To ensure that your production environment continuously meets the highest cleanliness standards, we offer you regular cleanroom inspections to confirm your existing qualifications.
Requalification
Our experts are on hand to guide you through the process and ensure that your production environment continues to meet the required cleanliness standards. Your previous cleanroom qualifications serve as a basis.
Depending on the qualification, the checks include
- In accordance with the guidelines, we recommend that you schedule a regular review (e.g. 1x / 2x per year) to ensure that your qualifications are always up to date.
- Air flow and calculation of the air exchange rate
- Differential pressure/displacement flow
- Leak-free duct filters, terminal filters (incl. filter scanning) and terminal filters in FFUs
- Particle measurement of the room air or supply air
- Temperature and relative humidity
- Sound pressure level
- Recovery time
- Microbiological workplace testing
- Microbiological air bacteria count
- Microbiological surface examination
Guidelines
- GMP (Good Manufacturing Practice):
GMP guidelines are used in many industries, especially in the pharmaceutical industry, to ensure the quality and purity of manufactured products.
- ISO standards DIN EN ISO 14644:
The ISO 14644 series, in particular ISO 14644-1 and ISO 14644-2, defines standards for cleanroom classification and testing. Compliance with these standards is widespread in various branches of industry.
- Occupational health and safety regulations:
Industry-specific occupational health and safety regulations can also place requirements on cleanroom workstations in order to protect the health of employees. - Environmental protection laws:
In some regions, there are environmental protection laws that may apply to emissions and waste management, especially when certain cleanroom technologies are used.
We are at your disposal with our expertise. Please feel free to contact us: aussendienst@gfps.de