Medical

Device

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, our California and Florida Cleanroom Services locations feature ISO 14644-1 Class 5, 6, or 7 cleanrooms and labs of varying sizes and capabilities. They also maintain AS9100 certified Quality Management Systems.

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.

  • Passivation & Derouging
  • Sanitization & Biofilm Removal
  • Precision & Ultrasonic Cleaning
  • Oxygen Cleaning
  • Particle Testing & NVR Validation
  • Assembly & Packaging
  • Electropolishing & Mechanical Polishing
  • Solvent Dryness Testing
  • Dew Point
  • Gel Passivation
  • High Pressure Wash
  • Alkaline, Solvent, Detergent Cleaning
  • Room & Equipment Sterilization
  • 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