Automatic Liquid Packaging Solutions LLC (ALPS)
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ALPS - Isolation Insertion Technology (IIT)
This technology is used to enhance functionality of an already Robust Aseptic BFS/FFS technology to process.
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A few examples:
- A device or a sterile insert such as a tip & cap of for eye-dropper bottle can be fed through an isolator then placed in the bottle after the filling operation during the BFS process, prior to closing of the container, and hermitically seal the Insert into the vial/bottle. The Tip & Cap Inserts are made with precise dispensing orifice(s) to dispense a controlled drop of liquid product.
- Sterile drug additive(s) can be injected into the vial/bottle through a rubber stopper at the point of use.
- Sterile Powdered Capsules can be inserted into the containers and mixed at point of use with the liquid already present in the container (prior to opening the container for different therapies).
C-RABS(Closed Restricted Access Barriers) can have RTP (Rapid Transport Ports) or Transfer Chambers to load Inserts (e.g. eye drop inserts , rubber stoppers etc.) into the main isolator that has been integrated in-line with an ALPS BFS/FFS machine. These isolators maintain class 100 (ISO 5) for the Aseptic process. They include:
- VHP (Vapor Hydroxide Peroxide) Decontamination Cycle development for Sterility assurance of the Integrated process for Insertion (e.g. Tip & Caps) and the BFS/FFS process.
- Pre-validation Documents DQ/IQ/PQ for the IIT process
- Integrated LIVE Viable and Non-viable particle counters
- Glove Port Integrity tester
- Built-in Hydrogen Peroxide (H2O2)