CRITICAL CLEANING

WHEATON can provide product processed and certified to meet your requirements.

Trace and residues – Sophisticated methods including the use of USP or WFI purified water, HEPA filtering and packaging items in certified 100/10 cleanrooms are employed to remove trace organics, trace inorganics, volatile organics and organic carbon residues.

Processes
  • Low particulate cleaning
  • Depryogenation - endotoxin levels less than 0.06 EU/mL with full documentation and certification
  • Chemical cleaning for trace analysis
  • Sterilization (E-beam and gamma irradiation, autoclaving, dry heat)
  • Water for Injection (WFi) and USP rinses
  • Total Organic Carbon process
  • Class 1000: Container and closure without washing treatment
  • Class 2000: Container and closure cleaned and assembled
  • Class 3000: Container and closure cleaned, assembled and quality assurance analyzed
List of Certifications available
  • Certificate of Analysis, TOC
  • Certificate of Analysis, Endotoxin
  • Certificate of Analysis, Particles
  • Certificate of Process
  • Certificate of Sterility/USP
  • Certificate of Compliance
  • Selected Testing by USP Methods
  • Materials Certification
Custom Packaging configurations

Individual or multi-unit clean room bags

  • Single or double bagged
  • Autoclaved bagging in clean room bas (closure only)
  • Autoclaved bagging (single, double or triple bagged)
  • Anti-static tray pack with shrink-wrap