In #cleanroomafterhours #5 we continue the topic of certificates 🙂
Can we require a certificate from the contractor for the entire cleanroom?
To answer this question, let’s establish a few facts.
In #cleanroomafterhours #2, we took up the subject of attestation. We have indicated the applicable legal regulations, the legitimacy of the requirement, e.g. the Hygienic certificate, from suppliers of materials and systems. Based on this information – we have confirmed that the requirements for certificates for system building or HVAC are reasonable, provided that they will be useful in confirming that the User Requirements Specification (URS) criteria are met.
The most common certificate for cleanroom materials in the world is IPA FE 0008-190 Fraunhofer Institute for Production Technology and Automation (IPA).
This certificate confirms that the material tested in accordance with the VDI 2083-9.1 directive is safe for the cleanroom environment in the context of dust emissions. Test procedures are voluntary (and quite expensive;).
However, the certificate does not confirm that the environmental parameters and the ISO cleanliness class included, in the ISO standard and in the URS have been met.
The ISO 14644 standard itself does not indicate the need to purchase specific certified materials and does not solve the problem of the scope of requirements for contractors.
Part 3 of the standard identifies the need for test methods – such as particle counts, air changes, pressure cascades, and the tests of HEPA filters – to demonstrate compliance. It mean’s, that the only correct confirmation of compliance with the requirements, is the room qualification process.
Certificates prove useful when we want to confirm that the materials of the system do not emit excessive amounts of particles and are adequate to the cleanliness class required for the process. Of course – provided that these documents are issued by recognized organizations, such as the Fraunhofer Institute.
Importantly, the certification covers products, services and systems subject to the sales process, which means that it is not possible to expect the contractor to provide a certificate for the entire room! – it is worth bearing in mind during providing the requirements of the URS document.
Interestingly, on our business path, we often encounter controlled zones with attached binders for certificates confirming the quality of materials and, at the same time, without conducting qualification tests and without proof in the form of a report. !
From this point of view, looking at the requirements of the standard – such zones are not clean rooms
And what if the contractor presents us with another, previously unknown certificate, ensuring that it is required to meet ISO requirements? First of all – let’s not be fooled by the appearances of quality;)
And secondly – remember that the only certificate you should definitely expect is the IQ/OQ qualification report 🙂
#cleanroom#certificate#CRK