Biuro Naukowo-Techniczne SIGMA
ISO 14644 – Part 14 Assessment of the cleanroom suitability of equipment
|In new purchases and investments, as well as in change management process, one of the main difficulties facing cleanroom users, quality assurance and validation teams, is whether or not to accept a particular material or piece of equipment in the cleanroom without risk to production. “ISO 14644 – Part 14, Assessment of the cleanroom suitability of equipment based on airborne particle concentration” sets out a methodology which allows to assess the suitability of equipment (e.g.: construction materials, control and processing equipment, tools etc.) for use in a given cleanroom cleanliness class classified in accordance with “ISO 14644-1 Classification of air cleanliness by particle concentration”.|
In our ISO Class 2 Particle Emission Laboratory, based near Poznan, Poland, we are able to carry out tests according to ISO 14644-14 for materials and equipment planned to be used in ISO 3 – ISO 9 Class environment.
Some of the examples of items that can be tested in our laboratory:
- Construction materials (e.g. wall panels), ceilings, doors
- Storage units, furniture
- Equipment for transport and handling
- Laboratory equipment
- IT hardware, cables etc.
- Other items and equipment used in cleanrooms
“Suitable for Cleanrooms. Particle Emission test” - registered trademark/ sign
This sign can work for your business.
- You will receive it for the tested item once equipment suitability for cleanrooms is confirmed.
- You can use it in commercial communication regarding tested item (with no additional/periodic fees).
Why is it worth to work with us?
- We keep an eye on changes in cleanroom standards. We are a member of Technical Committee no 161 for Air Conditioning and Ventilation and Technical Committee no 317 for Indoor Air Quality at Polish Standardization Office. In this way we are involved in the process of development of ISO 14644 series standards.
- Our team well knows requirements and perspective of cleanroom users in Pharmaceutical and Laboratory sector. Previously, our team worked at Validation / Quality Assurance / Product and Technology Transfer Departments for the complains like GlaxoSmithKline Pharmaceuticals, R&D Unilever, Polpharma, National Institute of Hygiene (Poland). Currently at BNT SIGMA we are involved in many cleanroom validation projects for our clients from Pharmaceutical/ Medical/ Laboratory sectors.
- With our “Suitable for Cleanrooms. Particle Emission test” registered trademark/ sign, you can more easily distinguish your product from others, similar on the market.
- BNT SIGMA is a small size customer oriented company. You can easily contact with us and directly speak with the person who will be responsible for carrying out the test and test report preparation.
- We communicate and prepare test reports in English language. We are open for cooperation with clients both from and outside of the European Union.
ISO 14644-14: Method for assessing the suitability of equipment based on particle emission
General outline and key requirements of cleanroom suitability testing according to ISO 14644-14:
- Testing environment must be at least one ISO cleanliness class superior to the cleanroom or environment in which the equipment is intended to be installed.
- Mode of operation and eventual stress conditions applied to equipment during the test are to be agreed between laboratory and the client.
- Critical point/-s (high particle emission points) are determined after thorough scanning of the whole equipment with sampling probe connected to laser particle counter.
- Particles sizes considered during the test are established according to ISO 14644-1 (in a range 0,1 - 5µm).
- For statistical relevance, at least 100 samples (= minimum 100 minutes sampling time) are taken during final (classification) measurement.
- The particle concentrations measured are statistically processes with Student’s t test or Poisson distribution (depending on the number of particles measured) and compared with the respective classification limits specified in ISO 14644-1.
- Detailed test report shall cover the following points: description of test, description of piece of equipment including mode(s) of operation considered, documentation for assessment of test environment, test setup photo, pre-tests that have been carried out and their result, description of measuring probe location(s), description of testing equipment used and sampling parameters, analysis of data.
- The cleanroom suitability of the equipment is stated in the following way: “An assessment including and agreed upon representative mode of operation, according to ISO 14644-14 showed that equipment Z has cleanroom suitability for use within a cleanroom of ISO Class X (Y µm)”; where: X – is the ISO 14644-1 class number, Y – is the particle size range measured, Z – is the unique identification of the equipment tested (e.g. type, serial number, manufacturer).
Price for the test is individually calculated based on the following:
- Mode of operation and eventual stress conditions that are to be applied to equipment during the test.
- The type and size of the equipment.
- Number of items send for testing in one order.
If you want to ask for the quotation or you have any questions regarding the testing procedure itself, do not hesitate to contact us:
Contact person: Krzysztof Żarczyński, Validation Engineer, BNT SIGMA
Phone: 00 48 530 30 90 30