Stay on the safe side: surface and personnel monitoring solutions

Published: 7-Sep-2012

Merck Millipore’s complete portfolio of reliable, convenient and flexible environmental monitoring products enables pharmaceutical companies to keep production plants clean and minimise the risk of contamination.

Merck Millipore’s complete portfolio of reliable, convenient and flexible environmental monitoring products enables pharmaceutical companies to keep production plants clean and minimise the risk of contamination. A crucial means of monitoring the efficiency of manufacturers’ hygiene routines is sampling surfaces and personnel – using proven tools like easy-to-use contact plates, contact slides or swabs.

The product portfolio encompasses a wide range of swabs and contact plates adapted to cleanroom requirements and different surface types. For highly critical areas, such as cleanrooms (ISO 5) or isolators, Merck Millipore provides triple-sleeved, gamma-irradiated ICR and ICRplus contact plates and slides. These are ideally complemented by ICR Swabs for difficult-to-access locations like tubing or filling needles.

The reliable choice for less critical environments is single-bagged, non-irradiated RT and RTplus contact plates and slides. Since every country has its own standards, the available surface and personnel monitoring solutions have been designed to meet them all – making sure that end products are safe, wherever around the globe these may have been produced.

The versatile ICR Contact Plates, available in a variety of formulations for the monitoring of sanitised, dry surfaces in isolators and critical cleanrooms, are gamma-irradiated in their final packaging to minimise the risk of contamination. Their transparent, H2O2-impermeable triple-sleeve packaging ensures safe transportation in cleanrooms (ISO 5) and isolators. Each plate contains a data matrix barcode for paperless and reliable identification. To further minimise the risk of errors, SDA is provided in pink plates.

All plates may be stored at room temperature and thus at the site of use. Due to their long shelf life, fewer controls of incoming goods are needed. The plates are supplemented by neutralisers for a wide range of disinfectants.

ICRplus Contact Plates offer all the above features and benefits, plus CLOSED and VENT closure for safe transportation and flexible incubation conditions. A new formulation of non-animal origin is available to minimize the risk of BSE contamination.

RT Contact Plates for less critical cleanrooms are, like their ICR counterparts, produced in cleanrooms to minimise contamination risk. They also display a data matrix barcode on each plate and can be stored at room temperature. The RTplus Contact Plates, like the ICRplus plates, possess the CLOSED and VENT feature.

ICR Swabs for isolators and critical cleanrooms are suitable for presence/absence testing of difficult-to-access, dry surfaces such as filling needles and tubes. These gamma-irradiated swabs are opened only once for sampling. All subsequent steps, such as adding the broth, incubation, and detection of turbidity, are performed in the closed system. Triple-sleeve packaging enables them to be safely transported in cleanrooms (ISO 5) and isolators. Their H2O2-impermeable inner packaging protects the medium from VHP vapor during decontamination of isolators. The pre-moistened swab tips leave no growth-promoting residues on surfaces.

The flexible HYCON Contact Slides are universal tools for flat and curved surfaces in aseptic environments and isolators and provide a standardized contact area of 25cm2. To minimise the risk of contamination each slide is 100% visually inspected. The slides, which can be stored at room temperature on location, are provided with a re-sealable sleeve for safe transportation. A range of formulations is available, including total count media and selective media for yeasts and moulds, coliform organisms and Staphylococci.

For safe transportation in cleanrooms (ISO 5) and isolators, Merck Millipore offers HYCON Contact Slides that have been gamma-irradiated in their final, double-sleeve packaging. They are individually sealed, possessing an H2O2-impermeable primary packaging to allow storage of single slides in cleanrooms and isolators during contamination.

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