Page 94 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 81

(gamma and electron beam) allowed for the production of single-use dis-
posable medical devices. During the period, medical paper and film packag-
a
ing became prevalent ultimately joined by DuPont Tyvek in 1972.
In 1976, the United States passed the Medical Device Amendments reg-
ulating medical devices [5]. Companies producing single-use sterile med-
ical devices had their own rationales and methodologies for ensuring the
packaging maintained sterility to the point of use. During the next 10 years,
there was little consensus on this topic and standardized test methods were
not widespread. The first attempt to build consensus was in 1993 with
HIMA’s (now AdvaMed) “Reference on Sterile Packaging” by Curt Larsen,
John Spitzley, and Bernie Liebler [6]. The group initiated discussions in the
United States on sterile packaging within the industry. At about the same
time, the European Union (EU) published its medical device directives and
CEN Technical Committee TC102/WG4 developed the EN 868 series of
standards for medical packaging and materials. ISO Technical Committee
TC198/WG7 was formed and began development of ISO 11607 for pack-
aging of terminally sterilized medical devices. This was closely followed by
the US FDA publication of the Quality System Regulation which empha-
sized validation of product, process, and test methods [7].
The early days of developing the ISO standards for packaging were dif-
ficult because of the positioning occurring between members representing
CEN interests and those representing the interests of non-CEN member
countries. Standards and standards development were new to the packaging
industry, and concerns focused on how such standards would be applied.
Europe needed a standard that met the essential requirements of the medi-
cal device directives, while ISO needed one that was voluntary and applica-
ble globally. The strategy within CEN was to develop a horizontal standard
(EN 868-1 [8]) along with several vertical standards to address specific
performance requirements for various types of products used in medical
packaging (EN 868 Parts 2–10 [9–16]). Conversely, the ISO strategy was to
develop a single standard that addressed the required performance attributes
of medical packaging without establishing specific performance criteria.
At the meeting of ISO Technical Committee (TC) 198 in Ottawa, ON,
Canada in 1993, a resolution was passed with the following instruction:
ISO would develop its standard (ISO 11607) and the CEN should de-
velop its standards (EN 868 series) independently. When these standards are

a Tyvek is a registered trademarks of E.I. du Pont de Nemours and Company.