Elite Quality Enzymes

Reduce your time to market with our new enhanced Elite quality enzymes that are suitable for manufacturing of diagnostic kits and reagents.

Enzyme Benefits:

  • Supply chain transparency
  • Original manufacturer
  • Custom quality control
  • ISO 9001 certification
  • OEM kit assembly
  • Flexible packaging availability

Added Value with Elite Enzymes

  • Enhanced Change Control Notification - 12 Weeks
  • Certificate of origin
  • Retest date
  • Vendor assessment
  • Critical control parameter (CCP)
  • QA batch review
  • Lot sample retained
  • Vendor management

Enyzmes Available For IVD Applications:

  • Clinical chemistry
  • Coagulation
  • Histology
  • Immunoassay
  • Hematology
  • Molecular diagnostics
  • Diabetes care
  • Point of care
  • Microbiology

Sigma-Aldrich Quality Guidelines

Elite Quality Level Details

Product Use Recommended for upstream and downstream processing, registered starting materials and raw materials (material can be in regulatory filing). This level does not support the use of the product as an API or Excipient.
Features
  • Quality Management System, including some elements of industry standards
  • Controlled Manufacturing process, not validated
  • Internally qualified analytical method. If compendial methods are used, they are validated by definition.
  • Certificate of Analysis (CofA) and MSDS available
  • Certificate of Origin (CofO) available
  • Expiry or Recommended Retest Date supplied – supported by Sigma-Aldrich data
  • Manufacturing and risk assessment. Residual solvents, melamine, and BSE TSE statements available.
  • Retained sample
  • Quality review of batch records
  • Manufactured by Sigma-Aldrich or by qualified supplier who commits to notification of changes and transparency
  • Sourcing information disclosed under confidentiality agreement
Change
Notification*
Analytical release specifications and/or method, manufacturing site, packaging site, testing site, type of manufacture, significant manufacturing process changes.
Notification timeline: 12 weeks

 

Materials

     
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