Synergy Health, as a global supplier of sterilisation solutions to medical device manufacturers, offers a technology-neutral and bespoke approach to all members of the market. With over 30 years’ experience and a global network of technology and regulatory experts, Synergy Health is renowned for its service and quality leadership within the sterilization market.

In all locations, Synergy Health is proud of its record of exceeding environmental, ethical, and health and safety standards, which are essential in this highly regulated industry. The stringent controls and innovative quality systems incorporated in all processes ensure that all customers receive an exemplary service.

With a detailed understanding of all medical device sterilisation requirements, from design to regulatory compliance, Synergy Health offers support and guidance to a diverse range of medical device manufacturers. With an appreciation of the importance of sterilisation services to your business, Synergy Health endeavours to operate as an extension of your organisation, enabling you to offer a regulatory complaint and cost-effective product to the market.

Synergy Health employs the following sterilisation technologies:

Electron beam irradiation is an effective sterilization process for medical devices and pharmaceuticals.
Synergy Health has a global network of microbiology laboratories for medical device testing.
Synergy Health has a detailed understanding of all medical device sterilization requirements, providing compliance to ISO 11137 and ISO 11135.
Synergy Health provides tailored sterilization services for complex medical (combination) devices such as pre-filled syringes.

Gamma irradiation sterilisation

A wide variety of healthcare products from implants to pharmaceuticals employ gamma for its sterilising capability. In the context of sterilisation it is generally accepted that these species induce breaks in the DNA double helix, preventing replication and hence sterilisation.

Electron beam irradiation sterilisation

As well as being a highly established method used for initiating change at a molecular level in polymers, electron beam irradiation has also established itself as an effective sterilization process for medical devices, dressings and pharmaceuticals.

X-ray irradiation sterilisation

Processing by X-ray radiation is another form of irradiation processing and is suitable for a range of healthcare products, from medical devices to pharmaceuticals. X-rays are produced by placing a metal (tantalum) target between the electron beam and the product to be treated. A key feature of this technology is its ability to mix different products with different dose requirements in the same irradiation cycle.

Ethylene oxide sterilisation

Ethylene oxide (EO) is a gas that is widely used for sterilisation in the healthcare industry. During the sterilization phase, products are exposed to the EO gas which kills the organisms by reacting with its cellular constituents.

Microbiological laboratories for medical device testing

In addition to its technologies, Synergy Health operations are fully supported by microbiology laboratories. With its markets primarily in medical devices and related industries, these Synergy Health facilities are able to provide a range of regulatory complaint tests such as microbiological validations and determination of contamination levels. It is not just medical device customers that can benefit from Synergy Health’s laboratory services; the range of tests, training and consultation provided can assist a variety of customers whatever the industry.

Regulatory compliance in medical device sterilisation

In order to satisfy your customers’ requirements you need to work with a partner that can offer and deliver a reliable and comprehensive service. Synergy Health prides itself on its continued commitment to technical excellence by investment in its employees and active participation in ISO CEN committee working groups to ensure compliance to all the applicable regulatory standards is guaranteed.

Quality and regulatory affairs consultancy

Synergy Health has entered in to collaboration with High Edge Consultancy to provide additional support to our customer base. This collaboration creates invaluable links between Synergy Health and High Edge Consulting, which will benefit both companies’ clients. By working together, the manufacturers of medical devices can now have expert advice on both sterilisation technologies and on compliance to the relevant directives and standards.

Synergy Health – specialist outsourced services for healthcare providers

Synergy Health delivers a range of specialist outsourced services to healthcare providers and other customers requiring health management, and operates six core divisions globally:

  • Applied Sterilisation Technologies for single-use medical devices and other products
  • Hospital Sterilisation Services for reusable medical and surgical equipment
  • Healthcare Solutions to manage the patient’s environment, specialising in infection control, wound care and surgical products and services
  • Linen Management services for healthcare facilities
  • Laboratory Services including clinical pathology, toxicology and microbiological services, together with occupational health programmes
  • Pharmaceutical Laboratories for a comprehensive range of pharmaceutical testing services