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Contamination Control for Medical Devices

Contamination Control for Medical Devices24

Medical Devices Contamination Control Solutions can be the key to ensuring quality is maintained for manufacturers when developing and producing industry equipment.

The medical device industry covers implants, instruments and equipment intended for therapeutics, monitoring and diagnostics.

In recognition of the seriousness of risk of contamination, producers of medical devices are required to meet regulatory compliance standards for contamination control through manufacturing processes.

Even the most powerful, expensive sterilisation and contamination control methods can be rendered useless without a carefully thought out and planned process to reduce risk of contaminating products.

With a world-leading reputation for quality and innovation, Dycem contamination control solutions offer a proven protection for reducing the risk of contaminants in the demanding medical devices industry.

Examples of Medical Devices Dycem help to protect from contamination

  • First aid bandages
  • hip prostheses
  • X-ray equipment
  • ECG monitors
  • heart valves
  • dental materials
  • spectacles
  • depressors
  • reagent
  • reagent product
  • calibrator
  • control material, kit, instrument, apparatus
  • equipment or system intended for use in vitro to examine specimens including blood and tissue donations from the human body
  • leads, electrodes, adaptors for the above
  • stimulators
  • implants
  • catheters, sensors for item above
  • Active monitoring devices
  • programmers, software, transmitters

Regulation of Medical Devices in the UK

If you are a manufacturer based in the UK and you intend to supply medical devices in the UK or Europe then you need to be aware of regulations and guidelines that you have to follow to ensure correct compliance is followed.

You can find out more on the regulation of medical device manufacturing here:

Where Dycem Can Help

Dycem Can work with various medical device manufacturers globally, helping them to reduce the risk of contamination control in the following areas:

  • Gowning areas
  • Entry and exits to areas.
  • Specialty and Specialty associated areas
  • Airlocks
  • Manufacturing Zones

Medical Device Manufacturers who use Dycem

Micronit BBRAUN J&J

Case Studies

Worldwide medical device Company

This organisation offers a range of products and solutions for skin and wound care, infection prevention, oral care, health information systems, drug delivery and food safety.

The facility installed into is the group’s technical centre of excellence for drug delivery systems including inhalation research and development, manufacturing and distribution.

Dycem was chosen to be installed into a variety of transitional areas where personnel move from low care, through medium care, to high care areas. This organisation recognised the risk of contamination and cross-contamination entering production areas via goods in and warehouses. Equipment, packaging, ingredients, sub-contract supplies all are sources of contamination thus the Dycem is used to trap particles from feet, wheels in airlocks and transit locations.

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