Summary

Global supplier of sterilisation and microbiological control solutions to medical device and pharmaceutical manufacturers.

Profile

Synergy Health offers a technology neutral and bespoke approach to all members of the market. With more than 30 years' experience and a global network of technology and regulatory experts, Synergy Health is renowned for its service and quality leadership.

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 sterilisation and microbial control requirements, from design to regulatory compliance, Synergy Health provides its customers with full support and guidance. Synergy Health understands the importance of sterilisation services to your business, and therefore endeavours to operate as an extension of your organisation, enabling you to offer a regulatory compliant and cost effective product to the market.

Technologies

Gamma Irradiation (Cobalt 60): 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 (beta ray): As well as being a highly established method used for initiating change at a molecular level in polymers, Electron Beam has also established itself as an effective sterilisation process for medical devices, dressings and pharmaceuticals.

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

Microbiological Laboratories

In addition to its technologies, Synergy Health operations are fully supported by microbiology laboratories. With its markets primarily in medical device and pharmaceutical, these Synergy Health facilities are able to provide a range of regulatory compliant tests such as microbiological validations and determination of contamination levels.

Regulatory Compliance: 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