SubscribeSafety isolators for your aseptic processes with active ingredients
Air flow and filter technology
The air handling within the isolator guarantees safety for the product and the operator:
- Intake, circulation and exhaust air in the work chamber and the transfer hatch are protected by HEPAfilters on the basis of a three-filter system
- The isolator can be operated in positive or negative pressure
- The pressure control is rapid and stable
- The circulation air in the work chamber and the transfer hatch is vertical and unidirectional
- The double-filtered exhaust air meets the requirements of DIN 12980 for cytotoxic applications classes V1 and V2
FIBO: the "safe change" filter box
The patented filter box has the following features:
High process safety for the product and the environment thanks to efficient HEPA filtering- The filter boxes are positioned in an easily accessible location below the work chamber
- The filters can easily be changed by a single individual
- The isolator and the filter boxes both remain safely sealed throughout the filter change process
- Fully incineratable filters for easy disposal
A wide range of services to round off the package
- Comprehensive documentation of the isolator that meets all the possible requirements of the authorities
- Installation and start-up with functional tests onsite
- Documented training for operation and maintenance
Changes may be made as a result of technical progress.
Our experience is your safety
You process parenterals and active ingredients. How do you avoid:
- Microbial and particulate contamination of your product?
- Cross-contamination with other products?
- Endangering the operator or the environment?
Our solution from isolator technology
Isolators safely separate the operator from the process and products. The CSI, the Skan safety isolator, is based on a high-quality, state-of-the-art system that also complies with Pharmacopeia USP <797>, "Pharmaceutical Compounding and Sterile Preparations".
The purpose of the isolator is product, operator and environmental protection.
The CSI isolator is designed specifically for working with aseptic-toxic products and is therefore very flexible for use in the preparation of cytotoxics and active ingredients and the handling or infectious micro-organisms. Preferred locations for use are phar- macies, hospitals and laboratories, which carry out aseptic work with active ingredients on a daily basis.
Features
- Short transfer times
- Easy to operate
- High-grade construction of stainless steel and glass
- Integrated hydrogen peroxide decontamination
- Aseptic-toxic mode of operation
- GMP clean room class A, ISO 5
- Automatic leak test
- Optional hydrogen peroxide room monitoring (TLV value)
- Optional glove tester
Complete process safety and high flexibility
- High integrity level
- High level of protection against operator error
- Low risk of cross-contamination
- Straightforward and reproducible cleaning
- Low production and maintenance costs
SIS-A: the integrated H2O2 decontamination system
The integrated decontamination system facilitates rapid, safe and fully automated decontamination of the work chamber and the transfer hatch with hydrogen peroxide (H2O2).
- In the transfer hatch, the extremely short cycle time of just 15 minutes is achieved by means of optimal H2O2 process control and efficient aeration to a residual concentration of <1ppm
- The table, reproducible decontamination process guarantees a quantifiable spore reduction of >10 -6 on the interior surfaces of the isolator
- The work chamber and transfer hatch, which are hermetically sealed against the surrounding environment, can be decontaminated separately
- High productivity levels can be achieved thanks to the short transfer time, which allows for a large number of formulations or laboratory samples per day
H2O2 decontamination in the transfer hatch
