German Chinese Trading GmbH

 

CEIA THS/PH21-FFV


For powder, granules and similar products
 

 

  • Enhanced product throughput rate
  • Design and Construction Compliant with 21 CFR Parts 210 and 211
  • Electronic Records and Signatures Management Compliant with 21 CFR Part 11
  • Validation Solutions Available:
    • Calibration Standards
    • Validation Manuals
    • Compliance Tools
    • Comprehensive Service & Support

 

The line of Quality Control detectors includes the THS/PH21™ Pharmaceutical Metal Detection Systems, featuring state-of-the-art performance and full compliance with pharmaceutical sector regulations.

The design and construction of the THS/PH21™ Metal Detection Systems comply with FDA requirements Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General – and Part 211 – Current Good Manufacturing Practice for finished Pharmaceuticals – of Title 21 of the Code of Federal Regulations (CFR).

The carefully-selected materials used in construction do not interact with pharmaceutical products, and thus do not modify or alter their composition.

The mirror finish applied to the surfaces guarantees quick, easy cleaning of the components that are in contact with the product. The technological choices made by CEIA allow the parts in contact with the product to be disassembled and maintained in a short time and without the use of machine-specific tools.

In the new version of the THS/PH21, the mechanical tablet control unit has been revised so as to increase the maximum product throughput by up to 70%.

Particular attention has been paid to the deflector opening/closing couple and to its geometric profile in order to prevent trapping the product during activation phases.

CEIA THS/PH21™ Metal Detection Systems feature extremely high detection sensitivity towards contaminating metals, whether ferrous, non-ferrous or stainless steel, even when these are present in tiny quantities. The ejection system, housed in a one-piece casing moulded in AISI 316L stainless steel, is fitted with an innovative deflector that features quick response, precise ejection of the contaminated tablets and high production flow rate.

The CEIA THS/PH21™ Metal Detection Systems operate in Fail-Safe Mode, thus avoiding the risk of contaminants passing through even when the system is deactivated or when the electrical power supply is interrupted.

CEIA THS/PH21™ systems can be linked to local computer networks via a TCP/IP (Ethernet) interface or RS-485. Whether in stand-alone operation or centralised via a computer network, the CEIA THS/PH21™ Metal Detection Systems satisfy the standards of Security, Integrity and Traceability of production data as required by Part 11 of Title 21 of the Code of Federal Regulations (CFR) – Electronic Records; Electronic Signatures (ER/ES).

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