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Accreditation for service companies that perform metrological tests in Cleanrooms

Necessity or marketing trick?

© reinraum online
© reinraum online

Clarification to the question:
Do companies that carry out metrological tests for the qualification of cleanrooms have to be accredited?

The following are the requirements from the relevant standards and guidelines:

ISO EN DIN 14644:
This series of standards specifies the requirements for the measuring instruments (suitability and valid calibration certificate). Furthermore, the metrological personnel must be familiar with the measuring instruments and be trained. An obligation for accreditation is not listed.

VDI 2083:
In VDI 2083, Sheet 4.1: 2006.
Under 4.3.2 Specific requirements it says: "In principle, demonstrably trained, qualified personnel should be assigned for planning, execution and initial commissioning."

In the VDI 2083, sheet 7: 2015
Under 5.5.8.4.1 Personnel it says: "In principle, the following knowledge or certificates of competence must be provided. ...Knowledge of the measuring instruments and measuring procedures for qualification tests."

In the VDI 2083, page 15: 2007.
4.1 Definition of training categories states:
In view of the diversity of activities performed by personnel in the cleanroom and the different qualification requirements, two training categories are defined. They are defined as follows:
•    Basic competence
Execution of common cleanroom activities by operating and service personnel. This also includes maintenance, cleaning, repair and qualification (execution).
•    Professional competence
Carrying out management or control activities (these are also cleanroom technology managers / operating engineers as well as also persons from the areas of inspection / auditing).

EG Guide to Good Manufacturing Practice for Medicinal Products for Human or Animal Use: 2003.

Chapter 1.3
Paragraph IV: "Suitably qualified and trained personnel".
Paragraph XI: "The personnel carrying out the work are trained to be able to perform the work correctly".
Chapter 1.4
Paragraph I: "Appropriate facilities, trained personnel and approved procedures are available for sampling and testing ... and, where required by Good Manufacturing Practice, for environmental conditions".

Annex 1 to EG Guideline: 2008
Chapter 37: "All personnel working in clean areas (including cleaning and maintenance personnel) should receive regular training. Training should include hygienics and basic microbiology. If non-operator personnel (e.g., those assigned to construction or maintenance work) who are not properly trained must enter clean areas, they should be instructed and supervised very carefully"

Conclusion:
The relevant regulations only require trained personnel with knowledge of the measuring equipment and the measurements to be performed. Work instructions for the measurements to be performed must also be available.

Accreditation of the service and measurement company is not required.
The demand and statement that a company offering metrological services "must be accredited" is a pure marketing trick, or in other words, simply WRONG!

For further information:
Since training as a cleanroom service & measurement technician is not an apprenticeship, almost all technicians and engineers working in this field are career changers. Technically experienced persons who would like to carry out the measurements for qualification can continue their education in seminars and courses and thus prove that they have the necessary training. Unfortunately, most events only teach the theory.

In order to be able to exercise the activity of the cleanroom service & measurement technician demonstrably trained, in theory and practice, a suitable further training is therefore essential.

The IHK offers suitable further training at two locations in Germany. One organizer is the IHK-Mittlerer Niederrhein, in Krefeld, which has been offering a certificate course for cleanroom service technicians with proof of expertise for service technicians for microbiological and cytostatic workbenches (IHK) since 1996.

The second training course is offered at the IHK-Akademie München and Upper Bavaria, in its training center in Westerham. This certificate course serves as nationally and internationally recognized proof of professional qualification as an expert in accordance with the c'GMP and FDA guidelines and as required by the BG Chemie data sheet B011, as well as proof of expertise for service technicians who inspect and support cleanroom workstations, workbenches, isolators and systems in general and toxic areas of application in the technical and aseptic industries. The target group of the training are master craftsmen, technicians and engineers of all technical and application areas who have their own cleanroom technical systems, operate them or plan, qualify and supervise them as part of an external service.

These IHK courses are then concluded by a written examination and certified by a nationally and internationally valid certificate.


DRRI_Logo_web_800px
Deutsches Reinrauminstitut e.V. (DRRI e.V.)
An der Breiten 1
82444 Schlehdorf
Germany
Phone: +49 (0) 88 51 615900
email: g.dittel@dittel-ce.de
Internet: http://reinraum-institut.de


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