Medical device manufacturers (MDMs) have their hands full, not just in coping with the complexities of designing, manufacturing, and distributing effective medical devices, but also in facing rising economic and environmental pressures. An ever-developing number of tests and standards can help MDMs navigate these challenges.
“Keeping the sterile barrier intact and the product usable is a main responsibility we have in medical device packaging,” said Jan Gates, principal packaging engineer for Abbott Vascular. Gates made a presentation entitled “ASTM Distribution Testing for Sterile Medical Devices,” at the Feb. 9 Medical Device Packaging session during the Medical Design & Manufacturing West 2009 Conference in Anaheim, CA.
Gates provided attendees with a series of new terms, regulatory requirements, and package testing-versus-conditioning test details. She noted that under ANSI/AAMI/ISO/EN 11607 - 1 and 2, the term “sterile barrier” now includes primary packaging (see chart, page 20). She said that conditioning tests equate to tests conducted on packages with product, or with simulated product, to condition or simulate environmental stress on a packaging system until the point of use before conducting package or product integrity/design tests.
Collecting your own data from multiple shipments is considered to be the best option for transit conditioning tests, Gates said. “However, this is expensive and time-consuming, and it takes some specialized expertise to complete,” she added. Testing by a standard is the next best option, Gates noted, saying that the U.S. Food & Drug Administration prefers the use of consensus test standards. She then referred attendees to two specific Web sites: www.fda.gov/cdrh/osel/guidance/321.html and www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
Through a series of photos, Gates showed how the distribution environment can be brutal for medical devices. “It's amazing what can happen to a long, skinny catheter box out in the field,” she said. Another difficulty, she noted, is that “more recycled material is being used in corrugated, making it weaker.”
Still, it's an MDM's responsibility to safely get its product through the rigors of distribution. Gates cited the FDA's Code of Federal Regulations, Subpart K, Section 820.130: “Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”
She advised MD&M attendees, “Understand your distribution system. Distribution conditioning is not package integrity testing. Distribution testing labs require your interpretation of the conditioning tests to be conducted.” Gates recommended joining and becoming involved in the ASTM D10 committee and suggested that MDMs send questions and comments regarding performing distribution conditioning tests to www.astm.org/COMMIT/COMMITTEE/D10.htm, then click on Kevin Shanahan's underlined name for his direct e-mail link and his phone number.
Standards help serve MDMs
With so many test standards, “there becomes some confusion in the industry,” said Curt Larsen, CPP and principal of Spartan Design Group. “The standards and glossary of ISO 11607 are important and helpful.” During his presentation, “Customer and Supplier Test Synergy through Test Method Validation,” Larsen recommended that attendees refer to a compendium of terms used in the standards of Flexible Barrier Packaging Committee F02 (F17).
He said that in considering testing versus aging, “it's all about what you do with the samples. The preparation of samples is the conditioning when evaluating them as good enough to get to the end user. When you're done preparing, then you go to a post-stress evaluation.” Addressing conditioning and aging, he referred to F1980-07, saying, “The objective is to see what happens to the seals and materials that make up that sample due to the passage of time.“
Larsen also offered the following insights:
• Don't use the same samples for both aging or shelf-life studies and for distribution or design qualification testing.
• Humidity has detrimental effects on materials in that it can act as a reactant in a chemical reaction, and can modify the characteristics of a material.
• To save time and money, don't repeat test work that has already been performed.
Once you have established aging characteristics of a “sterile barrier system,” sterilized in a particular methodology, you do not need to repeat it for new or additional products. Aging won't change from a 3 x 5-in. pouch to a 12 x 14-in. pouch if the two materials and sterilization processing remain the same.
• Distribution environments are normally less severe than canned tests.
• Ten boxes with a dozen packages in each box does not equal 120 samples—it's 10 samples. Use 30 as a typical sample size for attribute data.
Evaluating medical device distribution
Russell Darley, project manager, Global Packaging Development for Smith & Nephew, made a presentation called “Investigation and Evaluation of the Distribution Environment for a Medical Device.” In it, he discussed how to design packaging that protects its products in a cost-effective manner that efficiently employs material configuration.
The Smith & Nephew project ran from August 2007 to December 2008 and included data collected from 10 states, 11 cities, and seven countries. The distribution channel was segmented into four parts: sterilization, warehouse (Global Distribution Center), the FedEx distribution system, and sales rep cycle.
Smith & Nephew measured its distribution environment by employing Lansmont Saver® 3X90 equipment that measures internal temperature and senses relative humidity. It can record shock, vibration, and drops using a tri-axial accelerometer. Darley said a data recorder was used within a shipping case for the testing.
Among the lessons learned from the study:
• Domestic and international shipping are similar, so there's no need for separate test protocols.
• Standard Overnight® delivery has the least variation in temperature and relative humidity.
• Sales representatives can have an impact on product exposure to different temperature ranges.
Darley said the tests helped Smith & Nephew develop three key “next steps”:
• Conduct further internal evaluation of sterilization and warehouse procedures.
• Select one location and ship product multiple times to better track temperatures over seasons and increase statistical confidence.
• Share data and information between Smith & Nephew locations, and use the data as an educational tool within the company.
The Medical Device Packaging session concluded with a brief update on the Institute of Packaging Professionals' (IoPP) Medical Device Packaging Technical Committee. MDPTC officers Darley and Karen Greene of DDL spoke of MDPTC as a source for education, networking, “and tackling industry problems.” Greene said the committee “is trying to be an educational voice regarding regulatory issues, packaging systems, barrier materials, sterilization, labeling, and equipment. We're involved in liaison activity and standards interpretation,” she added.
MDPTC has developed five task groups: Materials Specifications, Industry Benchmarking, Labeling, Electrostatic Discharge, and Materials Data Base. Abbott's Gates said, “Learning how people apply and interpret standards is important. The FDA allows you to benchmark with other companies, helping you to see where you are at next to others.”
MDPTC co-chairs are Harold Reisman, C.R. Bard and Alison Tyler, Beacon Converters. Greene and Darley welcomed packaging session attendees to join and become involved in the IoPP committee by visiting the association's Web site and going to the MDPTC portion of the site.
“Keeping the sterile barrier intact and the product usable is a main responsibility we have in medical device packaging,” said Jan Gates, principal packaging engineer for Abbott Vascular. Gates made a presentation entitled “ASTM Distribution Testing for Sterile Medical Devices,” at the Feb. 9 Medical Device Packaging session during the Medical Design & Manufacturing West 2009 Conference in Anaheim, CA.
Gates provided attendees with a series of new terms, regulatory requirements, and package testing-versus-conditioning test details. She noted that under ANSI/AAMI/ISO/EN 11607 - 1 and 2, the term “sterile barrier” now includes primary packaging (see chart, page 20). She said that conditioning tests equate to tests conducted on packages with product, or with simulated product, to condition or simulate environmental stress on a packaging system until the point of use before conducting package or product integrity/design tests.
Collecting your own data from multiple shipments is considered to be the best option for transit conditioning tests, Gates said. “However, this is expensive and time-consuming, and it takes some specialized expertise to complete,” she added. Testing by a standard is the next best option, Gates noted, saying that the U.S. Food & Drug Administration prefers the use of consensus test standards. She then referred attendees to two specific Web sites: www.fda.gov/cdrh/osel/guidance/321.html and www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
Through a series of photos, Gates showed how the distribution environment can be brutal for medical devices. “It's amazing what can happen to a long, skinny catheter box out in the field,” she said. Another difficulty, she noted, is that “more recycled material is being used in corrugated, making it weaker.”
Still, it's an MDM's responsibility to safely get its product through the rigors of distribution. Gates cited the FDA's Code of Federal Regulations, Subpart K, Section 820.130: “Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”
She advised MD&M attendees, “Understand your distribution system. Distribution conditioning is not package integrity testing. Distribution testing labs require your interpretation of the conditioning tests to be conducted.” Gates recommended joining and becoming involved in the ASTM D10 committee and suggested that MDMs send questions and comments regarding performing distribution conditioning tests to www.astm.org/COMMIT/COMMITTEE/D10.htm, then click on Kevin Shanahan's underlined name for his direct e-mail link and his phone number.
Standards help serve MDMs
With so many test standards, “there becomes some confusion in the industry,” said Curt Larsen, CPP and principal of Spartan Design Group. “The standards and glossary of ISO 11607 are important and helpful.” During his presentation, “Customer and Supplier Test Synergy through Test Method Validation,” Larsen recommended that attendees refer to a compendium of terms used in the standards of Flexible Barrier Packaging Committee F02 (F17).
He said that in considering testing versus aging, “it's all about what you do with the samples. The preparation of samples is the conditioning when evaluating them as good enough to get to the end user. When you're done preparing, then you go to a post-stress evaluation.” Addressing conditioning and aging, he referred to F1980-07, saying, “The objective is to see what happens to the seals and materials that make up that sample due to the passage of time.“
Larsen also offered the following insights:
• Don't use the same samples for both aging or shelf-life studies and for distribution or design qualification testing.
• Humidity has detrimental effects on materials in that it can act as a reactant in a chemical reaction, and can modify the characteristics of a material.
• To save time and money, don't repeat test work that has already been performed.
Once you have established aging characteristics of a “sterile barrier system,” sterilized in a particular methodology, you do not need to repeat it for new or additional products. Aging won't change from a 3 x 5-in. pouch to a 12 x 14-in. pouch if the two materials and sterilization processing remain the same.
• Distribution environments are normally less severe than canned tests.
• Ten boxes with a dozen packages in each box does not equal 120 samples—it's 10 samples. Use 30 as a typical sample size for attribute data.
Evaluating medical device distribution
Russell Darley, project manager, Global Packaging Development for Smith & Nephew, made a presentation called “Investigation and Evaluation of the Distribution Environment for a Medical Device.” In it, he discussed how to design packaging that protects its products in a cost-effective manner that efficiently employs material configuration.
The Smith & Nephew project ran from August 2007 to December 2008 and included data collected from 10 states, 11 cities, and seven countries. The distribution channel was segmented into four parts: sterilization, warehouse (Global Distribution Center), the FedEx distribution system, and sales rep cycle.
Smith & Nephew measured its distribution environment by employing Lansmont Saver® 3X90 equipment that measures internal temperature and senses relative humidity. It can record shock, vibration, and drops using a tri-axial accelerometer. Darley said a data recorder was used within a shipping case for the testing.
Among the lessons learned from the study:
• Domestic and international shipping are similar, so there's no need for separate test protocols.
• Standard Overnight® delivery has the least variation in temperature and relative humidity.
• Sales representatives can have an impact on product exposure to different temperature ranges.
Darley said the tests helped Smith & Nephew develop three key “next steps”:
• Conduct further internal evaluation of sterilization and warehouse procedures.
• Select one location and ship product multiple times to better track temperatures over seasons and increase statistical confidence.
• Share data and information between Smith & Nephew locations, and use the data as an educational tool within the company.
The Medical Device Packaging session concluded with a brief update on the Institute of Packaging Professionals' (IoPP) Medical Device Packaging Technical Committee. MDPTC officers Darley and Karen Greene of DDL spoke of MDPTC as a source for education, networking, “and tackling industry problems.” Greene said the committee “is trying to be an educational voice regarding regulatory issues, packaging systems, barrier materials, sterilization, labeling, and equipment. We're involved in liaison activity and standards interpretation,” she added.
MDPTC has developed five task groups: Materials Specifications, Industry Benchmarking, Labeling, Electrostatic Discharge, and Materials Data Base. Abbott's Gates said, “Learning how people apply and interpret standards is important. The FDA allows you to benchmark with other companies, helping you to see where you are at next to others.”
MDPTC co-chairs are Harold Reisman, C.R. Bard and Alison Tyler, Beacon Converters. Greene and Darley welcomed packaging session attendees to join and become involved in the IoPP committee by visiting the association's Web site and going to the MDPTC portion of the site.
![Alison Bryant, senior consultant at Antea Group and communications director for the Healthcare Plastics Recycling Council (HPRC), addressed the crowd at the[PACK]out.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2024/05/Alison_Bryant.6644005a513b0.png?auto=format%2Ccompress&fit=crop&h=167&q=70&w=250)
