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DoverPac ® - Contained Powder Transfer FLEXIBLE C ONTA INMENT TECHNOLOGIES Use of Lifting Bar Lifting Bars Attaching the restraint to lifting bar Securing the liner neck 24 A lifting bar and hoist are used in order to position the DoverPac ® restraints over the vessel interface for charging. The lifting bar comes in two sizes to accommodate DoverPac ® sizes. Hoists typically are supplied by the customer. Typical DoverPac ® Charging Arrangement Other System Components and Accessories Other system components and accessories developed by ILC Dover to support contained pharmaceutical ingredient processing include: • Wash In Place Enclosure • Clean In Place System • In Line Filter Kit 4 ILC Dover www.doverpac.com customer_service@ilcdover.com Ph 1.302.335.3911 • Fax 1.302.335.1320 O N E M O O N W A L K E R R D . , F R E D E R I C A , D E L AWA R E U S A 1 9 9 4 6 - 2 0 8 0 Containment Systems Containment Systems
Coaxial DoverPac ® - Nanogram Powder Transfer OVERVIEW The Coaxial neck DoverPac ® was originally designed to allow secondary containment to be used with a DoverPac ® in the late 1990’s for charging and offloading vessels through isolators. Given the increase in highly potent API manufacturing, the use of this system with either rigid isolators or flexible enclosures is a complimentary processing option. The Coaxial Neck DoverPac ® serves the dual function of contained transfer and storage system. These are available in standard 45, 185, 400, and 700Liter volumes. Custom sizes can also be accommodated. HOW DOES IT WORK? This system is designed to provide containment to the OEB 5 (less than 1 μg/m3 with a goal of below 200 nanograms/m3 on a task basis). To achieve this, the secondary containment (i.e. flexible enclosure and the outer neck) at the primary connection points are applied. Figure 1 shows the offloading set up during exposure monitoring trials. The installation sequence follows: • The top of the enclosure is attached to the first canister on the vessel outlet. • The bottom of the enclosure is attached to the canister on the support frame. • The external neck on the DoverPac ® is then attached to the outlet point of the canister on the frame. • The internal neck of the DoverPac ® is pulled up through the lower canister and is attached to the groove on the vessel canister by using the integral glove sleeves on the flexible enclosure. Figure 2 4 1 Figure 1 3 2 5 Containment Systems 1. Vessel Outlet 2. Flexible Enclosure 3. Inner Neck Attachment 4. Support Frame 5. Outer Neck Attachment Once the vessel is offloaded, the internal neck is crimped off and pushed back down through the canister on the frame by using the enclosure to access the neck area. The operator then extracts his/her arms from the enclosure and crimps off the external neck. The crimping process, Figure 2, is employed for the contained separation operations. This process consists of installing two injection molded crimps into the hand tool, twisting the liner neck, ratcheting the crimps closed, cutting between the two crimps, and installing the protective cap. 25
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ILC Dover has been “creating what
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Q - Jetsolutions SA

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