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Packaged wet wipes give hospital personnel and patients a weapon to fight the spread of bacteria. Sustainable packaging of these wipes could be next. ...The healthcare community is understandably concerned with the spread of diseases such as MRSA (Methicillin-Resistant Staphylococcus Aureus), or staph, and C. Diff (Clostridium Difficile), a diarrheal disease. One way to combat such diseases, either in a medical facility or at home, is through hygiene, which may include the use of specialized wet wipes, contract-manufactured and packaged by Fredonia, WI-based Guy & O’Neill, Inc. for a wide range of customers and applications.
Synchronized lines, rather than individual pieces of equipment, will be a focus of pharmaceutical manufacturers, predicts PMMI’s Ben Miyares. In this exclusive Q&A interview with Healthcare Packaging, Miyares addresses multiple healthcare packaging-related issues, including mechatronics and robotics, which, he says, "have the potential to transform the development of packaging equipment." He also looks at sustainability, packaging equipment purchase considerations, E-machinery, and counterfeiting topics.
Are restricted access barrier systems (RABS) and isolators replacing traditional cleanrooms? All have the same aseptic requirements, but some argue that isolators and RABS increase asepsis. Many companies, especially large pharmaceuticals, are making the switch from cleanrooms to RABS or isolators. But others remain leery of these relatively new technologies. The first isolators of the early 90s fell short of expectations, leading to the development of RABS as an alternative.
Arguably, one of the most promising areas in the healthcare sector is biologics. Biologics-based products and combination products appeal to some pharmaceutical firms not just for their treatment potential, but for their financial prospects, and for their ability to extend patent protection. “There is a lot more patent protection around these [biologics] molecules,” says Robert Smith, a director at Genzyme in the U.K. “Proteins and biologics are larger molecules than typical drugs."
A medical device packaging track chaired by Randall Troutman (shown in photo), CPP, Oliver Medical Products, will take place from 9 a.m. to 4 p.m. Monday, Jan. 28, during the MD&M (Medical Design & Manufacturing) West Conference at the Anaheim Convention Center, Anaheim, CA. MD&M will be co-located with six other manufacturing shows at WestPack.
Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.
Panelists from McKesson Corp., Pfizer Pharmaceuticals, Amerisource Bergen Corp., and Ahold USA recognize that while radio-frequency identification (RFID) offers promise in the pharmaceutical sector, its adoption raises questions. That message came through loud and clear at a recent gathering at the EPC Connection event, held in Chicago in October.
Healthcare Packaging and Packaging World, producers of the Pharmaceutical Packaging Forum, and Ipack-Ima Spa, organizers of Pharmintech, announce a cooperative agreement in which Healthcare Packaging and Packaging World will offer promotional support to Ipack-Ima Spa, increasing the visibility for their Italian trade event, Pharmintech, to the U.S. pharmaceutical market. Pharmintech, held every three years in Italy, will next take place May 12th -14th, 2010 in Bologna, Italy.
Wyeth’s Charlie Portwood and Teva Global Generic Resource’s Uri Boneh will serve among the keynote speakers at The International Society for Pharmaceutical Engineering’s (ISPE) annual meeting Nov. 4 – 7 at Caesars Palace in Las Vegas. The event will feature more than 40 sessions, with topics including packaging, product quality lifecycle implementation, pandemic flu preparedness, personalized medicine, nanotechnology, disposables, and project management.
A new law that was widely described as strengthening Food and Drug Administration powers over approved drugs contains a spotlight on packaging that, among other things, will soon require unique numbering of individual packages of prescription drug products. In the FDA Amendments Act of 2007, little-noticed section 913 adds a new section to the law called "Pharmaceutical Security" that calls for federal government officials to "develop standards and validate effective technologies" to secure the drug supply chain against "counterfeit, diverted, subpotent, substandard, adulterated, misbranded, or expired drugs."
Packaging Hall of Fame inductee Edward J. Bauer, investigative reporter and award-winning author Katherine Eban, and Joint Equipment Transition Team (JETT) Chairman Jim John are among the speakers scheduled to make presentations at the upcoming Pharmaceutical Packaging Forum (PPF) 2008. Produced by Healthcare Packaging and Packaging World magazines, the event will be held on Wednesday, March 12, 2008 at The Rittenhouse Hotel in Philadelphia, the same venue that hosted the initial PPF March 29, 2007.
At the Pharmaceutical Packaging Forum, Attorney Eric F. Greenberg revealed key Food and Drug Administration issues pertaining to healthcare packaging. Among them were drug safety, inspections, cGMPs, labeling of prescription and OTC drugs, and how a unique coalition came together last year to lobby for more FDA funding.
Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show.
Compliance with ANSI/AAMI/ISO 11607-parts 1 and 2 involves more than crossing items off of a checklist. It requires a medical device company to understand its applications and processes, the ability to read, visualize, and understand both parts of the standard, and the development of a strategic plan. That was the message from Randall J. Troutman, CPP and senior engineering manager with medical packaging supplier Oliver Medical during a Feb. 15 presentation at the Medical Design & Manufacturing (MD&M) show .
Spend an educational day with your peers and solution providers at the Pharmaceutical Packaging Forum (PPF) in Philadelphia March 29. The event is produced by Summit Publishing Company, publishers of Healthcare Packaging and Packaging World business publications. Seats are going quickly, so register soon.
Abbott Vascular's Jan Gates will chair a Feb. 15 Medical Device and Packaging session that includes Part I, Packaging Engineering, from 9 a.m. until 12 p.m., followed by Part II, Packaging Validation and Compliance from 1 p.m. to 4 p.m. The session is part of Medical Design and Manufacturing West event at the Anaheim Convention Center in Anaheim, CA. The conference will be held Feb. 12-15, while the exposition runs from 10 a.m. until 5 p.m. Feb. 13-14, and 10 a.m. to 4 p.m. Feb. 15.
Need to get on the same page with your supplier(s) and consultant(s) in commissioning and qualifying packaging machinery? Try boarding the Joint Equipment Transition Team , or JETT. A small team of end users, suppliers, and consultants finalized the language and a complex diagram for a JETT equipment acquisition model that’s been in the works for more than a year during a January 18 meeting hosted by Abbott Laboratories at its Waukegan, IL, facility.
Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain. (Part I of II)... Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA. The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.
More and more people are beginning to think that the FDA system for assuring the safety of drugs--especially new drugs--is broken.
One could read recent headlines about Food and Drug Administration-approved new drugs that, within a few years of their approval, are the subject of serious health questions and get pulled from the market. Vioxx was the most prominent recent example, but there have been others. There was a time when FDAers would say that kind of thing only happened in Europe, so when critics asserted that some drugs got approved there that didn’t get approved here, the FDA would counter by saying it is more careful, since the Europeans pulled more drugs back off the market after approval. It appears that is no longer so.
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.”
Respondents address the issue in an exclusive Packworld.com survey.
A Packworld.com survey completed in January asked respondents to identify the most important among five healthcare packaging-related issues for their company in the next year or two; 37% of packagers cited validation. Counterfeiting and good manufacturing practices (GMPs) each received 17% of the “vote,” followed by FDA regulations at 12%, and outsourcing at 7%. Among the 10% who selected “other,” the most frequently mentioned topics were package innovation, and offshore regulations. Here’s a sampling of some of the responses regarding validation:
As smart machines become more prevalent, the process of validating the software becomes more complex. But by making the software modular, manufacturers are further easing the validation process.
For instance, a packaging machine might have 20 servo axes, which all use basically the same subroutine. Instead of validating each axis performance individually, could you validate the subroutine once and be done? The manufacturer could hand over the validated modules and documentation, and the process would be complete.
MGS Machine Corp., a packaging machinery OEM with a keen interest in pharmaceutical packaging, is developing templates to help its customers with the validation process. For example, for machines that attach an outsert, MGS provides a five-page template that explains in explicit terms how the machine works, how bad product is rejected from the line, how the machine communicates, and how it verifies that the reject really did happen.
Also developing templates is the JETT (Joint Equipment Transition Team) Consortium, a special interest group of the International Society for Pharmaceutical Engineering, created to help ease the cGMP process. JETT aims to improve communication between users and suppliers of automated production and process equipment to meet validation requirements more effectively.
Joint Equipment Transition Team (JETT) Consortium leaders work to improve communication between end users, suppliers, and consultants to meet pharmaceutical validation requirements.
Bristol-Myers Squibb's Paula Mastrangelo, associate director of clinical supply operations, offers the following tips on selecting an electronic solution for batch execution and disposition:
• Develop a solid project framework with a team of global members made up of professionals from quality assurance, technical experts, and project leaders for technical and business sides.
