Our mostly used qualification services are also accreditated by NAH (the Hungarian Accreditation Authority) and comply with the criteria of Standard MSZ EN ISO/IEC 17025:2018.
- temperature distribution test
- humidity distribution test
- cleanroom particles count test
Other services offered:
- manufacturing and sterilization equipment, supply system IQ, OQ, PQ qualification
- Storage room, warehouse temperature and humidity distribution testing
- HVAC systems qualification (Clean rooms, LAFs, chemical cabs)
- qualification and preventive maintenance
- installation and validation of monitoring systems (software validation 21CFR Part 11, ANNEX 11)
- Compressed Air supply and distribution systems Quality Measurements According to ISO 8573-1 standard (dew point, particle and oil vapor)
We provide full qualification service, including working out protocols; giving the method of the needed tests; collecting the references needed for definition of the user’s requirements.
Furthermore we make qualification tests on the basis of the test plans, and record the results. After evaluation – with making qualification report and adding the necessary attachments – we hand a complete documentation to our Partners which are presentable in case of audits.
During working out documentation we are ready to create a special form in accordance with the Partner’s requirements on the basis of internal methods, instructions, templates.
In several cases we take part in the qualification work of the installed equipment as the producer-vendor’s partner.
We cooperate with our Partners as members of the qualification team, and we can help avoiding the known mistakes during the working procedure.
Our colleague’s’ high level preparation and knowledge guarantees that our tasks are done in the most consummate way.
