Your Partner in Validation
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.
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.
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.
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 (GDocP — or GRK for Good Record Keeping) 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.
CMI worked hand-in-hand with Big Pharma to ensure the whole GMP process in an adequate manner. After all, production planning is critical within the pharmaceutical industry and the requalification work must be completed within the scheduled shut down period. 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.
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, 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.
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.
Cleanroom and Equipment Qualification of:
Cleanrooms conform ISO 14644
Hospital Operating theatres
Validation of Laminar Flow Cabinets
Validation of Microbiological Safety Cabinets
Validation of Weighing Enclosures
Thermal mapping of incubators
Thermal mapping of fridges and freezers
Thermal Mapping of ultra-low freezers
Thermal Mapping of warehouses
Thermal Mapping of ovens
Endoscope washer disinfector
Endoscope drying cabinet
Validation of steam sterilizers
Validation of low temperature sterilizers
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.
Examples of temperature controlled units (TCU) are incubators, fridges, freezers, -ultra-low freezers and sterilization equipment like autoclaves and sterilization tunnels. Many 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.
Cleanroom & Equipment Validation
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.