Particele Emission Test: Assessment of the cleanroom suitability of equipment, materials and products (ISO 14644 – Part 14, VDI 2083 Part 9.1, IEST-RP-CC003.4)  

One of the main difficulties faced by cleanroom users, quality 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 Classification of air cleanliness by particle concentration". 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).

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:

• Cleanroom garments/clothing: coveralls, lab coats, hoods, overshoes, gloves, trousers, T-shirts, blouses, jackets, etc.
• Cleanroom consumables: packaging film, paper, sticky mats, wipes/cloths/mop wipes [in dry condition; reusable and single use].
• Building materials - wall panels, ceilings, doors, luminaires / lighting fixtures
• Storage units, furniture
• Transport and handling equipment
• Tools
• Laboratory equipment
• IT hardware, cables, etc.
• Other items and equipment used in cleanrooms

Method for assessing the suitability of equipment based on particle emission

General outline of cleanroom suitability testing:

ISO 14644-14:

• The mode of operation and stress conditions applied to the equipment 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 is at least one ISO class higher than the cleanroom or environment in which the equipment is to be installed.
• Critical point(s) (high particle emission points) are determined after thorough scanning of the entire equipment with a sampling probe connected to a laser particle counter.
• The sampling time is 100 minutes (100 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 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).
• Some examples of products tested according to ISO 14644-14 are:
  - Building materials: wall panels, ceilings, doors, luminaires / lighting fixtures
  - Storage units, furniture
  - Transport and handling equipment
  - Tools
  - Laboratory equipment
  - IT hardware, cables, etc.
  

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.
• Some examples of products tested according to VDI 2083 part 9.1:
  - Materials for the manufacture of cleanroom products:
  e.g. films, paper, wipes/cloths/mop wipes [in dry condition; reusable and single use].

IEST-RP-CC003.4 (Helmke drum test):

• The garment is placed in a Helmke drum - a stainless steel drum similar to a tumble dryer. The drum is rotated to generate particles (rotation speed: 10 rpm).
• Particles released from the test item are collected by the isokinetic probe of the laser particle counter.
• The sampling time is 10 minutes.
  The measured particle concentrations are compared with the respective classification limits given in IEST-RP-CC003.3.
  IEST-RP-CC003.3 defines three categories of clothing: Category I (recommended for ISO 1-3 Class cleanrooms), Category II and III (recommended for ISO 4-9 Class cleanrooms). The IEST-RP-CC003.3 standard lists acceptable particle emission rates (particles/min) for each category depending on the size (average area for both sides) of the tested item.
• This test method is used worldwide, mainly due to the fact that the whole garment can be tested.
• Some examples of products tested to IEST-RP-CC003.4 (Helmke drum test) are
  - Cleanroom garments/clothing:
  e.g. coveralls, lab coats, hoods, overshoes, gloves, trousers, t-shirts, blouses, jackets, etc.

“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).

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 in the ISO 14644 series.
• Our team is familiar with the requirements and perspectives of cleanroom users in the pharmaceutical and laboratory sectors. Previously, our team worked in Validation / Quality Assurance / Product and Technology Transfer departments for the companies such as 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 registered trademark "Suitable for Cleanrooms. Particle Emission Test", 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 us and speak directly to the person responsible for carrying out the test and preparing the test report.
• We communicate and prepare test reports in English. We are open to cooperation with clients from within and outside the European Union.

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

If you would like to request a quote or have any questions about the testing process itself, please do not hesitate to contact us:

Contact person: Krzysztof Żarczyński, Senior Validation Engineer, BNT SIGMA
Email: k.zarczynski@bnt-sigma.pl [English or your local language]
Phone: 00 48 530 30 90 30 [English]