COA & Sterility
Verified Quality for Every Lot
Trusted Sterile provides a Certificate of Analysis with every lot, plus complete sterility validation data for our gamma-processed products. This page explains what’s included and how sterility is validated.
What’s Included in Your COA
Each COA contains the results and verification your QA teams expect:
Material Verification
Type I borosilicate glass confirmation
Composition compliance (USP <660>)
Dimensional conformity
Sterility & Gamma Dose Confirmation
ETOirradiation lot number
Dosimetry results
Verification meets USP
Process validation references
Particulate & Bioburden Testing
Pre-sterilization bioburden levels
Post-processing particulate inspection
Acceptance criteria and pass/fail results
Visual & Mechanical Quality Checks
Crimp seal integrity (for crimped vials)
Neck finish measurements
Cosmetic inspection
ETO Sterilization: How We Validate
All sterile-ready products undergo processing validated through:
Dosimetry Mapping
Ensures consistent dose delivery throughout the load.
SAL 10⁻⁶ Validation
A sterility assurance level of one in a million probability of a non-sterile unit.
Third-Party Oversight
Annual audits and dose validation performed by accredited partners.
Load-Specific Traceability
Each sterilization cycle includes: Date of processing
Dose range
Batch identification
Equipment logs
This data supports compliance with ISO 11137 sterilization standards.
Accessing COA & Sterility Documents
You can download:
Individual COAs from product pages
Sterilization summaries upon request
Bulk COA packages for wholesale and multi-lot orders
For document requests:
compliance@trustedsterile.com | support@trustedsterile.com
