Cleanroom Qualification

Cleanroom Qualification tarjoaa Berner International

Olemme Berner International - Saksassa toimiva omistajayritys. Yli 40 vuoden ajan olemme olleet pätevä kumppanisi farmaseuttisissa ja bioteknologisissa suojausjärjestelmissä. Yrityksen perustamisesta lähtien olemme jatkuvasti kehittäneet ja laajentaneet tuotteitamme ja palveluitamme. Ydinosaamisemme turvakaappien lisäksi henkilökohtaiset suojavarusteet, tarvikkeet ja LEAC: n kautta suoritettavat koulutuskurssit ovat nyt olennainen osa liiketoimintaamme. <br/><br/>Tarjoamme valikoiman turvakaappeja, jotka on suunniteltu optimaaliseen henkilö-, tuote- ja siirron suojaamiseen puhdastilalaboratorioissa. Nämä kaapit ovat välttämättömiä sytostaattien aseptisessa tuotannossa, parenteraaleissa ja mikrobiologisten aineiden käsittelyssä.

Tutustu Berner International

Miksi Qualification of cleanrooms according to GMP and ISO?

We offer you professional support with all GMP and ISO measures in the area of cleanroom qualification. By complying with the requirements of EU GMP Annex 1 & EC guidelines, VDI 2083, ISO 14644 and DIN 1946-4, we ensure that your facilities meet the highest standards.
We support you in creating or reviewing your qualification plan in accordance with current standards and guidelines. We also carry out measurements in your cleanroom and create detailed documentation for both internal and external audits.
We are always available to answer any questions you may have about qualifying your cleanroom. With us, you have a partner at your side who, in addition to servicing safety cabinets and isolators, also looks after all aspects of your cleanroom area.
Together, we will achieve a high level of quality and performance to ensure a safe working environment.

Hyödyt

One contact for safety cabinets, LAF, insulators and qualification
Less organizational and downtime due to bundled implementation
Reliable availability for questions about cleanrooms and safety cabinets
TÜV-certified service technicians carry out on-site inspections
Complete and traceable documentation

Keskeiset ominaisuudet

Qualification Plans per ISO/GMP

Creation and testing of qualification plans in compliance with ISO and GMP standards to ensure regulatory conformity and process reliability.

Visual Inspection of Room Closures

Inspection of room sealing surfaces to detect leaks or structural issues that may compromise cleanroom integrity.

Airflow and Air Exchange Measurement

Measurement of volume flow and calculation of air exchange rates to assess air quality and cleanroom performance.

Temperature and Humidity Monitoring

Accurate measurement of room temperature and relative humidity to maintain required climate conditions in cleanrooms.

Room Pressure Differential Measurement

Monitoring of positive and negative pressure differentials to ensure controlled airflow between cleanroom zones.

Filter Integrity Test per ISO 14644-3

Testing of filter integrity according to DIN EN ISO 14644-3 to prevent particle ingress and maintain air purity.

Cleanroom Classification per ISO/GMP/VDI

Determination of cleanroom class according to ISO 14644-1, GMP/EC guidelines, and VDI 2083 for compliance and quality assurance.

Recovery Time Measurement

Measurement of recovery times (100:1 / 10:1 / clean-up phase) to evaluate air purification efficiency after contamination.

Sound Level Measurement

Recording of sound pressure levels to ensure ergonomic working conditions and compliance with noise regulations.

Illuminance Measurement

Measurement of lighting intensity to guarantee optimal visibility and adherence to workplace standards.

In-Place Calibration of Devices

On-site calibration of display units and sensors to ensure accurate and reliable measurement results.

Flow Visualization

Visualization of airflow patterns to identify turbulence and optimize cleanroom air management.

Filter Replacement Service

Professional replacement of air filters to maintain cleanroom classification and operational safety.

Audit-Ready Documentation

Comprehensive measurement and inspection reports providing transparency for internal and external audits.

Measuring Point Plan Adaptation

Customization and expansion of measuring point plans, including additional room diagrams for precise documentation.

Initial Qualification with DQ/IQ/OQ/PQ

Execution of initial qualification in collaboration with Pitzek GMP Consulting, covering DQ, IQ, OQ, and PQ phases.

Microbiological Environmental Monitoring

Monitoring of airborne microbes, swab samples, sedimentation plates, and glove fingerprints to ensure microbiological safety.