Cleanrooms and controlled environments are precision-engineered to manage airborne particulates, both viable and non-viable, while maintaining rigorous control over airflow, pressure, temperature, and humidity.
HVAC Validation and Monitoring
Cleanrooms and controlled environments are precision-engineered to manage airborne particulates, both viable and non-viable, while maintaining rigorous control over airflow, pressure, temperature, and humidity.
HVAC Validation and Monitoring
In sectors where air quality is non-negotiable, including pharmaceuticals, life sciences, and aerospace. Validation is the cornerstone of operational integrity. As a brand-independent service provider, we offer unbiased qualification for cleanrooms, operating theaters, and safety cabinets. Our neutrality is our greatest asset, ensuring your critical environments meet the highest standards of accuracy and compliance without conflict of interest.
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 our extensive experience, we help customers to validate their controlled environments such as operating rooms, central sterilization departments, pathology labs, IVF clinics and GMP critical pharmaceutical production environments.
Cleanroom and Equipment Qualification of:
- GMP Cleanrooms
- 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
- Centrifuge validation
- Washer disinfectors
- Endoscope washer disinfector
- Endoscope drying cabinet
- Validation of steam sterilizers
- Validation of low temperature sterilizers
Periodic Qualification
Periodic requalification is essential to meet National and International standards (including FDA, cGMP, and ISO). We develop customized validation protocols for client QA approval prior to any intervention. All testing follows Good Documentation Practices (GDocP/GRK), ensuring that every report is internally verified by our QA department before delivery. By integrating clear PASS/FAIL criteria into our protocols, we provide a definitive and compliant qualification of your controlled environments.
Equipment Validation
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.
Thermal Validation
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.
