Intech provides complete cleanroom Validation and Testing solutions for both unidirectional and non-unidirectional
Cleanrooms, all work is performed in accordance with the following standards:
ISO 14644-1 (ISO Class 1 to ISO Class 9) and EU GGMP (Grade A to D).
We use the latest equipment maintained and calibrated to the latest standards for all work.
Our Cleanroom Validation reports are clear and concise. Our careful attention to detail means that customers can be confident in our measurements and that our reports will satisfy the requirements of regulatory bodies including MHRA, FDA and IMB.
Our services include:
- HEPA Filter Integrity testing using DOP method
- Differential pressure measurements and instrumentation calibration
- Airborne particle counting
- Airborne particle counting
- Room air change rate calculation
- Cleanroom containment leak test
- Airflow visualisation studies
- Temperature measurements and temperature mapping
- Relative humidity measurements and humidity mapping
- Sound level measurements
- Light level measurements
Our Cleanroom Validation services also include:
HTM03-01 Surveys
Our engineers survey various hospitals, drafting detailed reports to confirm that the requirements of HTM 03-01Specialised Requirements For Healthcare Premises are being met. Where issues are identified and improvements can be made, our clearly presented reports make the implementing change a much easier task.
Energy conservation audits are performed to assess the efficiency of clean air systems and look for improvements in the operation of AHU units and Building Management Systems (BMS). Energy savings solutions include: HEPA filters with improved efficiency ratings, calibrated AHU sensors and monitoring systems & reducing air change rates (where they are Unnecessarily too high).
We offer Maintenance Contracts for AHU systems. A good preventative maintenance program is vital in providing maximum reliability with the minimum of downtime. Equipment testing frequencies must be set and adhered to as required by regulatory authorities and to help provide maximum equipment life.
All of our engineers are fully trained in cleanroom and GMP/cGxP practices for both Hospital and Pharmaceutical
research and production facilities. Although we focus on the Pharmaceutical and Healthcare industries we are by no means limited to it. Current customers include the following industries: Healthcare, Pharmaceutical, Nuclear, Space, Electronic and the Semiconductor industry.
Our team provide an SOP development service for the creation and amendment of SOP’s and test procedures for your facility. Existing procedures can be re-written as the demands of your facility change.
*Orange Guide (MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007).