CES Services - Cleanrooms & Validation

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Cleanroom Validation

We offer a full range of validation services for start up and existing facilities, all our lead engineers are professionally accredited for clean room validation (Cleanroom testing (S2C2) with the Glasgow university) & we have vast experience working with compliance & validation departments with regard to doc prep, FDA, IMB audit preparation. We have previously worked in all sectors of the industry dealing with Pharma, Biopharma, Bulk, sterile & API facilities giving us a strong knowledge of all design requirements & standards within the industry.
We provide a very high standard of documentation for our reports & can develop in house documentation for annual compliance testing.

We troubleshoot all problems encountered i.e. non-compliant results, filter replacements,Re balancing of systems & there fore offer a one-stop shop when it comes to validation services.

Our main services include,

·         Clean room validation (in compliance with ISO 14644 parts 1-4, IEST-RP-CCOO 6.3 IEST-RP-CC 34.2,ISPE baseline guides, EU cGMP guidelines (orange guide & annex 1), World Health organization (WHO))

·         Biological Safety Cabinet testing (BSCs, class 1,2&3) in compliance with EN 12469 & National Sanitization Foundation (NSF) standard 49

·         Fume cupboard testing to BS 7258

·         Down flow booths, weigh booths, unidirectional flow hoods units (ISO, IEST-RP-CC002.2 & PD 6609)

·         Isolators, glove boxes

·         Dust collectors

·         Process filtration

·         Audit preparation

·         Documentation preparation & execution of client protocols

Specific tests include,

·         HEPA filter integrity testing

·         Room pressurization setup & verification

·         Particle counts

·         Air Chances Per Hour (ACPH)

·         Air volumes

·         Filter face velocities

·         Filter differential pressures

·         Temperature verification & mapping

·         Humidity verification & mapping

·         Airflow visualisation

·         Room recovery rates

·         Building Management System (BMS) verification

·         Fume Cupboard testing (velocities, KI discus)

·         BSC testing

·         Isolators

·         Continuous monitoring

·         Indoor air quality

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