HVAC Validation of 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.
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.
HBE 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.
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
- Glove box verification
- Hepa filter replacement
- Inspection, Repair and Maintenance Services for:
- Fume Cupboards (Including Radiochemical)
- Microbiological safety cabinets classes I, II and III
- Laminar flow hood / units
- LEV/fumehood verification
- Dust Extraction
For more information about HVAC Validation of Controlled Environments call us on 0845 6399 673 (outside the UK +44 28 3083 9033) or email email@example.com
An accident repair company has been fined after it failed to comply with an improvement notice for a failing to have its spray booth inspection undertaken by a competent person. Swansea Magistrates’ Court heard that [...]