HVAC Validation of Cleanrooms and Associated Controlled Environments
Many products and processes require the control of airborne contamination during manufacturing and processing include aerospace, food & drink, healthcare, medical devices, microelectronics, pharmaceutical, biotechnology and automotive industries.
Cleanrooms and associated control environments require continuous testing, monitoring and routine re-qualification to ensure compliance with the controlled low levels of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapours, sometimes using separate devices such as Clean Airhoods, Gloveboxes, Isolators and mini environments.
Some HVAC systems also control temperature, pressure and humidity using ionizers to prevent electrostatic discharge problems. All these systems require routine re-qualification, testing and monitoring to provide evidence of continual compliance with the legislation.
HBI provides testing and monitoring services to ensure continual compliance to ISO 14644 ‘Cleanrooms & Associated Control Environments’; ISO 14698 ‘Cleanrooms and Associated Control Environments – Biocontamination control’ and EU GMP.
Indoor Air Quality Services
Our Services include:
- Particle count test
- Airflow volume and airflow velocity test
- Room air change rate calculation
- Air pressure difference test
- Installed filter system leak test
- Recovery test
- Airflow visualization test
- Containment test
- Temperature and relative humidity test
- Noise level test
- Lighting level test
- System rebalancing
- Microbiological safety cabinets
- Glove box verification
- Hepa filter replacement
- LEV/fumehood verification
Data at your Fingertips
We understand how important it is to have access to your risk assessments and monitoring reports, so with our online MBR Risk Management System you will have secure, realtime access to your data, as well as delivering you an audit trail for your health and safety compliance.