our clients with a strong emphasis reliability and speed. Flexible on throughput times and maintaining a strong emphasis on quality assurance, we provide a customised tailor-made package of services sensitive to the requirements and specifications of our sponsors.

Microbiological studies

Our experience and expertise, together with that of our global clients and partner network from across different industry segments, assure the best of reliability, speed and quality in all Bactimm services.

Bactimm caters to more than 150 clients from across the world, including the UK, mainland Europe, the Middle East, India and the US, in a variety of industry sectors such as generics, medical devices, proprietary products, raw materials, hospitals and cosmetics.

Our major clients include Sanquin, Novartis, Astellas, Ratiopharm, Ranbaxy Laboratories, Actavis, Abbott and MGI-SP among others.

 

Bactimm B.V.
Middenkampweg 19
6545-CH Nijmegen
The Netherlands

Tel: +31 24 371 5265
Fax: +31 24 371 5253
info@bactimm.coml
www.bactimm.com

Environmental Monitoring

Bactimm performs environmental monitoring projects routinely for manufacturing sites, hospitals and competitors.

Environmental monitoring projects certify various processes including: Microbiological clean room qualification Microbiological cleaning validation Media fills Process validation - sterilization as per ISO guidance disinfectants efficacy testing (suspension and surface testing) as per ISO Please contact us for a full list of our quality assurance and consultancy services as well as sample project reports.

Laboratory Investigations

Bactimm carries out method development and validation studies according to international guidelines, using standard validation packages in conformity with ICH guidance.

A validation project, executed as per GLP guidelines, comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report. Validation studies are performed by dedicated staff with special training on study handling, in accordance with international guidelines, such as PhEur, USP and ICH.…

Quality Control Testing

Bactimm performs pharmacopoeial and non-pharmacopoeial microbiological tests routinely on a large scale basis for pharmaceutical products and medical devices in compliance with GMP-GCLP.

We combine chemical and microbial product knowledge with quality control testing, method development and validation studies for finished formulations, active pharmaceutical ingredients, excipients and medical devices. In our state-of-the-art laboratories we offer a complete range of services including chromatography facilities (HPLC, UPLC, GC, LC-MS and TLC), spectroscopy (UV and IR) dissolution testing and GMP certified…
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