{"id":1579,"date":"2020-09-11T14:44:15","date_gmt":"2020-09-11T14:44:15","guid":{"rendered":"https:\/\/cleanroom.questo.nl\/?page_id=1579"},"modified":"2021-04-04T11:40:23","modified_gmt":"2021-04-04T11:40:23","slug":"validation","status":"publish","type":"page","link":"https:\/\/www.cmitest.nl\/fr\/validation\/","title":{"rendered":"Validation"},"content":{"rendered":"
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Validation<\/h1>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Your Partner in Validation<\/h1>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

Cleanroom Validation<\/h4>\n<\/div><\/div>
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Cleanrooms and other controlled environments are designed and constructed to control the concentration of viable- and non viable airborne particulates and in many cases also other environmental conditions such as airflow, differential pressure, temperature, and relative humidity.<\/h5>\n<\/div><\/div>
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Air quality in Cleanrooms, Operating theatres, Isolators, Laminar flow benches and Microbiological safety cabinets is critical within the pharmaceutical industry, life sciences, medical devices, research labs, hospitals and communication and satellite industries. The core task of our validation services is to qualify your controlled environment as an independent company not linked to any brand or supplier. Neutrality is our biggest asset all set to provide reliable classification of critical areas.<\/h5>\n
We have the knowledge to develop a personalized validation protocol in collaboration with our QA department. All reports are first verified by our internal QA-department before the final approved report is distributed to the end user. With over 25 years of experience, we help customers to validate their controlled environments such as operating rooms, central sterilisation departments, pathology labs, IVF clinics and GMP critical pharmaceutical production environments.<\/h5>\n<\/div><\/div>
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HEPA filter integrity testing<\/div>
ISO 14644-3<\/div><\/div><\/div><\/div><\/div><\/div><\/div>
Periodic Qualification<\/h6>\n<\/div><\/div>
Periodic requalification is required for Customers to National and International Standards. Depending on the requirements for the validation and the applicable standards (FDA Guidelines, cGMP, ISO, ICH etc) we have the possibility to develop a validation protocol which can be reviewed, edited and approved by the QA department of our client before the intervention is scheduled. The reports are filled out according to Good Documentation Practices (GDocP) and the official report is verified internally by the QA department of CMI before sending the report to the end user. Good Documentation Practice<\/em><\/strong>\u00a0(GDocP \u2014 or GRK for\u00a0Good Record Keeping<\/em>) is an essential component of your (and our) overall quality management systems (QMS) and risk management strategies (QRM). All important PASS\/FAIL criteria are incorporated in the validation protocol which enables us to qualify the cleanroom or equipment based on these clear criteria.<\/h5>\n
CMI worked hand-in-hand with Big Pharma to ensure the whole GMP process in an adequate manner.\u00a0 After all, production planning is critical within the pharmaceutical industry and the requalification work must be completed within the scheduled shut down period.\u00a0 Production lines are not shut down in the hope that validation goes as planned, they want to be sure that it is. We therefore work with large teams to ensure the work will be completed.<\/strong><\/h5>\n
With over 25 years of experience in the cleanroom technology industry and support of many large pharmaceuticals customers in aseptic and non-sterile production environments, hospitals operating theatres,\u00a0 pathology labs and pharmaceutical research and production facilities, we understand the importance of your cleanroom qualification to regulatory standards including: ISO 14644:2015, cGMP, and other guidelines stipulated by international agencies such as FDA, EMA , ICH and WHO.<\/h5>\n<\/div><\/div><\/div><\/div><\/div><\/div>
Thermal Validation<\/h6>\n<\/div><\/div>
Next to our HVAC services we provide thermal validation services for all kind of equipment used within the pharmaceutical industry and in hospitals. We provide validation services for Washter Disinfectors, Sterilizers, Endoscope Drying cabinets, Fridges, Freezers, Ultra-Low Freezers and many more. The reports are generated with a 21 CFR part 11 compliant software package DTPRO from MESALABS, for more information visit our specific page for our thermal validation services and solutions.<\/h5>\n<\/div><\/div>
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\"Validation\"<\/div>
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Cleanroom and Equipment Qualification of:<\/h6>\n<\/div><\/div>
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    GMP Cleanrooms<\/h5>\n<\/li>\n
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    Cleanrooms conform ISO 14644<\/h5>\n<\/li>\n
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    Hospital Operating theatres<\/h5>\n<\/li>\n
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    Validation of Laminar Flow Cabinets<\/h5>\n<\/li>\n
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    Validation of Microbiological Safety Cabinets<\/h5>\n<\/li>\n
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    Validation of Weighing Enclosures<\/h5>\n<\/li>\n
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    Thermal mapping of incubators<\/h5>\n<\/li>\n
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    Thermal mapping of fridges and freezers<\/h5>\n<\/li>\n
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    Thermal Mapping of ultra-low freezers<\/h5>\n<\/li>\n
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    Thermal Mapping of warehouses<\/h5>\n<\/li>\n
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    Thermal Mapping of ovens<\/h5>\n<\/li>\n
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    Centrifuge validation<\/h5>\n<\/li>\n
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    Washer disinfectors<\/h5>\n<\/li>\n
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    Endoscope washer disinfector<\/h5>\n<\/li>\n
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    Endoscope drying cabinet<\/h5>\n<\/li>\n
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    Validation of steam sterilizers<\/h5>\n<\/li>\n
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    Validation of low temperature sterilizers<\/h5>\n<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><\/div>
    Equipment Validation<\/h6>\n<\/div><\/div>
    Equipment qualifications can be divided in equipment that prevents a product from contamination sources by providing a clean work environment and temperature controlled equipment that needs a periodic thermal mapping. Examples of local clean environments are laminar flow cabinets , microbiological safety cabinets and pharmaceutical grade isolators.<\/h5>\n<\/div><\/div>
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    Examples of temperature controlled units (TCU) are incubators, fridges, freezers, -ultra-low freezers and sterilization equipment like autoclaves and sterilization tunnels.\u00a0Many of our engineers are educated to perform both type of validations related to HVAC- and Thermal validations allowing us to combine interventions and save money related to travelling or ineffiency in the workflow.<\/h5>\n<\/div><\/div>
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    Cleanroom & Equipment Validation<\/h2>\n<\/div><\/div>
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