PRO-TECH Design

(562) 207 1680 info@protechdesign.com

LABORATORY SERVICES

 

PRO-TECH owns and operates its own laboratory on premises. Our laboratory is staffed with Scientists, including Ph.D. level, overseeing your product development and ongoing compliance.

List of Services:

  • Sterilization Validations (Ethylene Oxide, Radiation, Steam)
  • Product Adoption Studies
  • Packaging Validations (Baseline, Distribution, Aging)
  • Custom Protocol Development
  • Cleaning Validation Studies
  • Bioburden Testing – Product, Environmental, Water
  • Package Testing – Visual, Integrity, Peel Strength
  • Accelerated and Real-Time Aging
  • Total Organic Carbon
  • Osmolality
  • pH
  • Viscosity
  • UV / Vis Spectroscopy
  • LAL / Endotoxin Testing
  • Gravimetric Analysis

STERILIZATION SERVICES

 

PRO-TECH offers full sterilization services including validation and cycle development.

We currently sterilize both implantable and non-implantable medical devices by ethylene oxide, gamma irradiation, and steam.

PRO-TECH is an ISO 17665-1:2006 registered contract steam sterilizer.

PRO-TECH employs a team of microbiologists specializing in Medical Device sterilization; capable of managing your cycle development, validation needs, and product release testing.