Clean Room Testing
Cleanroom Testing and Certification
Cleanrooms play critical roles in maintaining contamination free production environments for critical processes. To ensure your cleanroom is working as designed it is essential that a well planned and executed cleanroom testing and certification and maintenance program is undertaken for operation and regulatory compliance. APT cleanroom testing offers clean room testing and clean room certification. In Pharmaceutical, Biotech, and Medical Device cleanrooms, it is imperative that companies know if any airborne contaminants put products at risk. It is also very important to understand what the contaminants are, and their origin. Important environmental measurements, like airborne viable particle measurements, assist with keeping processes in control and with helping to find the root cause of unwanted events to monitor cleanrooms for viable particles and other potential contaminants to ensure a clean environment is maintained at all times.
We undertake the testing of cleanrooms in accordance with international standards and customer quality specifications. Cleanroom test protocols and report documentation can be customised to customer specifications. Our primary cleanroom tests include:
> Non-viable particulate monitoring
> Airflow volume/velocity profiling
> Room air exchange rates
> HEPA filter integrity testing
> Room pressurisation monitoring
> Temperature and humidity monitoring
Using our technical knowledge and experience in cleanroom testing coupled with our steadfast commitment to quality and the highest standards of customer service we provide our clients with reliable, accurate and thoroughly documented clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimised facility down time as most companies clean rooms are their main critical asset.
Our Typical Clean Room Testing Process
In order to ensure that your clean room environment is working effectively a number of factors relating to the air supply coming from your ventilation need to be tested. These tests apply to every type of clean room, whether used for the manufacture of pharmaceutical products, sterile and aseptic production.
We will need to test the quantity of air to ensure that there is enough to dilute or remove any contamination generated within your clean room, and we will need to test the quality of the air to ensure that it is not adding to any contamination, rather than removing it.
We also need to test the flow of the air to ensure that it is moving from clean to less clean areas, minimising the movement of any contaminated air into your clean area, and also to ensure there are no areas of the room with high concentrations of pollutants.
In order to carry out these tests, for every clean room we are working in, we will measure and check:
1. Air supply and extract quantities - If your air supply is unidirectional we will measure and record the air velocity, while for non-unidirectional systems we will measure air supply.
2. Differential pressure - Here we will be testing to ensure that the air in your clean room always moves from clean to less clean areas, with your clean room having a higher pressure than adjacent less clean areas.
3. Filter installation leak testing - Your ventilation system's high efficiency particulate air (HEPA) filter, and its housing will be tested with DOP (Dispersed Oil Particulate) to ensure their integrity.
4. Containment leak testing - We will check the construction of your clean room to ensure that no airborne contamination can occur via leaks from higher pressure work areas adjacent to it.
5. Air movement control - Studying the movement of the air within your clean room we will check that there is sufficient air movement to dilute or remove pollutants, preventing any contamination build-up.
6. Room recovery - Reviewing the effectiveness of airflow we will measure how quickly a clean room recovers to its normal operating cleanliness following a release of particulate contaminant.
7. Airborne particles and microbial concentrations - Finally, we will carry out measurements to ensure that the concentration of particles and micro-organisms is compliant with the specification set out for your clean room.
8. Temperature, Relative Humidity - We may also need to carry out tests on temperature, relative humidity, and the heating and cooling capabilities of the room, as well as noise, lighting and vibration levels.
Ensuring that you fully understand our process and your results, following any clean room testing or validation service, we will present you with clear, easy to follow reports that can be compiled, quality checked and issued to you while still on site, minimising the down time of your operations.
We are customer driven and continually try to exceed our customers' expectations, both in terms of price and service. Our careful attention to detail ensures that our reports and certificates are of the highest quality and customers can be confident that their external calibration and validation requirements have been met. Our commitment to quality is backed up by our UKAS accreditation. Our test engineers are well trained, highly motivated and flexible individuals who ensure constant and consistent delivery of our high standards.
If you have a clean room that requires particulate monitoring or any of the above testing then please get in touch with us as soon as possible as we should be able to offer you an expedient solution for all your cleanroom testing and certification. We can also offer maintenance programmes to ensure your cleanroom is in compliance with the corresponding ISO standards- it's why we place such emphasis on the process of 'expert intervention'.
Contact Us Now
We provide full ISO compliant UKAS accredited Air & Sound Testing and Noise Surveys. We use the latest 'state of the art' Norsonic sound testing equipment which is UKAS calibrated class 1 rated.
If you are unsure of your projects acoustic requirements please call us now on: 01525 303905 or email us at: firstname.lastname@example.org
APT Sound Testing Services
Head Office: Sayells Farm, 7 Harlington Road, Upper Sundon, Bedfordshire, LU3 3PE