Validation, audits and documentation support so your product clears every regulator, first time.
02 / 06Validation, audits and documentation support so your product clears every regulator, first time.
Sterilization dose establishment per ISO 11137-2 — Method 1, VDmax25 or VDmax15 — coordinated with your testing laboratory.
Periodic dose audits to confirm your sterilization dose stays valid, scheduled with your production calendar.
Mapping of your exact carton and loading pattern to locate minimum and maximum dose zones.
Adopting new products into existing validated families, avoiding repeat full validation where justified.
Guidance on radiation-compatible polymers, density and carton configuration before you finalise design.
Certificates, dosimetry records and validation reports to support CDSCO, CE / MDR and US FDA files.
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