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Originally Published MPMN October 2004

Outsourcing Outlook


Company Offers EtO Sterilization Services

EtO sterilization services are available from a ISO 13488-certified company. Its 30,000-sq-ft facility allows for quick order processing and delivery. The company also performs sterility testing on customer products. Long Island Sterilization, Hauppauge, NY 206/20669.html

Support Services Are Available

A range of services, from process selection and cycle development through performance qualification and certification, are available from a sterilization contractor. Validations for EtO, VHP, moist heat, dry heat, E-beam and gamma irradiation, and aseptic processing are offered. The company provides process selection
and customized protocol development to meet current AAMI and ISO standards, as well as consultation services. Sterilization Validation Services, Oceanside, CA

Contractor Provides Three Types of Sterilization

A contract sterilization service provider offers gamma, EtO, and E-beam sterilization. The company's technical support team assists customers in all phases of the sterilization design process, including product development, materials testing, protocol generation, and sterility validation. There are 16 facilities available for sterilization services. Steris Isomedix Services, Mentor, OH

Contract Sterilization Services Are Offered Globally

Sterilization and laboratory services are offered worldwide by a firm with expertise in gamma, EtO, and E-beam technologies. With more than 1000 employees in 38 facilities around the globe, the company offers customized distribution and sterilization services, equipment, and technical advice.

Many of the company's EtO sterilizers have been fitted with microwave spectrometers. These devices monitor the EtO gas concentration and in-chamber humidity during the sterilization process. Spectrometers are reliable and easy to calibrate; most importantly, they provide the measurement capability to allow the elimination of biological indicators in routine processes, according to the company. This reportedly accelerates product release. Sterigenics, Oak Brook, IL

Assembly and Packaging Services Supplier Also Provides EtO Sterilization

Low-cost and high-quality assembly, packaging, and EtO sterilization services are offered in state-of-the-art Class 10,000 and Class 100,000 cleanrooms. The Istanbul-based firm is certified to ISO 9001, ISO 13485, and EN 550. "Apart from our regular manufacturing activities, we also offer contract sterilization services to third parties," says general manager Utku Oguz. "Our sterilization system is revalidated every year. Also, we are the only company in Turkey to have completed the software validations that are required by the new ISO 13485 standard."

In the Class 100,000 cleanroom, the company currently manufactures surgical sutures and carries out suture-needle attachment operations. Daily packaging capacity for IV infusion sets is 120,000. Sterile Health Products Inc., Istanbul, Turkey

Packaging, Lab Testing, and Sterilization Are Available On-Site

Medical device sterilization, including custom packaging and laboratory services and all necessary validation support, is available to customers nationwide. The company will accept projects ranging from processing only to complete turnkey services. Three facilities are equipped to complete all services on-site.
Centurion Sterilization Services, Howell, MI

Copyright ©2004 Medical Product Manufacturing News

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