Technology Overview. X-ray

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Rosamund Clarke
7 years ago
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1 Technology Overview X-ray

2 Why X-ray? Due to X-ray being powered by electricity there is no reliance on cobalt 60 as a sterilisation resource Due to reduced processing time, lead times are improved whilst delivering the same dose levels as Gamma Adverse effects on products are reduced because it is not a thermal process X-ray is expected to become the sterilisation method of choice due to its reliability, flexibility and efficiency when processing pallets of product We have the capability to handle more than 80,000 pallets of product annually with 25 kgy minimum dose

3 X-Ray Overview The effective way to generate high-energy electromagnetic radiation Automated alanine dosimetry system for quick and efficient production of data and results. Benefits of X-ray: Quality Improved dose uniformity ratio compared with Gamma Efficiency More X-rays are delivered to the product due to our sophisticated conveyor system Flexibilty X-ray has the ability to mix a range of dose requirements and process loads with a wide density range in the source without any impact on the quality of the treatment Penetration Better than E-beam and similar to Gamma with less impact on product materials Beta (ß) Gamma (Y) X-Ray (X) In-depth effect: X-rays have excellent penetrative capabilities

4 Cosmetics & Toiletries Pharmaceuticals Commercial use of X-ray: Commercial use of X-ray began around 20 years ago. However, due to the low power output of the accelerators used, the technology was generally overlooked as a viable sterilisation method. Medical Devices Now, with the introduction of high power, high energy accelerators we are able to offer X-ray technology at a commercial level equivalent to traditional methods. Synergy Health operates the first large-scale X-ray radiation plant in the healthcare environment. Document Recovery

5 Synergy Health Däniken Switzerland The site uses the Rhodotron electron beam to generate X-ray, and has more than 4500m 2 of space for easy and safe product handling, with the capacity to handle more than 80,000 pallets of product annually. The combination of shorter exposure time and improved dose uniformity ratio (DUR) with X-ray sterilisation means there is the option to use this technology for products that up to now, have been processed using traditional methods such as Ethylene Oxide gas sterilisation or Gamma irradiation. This avoids the polymer degradation issues of Gamma or the density restrictions of E-beam. X-ray is offering a new viable alternative to existing technologies and their limitations. The layout of the plant and manufacturing process is designed to fulfil international standards, including the quality management system standard for medical devices ISO 13485, ISO 11137: Sterilisation of Healthcare Products - Radiation, cgmp and Food and Drug Administration guidelines. The use of X-ray is not restricted to the sterilisation of medical devices; pharmaceutical products and decontamination of packaging materials, raw materials for pharmacy and cosmetic businesses are processed regularly. Treatment Characteristics Pallets pass in front of the X-ray beam on two levels. Pallets can pass in front of the beam multiple times with each pallet quadrant being exposed equally. Speed regulation is independent of the number of pallets loaded on this section of the conveyor. Conveyor mechanism provides a gap closing conveyor sequence so that minimal gap between pallet is constant. The Rhodotron TT-1000, with an energy of 7 MeV (7 million electron volts) and a power of 700 kw is one of the most powerful electron accelerator of its kind worldwide.

6 Our Vision To build a lasting reputation as the trusted experts in global healthrelated markets by differentiating our services and products through the way we work. Achievement We believe our success comes from our focus on exceeding expectations and our commitment to go that extra mile, however small the difference may seem. Accountability We take personal responsibility for our actions and are equipped to take the right course of action. Integrity We believe that the way we work is as important as what we do. We care deeply about that quality of our work and inspire trust by delivering on promises. Innovation We achieve the best possible results by working with customers to develop new ways of solving problems and reducing risk. Europe Switzerland: +41 (0) assistance@synergyhealthplc.com Synergy Health 2014 Ref: XRT - 01/14

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Sterile Cleanroom Management Lynn Stanard, Sr. Quality Manager, Berkshire Corporation When manufacturing in an aseptic environment, it is critical to ensure that the various cleanroom consumables, such