North American Suppliers Directory Index

Steritec Inc.

1705 Enterprise St.
Athens, TX 75751 USA
Tel: 903/677-3950
Fax: 903/677-3951

Web: http://www.steritecinc.com
E-mail: info@steritecinc.com

Steritec, Inc, is a medical device sterilization and biological testing company which operates a quality management system in accordance with the requirements of ISO 13485:2003. The Athens, TX facility (20,000 square feet) houses steam and 100% ethylene oxide sterilizers, and chemical and biological testing laboratories. The Anderson, SC facility offers laboratory analyses only.

• EO Sterilization
• Steam Sterilization
• Sterility Testing
• Stasis Testing
• LAL Endotoxin
• EO Residuals
• Bacterial Barrier Analyses
• Bioburden

100% Ethylene Oxide Sterilization (ISO 11135/EN 550)
State-of-the-art computer control technology allows precise control of processing parameters, maximum cycle design flexibility, statistical analyses, graphic data display and reporting, multi-point temperature monitoring and in-house programming control. Monitors and records process data with print and backup. EO emission control through thermal oxidizer avoids waste and disposal. Minimizes EO residuals. Conforms to regulatory requirements and provides maximum process flexibility. External preconditioning or internal dynamic conditioning. High-efficiency oil sealed evacuation system with rate control for pressure excursions. EO/Nitrogen available for vacuum sensitive products. Constant high velocity hot air washed aeration for EO removal.

Steam Sterilization (ISO 17665/EN554)
Efficient, high-volume processing of heat and moisture stabile materials. Computer system operates cycle through conditioning, sterilizing, exhaust and post-vacuum (drying) phases. No residuals. Cost effective. Quick release for disposable and reusable devices. Suitable for a variety of materials and packaging.

Areas of Expertise
Professional consulting services are offered to guide the customer through the regulatory process. This includes protocol and procedure development, sterilization process development, sterility assurance program and GMP auditing for EO, Steam and Gamma Radiation. Also, process capability analysis, regulatory compliance programs/audits, pro-production quality assurance programs and equipment calibration.

Laboratory Services, Microbiology:

• Pre-Sterility Tests
• Sterility Test
• Supplemental Sample Testing
• Spore Strip Population Verification Count
• LAL Pyrogen Analysis (Gel Clot Method)
• Ethylene Oxide, Ethylene Glycol and Ethylene Chlorohydrin Residual Analysis
• Physical Tests (Pull, Peel Strength, etc.)
• Stericheck—Sterilizer Monitoring Service

Our Anderson, SC Facility
1704 E. Greenville St.
Ph. 868/260-0200

Categories this company is listed under in the North American Suppliers Directory:

• Sterilization: EtO: Services (62 companies)
• Sterilization: Steam/Autoclave: Services (53 companies)
• Testing Equipment and Services: Services: Microbiology/Chemical testing and analysis (134 companies)
• Testing Equipment and Services: Services: Other testing services (368 companies)
• Testing Equipment and Services: Services: Product safety/Performance testing (265 companies)