Julie S. Tuinstra

Julie has been in the MedTech industry for over 20 years, with a focus on cleaning, disinfection and sterilization of non-sterile reusable and sterile medical devices. Julie has been a Validation Scientist at NAMSA for the past 8 years with extensive experience in sterile process validations and product adoptions using Steam, Ethylene Oxide, Gamma, E-Beam and Gas Plasma.

Prior to working at NAMSA, Julie was a Senior Sterilization Scientist in Sterilization and Microbiology for 16 years at DePuy Orthopaedics.

Julie is a 2004 Grace College graduate with a B.S. in General Science and a minor in Information Processing.

CORE COMPETENCIES

• Providing consultation on cleaning, disinfection and steam efficacy validation studies for reusable devices and gamma, e-beam and ethylene oxide sterilization validations for sterile devices
• Practical knowledge of regulatory agency submissions and Quality/Regulatory compliance audits
• Knowledge and usage of ANSI/AAMI/ISO sterilization guidelines for radiation, ethylene oxide, steam, gas plasma sterilization, biological indicators and reusable device validations
• Sterilization & microbiology Subject Matter Expert (SME) of orthopaedic implant and instrument product development teams to ensure the device’s total lifecycle is designed to meet all applicable performance inputs
  • Assessing feasibility and operational success
• Performing in-house sterilization validation studies to validate FDA recommended standardized steam sterilization cycle time for non-sterile reusable products
• Conducting annual re-qualifications for contract sterilizers
• Logistical management of the Microbiology Laboratory at DePuy Orthopaedics
• Laboratory equipment validations – IQ, OQ, and PQ
• Bioburden and dose audit testing
• In-house Kinetic Chromogenic Limulus Amebocyte Lysate (LAL) testing
• Environmental monitoring and trending of ISO certified cleanrooms
• ISO 7 and ISO 8 Cleanroom Validation activities – IQ, OQ and PQ

RECENT PROJECTS

• Large steam validation project including four (4) sterilization trays processed in both 132°C and 134°C sterilization cycles including packaging configurations for both Aesculap^® rigid sterilization container and blue wrap
• Gamma validation for an intrauterine device including a bioburden recovery validation, bacteriostasis/fungistasis testing, bioburden testing, calculation of the verification dose, verification dose exposure and tests of sterility
  • Conducted post-validation product adoption assessment as packaging materials had changed
• Ethylene oxide validation on a catheter device and accessory instruments
• Bioburden evaluation on a large product family to determine a simulated master “worst-case” kit
  • Conducted a gamma validation on the simulated master “worst-case” kit