PHYSICAL TESTS

Accelerated Aging of Medical Devices
1 year at 23ºC simulation = 6 weeks at 55ºC: 3 weeks at 75% R.H.; 3 weeks at < 20% R.H.

*The above accelerated aging interval is based on guidance provided in ASTM 1980-99 Standard Guide for Accelerated Aging of Sterile Medical Device Packaging and ANSI/AAMI/ISO 11607-1997 Packaging for terminally sterilized medical devices. Alternate temperature and humidity conditions are also acceptable and available at SGS. Please contact us or submit our Request for Quotation Form to discuss your requirements.

Accelerated aging is a technique used to rapidly simulate an extended time at room temperature. The technique is commonly used in studies designed to determine expiration dating for sterile medical devices. While 55C is most commonly used as the accelerated temperature, many other elevated temperature are also used and may be desirable depending on product composition and packaging. Two values are required to determine the real time aging equivalency for a storage period at an elevated temperature.

The values are

1. the temperature used for accelerated aging and
2. the temperature assigned as ambient.

Different temperatures may be assigned as ambient depending on the anticipated storage of the product. As a convenience, we have posted an accelerated aging reference chart which lists real time aging equivalencies for several elevated, ambient temperature conditions.

For more information about SGS's accelerated aging and related services, refer to page 20 or 21 of our online Sterility Assurance Compliance Guide.

A good reference for more information on accelerated aging is ASTM F1980-99 "Standard Guide for Accelerated Aging of Sterile Medical Device Packages" available at www.astm.org.

Packaging Tests
Package Expiration Dating Validation Protocol

*A typical package expiration dating study includes accelerated aging of packaged products plus packaging tests after each of several aging periods (eg. 1, 3 and 5 year equivalency). Also, aged products are usually returned to the client for physical evaluation and testing. In addition to storage fees, there is usually a fee for pulling and returning samples per storage interval. This charge varies depending on the size and quantity of samples to be pulled. Shipping charges for returning samples are billed at cost. A laboratory report specifying aging conditions, room temperature equivalency and sample storage dates in provided for each sample return date. We can follow your protocol or write a protocol to meet your specific requirements. Please contact us or submit our Request for Quotation Form for a quotation for your project.

Environmental Stressing (optional) plus Package Integrity by Dye Penetration
13 sample recommended (10 test samples and 3 positive control)

Environmental Stressing (optional) plus Package Integrity by Microbial Challenge – B.I. Dust Method
13 sample recommended (10 test samples and 3 positive control)

• Package Integrity by Microbial Challenge - Small Device
• Package Integrity by Microbial Challenge - Medium Device
• Package Integrity by Microbial Challenge - Complex Device
• Package Integrity by Microbial Challenge - Large Device
• Package Burst Test
• Package Creep Test
• Package Distribution Simulation
• Seal Peel Test

Particulate Matter – Medical Devices
Light Obscuration Method (2 to 100 microns)

• 1 sample (small medical device)
• 2+ samples (per sample)

Microscopic Method (>10 and >25 microns)

• 1 sample (small medical device)
• 2+ samples (per sample)

*The medical device is rinsed with filtered water (0.2 µm pore size). The particulate test is run on the rinse water. Usually, results are reported asparticles per mL. There is an additional charge for the sample handling required for larger and/or more complex medical devices such as I.V. bags and tubing assemblies.