ISO 14644-14: Assessment of suitability for use of equipment in Cleanrooms
One of the main difficulties faced by Cleanroom users, Auality Assurance and Validation teams when making new purchases and investments, as well as in the change management process, is whether or not a particular material or piece of equipment can be accepted in the cleanroom without risk to production. “ISO 14644 – Part 14, Assessment of the cleanroom suitability of equipment based on airborne particle concentration”, provides a methodology for assessing the suitability of equipment (e.g. tools, construction materials, etc.) for use in a given Cleanroom cleanliness class classified in accordance with ISO 14644-1 standard.
About our laboratory
BNT SIGMA is an independent testing laboratory for cleanroom materials and products. In our ISO Class 2 Particle Emission Laboratory, located near Poznan, Poland, we are able to perform tests according to ISO 14644-14, VDI 2083 Part 9.1 and IEST-RP-CC003.4 (Helmke drum test) for materials, products and equipment intended for use in ISO 3 – ISO 9 Class environments. We can assist your company both in the assessment of a particular end product offered by your company, as well as in carrying out some comparative analysis e.g. during the new product development process or when searching for some alternative suppliers of materials and products for your company.
Some examples of items that can be tested in our laboratory include:
Building materials: wall panels, ceilings, doors, luminaires
Storage units, furniture
Transport and handling equipment
Tools
Laboratory equipment
IT hardware, cables, etc.
Other items and equipment used in Cleanrooms
Test conditions
The mode of operation and stress conditions applied to the product to be tested are agreed between the laboratory and the client. Typically, vibrations present in buildings, which increase the release of particles from the test object, are introduced during the test (structure-borne noise 30-50 Hz).
The test environment meets ISO 2 Class requirements
(it needs to be at least one ISO class higher than the Cleanroom or environment in which the tested product is to be installed).
Critical point(s) (high particle emission points) are determined after thorough scanning of the entire product with a sampling probe connected to a laser particle counter.
The sampling time is 100 minutes – 100 individual samples are taken during the final (classification) measurement.
The measured particle concentrations are statistically processed and compared with the respective classification limits specified in ISO 14644-1.
The cleanroom suitability of the product 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).
Why is it worth working with us?
We keep abreast of 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 the Polish Standards Institute. In this way, we are involved in the process of developing standards of the ISO 14644 series.
We know requirements and perspectives of Cleanroom users
Our team worked in Validation amd Quality Assurance Department for leading companis in Pharmaceutical inductry. Currently at BNT SIGMA we are involved in many cleanroom validation projects for our clients from Pharmaceutical/Medical/Laboratory sectors.
We are customer oriented company
You can easily contact us and speak directly to the person responsible for carrying out the test and preparing the test report.
We operate internationally
We prepare test reports in English. We are open to cooperation with clients from within and outside the European Union.
“Suitable for Cleanrooms. Particle Emission test”
- registered trademark
This mark (registered trademark) can work for your business. You will receive it for the tested item once the cleanroom suitability of the equipment has been confirmed. You can use it in commercial communications about the tested item (with no additional/periodic fees).
Pricing
The price of the test is calculated individually based on the mode of operation and possible stress conditions to be applied to the equipment during the test, the type and size of equipment/materials, the number of items to be tested in one order. Contact us by email to receive a quote.
Testing process
Step 1. Contact us by email. Briefly describe your product, give its dimensions and weight, tell us where the product must be returned after testing.
Step 2. We will send you the quotation for testing.
Step 3. After accepting the quotation, you send the product to our laboratory (located in Poland).
Step 4. Once the test is completed and the report is ready (lead time: 7-14 days), we will send you the invoice for the test.
Step 5. Once we have received your payment, we will send you the test report and return the product to you.
Contact us
Contact person: Krzysztof Żarczyński, Senior Validation Engineer
Email: info@hygienicdesign.eu [English or your local language]
Phone: 00 48 530 30 90 30 [English]