EU GMP Annex 1: Full compliance with MAS-100 Iso microbial air samplers »
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MICROBIAL AIR SAMPLERS FOR PHARMA
Microbial air quality monitoring is essential in the bio/pharmaceutical industry to ensure and document product quality. Our MAS-100 instruments are in standard use worldwide for active microbial air monitoring in cleanrooms, pressurized gas systems, isolators and RABS. They have been developed according to GAMP, validated according to ISO 14698 and EN 17141 and meet all applicable standards and guidelines. In addition to high-precision and durable instruments, compliant documentation and traceability of measurement data to international standards are just as important criteria as easy cleaning and decontamination. We offer perfection - on every level.
FITTING EQUIPMENT
MAS-100 MICROBIAL AIR SAMPLER - YOUR ADVANTAGES AT A GLANCE
- High-precision reliable microbial air sampling
- The microbial air samplers are specified for use in ISO 14644-1 cleanroom class 5 / GMP grade A Developed according to GAMP and validated according to ISO 14968 and EN 17141
- Possibility of independent, fully automatic calibration of the microbial air samplers
- Traceability of the air sample quantity to international standards by means of MAS-100 Regulus digital anemometer and our ISO 17025 calibration laboratory
- The microbial air sampler model MAS-100 NT is also available as an explosion-proof version - so the same instrument can be used in all rooms
- All microbial air samplers have the same physical sampling efficiency. This allows the comparison of results from different cleanroom classes and applications
- IQ/OQ can be performed autonomously,with prepared documents from MBV, or accompanied by MBV Service
ANY QUESTIONS?
Our expert Andy Zingre will be happy to assist you. We look forward to hearing from you.
+41 44 928 30 80
welcome@mbv.ch
Schedule a 30 minutes online meetingSATISFIED CUSTOMERS
These are some of the companies from the pharmaceutical industry who successfully rely on our innovative products. They benefit from perfect Swiss quality, easy handling and reliable safetyich makes all the difference.
FAQ
FREQUENTLY ASKED QUESTIONS FROM YOUR INDUSTRY
Here you will find a compilation of all the questions we receive on the subject of microbial air sampling from operators of cleanrooms and isolators/RABS from the pharmaceutical/biopharmaceutical sector.
