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