単回使用およびフィルターバリデーションサービス

関連製品リソース

• Validation Services Extractables and Leachables Testing Brochure

  This brochure provides details on our validation services for extractables and leachables.

• Validation Services Global Brochure

  Regulatory guidance documents provide a framework to manufacturers for the production of drugs that are safe for administration to patients.

• App Note: When Do You Need to Consider Revalidating the Performance of Your Sterilizing-grade Filter?

  Any product or process change that could potentially affect the cGMP compliance of a validated process or system should be evaluated and a risk assessment should be performed to evaluate the impact.

• Aseptic Validation Master Plan

  Our experienced Validation Services team has summarized best practices for validating performance of critical filtration systems used in aseptic processing. If you need help, they can provide support on the various tests to meet global regulatory requirements.

• Process Development and Drug Manufacturing: Support Services

  We provide comprehensive services for drug development and manufacturing, including technical and regulatory expertise and process development support.