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: assistance@synergyhealthplc.com
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
assistance@synergyhealthplc.com
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
education@synergyhealthplc.com
@synergy_health
Synergy Health PLC