GMP Clean Air Services: Cleanroom Testing Solutions

GMP Services: Testing for Cleanroom Qualification, Certification, Classification

The Measurement team provides qualification of cleanrooms and clean production areas in accordance with EN ISO 14644, EU GMP Annex 1 and VDI 2083. Our strengths include many years of experience, very well trained technicians, STS accreditation and a worldwide
network of specialists in the field of pharmaceuticals, health and hygiene. Our unique high level quality management system assures fully described Standard Operating Procedures (SOP’s), processes, instructions, and standard protocols.

CAS specialists are customer focused, follow international standards and provide technical expertise for cleanroom applications. We perform these services for our customers:

• Air velocity and air volume measurement (determining number of air changes)
• Temperature and relative humidity (Cleanroom TRH measurement)
• Room differential pressure (DAP)
• Filter system integrity test (DEHS)
• Cleanroom classification (according to ISO 14644 and GMP guidelines)
• Recovery test (recovery time)
• Microbiological sampling, airborne and surface
• Compressed air parameters (particles, aerosol oil content, dew point, microbiological)
• Rating-related work for hospitals according to standards and regulations
• Sound levels and luminosity
• Smoke studies
• Maintenance of filters including changes and installations

The Swiss Accreditation Service (SAS) grants to CAS the accreditation as testing laboratory for the testing of cleanroom systems in accordance with ISO/IEC 17025. The scope of the STS0566 accreditation is defined in the Official Directory of the Accredited Testing Laboratories.

GMP Services: Thermal Validation

The CAS Thermal Validation team uses high-precision measuring systems to perform thermal process ratings according to your requirements. Our advanced practical knowledge allows us to meet your needs, whether you require routine validation outsourcing or project support. Well-equipped and with highly technical experience, we perform on-site validation for:

• Steam and dry heat sterilization processes
• Temperature and humidity mappings
• Cooling and heating processes
• Freezing and thawing processes

We provide experienced services for autoclaving, SIPprocesses (e.g. vessels, filling lines, freeze dryers, stopper sterilization), sterile tunnels and hot-air apparatuses, in addition to cooling and heating devices (e.g. freezers, ultra-deep freezers, liquid nitrogen storage tanks, incubators, climatic chambers, cold and storage rooms, warehouses). Thereby, we ensure operational competences and support you with customer-fit documentation like validation plans, reports and SOP’s for your system validation.

PMS/CAS conforms with international guidelines and country regulations. We use state-of-the-art measurement instruments and promise traceable certificates of calibration. The Swiss Accreditation Service (SAS) grants to CAS the accreditation as testing laboratory for thermal processes in accordance with ISO/IEC 17025.

Contamination Monitors

Particle Measuring Systems specializes in viable and nonviable particle counters that measure and monitor contamination levels in clean and controlled environments. Since 1972, our knowledgeable and experienced team has been developing innovative technologies to advance the cleanroom monitoring industry. Led by our technology which provides accurate and reliable results and information for our clients, Particle Measuring Systems is one of the world’s leading companies and manufacturers for particle counting instruments, and molecular and microbial monitoring.

Technology Particle Measuring Systems provides are:

• Particle Counters for Air and Gas
• Liquid Particle Counters
• Microbial Viable Contamination Monitors
• Molecular Contamination Monitors
• Facility Monitoring Systems

In addition to manufacturing cleanroom contamination monitors and equipment, we provide software, environmental monitoring, data management, advisory, training, GMP, projects, and calibration. It is important that we not only provide the proper instruments and equipment for our clients, but also the essential services and support they require to gain meaningful insights to the data generated.

Particle Measuring Systems also leverages our experts to provide advisory services and educational training and information including Particle College, knowledge center blogs, and application notes for products and equipment. In addition, we host in-person and video webinars about industry specific events and products. Be sure to register for our upcoming webinars today!

For additional product and/or service information, or order requests, please contact us today.