SOLUTIONS

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 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

Visit us 

1836 Stone Ave.  
San Jose, CA 95125

Call

 408.667.6817

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