Environmental Monitoring in Isolators

IsoBag™ optimize your environmental monitoring workflow

Mount readily gamma-irradiated contact or settle plates directly to your isolator without prior decontamination.

IsoBag™ improves the environmental monitoring workflow in aseptic production isolators by ensuring fast and safe transfer of contact and settle plates to your production isolator. These unique transportation and packaging bags are simply mounted to the alpha port of the isolator. This keeps the plates available for use at any time – and conveniently stored, without taking extra space within the isolator. There is no need for decontamination cycles before introducing settle or contact plates, freeing up time for your actual production processes and thus saving costs.

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Figure 1. IsoBag™ optimize your environmental monitoring workflow in aseptic production isolators.

Figure 2. IsoBag™ is designed to reduce the decontamination cycles in production isolators.

Unquie Features of IsoBags™:

• Pre-packed DPTE BetaBag^® with ready-to-use single-bagged contact or settle plates
• Beta port connectable to any 190 mm DPTE^® Alpha port
• Available with TSA + LTHTh media in lockable and non-lockable contact and settle plates
• Includes traceable plates corresponding to batch of ICR plates
• Multiple connections possible
• Sterile transport bags for safe transport of used plates

ICR/ICR PLUS CONTACT AND SETTLE PLATES AVAILABLE IN ISOBAGS™

We offer a comprehensive range of plates specifically designed for environmental monitoring in isolators and critical cleanrooms: the non-lockable ICR and lockable ICRplus Contact and Settle Plates containing TSA + LTHTh.

ICR Contact and Settle Plates ensure maximum safety, reliability, and convenience:

• Data matrix barcode on each plate
• Transparent, VHP-impermeable, barrier packaging
• Produced in cleanrooms and gamma-irradiated in the final packaging
• Prepared according to European and US pharmacopeia recommendations
• Room temperature stability
• Long shelf life
• Available with 4 neutralizers for the inactivation of a wide range of disinfectants and inhibiting VHP residues
• The contact  and settle plates of our ICRplus range additionally feature CLOSED and VENT closure options for safe transportation and variable incubation conditions

Comparison of environmental monitoring workflow in an aseptic production with and without IsoBag™

Workflow without IsoBag™

Limited time between two decontamination cycles due to required space for media storage > results in a short campaign duration

Introduction of ICR plates into the isolator	Decontamination cycle	Storage and use of plates	Repeat process
ICR plates are transferred into the isolator by removing the two outer bags in material locks within the inner packaging.	The decontamination cycle is performed with single-bagged plates. Use holes in bags to hang them up.	Decontaminated ICR plates are stored in the isolator and used for environmental monitoring during a specified period of time.	Introduction of ICR plates into the isolator before the next scheduled decontamination takes place.

Workflow with IsoBag™

Extended operation time between 2 decontamination cycles using IsoBag™

Introduction of ICR plates into the isolator	Decontamination cycle	Use of Plates	Repeat process
ICR plates are transferred into the isolator by connecting the IsoBag™ to the alpha port of the isolator. (Minimum of 1 staple with 10 plates per connection)	This step is removed with use of IsoBag™	Save storage room for plates in the isolator. ICR plates can be used immediately for environmental monitoring.	ICR plates are transferred into the isolator by connecting the IsoBag™ to the alpha port of the isolator. (Minimum of 1 staple with 10 plates per connection)