MARKET PLACE
Contract sterilisation
STERIS Isomedix Services provides contract sterilisation and microbial reduction services. It has 21 facilities across North America offering gamma irradiation, 100% ethylene oxide and e-beam technologies. According to the company, its GammaExpress and EOExpress expedited processing options provide a cost-effective solution to reducing inventory costs, eliminating backorders, and getting products to customers faster.STERIS Isomedix Services, Mentor, Ohio, USA.
Tel. +1 440 392 8057, www.isomedix.com
Sterilisation process validation
Iotron offers full service contract e-beam irradiation sterilisation and full process validation and assists in meeting packaging requirements to optimise the e-beam sterilisation process. Assistance with all aspects of validation are provided, from preliminary stages such as material selection, through packaging design for optimal sterilisation efficiency, to the end result of a process specification for the validated product or device. The company claims its high throughput capacity allows for supply chain efficiencies not found with other sterilisation technologies.
Iotron Technologies Corp., Port Coquitlam, British Columbia, Canada.
Tel. +1 604 945 8838, www.iotron.com
Sterilisation and ionisation solutions
IBA offers sterilisation and ionisation solutions. Products include Rhodotron, a recirculating accelerator that can be operated in continuous mode for maximum efficiency and throughput; Dynamitron, an adaptable system with changeable operating conditions that makes it suitable for flexible, multiproduct processing environments and specialised applications; and eXelis, a high penetration, high throughput X-ray integrated system with good does uniformity that is suitable for replacing gamma sterilisation facilities. The company has also introduced VLEE, a proprietary customised low energy e-beam system used to sterilise the cap of a closed vial before peircing it with a filling needle.
IBA, Louvain-la-Neuve, Belgium.
Tel. +32 104 75811, www.iba-worldwide.com
Sterilisation assurance products
Bennett Scientific is a distributor for 3M’s Comply sterilisation assurance range. Its most popular product is Thermalog-S, a chemical integrator that correlates time, temperature and saturated steam in autoclave cycles. When all three criteria for a successful cycle have been met, Thermalog-S shows SAFE. This should be used as a load and pack test for every cycle for assurance that each load has been successfully processed.
Bennett Scientific Ltd, Newton Abbott, UK.
Tel. +44 1626 369 990, www.bennett-scientific.com
Rapid e-beam service
Isotron has extended its 24-h rapid turnaround sterilisation service to include electron-beam (e-beam) processing in addition to its existing gamma technology. The improved DaRT service is targeted at a variety of products that require urgent processing to meet delivery or shipment deadlines. The service offers guaranteed 24-h turnaround for volumes up to a single pallet.
Isotron Ltd, Swindon, UK.
Tel. +44 1793 601 050, www.isotron.com
Sterility assurance products
SPSmedical manufactures a line of sterility assurance products including monitoring, packaging and record-keeping products for steam, ethylene oxide, Sterrad, Sterris System 1, dry heat and chemical vapour sterilisers. The company also provides sterilisation training, testing services and consumable products. Custom manufacturing is available on request.
SPSmedical Supply Corp., Rush, New York, USA.
Tel. +1 585 359 0130, www.spsmedical.com
Radiation processing
Leoni operates seven e-beam accelerators and a gamma plant and offers sterilisation services to companies that manufacture medical devices, packaging and raw materials throughout Europe.
Leoni Studer AG, Däniken, Switzerland.
Tel. +41 62 288 90 60, www.studerhard.ch
Inline sterilisation tunnel
Linac Technologies, a designer and supplier of industrial linear accelerators, manufactures self-shielded inline sterilisation units for surface decontamination or complete sterilisation by e-beam. The SterBox unit, with medium energy accelerator, is installed in the production line for rapid sterilisation of individual as well as packed products. The SterStar unit with low energy accelerators decontaminates the surface of products entering a clean area.
Linac Technologies SAS, Paris, France.
Tel. +33 1 69 35 25 00, www.linactechnologies.com
Irradiation services
Gamma-Service offers irradiation services including the sterilisation of medical devices. The company operates two large irradiation facilities. Its GS3000 gamma irradiation facility uses an automatic transport system and provides Co-60 gamma irradiation in dose rates of 2–5 kGy/h over irradiation periods of 5–24 h; and the GSE 80 electron irradiation facility has an TT300 accelerator with 10 MeV/100 kW radiation power providing dose rates up to 12000 kGy/h and irradiation periods of a few seconds.
Gamma-Service Produktbestrahlung GmbH, Radeberg, Germany.
Tel. +49 3528 4364 11, www.gamma-service.com
Sterilisation developments
Sterigenics has announced that it has gained accreditation to DIN ISO/IEC17025:2000 for the microbiology laboratory in its EtO sterilisation facility in Wiesbaden, Germany. This will allow customers to single source sterilisation and testing. The company has also announced that processes have been developed, though practical experimentation and mathematical modelling, for low dose sterilisation of drug–device combinations at its gamma sterilisation facility at Fleurus, Belgium. This development has been made in conjunction with colleagues in the US using their ExCell irradiator, to allow customers to develop and manufacture products on either continent.
Sterigenics International, Wiesbaden, Germany.
Tel: +49 611 96 27 866, www.sterigenics.com
