Cleanroom Qualification
Safety, Compliance and Quality — from the Very Start
Cleanroom qualification is a decisive element for the safe, standards-compliant and economical operation of cleanrooms. It ensures that all systems, processes and environmental conditions meet the defined requirements — and that this can be demonstrated at any time with verifiable evidence.
Already in the planning phase, we work together with you to lay the foundations for efficient and audit-compliant qualification. This avoids later deviations, reduces risks and saves valuable time in the course of the project.
Standards-compliant qualification — fully documented and audit-ready.
Measurement Technology
Precise Measurements with Modern Technology
Our qualified specialists work with state-of-the-art measurement technology to capture all relevant parameters precisely:
- Particle measurements (at rest and in operation)
- Filter integrity tests (HEPA / ULPA)
- Air volume flow and air change rate measurements
- Differential pressure measurements
- Temperature and humidity measurements
All measurements are carried out to current standards and fully documented in audit-ready form.
GMP
GMP Qualification — Safety, Traceability and Compliance
GMP qualification ensures that systems, cleanrooms, utility systems and technical equipment function reliably and are suitable for their intended use. It is an essential component of Good Manufacturing Practice (GMP) and a prerequisite for the manufacture of high-quality, safe products.
Our Services at a Glance
- Qualification of cleanrooms and technical systems
- Creation of GMP-compliant qualification documentation
- Risk analyses and qualification planning
- Execution of DQ, IQ, OQ and PQ
- Requalifications and change management
- Support during audits and regulatory inspections
Qualification Phases
The Four Phases of GMP-Compliant Qualification
Proof that the planning and design fulfil the user requirements and GMP specifications.
Documented verification of the correct installation of all components and systems.
Proof that all functions and operating parameters perform in accordance with the specification.
Confirmation that the system consistently delivers the required performance under real operating conditions.
Summary
Your Advantages at a Glance
Standards-compliant and legally secure operation
Complete, audit-ready documentation
Minimisation of contamination risks
Increased process stability and product quality
Efficient project execution through early qualification
Confidence during regulatory and customer audits
Request Qualification
Your Cleanroom. Properly Qualified.
Do you need qualification of your cleanroom or technical systems? PETEK guides you from planning through to audit-ready documentation.