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1,251 Results
Type: News
Section: Industry News > Regulatory
Regulatory
RFID in Healthcare Consortium forms
Organized under the auspices of The RFID Educational Foundation, the RFID in Healthcare Consortium recently formed to promote the understanding of, and where appropriate, the adoption of radio-frequency identification technology for the benefit of the healthcare community. Harry Pappas, CEO and founder of the RFID Educational Foundation, says the Consortium includes a steering committee of 10 people, representing academia, medical devices/instruments, hospitals, RFID representatives, medical doctors, and systems integrators. The organization is seeking one or two members from the packaging community. A two-day educational conference is in the planning stages for early next year.
October 24, 2008
Packaging/Filling
Pharmaceutical/medical device packaging helping Ireland's economy
After enjoying years of prosperity, Ireland has been hit by challenging economic times that have touched many countries around the globe. A medical device sub-contract manufacturing/packaging company's managing director believes "things are likely to get worse before they get better" in Ireland. The good news: Through government-based groups such as Enterprise Ireland, there is a commitment to financial investments in the life sciences sector, as well as to student education, and workforce development, all of which bodes well for the future. Today, pharmaceutical and medical device businesses provide considerable employment and generate revenues in Ireland. That's the take from Healthcare Packaging's visit to Ireland.
October 23, 2008
Inspection
FDA Guidance Document addresses sterility issues
If you make a sterile medical product, and you want to avoid sterility testing by instead confirming container and closure system integrity, the Food and Drug Administration has prepared a written Guidance Document just for you. The FDA Guidance Document on the subject has been in draft form since 1998, and was made final in February 2008.
October 22, 2008
Packaging/Filling
Tolmar transitions to thermoformed trays for packaging prefilled syringes
As specialists in formulating, filling, and packaging of pharmaceutical products, Tolmar, Inc. of Fort Collins, CO, has been packaging prefilled syringes for more than a decade. Using barrier thermoforming material for packaging of prefilled syringes into trays is new. According to Lori Fischer, Tolmar's engineering manager, "The contents of the polypropylene syringes can be damaged by exposure to air or moisture, which is why we need barrier packaging in the first place. We had been using a foil pouch with a tear notch, but it was cumbersome. You had to shake the contents out. Also, once packaged, you could not see inside to do a check of the contents." Enter Klöckner Pentaplast with its Pentamed Aclar polyester barrier material. Tolmar also installed a Model R230 thermoform/seal machine from Multivac when it switched to the new Klockner Pentaplast material.
October 17, 2008
Medical Device/Packaging
RFID addresses liability, patient care, safety, and tracking in growing cabinets market
Liability and patient care, and inventory visibility, are two key drivers of a growing trend in the Radio-frequency identification-enabled cabinets market that's emerged over the past 18 months. An RFID cabinet is a cabinet, freezer, or refrigerator equipped with an RFID reader to read the RFID-tagged items stored inside. Readers can upload the data via the Internet. During an Oct. 2 Webinar sponsored by Odin Technologies and Terso Solutions entitled "Using RFID Cabinets and Freezers to Protect and Manage High-Value Inventory." The event featured three case studies.
October 9, 2008
Packaging/Filling
Alcan Pharma Center more than doubles in size
Complex and sometimes confusing, the Drug Supply Chain Security Act poses challenges to the pharmaceutical industry. Dirk Rodgers’ book explains the law for stakeholders throughout the supply chain.
September 22, 2008
Sustainability
Schreiner MediPharm Global opens U.S. facility
Surrounded by Rockland County, NY government officials and business leaders, Roland Schreiner, president of Schreiner MediPharm Global, cut the ribbon for the U.S. facility opening September 12, 2008. On the left is Gene Dul, U.S. president. The pharmaceutical label printer's expansion in the U.S. "is to serve our customers better by being closer," said Schreiner, who pointed out that Rockland County officials, with the help of an Empire State tax-incentive package, were eager to aid the startup of the plant, projected to hire as many as 80 people. The company said that several German employees have relocated to the U.S., with local talent brought in by an executive recruiter.
September 15, 2008
Packaging/Filling
Roche goes green, saves greenbacks
A change to more readily recyclable fiberboard for its Boniva (ibrandronate sodium) prescription-only osteoporosis wallet pack is yielding economic and environmental benefits for Nutley, NJ-based Roche, a division of Swiss pharmaceutical giant, the Roche Group (F. Hoffmann La Roche, Ltd.). Roche's reintroduction of Boniva in the fiberboard wallet packs reduces costs, while machinery modifications increase OEE to 84%.
September 9, 2008
Regulatory
Managing global packaging artwork
Some of the world's most recognizable generic pharmaceutical product manufacturers are now employing the GL-AMS (Global Artwork Management System) from The Perigord Group. Dublin-based Perigord was the first of four life sciences-related companies visited by Healthcare Packaging editor Jim Butschli Aug. 20 - 22 during an exclusive trip to Ireland supported by Enterprise Ireland .
August 20, 2008
Pharmaceuticals
Track-and-trace mandate could be costly
Implementing track-and-trace technology to help safeguard the U.S. pharmaceutical supply chain from counterfeit drugs could cost pharmacies between $84,000 and $110,000 per store in the first year alone. That was learned from a study on the safety of the U.S. pharmaceutical supply chain and the impact of a federally mandated track-and-trace system on the U.S. retail pharmacy segment, if implemented. The study was released in June by the Coalition for Community Pharmacy (CCPA), comprised of the National Community Pharmacists Assn. (NCPA) and the National Assn. of Chain Drug Stores (NACDS).
August 14, 2008
Nutraceuticals/Dietary
FDA Warning Letters address fraudulent product claims
Packagers of nutritional supplements and food products must substantiate claims for certain medical benefits.
August 14, 2008
Adherence/Delivery
Sustainability issues challenge package designers
Package design for pharmaceutical and nutraceutical products is becoming more complex and challenging for companies striving to reach a balance between becoming more sustainable while adhering to regulations and patient safety initiatives. "Furthermore, each change to packaging materials requires new validation trials, which are time-consuming and costly." That's according to the "Pharmaceutical/Nutraceuticals Packaging Machinery, Industry Segment Market Research Study," a Packaging Intelligence Brief issued by the Packaging Machinery Manufacturers Institute.
August 5, 2008
Regulatory
The best counterfeiting disinfectant is sunlight
Greed is a mighty and powerful driver that fuels the dark world of counterfeit and diverted drugs. At the recent Pharmaceutical Packaging Forum (www.packworld.com/ppf), presenter/investigative reporter/author Katherine Eban shined the light on criminal activities while conducting research for her book "Dangerous Doses: A True Story of Cops, Counterfeiters and the Contamination of America's Drug Supply."
June 15, 2008
Supply Chain
Anti-counterfeiting tops agenda at Americas Technology Summit
The task of securing the supply chain and the need to adopt a layered approach using overt and covert security features often seems overwhelming; companies don't know where to start or what technologies to invest in. That was a key message taken from anti-counterfeiting sessions at the 2008 Americas Technology Summit, an event focusing on brand protection and sustainability held in San Juan, Puerto Rico April 16-17. Americas Technology Summit was sponsored by National Label Co. and MWV .
June 15, 2008
Supply Chain
National Geographic shines light on 'dark trade'
Could illicit trade--involving everything from handbags to humans to counterfeit pharmaceuticals to weapons-grade uranium--be an even greater threat to our way of life than terrorism? Dr. Mois•s Na•m, editor of Foreign Policy magazine, believes that could be the case. A new National Geographic Special, Illicit: The Dark Trade, which aired April 16 on PBS television stations, estimated the global value of this trade to be as high as $3 trillion, with some assessments believing it represents 10 percent of the world's trade. As the accompanying photo of counterfeit drugs seized in Bogota, Columbia, shows, counterfeit packaging is part of this illicit trade. (Photo by Richard Numeroff/©2008 National Geographic Television.)
June 15, 2008
Regulatory
Trade agreement reached to combat counterfeiting
According to a recent report by in-PharmaTechnologist.com, The European Commission (EC) sought a mandate from European Union member states to negotiate the new Anti-Counterfeiting Trade Agreement (ACTA) with major trading partners including the U.S., Japan, Korea, Mexico, and New Zealand.
June 15, 2008
Regulatory
Drug packaging makes advances on the counterfeiting front
Packaging technologies help secure America's drug supply, but the war rages on, says investigative reporter/author Katherine Eban at the Pharmaceutical Packaging Forum. Eban admits she's not a technical expert on packaging. "But I know a lot about why you need secure packaging," she says. "It is critically important. You [packaging professionals] save lives with your packaging." Eban's appreciation of pharmaceutical packaging comes in part from the investigative research she completed to write her book "Dangerous Doses: A True Story of Cops, Counterfeiters and the Contamination of America's Drug Supply."
June 15, 2008
Pharmaceuticals
Implementing a brand protection program
David Howard (shown), director product protection global brand integrity at Johnson & Johnson, spoke about how to implement a brand-protection program. "The first step in any organization is to know thyself," Howard advised. "Where are your products made? How do you distribute? Where do you market? Are you local? Regional? Global? Who touches your products?" Without detailed answers to such questions, solutions being considered or the ones already being implemented may be misguided, Howard told the audience at the first Brand-Protection Packaging Forum.
June 15, 2008
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