Get Merk’s Winning Combination for Environmental Monitoring in Isolators
Posted on November 15, 2016
When choosing a viable air monitor system there are a few basic questions you should always ask yourself.
Starting with: the requirement to perform environmental monitoring inside isolators mentioned in all standards and guidelines, but also the biological and physical recovery rates, the calibration frequency, if working with LIMS, the instrument control, the GMP compliance for records and error logs, the industry compliant IQ OQ documentation, and lastly if your production can quickly and easily restart. Many interrogations to be carefully taken into account.
Microbial environmental monitoring in aseptic manufacturing processes in isolators and RAB systems needs specifically designed and validated products. Air samplers and products, such as the MAS-100 Iso NT®, MAS-100 Iso MH® and IsoBag™ are designed for this purpose. These microbial air samplers are able to communicate with your isolator and are validated according to ISO 14698 part one annex B in combination with ICR culture media. ICR culture media is now available in IsoBag™ which allows the use of plates without any need for decontamination in order to increase productivity and save space in your isolator.
Meet Merck’s family of instruments, the winning combination to make you more efficient and compliant.
Benefit from our IsoBag™ and MAS-100 Iso MH®:
• Iso 14698 compliant validated solution using ICR plates out of IsoBag™ combined with MAS-100 Iso MH®
• Improved productivity of production in isolators by use of IsoBag™
• Use of one control point for 4 distant air sampling locations by use of MAS-100 Iso MH®
• Offer complete service package including validation, training and maintenance
This solution allows for better and more efficient use of space, follows guidelines and regulations and meets your applications and expectations by being easy to work with your Isolator or production line.
New MAS-100 Iso MH®, communicates directly with your Isolator
• Permits the installation of various sampling heads for standard 90 – 100 mm Petri dishes
• Has an additional internal pump with flow control for automatic decontamination of the sampling head and aspiration tube.
• Fail safe double valve system
• Has a fully autonomous air pump and decontamination pump for each unit
• Designed in accordance with GAMP 5 Guidelines
• Validated to the ISO 14698 Part 1 annex B
• d50 below 1μm
For more information: www.merckmillipore.com/MAS-100producttour
IsoBags™ save time and increase flexibility
• Plates are held ready for immediate use
• No need to decontaminate primary bags of plates saves time
• Use of small amounts of plates out of IsoBag™ saves storage space inside the isolator
For more information:www.merckmillipore.com/IsoBag
Find out more about a sound environmental monitoring program in the Webinar:
Environmental Monitoring in Isolators and RABS.
Related Topics and Keywords
air monitor system, aseptic manufacturing processes, biological and physical recovery rates, calibration frequency, decontamination, Environmental Monitoring in Isolators, ICR culture media, industry compliant, IQ OQ documentation, ISO 14698 part one annex B, IsoBag, Lims, Merk’s Winning Combination, Microbial environmental monitoring, perform environmental monitoring, RAB systems, standards and guidelines, the GMP compliance, the instrument control, validated products
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