Approval and publication of a revised ISO 11607 standard was expected this month, incorporating the provisions of the EN 868-1 standard. (Part I of II)
The International Standards Organization (ISO) 11607 standard is the foremost guidance document for validating packaging for terminally sterilized medical devices. Packaging must comply with ISO 11607 to ensure that the enclosed medical device is kept sterile throughout manufacturing, shipping, and storage environments.
Medical device manufacturers and packaging professionals should take note of the upcoming revisions to the ISO 11607 standard, as the revisions could mean the difference between pass or fail when it comes to package validation. Many terms have been added or eliminated from the current standard, including the following:
• The definition of "medical device." ISO 11607-01 includes some medical devices that were not previously covered by the old standard.
• "Primary package" is replaced by "sterile barrier system," defined as the "minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of end use."
• "Final package" is replaced by "package system," defined as "[the] combination of the sterile barrier system and protective package." This combined package could include the second sterile barrier, or outer package, in a dual pouch or tray; a paperboard carton or shelf box; and the shipping container. These all may combine to form the "package system."
• The elimination of "package integrity," which was defined as "unimpaired physical condition of a final package." Now it is implied that package integrity is lost if the sterile barrier system is breached or does not "prevent the ingress of microorganisms to the product." April 10, 2006
Packagers share enthusiasm at February's RFID World event in Grapevine, TX.
Purdue Pharma's 60-day pilot of RFID- enabled OxyContin at the item level was summarized by Mike Celentano, the company's associate director, supply chain and RFID systems: "We had fantastic reliability—only 10 to 15 bad tags out of 230,000. We concluded that the fundamental building blocks for RFID-based serialized point-to-point e-Pedigree exists today." He said the company has an interest in case and pallet-level tagging.
Ken Reich, TAGSYS marketing director, revealed that Pfizer's item-level RFID program for bottles of Viagra manufactured in France features Web-based authenticity that permits pharmacies to verify the Viagra it receives.
Meanwhile, Randall Lutter, the U.S. Food and Drug Administration's associate commissioner, policy and planning, reminded attendees that, unlike overseas, counterfeit drugs in the United States are quite rare. He suggested that the rise in cases in 2004 to 58 versus 30 in 2003 may be due to awareness. Final figures for 2005 will see a decline, he said, thanks to proactive investigations. April 10, 2006
