Quality Control Instruments
Product quality is important for every industry, but in particular for the pharmaceutical industry and related industries like food and healthcare. The Quality Control department must be an independent department with the responsibility for product quality only.
The QC -manager must analyse and store all important records related to product quality and quality of the production environment before batch release can be approved. CMI plays an important role here with the QC-suite of instruments and services we offer in the Benelux and France.
CMI offers a large range of analytical instruments to facilitate companies to comply to the quality requirements for their specific products under GMP or ISO or any other standard that is required for their product release. our instruments are often integrated into Environmental Monitoring Systems used in controlled environments like, cleanrooms, aseptic filling lines, isolators, but also for quality control of pharmaceutical waters like purified water (PW) and water for injection (WFI). The QC-instruments are designed to meet the FDA ALCOA Guidance to ensure the best possible Data Integrity Solutions.
The instruments can usually also be easily integrated into any third party software or via our own Environmental Monitoring software solutions. Everything we do within CMI is related to compliance and we understand your needs related to implementation of new GMP -critical instruments or monitoring systems. We have an (IQ/OQ) qualification protocol available for every instrument we supply and trained engineers to qualify these instruments together with the end-users.
We have summarized our Quality Control Instrumentation below for all applications, like:
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Airborne particle counting
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Datalogging 21 CFR part 11 Compliant
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Filtertesting
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Liquid particle counting
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Pharmaceutical water monitoring
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Microbial sampling
Within CMI we supply the following QC-Instruments:
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MET ONE airborne particle counters
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EMTEK microbial airsamplers
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ANATEL on-line TOC Analyzers
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ANATEL laboratory TOC analyzers
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HIAC liquid particle counters for USP testing of parenterals
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HIAC liquid particle counter for Fluid Power applications
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Temperature sensors for cold-chain monitoring
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Relative humidity sensors
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Differential pressure sensors from CMR
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Photometers for HEPA filter integrity testing
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Aerosol generators
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Smoke generators for flow studies
Our Quality Control Instruments
Datalogging 21 CFR part 11
Microbial Air Sampling
Airborne Particle Counters
HEPA Filter Testing ISO 14644-3
Liquid Particle Counters
What our clients are saying
As CMO in the biopharmaceutical sector, Novasep Belgium pays special attention to the qualifications of production areas and equipment. For some 10 years now, CMI has been a partner we can rely on for the realisation of these operations.
Flexibility and professionalism are two of CMI’s assets.
It is always nice to work with the motivated CMI team! Everyone is very helpful, enthusiastic and they have a great sense of responsibility. They are always welcome!
CMI is a reliable and professional partner where quality and service are of paramount importance and with whom we will undoubtedly continue to work together.
I would like to thank you again in this way, I have been working here at Novartis (Alcon Couvreur NV) for 17 years. Quality and correctness are our top priorities. Nevertheless we always bring it to a succesfull conclusion, partly through your great support.