Pharma Technology

Pharma Technology

Rue Graham Bell 8, B-1402 Thines (Nivelles)

High Containment ≤OEB5 – iCaps capsule polisher with metal check

High Containment ≤OEB5 – iCaps capsule polisher with metal check

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)

Technical Data

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

Product Enquiry

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