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)  

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.: 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 case of samples of the materials (e.g. for garment/clothing production, packaging films, etc.) VDI 2083 Part 9.1 standard is usually chosen as a testing procedure, while in case of whole 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 facility for cleanroom materials and products. In our ISO Class 2 Particle Emission Laboratory, based near Poznan, Poland, we are able to carry out tests according to ISO 14644-14, VDI 2083 Part 9.1 and IEST-RP-CC003.4 (Helmke drum test) for materials, products and equipment planned to be used in ISO 3 – ISO 9 Class environment. We can support your company both in assements of a given final product offered by your company, as well as in carrying out some comparison analysis e.g. during new product development process or when searching for some alternative suppliers of matarials and products for your company.

Some of the examples of items that can be tested in our laboratory:

• Cleanroom garments/clothing: overalls, lab coats, hoods, overshoes, gloves, trousers, t-shirts, blouses, jackets, etc.
• Cleanroom consumables: packaging films, paper, sticky mats, wipes/cloths/mop wipers [in dry state; reusable and single use]
• Construction materials - wall panels, ceilings, doors
• Storage units, furniture
• Equipment for transport and handling
• 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:

• Mode of operation and stress conditions applied to equipment under test are agreed between laboratory and the client.
  Typically, vibrations present in buildings enhancing particles release from the tested object are introduced during the test (structure bore noise 30-50 Hz).
• Testing environment is at least one ISO class superior to the cleanroom or environment in which the equipment is intended to be installed.
• Critical point/-s (high particle emission points) are determined after thorough scanning of the whole equipment with sampling probe connected to laser particle counter.
• Sampling time is 100 minutes (100 samples are taken during final (classification) measurement).
• The particle concentrations measured are statistically processes 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: 
  - Construction materials: wall panels, ceilings, doors
  - Storage units, furniture
  - Equipment for transport and handling
  - Tools
  - Laboratory equipmen
  - IT hardware, cables etc.

VDI 2083 Part 9.1:

• For motion-induced particle release from the tested material, test bench is built according to EN ISO 9073-10 (modified Gelbo Flex machine). Test specimen is located in an closed chamber in at least ISO Class 3 environment according to ISO 14644-1. The formatted test piece (220mm x 285 mm) is fixed by means of clips on to two oppositely disposed, rotationally mounted disks. The disks are rotated (flexed) relative to one another (torsion: 180°). At the same time, the spacing of the disks from each other is cyclically changed (linear compression: 120 mm; cycle time: 1 second). Particles released from the test specimen are collected by isokinetic probe of laser particle counter. 
• Sampling time is 100 minutes.
• The particle concentrations measured are statistically processes 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 VDA 2083 Part 9.1 showed that item 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 item tested.
• Some examples of products tested according to VDI 2083 Part 9.1: 
  - Materials for production of cleanroom products:
    e.g. films, paper, wipes/cloths/mop wipers [in dry state; reusable and single use]

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

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

“Suitable for Cleanrooms. Particle Emission test” - registered trademark

 
This sign (registered trademark) 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.

Pricing

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/materials.
• Number of items sent for testing in one order.

Contact us

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
Email: k.zarczynski@bnt-sigma.pl
Phone: 00 48 530 30 90 30