Settle Plates for Active and Passive Air Monitoring

Our high-quality agar settle plates (also known as sedimentation plates [AK1] or settling plates) are perfectly tailored for use by the pharmaceutical and cosmetics industries. Whether designed for use in clean rooms and isolators, or less critical controlled environments, our settle plates meet all relevant international standards and regulations, including EU cGMP, FDA Aseptic Guidance, and USP <1116>.

• ICR and ICRplus gamma-irradiated settle plates
  • Non-lockable ICR settle plates for isolators and critical cleanrooms
  • Lockable ICRplus settle plates for isolators and critical cleanrooms
• NEW - TSA LTHThio ICR/ICR+
• Non-irradiated settle plates (LI settle plates)

ICR AND ICRPLUS GAMMA-IRRADIATED SETTLE PLATES

Figure 1. Tripled bagged and gamma irradiated ICR and ICRplus settle plates

Our gamma-irradiated and triple-bagged ICR (Isolator Clean Room) and ICRplus settle plates are suitable for use in critical cleanrooms, RABS, and isolators. They can be used for passive and active air monitoring with the MAS^® Air Sampler family, as well as for glove prints. In addition, they are available as non-lockable ICR plates and lockable ICRplus plates.

To minimize the risk of contamination during transportation of the samples from a sterile to a non-classified environment, we offer gamma sterilized zip lock bags, suitable for contact and settle plates.

Non-lockable ICR settle plates for isolators and critical cleanrooms

Secure and reliable	Convenient	Flexible
2-D data matrix barcode on each plate for paperless and secure identification of individual plates H2O2-impermeable triple-sleeve packaging (transparent) for safe transfer into cleanrooms (ISO 5) and isolators. Protects media during decontamination of isolator Produced in cleanrooms, gamma-irradiated in final packaging to minimize the risk of contamination	Storage at room temperature: storable at the site of use Long shelf life: Allows fewer incoming goods controls, cost-saving High filling volume settle plates (30 mL): Allows prolonged exposition and incubation SDA in pink plates easily distinguishes between TSA and SDA; Lessen the chance of mix up	Usable for personnel monitoring or active air monitoring with air samplers Supplemented by neutralizers for a wide range of disinfectants and β-lactam antibiotics New media formulation of non-animal origin available: Minimizes the risk of BSE contamination.

Lockable ICRPlus settle plates for isolators and critical cleanrooms

Figure 2. Lockable ICRPlus settle plates

In addition to all the above features and benefits, our ICRPlus settle plates combine the high-quality features of standard ICR Settle Plates with the new two-way closure system (CLOSED- or VENT-position) to:

• Increase safety during transport between the sampling area and laboratory/incubation
• Expand incubation for the detection of anaerobic and microaerophilic microorganisms

NEW - TSA LTHThio ICR/ICR+NEW - TSA LTHThio ICR/ICR+

Figure 3. ICR settle plate containing SDA media

The new TSA (Tryptic soy agar) media including the four neutralizers lecithin (L), Tween 80 (T), Histidine (H), and sodium Thiosulfate (Thio) provides additional unique features:

• 12 months shelf-life – decrease the frequencies of incoming controls – cost reduction
• Add-ons to the certificate of analyses:
  

              1)      Verification of anaerobic growth for lockable plates
              2)      Functionality check of individual 2-D matrix code
              3)      Disinfectant test part of the release testing

NON-IRRADIATED SETTLE PLATES (LI SETTLE PLATES)

Our range of non-irradiated settle plates is designed for use in non-controlled and less critically controlled cleanrooms. They can be used for passive and active air monitoring as well as glove prints. Ten plates each are single-bagged.

Single-bagged settle plates for environmental monitoring in less critical areas

Ideal for monitoring less critical cleanroom areas, such as grade C, D, and E, or non-specified environments, our single bagged long (L) incubation (I) settle plates are the ideal choice. Their high-filling volume of 30 mL in 90 mm settle plates reduces the percentage of water loss during the air monitoring procedures.

Secure and reliable	Convenient	Flexible
2-D data matrix barcode on each plate for paperless and secure identification of individual plates Produced in cleanrooms to minimize the risk of contamination Prepared according to the recommendations of the European and US pharmacopeias	Storage at room temperature: Storable at the site of use Long shelf life (6-9 months): Fewer incoming goods controls High-filling volume settle plates allow prolonged exposition and incubation	Use for active and passive air monitoring, personnel monitoring

These plates are available in Tryptic Soy agar (TSA), or Sabouraud Dextrose agar (SDA), which is ideally suited for the growth of yeast and molds. They are supplemented with neutralizers such as lecithin (L), tween 80 (T), histidine (H), and sodium thiosulfate (Th) to inactivate a wide range of disinfectants. To suppress the growth of bacteria SDA media is made available with chloramphenicol.

We offer GMP-compliant solutions and services for environmental monitoring in pharmaceutical manufacturing.