Originally Published MPMN October
2004
Outsourcing Outlook
Sterilization
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
www.devicelink.com/company98/co/
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 www.svs.com
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 www.isomedix.com
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
www.sterigenics.com
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 www.steril.com
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 www.centurionsterile.com
Copyright ©2004 Medical Product Manufacturing News
