Cleanroom Validation — ISO 14644
— Validation Support Cleanroom Validation A sterile process is only as reliable as the environment around it. 10AR provides independent cleanroom classification and qualification to ISO 14644, bridging facility design…
Sterilization Validation — ISO 17665 & USP 1229
— 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…
Sterilization & Cleanroom Validation Support
— 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…
Support on-going Production Activities
— Expertise Support on-going Production Activities Reliable technical support for routine sterile manufacturing Sterile manufacturing requires continuous control, technical discipline, and fast response to operational challenges. Even well-designed and validated…
Eliminating Repeat Penetration Studies After a Component Change
A production-driven component swap inside a validated autoclave loading pattern would normally have triggered three full penetration studies. A targeted scientific assessment removed the need entirely — saving a full…
Smart Revalidation: Risk-Based Selection of IQ/OQ Tests
A structured methodology that decides — test by test — which IQ and OQ activities should be repeated, modified, or omitted during annual requalification. Defensible, efficient, and fully compliant.
A New Sterile Suite for Inhalation Products at a CDMO
Following an FDA mock inspection at a CDMO site, the client built a brand-new sterile production suite engineered, qualified, and inspection-ready for FDA approval of inhalation products — from conceptual…
Annex 1 §8.50 — Is Total Sensor Separation Really Required?
Total physical separation between autoclave control and monitoring instrumentation is one valid solution — but it isn't the only one. Modern integrated PLC-based systems can deliver superior compliance with the…
Clarifying the True Purpose of the Bowie-Dick Test
The Bowie-Dick test confirms that an autoclave is functioning correctly. It does not — and cannot — guarantee that the items you sterilize later in the day will be free…
