SERVICES 

SVC is pleased to announce the NEW 3M™ Steri-Vac™ Sterilizer/ Aerator GS Series- 100% ethylene oxide sterilization system that is an effective and safe low temperature sterilization method for medical devices and other applications. The GS Series sterilizer, Model GS8X are designed for use in medical device, contract sterilization, R&D laboratory applications, and other research and industrial applications for terminal sterilization. The GS Series sterilizers provide control and independent monitoring with state-of-the-art, compliant mechanical design. All in one processing

EO Cycle Development And Validation

Per ISO 11135 and CFR 820 QS requirements we can validate your product in our 3M Steri-VacTM sterilizers in preparation for routine sterilization at our facility or in preparation for acquisition of your own Steri-VacTM systems

Routine Contract Sterilization

2-3 Day turnaround service using 3MTM Rapid Readout BI (RRBITM) technology with three(3) Steri-VacTM chambers available

Comparative Resistance Studies

Your Master Challenge Pack / IPCD or EPCD compared with our patented PCDs to establish a better, more consistent process challenge device.

Sterilizer & Microbiology Validation

S&VC is proud to provide the following sterilization and microbiology validation:

 

For Radiation sterilized products

 

  • Microbiology and sterilization support for currently validated products

  • Product validation support

  • Process development for new or revised products

  • Validation requirements for changes made to existing “Sterile” products

 

For EO, steam and gas sterilization methods

 

  • Sterilization process development

  • Sterilization process validation

  • Product validation support

  • Validation requirements for changes made to existing “Sterile” products

Product Package Exposure

R&D testing and bio-compatibility evaluations.

EO Validation Testing for Healthcare Reprocessing of Medical Devices

We can reproduce any Hospital / Healthcare EO cycle to permit compliance testing per the 2 May 2011 FDA Draft Guidance document. This typically will be carried out in cooperation with other independent test laboratories to confirm compliance to a Medical Devices Manufacturer's IFU for any reusable device.

EO Sterilization Services Processing:
  • PQ Protocol and Final Report preparation

  • Full Validation Qualification

  • Batch Release Qualification

  • Pre-Conditioning Qualification studies

  • Aeration Qualification studies

  • PCD -Microbiological Qualification studies

  • EO Cycle Development

  • Routine production

  • Technical consulting

Product Design & Development

S&VC is expert in providing all aspects of product design and development with focusing on microbiology and sterilization methods for new products. In addition, SV&C is proficient in design control and new product development support including FDA and ISO support. This support can include auditing of potential sterilization, laboratory and most any other supplier to meet FDA and/or ISO needs.

Other Services

Other areas S&VC can provide support services for are the following fields:

 

  • Biocompatibility and Pyrogen Testing and other Laboratory testing.

  • Optimal Sterilization Methodology and Testing for new or revised products

  • Package Design and Development including aging studies

  • Package Design and Development

  • CER Validation and Certification

  • ISO 13485 and related Quality System Implementation and management

GS8X and 8XL Sterilizer

Chamber Dimensions

  • Width ........................................................ 51 cm (20 in)

  • Depth ........................................................ 97 cm (38 in)

  • Height ....................................................... 46 cm (18 in)

  • Diagonal .................................................. 117 cm (46 in)

Basket Dimensions
 

  • Width ........................................................ 46 cm (18 in)

  • Depth ........................................................ 91 cm (36 in)

  • Height ...................................................... 20 cm (8 in)

Note: Basket Dimensions is per basket; two baskets can fit in one chamber per run. However, depending on requirements, only one basket maybe used per run.

Visit us 

1836 Stone Ave.
San Jose, CA 95125

Call

 707.520.4500

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