Equipment Qualifications IOQ/PQ
Equipment qualifications (installation and operational qualifications (IOQ) and Performance Qualifications (PQ)) are a GMP requirement and assure your equipment is working properly and in accordance with your specifications. Azzur has expertise in temperature mapping of autoclaves, incubators, refrigerators, ovens, etc. We also provide and test biological, chemical and endotoxin indicators.
Cleanroom Services - Operational/Performance Qualification
Azzur Labs also provides environmental monitoring operational and performance qualification of your controlled environments (cleanrooms, buffer rooms, ante rooms (ISO 5, 6, 7, 8 and unclassified)) including particulate counts and viable sampling, incubation and analysis.
- Gowning validation
- HEPA leak testing
- Filter changes/installation
- Viable/non-viable routine sampling and analysis
Steam Quality Testing
Effective steam sterilization relies on continuous supply of dry, saturated steam. Our technicians have all the necessary equipment and technical expertise to carry out and report steam quality testing to the requirements of HTM2010, CFPP01-01, HTM2031 and EN285.
Typical steam quality tests include:
- Non Condensable Gases
- Dryness Fraction
Compressed Air Testing
ISO 8573 is an internationally recognized standard that defines major contaminants in compressed air and presents a comprehensive system for air purity designations. The implementation of this standard supports accurate testing of the major contaminants in compressed air - particles, water, oil, and microorganisms. ISO 8573 is used widely throughout the compressed air industry, acting as a common language available to the manufacturer, compressed air system supplier, and compressed air testing laboratory.
Food Grade Air Testing
Food grade air or clean process air in the food industry is integral to Quality Assurance and Quality Control and should always be considered a Critical Control Point (CCP) if used in your food manufacturing process. Many industry standards and schemes regarding quality control in food and beverage refer to the Hazard Analysis & Critical Control Points (HACCP) plan as an integral part of their directives.
We Offer Testing and Analysis for:
- Particle Classes 1–9
- Water Classes 1–6
- Oil Classes 1–4
- Gas Purity
- Total Microbial Count