GMP and ISO Cleanroom Validation
The Core competence of the validation department is to qualify and maintain your Pharmaceutical production Area’s.
All our engineers are VCA certified and are well trained on GMP requirements, cleanroom behaviour and sampling methods. We use state of the art validation equipment which is frequently verified on performance. We keep track of every piece of equipment so we know where and when the equipment was used between the last and next calibration date in case of deviations. In most cases we requalify the cleanrooms conform customer specific protocols, but we can also develop the protocols together with your QA department.
HVAC Validation Services
CMI offers HVAC qualification services for GMP-critical controlled environments like cleanrooms for sterile drug manufacturers and non-sterile pharma customers. We also validate your Isolator, Restricted Area Barrier Systems (RABS) or your microbiological safety cabinet or Laminar flow cabinet . We have a large team of well trained engineers that can help you to requalify your production area or qualify your new cleanroom in the as-built situation. Our validation department can prepare your qualification protocol or fill out your protocols depending on the quality system in place.
Our capabilities for testing consist of…
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HEPA filter integrity testing according to ISO14644-3
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microbial air sampling and surface contact sampling
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particle counting according to GMP and ISO14644-1
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airflow visualisation studies including recordings
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airflow and air velocity measurements
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differential pressure measurements
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temperature and relative humidity measurements
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Noise levels and Light Intensity measurements
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particle deposition measurements according to ISO 14644-17
Most requalifications are performed in the at-rest situation, but operational testing is becoming more important. We can test your HEPA filters in the sealing of the cleanroom or perform a global efficiency test of the HEPA filters in your air handling unit. We understand your needs to have a flexible partner that can help you to requalify your production area and production equipment during well planned maintenance stops (shutdowns). If we encounter irregularities during routine- or initial qualifications our experts will report this directly and look for a solution together with you to solve any problems in order to requalify your production area before production must be restarted. We therefore work with large teams to ensure we get the job done.
We supply HVAC validation services for:
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Cleanrooms
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Laminar Flow Cabinets
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Microbiological Safety Cabinets
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Weighing Enclosures
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Isolators
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Freeze dryers
Execution and reporting
Reports are filled out according to GDocP (Good Documentation Practices) and verified by our own internal QA department before the official report is presented to the customer. The report includes all raw data in compliance with Annex 11 (21 CFR part 11), calibration certificates of the equipment used and conclusions / recommendations based on the results of the measurements.
