Expertise

Sterilization

Arnan is recognized as a worldwide expert in moist‑ and dry‑heat sterilization, combining his engineering background in heat transfer and thermodynamics with a scientific, data‑driven approach to sterilization. This methodology enables sterilization activities to become more efficient, more robust, and fully justified from both technical and regulatory perspectives. In addition, Arnan has extensive experience in Vaporized Hydrogen Peroxide (VPHP) surface decontamination, including its application for isolator decontamination and other critical aseptic environments

Sterilization

Moist‑heat sterilization expertise covering components, equipment, media, and final product. Capabilities include cycle development, load‑pattern optimization, and operation of multi‑mode autoclaves. Technical proficiency spans:

  • dry and wet load configurations
  • steam‑air mixture or superheated‑water cycles for terminal sterilization
  • bulk sterilization processes

Vendors: Fedegari, Bosch-SBM, De-Lamma, Tuttnauer

Hot-Air Depyrogenation

Dry heat Sterilization & depyrogenation for glass containers and heat-stable components. Continuous tunnel depyrogenation for filling line integration:

  • Temperature uniformity mapping
  • FH value validation
  • Endotoxin challenge studies
  • Belt speed optimization

Steam-In-Place (SIP)

In-line sterilization of process vessels, piping, and equipment without disassembly. Critical for aseptic processing systems:

  • SIP system design and piping layout
  • Condensate management
  • Dead leg elimination
  • Temperature sensor placement strategy
  • Validation protocol development

VPHP Surface Decontamination

Vapor Phase Hydrogen Peroxide for isolator, RABS, and room decontamination — the standard per updated Annex 1:

  • Cycle development (conditioning, decontamination, aeration)
  • BI/CI placement and evaluation
  • Material compatibility studies
  • Residual H₂O₂ management
  • Integration with isolator control systems