— Validation Support
Sterilization & Cleanroom Validation
Sterile manufacturing is won or lost in validation. 10AR provides independent, standards-based validation support across two connected domains — the sterilization processes that make a product sterile, and the cleanroom environments that keep it that way. With 38+ years in sterile engineering, every engagement pairs first-principles knowledge with a data-driven, audit-ready approach.
Sterilization Validation — ISO 17665 & USP 1229
Development, validation, and routine control of moist- and dry-heat sterilization — cycle design, load-pattern mapping, IQ/OQ/PQ, and lethality assurance, aligned to ISO 17665 and USP 1229.
Cleanroom Validation — ISO 14644
Classification, qualification, and ongoing monitoring of controlled environments to ISO 14644 — translated into EU GMP Annex 1 grades and expectations.
