Customers
Most of our customers are pharmaceutical companies or public organisations (e.g., hospital pharmacies) that comply with GMP requirements. Medical device manufacturers and organisations operating in biosafety level (BSL) facilities have also made use of our services. In addition, we have customers from other industries that operate in compliance with relevant regulatory requirements and need classified cleanrooms (e.g., ISO 14644).
Examples of customer projects:
Construction of a new pharmaceutical plant:
- Participation in the preparation of the user requirements specification (URS) relating to the cleanroom
- Preparation of a technical risk assessment for the facility
- Participation in the preparation of the Validation Master Plan (VMP) document
- Preparation of facility validation plans (DQ, IQ, OQ, PQ)
- GMP supervision during planning and construction. Cooperation with normal construction supervision and support for planning and contracting by providing expertise in GMP requirements
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Cleanroom performance qualification (PQ)
- Preparation of a facility validation report
- Providing GMP expertise related to the cleanroom commissioning
- Participating in the preparation of the Validation Master Report (VMR)
Cleanroom re-validation:
- Preparation of a facility validation plan
- Assessing the maintenance of validity level requirements
- Validation measurements and analysis of results
- Creating the validation report
- Periodic validation of the purified water system (plan, testing, report)
Construction of a new biosafety level facility (BSL 3):
- Participation in the preparation of the user requirements specification (URS) relating to the cleanroom
- Preparation of a technical risk assessment for the facility
- Preparation of facility validation plans (DQ, IQ, OQ, PQ)
- BSL supervision during planning and construction. Cooperation with normal construction supervision and support for planning and contracting by providing expertise in BSL requirements
- Design qualification (DQ)
- Installation qualification (IQ)
- Cleanroom performance qualification (PQ)
- Inspecting the validation of the utility systems (purified water, compressed air, CO2)
- Creating the facility validation report
- Providing expertise related to facility commissioning
Validation and classification measurements of a medical device manufacturing facility:
- Performing the initial validation of the cleanroom (validation plan, inspections related to the facility and documentation, cleanroom measurements, validation report)
- Periodic classification measurements (ISO 14644). Preparation of the measurement report and the certificate related to the classification.
