STERIS AST of Swindon at COMPAMED 2017 in Düsseldorf -- COMPAMED Trade Fair
Service

STERIS AST

Moray Road, Elgin Industrial Estate, SN2 8XS Swindon
United Kingdom of Great Britain and Northern Ireland

Telephone +44 8456 889970
ast_info@steris.com

Hall map

COMPAMED 2017 hall map (Hall 8b): stand D25

Fairground map

COMPAMED 2017 fairground map: Hall 8b

Contact

Laura Hunt

Marketing Communications Manager

Visit us

Hall 8b / D25

13.11.2017

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Appointments with Sales Managers

Please email us at ast_info@steris.com to book an appointment.

We look forward to seeing you!

The Marketing team

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Our range of products

Product categories

  • 10  Equipment and technologies for laboratories and manufacturing
  • 10.01  Laboratory equipment
  • 10.01.12  Materials testing
  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.30  Sterilisation services

Our products

Product category: Sterilisation services

Ethylene Oxide

Ethylene Oxide Processing
Ethylene oxide (also known as EO or EtO) processing is widely used for the sterilization of healthcare devices and instruments. The process involves exposing products to ethylene oxide gas under vacuum in a sealed chamber. EO sterilization assures that a safe and sterile product will be delivered to the market each and every time.

What is Ethylene Oxide Processing?
Ethylene oxide sterilization is a chemical process consisting of four primary variables: gas concentration, humidity, temperature and time. EO is an alkylating agent that disrupts the DNA of microorganisms, which prevents them from reproducing. The EO penetrates the breathable packaging and sterilizes all accessible surfaces of the product to render products sterile by alkylation of proteins essential for cell reproduction.

What is Ethylene Oxide Used For?
Ethylene oxide can penetrate multiple layers of breathable packaging, making it suitable for the sterilization of a wide range of materials not compatible with other methods of sterilization:
  • Assembled complex devices
  • Catheters
  • Custom procedure packs
  • Equipment with integrated-electronics
  • Multi-lumen tubing products
  • Stents
  • Wound care dressings
When selecting a sterilization partner, manufacturers need to choose a contractor who has the flexibility and technical capability to meet the demands of the specific devices.

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Product category: Sterilisation services

Gamma Irradiation

Gamma Irradiation Processing
The gamma sterilization process uses Cobalt 60 radiation to kill microorganisms on a variety of different products. Processing with gamma irradiation yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials.

What is Gamma Irradiation?
The radioisotope cobalt 60 is the energy source for use in gamma irradiation with the irradiation process taking place in a specially designed cell. A key characteristic of gamma irradiation is the high penetration capability. This enables moderately dense or sealed products to be processed with relative ease and facilitates treatment of palletized product. The unit of absorbed dose is kiloGray, expressed as kGy. The absorbed dose is determined by product density, pack size, dose rate, exposure time and to some degree by plant design.

What is Gamma Irradiation Used For?
The gamma process can effectively sterilize a wide variety of products composed of different materials, with varying densities, configurations and orientations. Some examples of products processed include:
  • Medical devices
  • Pharmaceuticals
  • Combination drug/device products
  • Animal husbandry
  • Archives
  • Cosmetics and toiletries
  • Horticultural supplies
  • Packaging

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Product category: Sterilisation services

Electron Beam

Electron Beam Processing
The electron beam (E-beam) irradiation process uses high-energy electrons for a variety of applications. Electron beam irradiation processing is commonly used in the sterilization of medical devices, contamination control, as well as the modification of materials such as, heat shrink tubing and wire and cable insulation.

What is Electron Beam Irradiation?
The electron beam process can achieve widely differing effects, such as sterilization, polymer modification, cross linking and chain scission, via its action as an ionizing radiation.

In its simplest terms, the bombardment of a material with high-energy electrons results in a cascade of these electrons moving through the target material. These electrons are free to interact with molecules within the material, ejecting electrons from their orbits and generating free radicals. It is primarily the reactions of these species that are responsible for the ability of the beam to modify polymers. In the context of the electron beam’s sterilization capability it is generally accepted that these same species induce breaks in the DNA double helix, preventing replication or expression, resulting in the ability to sterilize.

The process utilizes high energy electrons as its radiation source. The electrons, which are produced by normal electrical current, are accelerated to near the speed of light by means of a linear accelerator. The resulting energies, ranging normally from 3 to 10 million electron volts (MeV) and coupled with 1 to 50 kW of power, have sufficient energy to penetrate a range of materials.

The process itself takes place behind a thick concrete wall, which prevents radiation from leaving the cell. Because electron beam utilizes high-energy electrons, the process takes place with minimal loss of efficiency and downtime.

What is Electron Beam Irradiation Used For?
As a result of increased energy available from new generation equipment, this technology has established itself as a flexible and high speed process for sterilizing medical devices and pharmaceuticals.

The E-beam process is also used as a method of controlling contamination in packaging, cosmetics and toiletries.

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Product category: Sterilisation services

X-Ray

X-ray Irradiation Processing
X-ray irradiation is a practical alternative to a variety of other commonly used sterilization and contamination control methods.

The STERIS Applied Sterilization Technologies (AST) X-ray processing site at Däniken, Switzerland uses the Rhodotron Electron beam to generate X-ray. The layout of the plant and manufacturing process is designed to fulfill international standards, including the quality management system standard for medical devices ISO 13485, ISO 11137: Sterilization of Healthcare Products – Radiation, cGMP and FDA guidelines.

What is X-ray?
The commercial use of X-ray irradiation began around 20 years ago. However, due to the low power output of the accelerators used, the technology was generally overlooked as a viable sterilization method. Now, with the introduction of high power, high energy accelerators we are able to offer X-ray irradiation technology at a commercial level equivalent to traditional sterilization methods.

A wide variety of healthcare products from implants to pharmaceuticals employ X-ray technology’s sterilizing capability, while industrial applications from semiconductors to micro-etching can benefit from its use. However, the use of X-ray is not restricted to the sterilization of medical devices; pharmaceutical products and decontamination of packaging materials, raw materials for pharmacy and cosmetic businesses are also processed regularly.

Why X-ray Irradiation?
The combination of shorter exposure time and improved dose uniformity ratio (DUR) make X-ray sterilization a viable processing option for a variety of products. Similar to electron beam, X-ray processing is powered by electricity.

Due to reduced processing time, lead times are improved whilst maintaining good penetration capability
Adverse effects on products are reduced due to the reduction in processing (exposure) time

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Product category: Materials testing

Our Sterility Testing Services

Sterility testing is carried out by our team of microbiological experts to verify the effectiveness of a sterilization process using ISO11137 or aseptic manufacture

STERIS Laboratories completes sterility testing to either USP or ISO 11737 using direct immersion, fluid pathway or membrane filtration techniques depending on product and Customer requirements.

Test for sterility
Sterility testing is performed for two reasons:
  • Confirm requirements for sterility of a product following exposure to a sterilization process or aseptic manufacture – USP/EP sterility testing methods required
  • Qualify the minimum irradiation dose needed to achieve a specified sterility assurance level (SAL)
STERIS Laboratories offers:
  • Sterility testing to USP/EP or ISO 11737
  • Isolated integrity maintained for individual Customer products within clean room suites
  • Custom method development and validations
  • Full protocols (provided upon request)
  • Bacteriostasis and Fungistasis (B/F) method performed
  • Antimicrobial activities assessed
  • Sterility testing on large or complex devices or products, for example products exceeding a capacity of 20 liters per sample
Sterility testing is used for:
  • Medical devices
  • Pharmaceuticals
  • Packaging
  • Raw materials

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Company news

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Oct 24, 2017

STERIS Applied Sterilization Technologies and STERIS Laboratories Global Expansion Update

STERIS Applied Sterilization Technologies (AST) has announced several expansion projects over the past year throughout our global sterilization and laboratory network.  We’re excited to provide updates on these projects as part of our commitment to providing both global and local Customers with processing capacity.

Americas

Chester, New York
Construction has finished at the new Chester, New York electron beam facility, with validation completed in late July. The new E-beam operation, which includes dual 30 Kw, 10 MeV vertical accelerators, is located directly across the street from our existing gamma facility. The Chester campus is approximately 55 miles northwest of New York City, offering flexibility in radiation processing and proximity to the ports of New York and New Jersey.

Mark Thomas, Vice President of Operations and Technology, comments, “we are extremely excited to see this expansion project come to conclusion and are pleased to offer new capacity and capabilities to our Customers. This new high volume electron beam operation complements our existing gamma irradiation facility, which contains two large volume continuous irradiators and one specialized batch processing irradiator. The Chester, NY site was originally built in 1992, expanded in 2000, again in 2012 and now 2017, demonstrating our commitment to strategically grow with our Customers.”

Spartanburg, South Carolina
The Spartanburg, South Carolina facility has completed its ethylene oxide expansion with the addition of two small-volume chambers. The new chambers provide additional capacity to Customers manufacturing small volume lots, and are capable of running “cold” processing cycles and parametric release.

With the addition of the two new chambers, existing and future Customers will benefit from having multiple validated chambers and the increased capacity will reduce turn times. Matt Brennan, Director of Operations, comments, “the new chambers further demonstrate our commitment to Customers by expanding our small-volume ethylene oxide processing options.”

Europe, Middle East, Africa and Asia

Tullamore, Ireland
Tullamore, Ireland, one of our largest sites within the EMEAA region, is undergoing a major expansion in order to secure capacity for a number of our European Customers in the years to come. The expansion includes a second E-beam facility, which is due to launch in late 2017. In 2018, we will also be making additional EO capacity available and adding a new, purpose-built laboratory expansion.

Lorraine Moran, STERIS AST Regional Director for Ireland, states, “this expansion is excellent news and supports our commitment to providing both our global and local Customers with processing options. It not only ensures the capacity for existing and new Customers to grow, but also gives small indigenous Irish Customers the assurance of a sterile solution for their new product developments close to home.”

Venlo, The Netherlands
Three new 32-pallet EO chambers are being added to our existing Venlo site in the Netherlands. These chambers will employ positive pressure technology (positive pressure, as opposed to 100% ethylene oxide). This expansion supports the market demand going forward to ensure we continue to meet our existing and future Customer requirements. Venlo 2.0 is scheduled to open in late 2017.

Komenda, Slovenia
STERIS AST is expanding its sterilization services offering within Europe with a new greenfield build in Komenda, Slovenia. The state-of-the-art facility will offer electron beam sterilization and bioburden reduction services, as well as warehousing, to medical device and other healthcare product manufactures in the region. The decision to locate in Slovenia was of a strategic nature, supporting the future requirements of our Customers within Europe, as this location provides an excellent route to market.

Kuala Ketil, Malaysia
Due to increased Customer demand, we have an expansion of our ethylene oxide capacity at our plant in Kuala Ketil, Malaysia, scheduled for mid-2018.

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About us

Company details

STERIS Applied Sterilization Technologies has been committed to providing contract sterilization and microbial reduction services to the medical device, pharmaceutical, consumer and industrial communities for over 40 years. Through our global network of over 50 locations, we deliver leading technology in gamma, electron beam, ethylene oxide, steam, X-rayand ion beam sterilization to meet our Customers’ needs. State-of-the-art sterilization capabilities are just part of a complete managed program that emphasizes exceptional process quality, efficient turnaround and optimum cost containment.

Together, the STERIS TechTeam® experts and STERIS Laboratories assist our Customers with sterilization validation and laboratory testing services. We are pleased to provide our Customers with a single source for every stage of the sterilization design process, from product development through routine processing.

STERIS’s mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. STERIS plc is traded on the NYSE under the STE symbol.

Contact our team of experts to find out more about our Global Contract Sterilization Services

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