Testing & Validation continued…
Total Clean Air offers validation service/support for all types of cleanroom facilities to confirm they meet international standards such as EU GMP classification and to ensure they are operating in compliance with ISO 14644-1:2015 and ISO 14698 cleanroom standards.
With our cleanrooms we offer a tailor-made testing schedule to meet regulatory and process needs. Our experienced and accredited validation engineers will visit your site and conduct a range of tests to evaluate your cleanrooms performance. Cleanroom testing and validation ensures a totally secure environment and ISO compliance. Tests to be carried out include:
- Airborne particle counts
- Airflow readings
- Filter integrity testing or dispersed oil particular testing
- Air Pressure differentials test
- Air changes and volumes
- Containment leak test
- Smoke visualisation testing
- Safety cabinet assessment
- Recovery rate testing
- Comfort tests
- Provision of particle counter calibration certificates
Total Clean Air also provides validation services for all associated clean air devices for Operational and Performance Qualification (OQ & PQ).
In addition, TCA offers a comprehensive maintenance service for cleanrooms and cleanroom equipment and a 24-hour support service and extended warranty for facilities using our cleanrooms.
We also offer testing and validation service after a cleanroom or any other area has been through a decontamination process in-order to establish if the risk to the environment has been completely eliminated.
Our decontamination validation process follows stringent guidelines to deliver a thorough service to make sure your site is completely safe. After a decontamination process has taken place it is advised that we go on to test and validate how successful the decontamination was. This is imperative in-order to understand how effective the interventions have been. It is the only way to ensure that any bacteria, bugs or hazards have been completely eliminated.
At TCA, we offer a fast and reliable decontamination testing and validation service. Our unique decontamination validation process is different because we don’t use the traditional biological indicator method which can take up to a week to produce results.
Our method is backed by our sister company Protak Scientific which provides us with access to enzyme indicator technology allowing us to get immediate decontamination validation results. By getting this validation information so quickly it means we are able to run further interventions if required or deem the location fit for operation as quickly as possible.
We understand that when a room or building is contaminated or scheduled for routine cleaning it can cause frustration for your employees. It can interfere with the functional operation of your workforce and put pressure on other departments and resources. Our decontamination validation process means you can get your rooms functional again as quickly as possible saving your organisation time and money.