Medical Device

Astro Pak’s proprietary High Purity Cleaning and Passivation chemistry and services are ideal for Medical Device implantables and components. We have partnered with OEM device manufactures to address cleanliness considerations utilizing our various services and our propriety chemistry and processes. Our services to remediate bio-burden, endotoxin levels, rouge and other contaminants address the requirements for meeting FDA standards. Our chemistry also delivers an optimal passivation (corrosion resistance) layer and maintains the integrity of laser mark etchings.

For components, parts and hardware to be cleaned in a Cleanroom environment, we have the capability to handle any job in our state-of-the-art cleanroom facilities located in California or Virginia. Our modern CA cleanroom facility is ISO 9001:2008 & AS 9100C certified, and uses Class 5 (Class 100) and Class 6 (Class 1,000) cleanrooms of varying sizes and capabilities. Astro Pak’s extensive experience, expertise and library of specifications and procedures afford us the know-how to meet almost any customer or end user requirements. Upon completion, we provide cGMP documentation with each job we perform.

Capabilities

  • Solvent Dryness Testing
  • Vacuum Bake
  • Dew Point
  • Gel Passivation
  • High Pressure Wash
  • Alkaline, Solvent, Detergent Cleaning
  • Room & Equipment Sterilization

Systems & Equipment Processed

  • Implantable Devices
  • Components & Hardware
  • Fittings, Fasteners
  • Valves (Relief, Ball, Butterfly, Needle, Gate)
  • Gauges (Pressure, Flow meter, Hydraulic, Cryogenic)
  • Process Piping, Tubing, Hoses
  • Sterilizers & Autoclaves
  • Clean Steam Generators and Clean Steam Systems
  • Reverse Osmosis, DI, Pure Water
  • Vessels, Tanks
  • Heat Exchangers
  • Boilers
  • Water for Injection (WFI) Tanks & Stills
  • Transducers & Sensors
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