Merck Millipore's Additions to the MAS-100® Product Family of Microbial Air Samplers Deliver Improved Functionality for Pharmaceutical Manufacturers

16 Jun 2015
Sarah Thomas
Associate Editor

Product news

Merck Millipore, the Life Science business of Merck, has announced three additions to its MAS-100® product family. The MAS-100 Iso MH® and MAS-100 Iso NT® systems were developed for use in isolators and enable sampling at critical control points. The distinguishing feature of the MAS-100 Iso MH® system is its four sampling heads, which allow for increased monitoring capacity compared to single-head systems. The compact and easy-to-handle design of the MAS-100 VF® air sampler makes it well-suited for use in controlled environments.

The MAS-100 Iso NT® system for monitoring air in isolators was developed according to GAMP 4 and ISO® 14698 standards. The fully validated air sampler contains an innovative double valve which integrates the sampling head into the decontamination process of the isolator. For added safety, electronic and moving parts remain outside the critical zone and an internal pump with flow control enables automatic disinfection of the sampling head and the aspiration tube.

The MAS-100 Iso MH® air sampler offers all the benefits of the MAS-100 Iso NT® and allows installation of up to four sampling heads at all critical control points. Multiple heads from one pump provide increased capacity, easier installation and lower cost than four equivalent single-head systems. Additionally, the system extends up to 10 meters in tube length, which facilitates use in larger isolators. The system was developed according to GAMP 5 and ISO® 14698 standards.

The MAS-100 VF® active air sampler was validated and developed for air monitoring in controlled environments. The system's compact design allows for ease of operation, and its added handle can be mounted on a tripod to test different angles for fixed applications. Electronic speed control ensures a consistent and accurate flow rate, and a touch-slide control menu enables simple menu navigation. The system programs sample volumes from 1 to 1,000 liters with five presets to assure reproducible results.

"Air contamination in manufacturing facilities can impact product quality and increase risk to consumers," notes John Sweeney, head of Lab Solutions Business, Merck Millipore. "It is therefore essential to implement robust and accurate microbiological monitoring of air in all manufacturing areas. With the MAS-100® product family, Merck Millipore offers its customers the broadest portfolio of the most accurate microbial air monitoring systems on the market, enabling manufacturers to ensure the highest quality products and increased consumer safety."

The MAS-100® family includes systems for testing air and compressed gases in cleanrooms, aseptic production areas, isolators, and other controlled environments. MAS-100® microbial air samplers comply with the guidelines as specified in the new ISO® 14698 part 1 and part 2 standards.

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Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Air SamplingAir sampling is described as the technique used to capture air for the subsequent purpose of analyzing, typically by thermal desorption, the presence of trace particulates, such as volatile organic compounds (VOCs).Microbial DetectionMicrobial detection is crucial for identifying and quantifying bacteria, viruses, fungi, and other microorganisms. This process is essential for food safety, environmental monitoring, clinical diagnostics, and pharmaceutical manufacturing. Explore the best microbial detection tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.