VDI 2083 Part 9.1: Assessment of suitability for use of materials and consumables 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. In the case of material samples (e.g. for garment/clothing production, packaging films, etc.), VDI 2083 Part 9.1 is usually chosen as the test method, while in the case of complete cleanroom garments (e.g. overalls, lab coats, hoods, overshoes, etc.), cleanroom suitability tests are usually carried out according to IEST-RP-CC003.4 (Helmke drum test).
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:
VDI 2083 Part 9.1:
Cleanroom consumables and materials for the manufacture of Cleanroom products:
– packaging film,
– paper,
– sticky mats,
– wipes/cloths/mop wipes (in dry condition; reusable and single use).
IEST-RP-CC003.4 – Helmke drum test:
Cleanroom garments/clothing:
– coveralls,
– lab coats,
– hoods,
– overshoes,
– socks,
– gloves,
– trousers,
– T-shirts,
– blouses,
– jackets.
ISO 14644-14:
Other items and equipment used in Cleanrooms
Test conditions: VDI 2083 Part 9.1
For motion induced particle release from the tested material, the test stand is built according to EN ISO 9073-10 (modified Gelbo Flex machine). The specimen is placed in a closed chamber in an environment of at least ISO Class 3 according to ISO 14644-1. The formatted specimen (220 mm x 285 mm) is clamped to two opposing rotating discs. The discs are rotated (flexed) relative to each other (torsion: 180°). At the same time, the distance between the discs is cyclically varied (linear compression: 120 mm; cycle time: 1 second). Particles released from the sample are collected by the isokinetic probe of the laser particle counter.
The sampling time is 100 minutes.
The measured particle concentrations are statistically processed and compared with the respective ISO 14644-1 classification limits.
The cleanroom suitability of the equipment is stated as follows: “An assessment, including an agreed representative mode of operation, according to VDA 2083 part 9.1 has shown that item Z has cleanroom suitability for use in a cleanroom of ISO class X (Y µm)”; where: X – is the ISO 14644-1 class number, Y – is the measured particle size range, Z – is the unique identification of the tested item.
Typical products tested according to VDI 2083 part 9.1 are Cleanroom consumables and materials for the manufacture of Cleanroom products e.g. films, paper, wipes/cloths/mop wipes [in dry condition; reusable and single use].
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 type and 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, 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]