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Sterilization & Lot Release

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Lot release testing ensures that your product is fully functional and ready to use upon arrival.

As an FDA registered and CGMP compliant company, Medical Murray can assist you with your full sterilization requirements meeting the exact requirements of the medical device industry. 

Our experienced engineering team can oversee the sterilization process and provide complete validation services, including material selection, protocol creation, sample preparation, coordinating third-party laboratory testing, and submitting a final report to you.

Our Sterilization Methods Include:

  • Sterilization validations (EtO, gamma, e-beam or autoclave)
  • Sterilization adoption studies (AAMI TIR28:2009)
  • Dose audits (gamma and electron beam)
  • Annual revalidations (ethylene oxide)

Coordination of Sterilization Testing Including:

  • Bioburden testing
  • Microbial identification
  • Ethylene oxide residuals testing
  • Endotoxin testing
  • Biological indicator testing

Our Capabilities

Medical device lot release testing ensures that your complex catheter designs get to market safely.  Lot release testing is an integral part of quality control, as well as sterilization confirmation. We perform product-specific testing protocols that are conducted prior to the final release of the product. This process ensures that your complex catheter design functions as intended after the sterilization process is completed.

We offer many services including but not limited to:

  • Sterility tests (ISO 11737-2)
  • Bioburden (ISO 11737-1)
  • Bacterial Endotoxins (LAL): USP 85 <161>, EP 2.614 (ISO 10993)
  • Visual and dimensional inspection
  • Simulated use testing
  • Medical balloon testing, including burst testing
  • Catheter tensile testing 
  • FTIR analysis of materials
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We’re ready for your next sterilization or lot release challenge!

We’re ready for your next sterilization or lot release challenge!

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NORTH BARRINGTON, IL
HEADQUARTERS

400 N. Rand Rd.
North Barrington, IL 60010
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

LAKE ZURICH, IL
540 Capital Drive
Suite 150
Lake Zurich, IL 60047
Ph: 847.847.3700
Fax: 847.847.3705
info@medicalmurray.com

CHARLOTTE, NC
4508 Westinghouse Blvd.
Suite B
Charlotte, NC 28273
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

Contact Us

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NORTH BARRINGTON, IL (HQ)
400 N. Rand Rd.
North Barrington, IL 60010
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

CHARLOTTE, NC
4508 Westinghouse Blvd., Ste. B
Charlotte, NC 28273
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

LAKE ZURICH, IL
540 Capital Drive, Ste. 150
Lake Zurich, IL 60047
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

Contact Us

© 2018 Medical Murray
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