— Validation Support
Sterilization Validation
Arnan Ben-David is recognized worldwide for moist- and dry-heat sterilization, pairing a heat-transfer and thermodynamics background with a scientific, data-driven method. 10AR delivers sterilization validation that answers both ISO 17665 and USP 1229 — not as two parallel checklists, but as one coherent, defensible lethality story.
ISO 17665 — Moist-Heat Sterilization
ISO 17665 sets the requirements for developing, validating, and routinely controlling a moist-heat sterilization process. 10AR supports the full lifecycle: cycle development, load-pattern optimization, temperature and F0 mapping, overkill versus bioburden-based approaches, biological-indicator and bioburden strategy, and multi-mode autoclave operation.
USP 1229 — Sterilization of Compendial Articles
USP 1229 and its method-specific subchapters — steam by direct contact, moist heat, dry heat, sterilizing filtration, biological indicators, and bioburden monitoring — govern the sterilization of compendial products. 10AR performs gap assessments against USP expectations, selects and justifies the appropriate method, and builds monitoring programs that hold up under FDA review.
Validation Lifecycle & Remediation
From IQ/OQ/PQ protocol authoring to requalification, deviation investigation, and audit readiness — 10AR turns findings into remediation that closes gaps for good.
