Cleanroom qualifications

Cleanroom Qualification and GMP Compliant Documentation

We qualify your cleanroom and provide complete, GMP compliant documentation. The objective of a cleanroom qualification is to check important functions from a manufacturing perspective. They are therefore a fundamental element of quality assurance. The cleanroom qualification shows whether the equipment and components used are suitable for their intended purposes and whether new manufactured products will have the required quality.

Measurements at a glance

The figure below shows all measurements which are executed by our compentent employees.

Reinraumqualifizierung: die Messungen im Überblick
Reinraumqualifizierung: die Messungen im Überblick
Hygieneinspektion nach VDI 6022

Hygiene inspection according to VDI 6022

Wartung von RLT, Kälte- und MSR-Technik

Maintenance of ventilation, refrigeration, measurement and control technology

Filterlecktest

Filter integrity test

Kalibrierung von Sensoren Luftströmung, Differenzdruck, Temperatur, Feuchte

Calibration of sensors for air flow, differential pressure, temperature, humidity

Luftvolumenstrom, Raumluftwechselrate, Filterdifferenzdruck

Air volume flow, air exchange rate, filter differential pressure

Verschleißteile

Wear parts

Qualifizierung von Prozessmedien und Druckluft

Qualification of process media and compressed air as per ISO 8573

Überprüfung der Trockenluftqualität

Inspection of the dry air quality

Erholzeitmessung, Prüfung von Temperatur und Raumluftfeuchte

Recovery test, inspection of temperature and room air humidity

SEM-Partikelanalyse, Staubmengenmessung, IAQ-Bewertung

SEM particle analysis, dust quantity measurement, IAQ valuation

Reinheitsklassenbestimmung nach DIN ISO 14644 oder EG-GMP-Leitfaden

Cleanroom class determination according to DIN EN ISO 14644 or EG GMP Guidelines

Strömungsvisualisierung (Produkt- und Personenschutz)

Smoke studies (product and personal protection)

 

Prozessvalidierung

Process validation

Beleuchtungsstärke

Illuminance

Wartung von LF-Modulen und Materialdurchreichen

Maintenance of LF-modules or hatches

Luftkeime

Airborne germs

Oberflächenkeime

Surface germs

Raumschallpegel

Measurement of the sound level

Elektrische Ableitfähigkeitsmessung Fußboden und Arbeitstischplatten

Measurement of the discharge capacity for floor and work table

Prüfung der Strömungsgeschwindigkeit in turbulenzarmen Bereichen

Inspection of the flow velocity in low-turbulence areas, visualisation of the uniformity

Überprüfung der Wasserqualität

Inspection of water quality as per the Drinking Water Ordinance

Raumdifferenzdruck, Visualisierung der Druckkaskade

Room differential pressure, visualisation of the pressure cascade

SOP-Erstellung

SOP preparation (cleaning plans, inward transfer, behaviour)

Mitarbeiterschulung

Employee training (hygiene, cleanroom clothing, rules of conduct)

 

TÜV-Certificate

As a TUV certified company, we offer extensive and high-quality qualifications of all cleanroom technical appliances and equipment in accordance with all established guidelines.
Among others:

  • ISO 14644
  • VDI 2083
  • EG-GMP-Guide
  • PIC/S
  • VDMA 24186
  • ISO 8573
  • VDMA 15390

In collaboration with our customers, we determine which legal standards and specifications respectively apply in relation to the process and product.

Cleanroom Validation: Professional Documentation in all Phases

All measurements are carried out in a predefined operating condition (“at rest” or “in operation”) and are documented consistently and professionally, based entirely on preassigned approved inspection protocols.

The results will then be evaluated using a specific report. Of course, you will also receive GMP compliant documentation using the validated inspection plan.

The stages of a cleanroom validation procedure at a glance:

QMP (Qualification Master Plan):
A documentation outlining the course of action during the whole qualification. All information about the contents of the qualification is included within it.

FMEA (Failure Mode and Effects Analysis):
A risk analysis is conducted.

DQ (Design Qualification):
This is effectively the first qualification phase, to verify the planning documentation and its conformity to the requirements of the operator (specification) as well as the official requirements and guidelines.

IQ (Installation Qualification):
This serves to check and determine the requirements and acceptance criteria for the installation of a mechanism.

OQ (Operational Qualification):
Based on different measurements, the OQ checks whether the installed system satisfies the requirements regarding the previously defined parameters. All measurements are carried out “at rest”.

PQ (Performance Qualification):
The PQ creates the documented proof that the device or equipment complies with the product requirements within the predetermined parameters. All measurements are carried out “in operation”.

 

Requalification and Maintenance

In order to ensure the optimum operation of cleanroom systems and equipment, regular requalifications and maintenance must be carried out. bc-technology offers you the complete requalification and/or maintenance according to all common guidelines.

We would be pleased to answer any questions regarding our qualification services in the field of cleanroom technology.