The medical packaging system services that we provide are wide and varied, with an emphasis on the following key areas of support:
Device Fragility Assessment
We work with our customers and qualified test laboratories to establish the fragility levels of the devices before packaging system design activities begin. Taking this proactive approach towards packaging design reduces packaging system development time and minimize costs by insuring that all critical aspects of the package system design are efficient and provide adequate protection resulting in a safe, effective and functioning device.
Medical Device Product Packaging Design
With our vast and varied experience in medical device packaging system design and development, SDG can provide you with innovative and practical solutions. We can work with your current suppliers or introduce you to new ones when we feel that they can provide the latest developments in packaging materials and technical capabilities. We do not sell or broker materials and equipment, we can provide a totally impartial and professional opinion.
Whether your packaging system is in the early stages of the product development cycle or it's been totally forgotten and as a result your company is involved in a full blown "packaging crisis", SDG can get involved quickly to resolve design issues and put your packaging on the fast track to success.
Packaging System Design Qualification Testing Development
It is not uncommon in the medical device industry for a packaging system to fail design qualification testing. Very often this is not because they are inadequate or poor designs, but because they have been subjected to simulated distributions and storage environment stresses that are unrealistically severe and not normally seen. When this happens, medical device manufacturers find themselves facing packaging system redesign efforts and potential costly program delays.
SDG can help you avoid these situations by developing protocols and test plans which are developed to stress your packaging systems at realistic levels while still insuring that your products will reach their customers safely. We use the latest test methodology and work with several qualified packaging test labs to test your packaging systems effectively.
Sterile Packaging Manufacturing Process Design, Development and Equipment Selection Advice
ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing, and assembly processes states in Clause 5.1.1 that "Preformed sterile barrier systems and sterile barrier system manufacturing processes shall be validated." If these processes are not properly designed and developed, it becomes extremity difficult, if not impossible, to validate them. This will lead to higher costs and potential program delays.
SDG can assist in your process validation activities to insure that these costly situations are avoided.SDG can also help in the equipment selection process by developing comprehensive specifications which can be invaluable when selecting, installing and integrating equipment into your validated process.
Design, Development and Implementation of Sterile Barrier System Shelf Life Testing Programs
Developing an ongoing and self sustaining Sterile Barrier System (SBS) shelf life stability program which continually evaluates new materials and combinations is critical to MDM's success.
SDG has been instrumental in implementing several of these programs for dozens of our clients. We are very effective in obtaining the critical data from materials suppliers when it is available, reducing or eliminating the costs and lead times for our customers. When data is not available from suppliers or the materials involved are new or in new combinations, we can work with you to develop shelf life stability protocols and test plans that will meet the requirements of ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging.
ISO 11607, Packaging for Terminally Sterilized Medical Devices: Parts 1 and 2 is the recognized global standard for medical device packaging. It is also part of the FDA's Consensus Standards program. SDG's principals, Curt Larsen and John Spitzley have been involved with the development of the several iterations of this standard from the commencement of activities in the mid 1990's. We have been authors or co-authors of several sections of the standard and continue to be involved with activities involved with the next version of the standard.
Because of our long term involvement with this standard, SDG is in a unique position to provide its customers with the skills and experience required to assess their level of compliance with ISO 11607. We are intimately familiar with the standard and its requirements. Whether your company has no awareness of the standard and it's requirements or if you have attempted to comply with it for several years, SDG can provide insight and knowledge that can only be provided by individuals who have not only authored several sections of the standard but have several years of experience in implementing and evaluating compliance with ISO 11607. The development of a corporate level document that addresses all of the "shall" requirements in both standard parts is a very effective way of approaching this compliance.
ISO 11607-Parts 1 & -2: Audits, Gap Analysis and Compliance Assessment
Standards Development and Involvement
Curt Larsen and John Spitzley have been active and participatory members of ASTM for several years. Mr. Larsen joined ASTM in 1988 and is currently an active member of the ASTM F04 Medical and Surgical Materials and Devices Committee, D20 Plastics Committee, D10 Packaging Committee and the F02 Flexible Barrier Packaging Committee. He has served as chairman of Subcommittee F02.60, Medical Packaging and recently completed 12 years of various positions on the Board of Directors of Committee F02. Mr. Spitzley joined ASTM in 1998. He is currently a member of the F02 and D10 committees and has served as a Member of the Board of Directors of the F02.
Curt and John have been very active at the committee and sub-committee level since their involvement with ASTM. They have authored test methods and standard practices and have readily shared their knowledge and experience with ASTM and its members to facilitate the development of new standards and improve existing ones.
ANSI AAMI ISO
Mr. Larsen is a member of the Association for the Advancement of Medical Instrumentation (AAMI) committee that developed ISO 11607, a Sterile Medical Device Packaging standard for the International Standards Organization (ANSI/ISO). Mr. Larsen is a past co-chair of the U.S. Delegation of ISO TC (Technical Committee) 198 / WG (Working Group) 7 on Packaging for medical devices. He was co-author of the initial draft of ISO 11607 and is a member of the ISO / EN harmonization revision task group. Mr. Spitzley was the co-chair of the US delegation of (working group) WG7 of that committee and was co-author of ISO11607 with Mr. Larsen. Mr. Spitzley was chair of the AAMI committee that published and revised the Technical Information Report (AAMI TIR 22), a companion guidance document for ISO 11607 and along with Mr. Larsen has been involved with all the revisions to that document.
Because of this level of participation with ANSI/AAMI/ISO, Mr. Larsen and Mr. Spitzley are intimately familiar with the requirements of ISO 11607-1 and -2. Since they have been involved with this global standard from its inception in the mid 1990's and remain involved with pending revisions, they are in a unique position to provide assistance and guidance to companies who are struggling with interpreting ISO 11607 or meeting its requirements.