welcome to our - Synergy Health
Transcription
welcome to our - Synergy Health
EUROPE ISSUE 13 MAY 2014 APPLIED STERILISATION TECHNOLOGIES S U B S C R I B E N O W AT w w w. s y n e r g y h e a l t h p l c . c o m WELCOME TO OUR MAY NEWSLETTER I am pleased to announce that we have final agreement to build a new Gamma pallet irradiator alongside the current plant in Bradford, UK and this will open in Q4 2015. In mainland Europe along with recent cobalt investments we have installed, we are now ramping our capacity delivery at our new Marcoule Gamma site. We are also continuing the capacity offer at the X-ray processing site at Däniken, Switzerland. This shows Synergy Health’s commitment to the rapidly growing Gamma market and will give us capacity to manage expected growth over the next 10 years. The EO market is also changing rapidly on the back of residual changes, concerns about lead times and cycle reduction. Over the coming months you will receive communications from us on how we can work in partnership with you in these areas. Upcoming Events: • Gamma Training Course - Ireland 8th May • Solvay - Pulse on Plastics Symposium - UK 17th-18th June • X-ray Webinars - Europe 15th, 22nd, 28th May • Medtech Europe - Germany 3rd-5th June • Gamma Training Course - The Netherlands 5th June • EO Processing Training Course - UK 10th June • Medtech Innovations Day - UK 11th June • ISO 11137 validation and Microbiological compliance Training Day - UK 25th June MARK BOTTING COMMERCIAL DIRECTOR AST UK & IRELAND • Medtech Innovations - Ireland 25th-26th June Europe The Netherlands AST Etten-Leur obtained GMP certificate Further expansion in Europe Synergy Health is to build a new gamma pallet irradiation facility in Bradford, UK. For many years, the AST Gamma plant in Ede has had a pharmaceutical license and GMP certificate to treat pharmaceutical end products. Due to an increased demand from our customers for more capacity, for treating this kind of product, we decided to certify the AST Gamma Etten-Leur site. In late March 2014, our AST Gamma plant in Etten-Leur was audited by the Dutch authorities IGZ (MHRA) and received their pharmaceutical license and GMP certificate. This was a successful audit with no observations. In the coming weeks we will receive our pharmaceutical license and GMP certificate. This state of the art facility will be the first pallet irradiator operating in the UK market and will open in fourth quarter of 2015 on the existing Synergy Health site. This project will provide vital capacity for the European region of Synergy Health AST, to help meet the increasing demands of our customers supporting their growth in the coming years. It will also facilitate additional opportunities for products requiring irradiation via pallet Mark Botting, Commercial Director for UK and Ireland said, “We are pleased that the Synergy Health Board has agreed to further investment in the UK market. This move supports our continued commitment to supporting the growth of our customers in the UK and Northern Europe. This investment follows on the heels of the expansion of the ethylene oxide site in Thorne, UK and the new gamma facility in Marcoule, France.” Telephone: +44 (0) 8456 88 99 70 We are pleased that now we can treat pharmaceutical products on both Gamma locations in the Netherlands and meet the growing demand of our customers. Hans van Elst Quality Manager, The Netherlands. @synergy_health Fax: +44 (0) 8456 88 99 78 Email: [email protected] www.synergyhealthplc.com Synergy Health PLC AN INSIGHT INTO UNDERSTANDING RESIDUALS... WWW.SYNERGYHEALTHPLC.COM Synergy Health have 30 years experience in Ethylene oxide processing; innovative cycle designs and supply chain solutions offer the greatest level of assurity on compliance to ISO10993-7 whilst meeting the lead time demands of the market through programs such as our DaRT fast turnaround service. When a product is sterilised with ethylene oxide (EO), some of the gas may be absorbed by the product and/or its packaging and retained after sterilisation. There may also be traces of EO bi-products present after sterilisation. The extent of degassing and aeration used during the sterilisation process will have a significant effect in reducing these residue levels. Why you need to test: Residual testing is your assurance that your product is safe to market. Determining the levels of EO and its by-products is a requirement for many medical devices. The International Standard (ISO) 10993-7 describes the categorisation of products, methods of residual testing and allowable limits of residues. ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EOsterilised medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes. The residues that may be found after processing are as follows: • Ethylene Oxide (EO) – the residue that may remain after processing has been completed • Ethylene Chlorohydrin (ECH) – the residue that may form when EO comes into contact with free chloride ions • Ethylene Glycol (EG) – the residue that may form when EO comes into contact with water Pulse on Plastics Symposium Global trends in Healthcare Plastics 17 - 18 June 2014 Forest of Arden, A Marriott Hotel & Country Club, Birmingham, England. Business Development Manager Jenni Tranter will be speak on An insignt into Sterilisation Methods To register for the event please visit www.pulseonplastics.com RADIATION STERILISATION OF MEDICAL DEVICES TRAINING DAY - UK This popular sterilisation course will The residues can be harmful to the end user or patient so it is important that all devices meet the limits set forth in the AAMI 10993-7 standard. The limits will vary depending upon the intended use of the device so there are three main categories a device may fall under: Limited Use, Prolonged Use and Permanent Use. In addition, there are several special device categories that have their own unique set of limits. Devices that do not have patient contact are not required to meet this standard. provide a valuable overview of the The primary concern is to ensure the EO and ECH residues are within the allowable limits. Devices considered as surface contacting or implantable must meet an additional set of criteria called the Tolerable Contact Limit (TCL). The purpose of this limit is to prevent localised irritation due to the release of EO or ECH from the device. The TCL is a calculated value that takes into consideration the surface area of a device and the EO and ECH residue levels in order to determine if irritation will be an issue. examine approaches for validating these available technologies as well as guidance on understanding the factors needed to take into account when considering sterilisation. It will also processes to ISO Standards. Our courses are designed to give practical guidance to the participants and to explore new cycle design and regulatory requirements. • There are several reasons why a device may contain high levels of residues after being exposed to the ethylene oxide sterilisation process: Training Date: Material – certain materials will absorb and retain gas Course outline: molecules more than others. Natural materials such as cellulose and cotton are known to be very absorbent. Some types of plastics have also shown a high absorption rate when exposed to EO processing. • Packaging – EO processing requires breathable packaging to allow the gas molecules to pass through. Packaging with a minimal or obstructed breathable surface area (i.e. large adhesive label) will not allow the gas to move as freely across the breathable barrier. “ • Load configuration – the volume, density and overall configuration of the load on a pallet can impact the ability of gas removal after processing. Please talk to our EO technical experts to further understand the range of solutions that Synergy Health may provide. ” Synergy Health has 3 Ethylene Oxide facilities in Europe: • Thorne, UK. • Tullamore, Ireland. • Venlo, The Netherlands. Telephone: +44 (0) 8456 88 99 70 [email protected] Email: Fax: +44 (0) 8456 88 99 78 w w w. s y n e r g y h e a l t h p l c . c o m 14th May, Daventry, UK. • Introduction to radiation • Background on Gamma, E-Beam and X-ray • Dose mapping validations • Routine processing • Effects of radiation on materials • Tour of gamma site • Practical aspects of radiation processing For more information or to book 08456 88 99 70 [email protected] @synergy_health Synergy Health PLC
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