CLEANROOMS AND ROOMS IN HEALTH CARE

PROJECT PLANNING

Expert advice in the planning, design and operation of new cleanrooms and cleanroom conversions and other areas of health care across all qualification phases (GMP)

Design Qualification (DQ)
Determination of requirements for equipment in a cleanroom facility, including buildings, premises and auxiliary equipment (e.g. ventilation system) with the evidence that the quality-related, GMP-related criteria have been adequately taken into account in the design

Risk analysis (FMEA)
Examination of the cleanroom facility for possible errors or weaknesses regarding a GMP-compliant operation

Hygiene concepts
Determination of necessary actions to fulfil the essential hygienic requirements in a cleanroom facility

Monitoring plans
Preparation of monitoring plans, advice on determining the nature and extent of all GMP-relevant measurements

CLEANROOM QUALIFICATION

Installation Qualification (IQ)
Review of the cleanroom facility in the deployment state (“as built”) in accordance with the stated requirements and legal requirements of GMP-related criteria and limit values for cleanroom classes

Operational Qualification (OQ)
Review of the cleanroom facility in a passive state (“at rest”) in accordance with the stated requirements and legal requirements of GMP-related criteria and limit values for cleanroom classes

Performance Qualification (PQ)
Review of the cleanroom system in an operating condition (“in operation”), demonstrating that the system provides the necessary performance while complying with the requirements set in the entire workspace under current operating conditions (with product)

Cleanroom requalification:
Examination of the cleanroom / ventilation facilities for continued compliance with DIN EN ISO 14644 and the guidelines for good manufacturing practice (EU GMP)

Qualification and requalification of Class Ia and Ib operating rooms

Validation of sealing processes in accordance with DIN EN ISO 11607-2

Validation of sterilisation processes

Microbiological water testing

Determination of hygiene status

TRAINING / IN-HOUSE TRAINING COURSES

We provide qualified training seminars on all relevant cleanroom issues at our premises.
Please refer to our current information and dates.

We can also provide training at your premises (in-house training).
Please feel free to make an individual request: Please contact our colleague Gabi Jobes on
+49 241-51 00 50-0