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Design & Materials: Page 331
Package Design
Foil medical pouches
Pharmaceutical company discovers discoloration problem through microanalysis.
July 10, 2006
Package Design
ClearFoil film
Report says the country aims to be the world's top packaging producer by the end of this year.
July 10, 2006
Labeling/Printing
Healthcare packaging services
Keeping patient safety in the forefront when designing packaging ensures that the drug or compound arrives intact and at optimal efficacy.
July 10, 2006
Medical Device/Packaging
Copolyesters for medical packages
To combat growing vaccine waste, a U.K. government initiative reportedly will back R&D of sheep's wool packaging for pharmaceuticals.
July 10, 2006
Adherence/Delivery
RFID breaks new ground in clinical trial packaging
A macrolide azithromycin chronic obstructive pulmonary disease (COPD) Phase III study is using Med-ic RFID smart sensors embedded in blister packs. Sponsored by the National Institute of Health, the multiyear, double-blind study will enroll more than 1,100 patients at 10 clinical centers across the country.
July 10, 2006
Labeling/Printing
New Rules For Patient Package Inserts
In June, new Food and Drug Administration rules for the format and content of patient package inserts in prescription drugs became effective. The new format emphasizes "highlights" of the label information, provides a table of contents, requires the information to appear in a different order, and sets forth specified graphic requirements. That goes along with a requirement put in place late last year calling for drug makers to submit labeling information in electronic format, for easier searching and cross-referencing. Says the FDA, "These revisions will make it easier for healthcare professionals to access, read, and use prescribing information, and will enhance the safe and effective use of prescription drug products."
July 10, 2006
Medical Device/Packaging
FDA Analyst Delivers Medical Device Labeling Insights
At a June 6 Medical Design & Manufacturing East conference session, Food and Drug Administration regulatory policy analyst Arthur Yellin offered the following advice on medical device labeling:
July 10, 2006
Medical Device/Packaging
Stent packaging at Cordis: A global operation
Perhaps the most widely recognized combination product is the heart stent. Years ago, physicians inserted a metal stent into a patient's clogged or occluded artery, using a balloon that would expand plaque against the artery walls. "It's a mesh-like metal tube that adheres to the artery wall and stays in position," explains Rolando Gonzalez, manager of pharmaceutical and packaging development for medical device maker Cordis Corp., a Miami Lakes, FL-based Johnson & Johnson company.
June 10, 2006
Labeling/Printing
Bar codes: Reducing medication errors in hospitals
Dangerous and costly medication errors come in many scary varieties, such as administering the wrong drug, or in the wrong dose, or at the wrong time. There are a lot of nightmarish scenarios built into that list of variables, and when one or more goes wrong, the results can include patient suffering and additional financial costs.
June 10, 2006
Medical Device/Packaging
Medical device packaging validation
Among the event's highlights is a new U.S. Pharmacopeia 1083 guidance chapter aimed at pharmaceutical counterfeiting in the supply chain.
May 10, 2006
Medical Device/Packaging
What ISO 11607 revisions mean to you
Compliance responsibilities that were clearly outlined in section 4.4 of the current standard have been omitted from the new International Standards Organization (ISO) 11607-01. Therefore, confusion may arise over certain areas of responsibility such as: • Who should test the packaging suppliers' seals? • Who is responsible for validating package sealing equipment? • Who is responsible for evaluating the biocompatibility or other material characteristics such as microbial barrier properties?
May 10, 2006
Package Design
Chevron pouch on roll machine
UN-certified SPIBC intermediate bulk container seen at Pack Expo Las Vegas is for packaging and shipping of hazardous and regulated materials.
May 10, 2006
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