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>.
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 |
|---|
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
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.
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.
To continue reading please sign in or create an account.
Don't Have An Account?