The intelligent compounding system (= ICS) is a fully automated robotic solution, controlled by software, which compounds parenteral medication doses into the appropriate final containers within a controlled environment (ISO class 4.8, grade A). environment. The ICS is for use within the compounding practices , both in hospitals and compounding centers, to prepare injections in accordance with appropriate regulations and to label final products in accordance with good practice requirements.
It is based on isolator technology and includes a bio-decontamination system with vaporized H2O2 sterilization technology; it can therefore be installed in an ISO class 8 (grade D) background environment, as per GMP Annex 1. The ICS can handle both hazardous and non-hazardous medications and both patient specific and batch production. The ICS includes state of the art automation and robotics to perform the following tasks without requiring human intervention:
- Sterilize all items with vaporized H2O2 prior to starting the compounding cycle;
- Calculate conversions between weight and volume on the basis of product and
concentration specific gravity data. - Reconstitute powder drugs with the appropriate fluid.
- Dilute liquid drugs to achieve a desired concentration.
- Remove excess liquid from i.v. bags and bottles.
- Compound doses into empty containers (syringes, i.v. bags, elastomeric infusors).
- Manage in-process waste.
The ICS addresses safety concerns for users as well as for patients:
- Access restricted to authorized personnel only.
- No exposure by using isolator technology.
- Automated waste management.
- No cross contamination.
- Safe identification of all items via a combination of vision systems, barcode readers and RFID technology.
- Traceability guaranteed throughout the process via RFID technology.
Intelligent_compounding_system.pdf.pdf
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Product_catalogue.pdf.pdf
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