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Pharmaceutical quality process applied to Hospital
pharmacies to provide protection to patient and the operator. |
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Capabilities
. Positive and/or Negative pressure isolators
. Configurations to suit the daily throughput
. For "just in time" delivery
The ISOCYT FREJA
It is a leaktight enclosure, equipped with means of transfer and manipulation which keeps an enclosed environment allowing a cross protection between the operator and the product, against microbiological and chemical contamination, without compromising the environment. It is designed to allow up to 50 reconstitutions per day.
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PRINCIPLE OF OPERATION
- Formulations are individually loaded in indivual baskets and transferred in the bio-decontamination airlock
- After completion of the bio-decontamination cycle, the baskets are transferred to the already bio-decontaminated work station (two bio-decontaminations per month are recommended)
- When all the baskets are in the work station, a new bio-decontamination cycle can be started in the airlock with a second series of baskets
- The operators do the reconstitutions, throw away the waste in the laterally located DPTE Betabag® and put(s) each preparation in a zip pouch before egress through the Dynamic Output Port
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 DESIGN FEATURES
- The system (Work station, bio-decontamination airlock, and Dynamic Output Port) is constructed from solid, high quality, stainless steel
- One transparent tempered glass window with four shoulder rings
- Bio-decontamination airlock, work station and dynamic output port comprise two modules (Air inlet and outlet modules)
- Integrated H2O2 for bio-decontamination system for airlock, work station and Dynamic Output Port
- Full automatic control PLC system
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Steritrace II - Integrated H2O2 sterilizer
The isolator contains the integrated H2O2 sterilizer Steritrace II for the bio-decontamination of:
- The work chamber
- All loads entered through the bio-decontamination airlock H2O2 is provided in the form of an aqueous solution at 35% in 250 ml bottles with an RFID chip containing the batch number and the expiration date for traceability. This solution is vaporized in the Steritrace IITM in a heated vaporizer.
The main phases of a bio-decontamination cycle are:
- Dehumidification
- Injection phase
- Aeration using the inlet and outlet air blower of the isolatorHydrogen Peroxide Vapor is a well established, proven chemical sterilant.
The different materials used in the manufacture of the isolators are compatible with the bio-decontamination agents (H2O2). The resistance of any other material used inside the isolator should be tested beforehand.
More information...
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Company Profile;)
DESIGN FEATURES