Browse the timeline below for highlights.
SPMC Is Founded
The Sterilization Packaging Manufacturers Council is formed as a council of the Flexible Packaging Association (FPA). Membership in SPMC is open to FPA member companies whose primary activity is the conversion of raw materials into flexible packaging or packaging components for medical devices.
The First Test Method
SPMC develops its first standard for peel strength, notably addressing differences in technique. This is later incorporated into ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials.
FPA publishes the first edition of SPMC’s Standards and Test Methods booklet, which includes non standards.
The First Guide
SPMC and other contributors draft the Guide for Design and Evaluation of Primary Packaging for Medical Products, which will later be recognized by ASTM and evolve into ASTM F2097.
SPMC’s Marketing Committee is Formed
The SPMC Marketing Committee is created to advance SPMC as an industry resource. The committee’s first order of business is the development of a logo and a website.
Participation in ASTM
Reflecting the important role SPMC plays in ASTM, an SPMC member becomes chair of the ASTM F02.60 Subcommittee on Medical Packaging.
Website is Launched
SPMC launches its first website at www.sterilizationpackaging.org. The FAQs become one of the site’s most heavily visited areas.
SPMC Standards Form Basis for ASTM Standards
Originally developed by the SPMC, the following standards are submitted by SPMC to ASTM and form the basis for the eventual ASTM standards:
A U.S. trademark is awarded for the SPMC logo, which depicts the chevron opening of a sterile package.
Participation in ASTM
SPMC members become chairs for ASTM Subcommittees F02.50 and F02.20.
SPMC Performs Intra-Laboratory Study
SPMC publishes A Round-Robin Approach to Seal Strength in PMP News. SPMC members are primary participants in the intra-laboratory study for ASTM F88.
Participation in AAMI
An SPMC member becomes co-chair of AAMI TC198/WG07 Packaging Work Group. AAMI releases TIR22, a compliance guide to ISO 11607. SPMC is recognized as a key contributor.
Standards Endure the Test of Time
Five standards submitted to ASTM by the SPMC and subsequently published by ASTM in 2003 reach the five-year review point and are reissued without any changes, proving that they have stood the test of time.
Series of Articles Published
SPMC’s Technical Group publishes several articles in the trade press including
SPMC and ISO
An SPMC member is named as convener of the ISO TC198/WG07 task force drafting an expanded guidance document for ISO 11607.
Understanding the Nuances of ISO 11607
SPMC participates in PMP News’ webcast titled "Understanding the Nuances of ISO 11607. Thirty-one new FAQs are developed, published in the magazine and added to SPMC’s website.
First Print Ad
SPMC publishes its first ad in Pharmaceutical & Medical Packaging News.
SPMC launches a fully automated online FAQ section.
The First International ASTM F02 Committee
SPMC organizes the first International F02 Subcommittee on Flexible Barrier Packaging. During a series of workshops in Prague, Americans and their European peers have the opportunity to experience the ASTM process.
SPMC Participates in Webcast
SPMC participates in PMP News’ webcast, Package Integrity: A Look at False Alarms. SPMC’s Technical Group discusses whether material anomalies can threaten sterile barrier integrity.
SPMC launches a redesigned and optimized website
SPMC’s new website is fully searchable, allowing visitors to easily find the information they need.
Balloting Process Continues on ISO 11607
The international guidance document for ISO 11607, now ISO 16775, continues through the ballot process. The industrial guidance section is substantially based on AAMI TIR22, to which the SPMC Technical Committee has made significant contributions.
Leadership at ASTM
An SPMC member becomes chair of ASTM Committee F02 on Flexible Barrier Packaging.
Presentation on Sustainability
SPMC delivers a presentation at HealthPack Europe on the sustainability of flexible packaging materials for medical devices.
Participation in Webcast
SPMC’s Technical Committee presents the webcast, “Sterilization: A Sterile Packaging Perspective,” covering the impacts that different sterilization methods have on medical packaging materials and what to consider when developing such packaging.
20 Year Anniversary
SPMC Celebrates 20 Years of Excellence!
Follow-Up FAQS on Sterilization
SPMC posts nine new FAQs following participation on PMP News’ webcast on “Sterilization: A Sterile Packaging Perspective.”