Cleanroom Validation Testing

Air Quality Testing to Cleanrooms Clean room facilities such as Semiconductor and pharmaceutical manufacturers are examples of environments that require periodic validation and certification.  An accurate air monitoring and testing regime is the only method for these clean room facilities to maintain that level of cleanliness needed during environmentally sensitive production. Our particle counters can activate alarms when contamination poses immediate threats to manufacturing processes thus warning the end user of potential risk from contamination.  Also, these cleanroom particle counters can document emerging contamination trends and weak spots within the process to guide cleaning personnel in maintaining air quality in their critical environments.   Testing with a Handheld Particle Counter As the manufacturing process becomes more efficient and more products are produced in the same space during the same amount of time the greater potential monetary los...

The Processfor Undertaking Air Particle Counts APT Sound Testing undertakes airborne particulate testing to data centres and/or server rooms to confirm the level of air quality against the Cleanroom ISO 14644-1 standard for Cleanrooms which encompasses server rooms and Data Centres’. The particulate tests are done using a UKAS calibrated air particle counter. APT Sound Testing aims to confirm that the Data Centre and each room within it meets the minimum ISO Class 8 for Data Centres and server rooms as per OEM best practice guidelines. Taking the airborne particulate measurements Using a hand held or static air particle machine that has been properly calibrated collect   5 air sample per 10 square meters of room space -   in a 50m2 room a minimum of 10 tests should be taken and in 100m2 square meters 15 tests should be taken. The exact location of each particle test should be documented and if you are looking to trend the air quality in a certain ro...

Clean Room Commissioning Cleanrooms are used in a wide variety of industries such as medical, Pharmaceutical and Biotech. Each Cleanroom 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 verification testing and certification and maintenance program is undertaken for operation and regulatory compliance. APT cleanroom testing offers clean room testing and clean room commissioning certification. Clean Room Environment It is essential 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 such as the ingress of filter p...

The Critical Role of Cleanrooms 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 validation testing ,   certification and maintenance program is undertaken for operation and regulatory compliance. T o achieve compliance with the relevant ISO standards, Cleanroom validation needs to be undertaken to ISO 14644-1:2015  - Classification of air cleanliness by particle concentration and  ISO 14644-2:2015  - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. Clean Room Validation Services We offer a comprehensive and proactive cleanroom validation service to the requirements of all current ISO standards and guidelines. We are customer driven and continually try to exceed our customers’ expectations, both in terms of price an...

Potential Cleanroom Validation Hazards There are many potential hazards in clean rooms, so maintaining the health and safety and adhering to the high standards of a controlled cleanroom environment requires thorough training and routine testing and inspections. Maintaining safety standards scan be quite a challenge as the unpredictability of things that can go wrong and ultimately contaminate a cleanroom are quite extensive. Some common examples cleanroom hazards include: Holes in the HEPA Filters - Sometimes employees accidently damage HEPA filters by lifting mop handles to high and hitting the underside of the HEPA filters. Electrical Outlets – check that your electrical outlets are properly sealed.  Sometimes, small insects can crawl through outlets as well as airborne duct and contaminates. Mechanical Pipe Runs - check that your pipes etc. are properly sealed where they terminate through the room/building envelope. Double Doors - when you’re designing an...

APT Sound Testing looks at the frequency of particulate testing required for compliance with to ISO 14644-1:2015 APT Sound Testing has been asked what impact the updated standard has on cleanroom validation and testing frequency and we will try to answer those questions here. In early January 2016, ISO introduced an update to standards ISO 14644-1:2015   - Classification of air cleanliness by particle concentration and ISO 14644-2:2015    - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. To ensure that your cleanroom continues to perform efficiently and enhance your business process, it needs to be tested and validated to prove it complies with ISO 14644-1:2015 - Classification of air cleanliness by particle concentration . ISO 14644-2:2015 - Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration, recommends customers to complete risk asses...