Merck Millipore has launched lockable ICRplus Settle Plates for viable air monitoring and personnel monitoring in clean rooms and isolators.
The new plates are based on the original Merck Millipore ICR Settle Plate technology and provide semi-quantitative determination of microbial contamination.
ICRplus Settle Plates feature a new two-way closure system: the "CLOSED" position allows safe transportation and aerobic incubation while the "VENT" position expands incubation for the detection of anaerobic and microaerophilic microorganisms.
ICRplus Settle Plates are filled with Casein Soybean Digest Agar (TSA), which is recommended by the Food and Drug Administration (FDA) Guidance for Industry (2004): Sterile Drug Products Produced by Aseptic Processing - cGMP.
The plates are offered in formulations with neutralizers for the inactivation of disinfectant. Additionally, the plates can be utilized for the detection of fastidious bacteria when used in combination with Chocolate Agar and lecithin, Tween® 80 and histidine (LTH).
"Efficient and reliable environmental monitoring of isolators and clean rooms is essential to support product quality and customer safety," said Yvonne Hochheimer, Product Manager at Merck Millipore.
Hochheimer continued, "With our unique two-way closure system of the ICRplus Settle Plates, customers can be assured of safer transport and reliable detection of aerobic and anaerobic microorganisms. The plates also offer the ultimate in convenience with room temperature storage at the site of use and a long shelf life. This translates into decreased storage costs and fewer incoming goods controls and QC testing."
ICRplus Settle Plates are produced under aseptic conditions, gamma-irradiated and triple-bagged, making them optimal for personnel monitoring, passive air sampling and active air sampling with sieve like samplers (e.g., MAS air samplers) in isolators and clean rooms.
Furthermore the new products enable inactivation of residual vaporous hydrogen peroxide (VHP) during active air sampling.
Each ICRplus Settle Plate contains a data matrix barcode, which allows secure identification of plates and supports the "paperless" lab. The 90 mm plates have a high filling volume of 30 ml, which allows prolonged incubation.
With the new ICRplus Settle Plates, Merck Millipore stands out as the first supplier of a complete portfolio of lockable, ready-to-use settle and contact plates (ICRplus contact plates) for environmental monitoring in the pharmaceutical industry.