It is vitally important that cleanroom validation is an essential part of ensuring that cleanroom facilities are operating at the levels of cleanliness required by facility owners, their customers and where required perhaps external regulatory bodies.

However, there are multiple standards for clean room performance; in addition, facility owners can specify variations from the main classes of cleanroom to meet the needs of specific applications.

The Purpose of Clean Room Validation
Cleanroom validation or cleanroom certification can be seen as “passing a cleanroom test“; thus allowing the facility to continue to operate and be productive as designed. In most instances cleanroom validation is really about quality control, for instance:

  1. Preventing external contamination of samples by ensuring reliable test or experimental results.
  2. Ensuring a clean sterile environment for pharmaceutical or food production.
  3. Ensuring a low particulate environment to preventing damage to sensitive electronics.

For many facilities a cleanroom is the top of the critical asset chain; therefore, cleanroom compliance is also business critical factor; not just for profitability but also business reputation which is just as important.

APT Cleanroom Testing is a specialist clean room services company and we fully understand the importance of not just undertaking the validation testingand commissioning, but in helping facility stakeholders maintain high ongoing levels of cleanliness.

For APT Cleanroom Testing ongoing clean room validation is therefore part of a much wider process of ongoing monitoring, testing and maintenance. Facility managers have to weigh up the costs of maintaining a higher grade of cleanroom against the costs of having to repair or replace a contaminated product; however they also have to attain the cleanroom ISO standard and regulatory requirements. It is critical that any judgement is carefully made, so that the agreed standards that have been decided sand agreed are rigidly enforced and validated, it’s worth noting that even small drops in quality may lead to an increase in contamination which may affect the bottom line and set experimental programmes/production by back by months.

APT Clean Room Testing and Validation Services
There arevarying standards that apply to different classes of clean room, and how to carry out the cleanroom testing in a consistent and reliable way. The Cleanroom Validation Standards are as follows:

ISO 1 class (No GMP Classification)

ISO 1 class is the cleanest, with an allowable particle count of just 10 per m3 at 0.1µm and just 2 per m3 at 0.2µm. This type of facility is very uncommon would be used only for the most sensitive research and development work involving, for instance, semi-conductors or nano-technology. ISO Class 1 is significantly cleaner than the cleanest cleanroom specified by either the BS 5295 standard or the EU GMP standard, whose highest grade cleanrooms equates approximately to ISO Class 3 and ISO Class 5 respectively.

ISO Class 5 (GMP classification A and B)

ISO Class 5 facility is considered a high grade cleanroom and is typically required for aseptic applications such as sterile filling of pharmaceutical products into containers, for example. It allows up to 100,000 particles of 0.1µm and up to 3520 particles of 0.5µm per m3. An ISO Class 5 cleanroom equates to EU GMP class A and B, and BS 5295 Class E and F.

ISO Class 7 (GMP classification D)

An ISO Class 7 facility can have an unrestricted number of small particles (0.1µm to 0.3µm) but must have no more than 352,000 particles at size 0.5µm and no more than around 2,900 particles at 5µm. This equates to an EU GMP Class C facility or a BS 5295 Class J facility and would typically be used for sub-sterile pharmaceutical processes.

ISO Class 8 (GMP classification D)

An ISO Class 8 cleanroom is permitted up to 3,520,000 particles at size 0.5µm and 293,000 particles at size 5µm, equating approximately to EU GMP Class D or BS 5295 Class K. This level of cleanliness would be used for less sensitive applications where sterility is not an issue but where it makes general sense to maintain a good level of hygiene, such as packaging or storage of pharmaceuticals.

It is worth noting that these classes provide a starting point for clarifying what standards are required for a particular cleanroom, they do not always give the full picture. Actual standards are set by a combination of different factors relating to the specific application, and may fall somewhere between the levels specified in these standards.

APT Cleanroom Testing is an independent  clean room services contractor, qualified to carry out clean room validation for all classes of facility, to ensure that not only are your facilities validated and maintained to the required levels, but that your customers and clients can have complete trust in the quality of your clean room processes.

APT has your Clean Room Validation Testing

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing serviceplease don’t hesitate to contact Darren directly on 07775623464.

APT Cleanroom Testing providesclients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing serviceand/or HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at: info@airpressuretesting.net