This relates to the Food and Drug Administration (FDA) standard, ASTM F1980, “Accelerated Aging of Sterile Barrier Systems for Medical Devices.” It is the most appropriate standard for medical packaging.

We typically see 55°C or 60°C, and for good reason. High-temperature aging tests can impact your study in a couple of different ways. Higher temperatures mean less time is necessary to complete the accelerated aging study. But higher temperatures also have higher risks. Some of the defects we might see are:

  1. Over time seals can soften and loosen up
  2. The material can delaminate
  3. The packaging could change color

Packaging materials can withstand these risks most of the time.

We follow International Organization for Standardization (ISO) standards for this. In ISO 11607-1: 2019, section 8.1, note# 2, it says the following:

“Stability testing and performance testing are separate entities. Performance testing evaluates the interaction between the packaging system and the products in response to the stresses imposed by the manufacturing and sterilization processes and the handling, storage, and shipping environment.”

All medical device manufacturers must follow this standard in regard to sterile medical devices, ISO 11607, as they consider stability testing and performance testing as separate items.

Yes. Life Science Outsourcing performs testing in house in our Brea location in Southern California. 

Life Science Outsourcing has been writing protocols for many years for various size medical device manufacturers – from start-ups to multi-million-dollar companies. These protocols describe what exactly will be tested, what testing will be performed, the acceptance criteria for each test, and the standards to which each test will be run to.

It is highly suggested that if, the testing being performed and the data from that testing is going to be used for an FDA, MDD, or any other type of regulatory submission, that you generate a protocol for the testing.

It’s easy to assume you won’t need to perform real-time aging if accelerated aging is a requirement of ISO 11607. But that assumption is not accurate.

ISO 11607 says stability testing shall determine that the sterile barrier maintains integrity over time and shall be performed using real-time aging. Furthermore, it states that real-time aging shall be started prior to commercialization. So, the answer is yes. Real-time aging has to happen and should not be overlooked.

  • Accelerated Aging
  • Package Validation Testing
  • Visual Inspection Test
  • Peel Strength Test
  • Burst Test
  • Dye Penetration Test
  • Creep Test
  • Bubble Emission Test
  • Real-Time Aging
  • Distribution Simulation
  • Drop Test
  • Vibration Test
  • Compression Test
  • Atmospheric Pre-Conditioning
  • Shock Test
  • Altitude Testing

  • ISO 13485
  • ISO 11607
  • ANSI – American National Standards Institute
  • AAMI – Association for the Advancement of Medical Instrumentation
  • ASTM – American Society for Testing & Materials
  • ISO – International Organization for Standardization
  • ISTA – International Safe Transit Association

  1. ASTM-D4169
  2. ASTM-D642
  3. ASTM-F1140
  4. ASTM-F1980
  5. ASTM-F17
  6. ASTM-D4728
  7. ASTM-D999
  8. ASTM-F1886
  9. ASTM-F2096
  10. ASTM-E171
  11. ASTM-D5276
  12. ASTM-D4332
  13. ASTM-F1929
  14. ASTM-F88
  15. ISTA 1A
  16. ISTA 2A
  17. ISTA 3A
  18. ISO 11607
  19. ICH
  20. AAMI TIR22

LSO will perform customized Accelerated Aging Studies, specific to each customer’s needs. In most cases, temperatures range from 55-60 degrees Centigrade. Any desired humidity, refrigerated and freezing temperatures can be achieved.

Accelerated Aging Chambers

  • 13 Accelerated Aging Chambers
  • Temperature (-40C to 250C)
  • Relative Humidity (5% to 90%)

Stability Chamber Environment Setting Ranges

  • 6 Multipurpose Chambers
  • Temperature (-40C to 250C)
  • Relative Humidity (5% to 90%)

At MPT, we can accommodate up to 120 Cu Ft. on our testing equipment.

Medical Package Testing (MPT) is a division of Life Science Outsourcing, Inc. (LSO), and is an ISTA certified packaging test lab (ID Number ST-2339).

MPT can advise clients on the following:

  • Packaging Design (primary & secondary)
  • Package Testing protocol
  • Product material
  • Complete packaging system

Through our six divisions, LSO strives to provide customers with a complete solution to their product development requirements. Service divisions include;

  • Medical Device Manufacturing (MDM)
  • Medical Package Testing (MPT)
  • Sterilization Validation Services (SVS)
  • Cleaning and Decontamination Services (CDS)
  • Fulfillment & Distribution Services (FDS)
  • Quality Incubator Services (QIS)

LSO has been in business for fourteen years and has served approximately 250 companies. There are several clinical spaces and market segments that we have served. Please see the list below for a broad list:

  1. Orthopedic
  2. Cardiac Rhythm Systems
  3. Cardiovascular
  4. Neurovascular
  5. Respiratory
  6. Gastrointestinal
  7. Dental Implants
  8. Minimally Invasive Devices
  9. Specialty Kits
  10. Oncology

New call-to-action
Go to Top