“HC” High Containment ≤OEB5 – iCaps capsule polisher with metal check

“HC” Containment ≤OEB5 washable model guarantees excellent polishing due to a patented system and it is used for highly toxic drugs, avoiding operator and production room contamination.

Key benefits
  • Patented ≤OEB5 WIP/WOL polishing and metal check - SMEPAC tested and ATEX certified
  • Pressure monitoring with fail security valves and Pressure decay
  • Total emptying with all capsules type
  • 4 elevation heights from 1000 mm to 2200 mm
  • FDA-approved light components to handle and wash
  • Ergonomic, Efficient, Robust, Reliable
  • No risk of cross contamination - Easy validation
  • Central HMI with OPC UA, CFR 21 Part 11 compliant

When manufacturing or planning to manufacture high potency drugs, a High Containment unit is required to protect the operator and his environment. We offer a complete end-of-the-line concept with all required High Containment connectivity. Our iCaps “HC” washable units ensure an OEB5 High Containment level. This solution permits to wash the equipment at the end of the production batch. During the flooding of the polisher, brush rotation is used to remove sticking powder from the surfaces. This guarantees that all volatile dust is removed before dismantling the equipment. A pressure decay system permits to verify tightness of the unit before starting the manufacturing process. This self-test system vacuums the unit and verifies that there is no leakage in the whole system. Continuous pressure monitoring verifies that the equipment is always under negative pressure, preventing dust particles from escaping into the production environment. If a problem is detected, the system automatically changes the valve status to create a safe environment for the operator. There are two versions of Washable systems:  the “HC” WIP version (Washing In Place, also called Washing in Line), the polisher is washed in the production room and can be linked to the capsule filling machine. The system remains connected and closed between production and washing process. In the “HC” WOL version (Washing Off Line), instead, the polisher should be disconnected from the production machine in a High Containment fashion, and washed in a separate washing room.   In this case, since the WOL trolley remains in the washing room, it can handle several machines, resulting in a cost-efficient solution.  A unique patented concept, called Autocheck, enables regular testing on the metal detector.

  • Sampling door
  • Capsule diverter
  • Metal check test sample inserters
  • Autocheck for metal checker
  • IPC tester for capsules (weight and length)

Products to process Capsules
Polishing technology Patented helicoidal brush system with side vacuuming
Polishing effect High performance level
Vacuum On each elevation tube section
Total emptying Yes, all formats and weight
Conveyor material FDA Hi-tec polymer
Capacity/Speed
Small capsules Size 4-5 Up to 750.000 caps/h
Medium capsules Size 1-2-3 Up to 400.000 caps/h
Large capsules Size 0-00 Up to 250.000 caps/h
Interfacing/Connectivity HMI with OPC UA capability
Inlet Height 558 mm (center of inlet tube DN50)
Available elevation heights 1000/1400/1800/2200 mm
Accessories
Pressure monitoring Standard
Pressure decade N/A
Metal check CEIA/PH21N - Head aperture Ø 70 mm
Intrinsic sensitivity SS 316L 0,40 mm
Ferro: 0,25 mm
Non ferro: 0,30 mm
Metal check Lock Insight - Head aperture Ø 70 mm
Intrinsic sensitivity SS 316L 0,50 mm
Ferro: 0,30 mm
Non ferro: 0,35 mm
Autocheck for metal detector Optional
Empty Capsule Eliminator N/A
Diverter Optional - 2 ways/ 4 ways / Euro Pallet
Regulations
Occupational Exposure Band "HC" High Containment ≤OEB5
Noise level <72 dB(A)
GMP compliance Yes
CE compliance Yes
Material certificate Available
IQ-OQ protocole Available
Cleaning and Dismantling
Manual cleaning Easy access for cleaning/No tools required
Automatic cleaning Washing in place - Washing off line
Floor dimension 711 mm x 460 mm
Frame mounted on wheels Yes

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