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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.
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.
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.
Nowhere in packaging are flexibility and fast changeover more necessary than in the contract-packaging arena, where multiple customers and their many SKUs are a fact of life. That’s why ease of changeover was a key machine characteristic sought by Brecon Pharmaceuticals recently when it came time to install a new line for blister packing and cartoning of tablets. This fast-growing contract packager, acquired last year by Amerisource Bergen, is located in the UK near the town of Brecon, Wales. Both thermoforming and cold-forming of foil are routinely done on this new and highly versatile blister-pack line.
In this question-and-answer interview, Andrew Billington (shown), operations manager at Brecon Pharmaceuticals in Wales, addresses recent trends in packaging. What is he looking for in new packaging machinery? Billington says: "Quicker changeover and anything that facilitates GMPs [Good Manufacturing Practices] are at the top of the list. Both are especially important for a contract packager because our runs can be quite short. Added changeover pressure can also come from the multiple languages we deal with here in Europe. That’s something our counterparts in the United States do not have to face."
The Food & Drug Administration’s new current good manufacturing practices (CGMPs) for dietary supplements are rich in requirements related to packaging and labeling. A decade in the making, the CGMP rule, compliance with which will be phased in according to size of company, sets minimum standards for assembly-line contact surfaces, packaging and labeling equipment, inspection of packaging received from suppliers, relations with third-party packagers, personnel hygiene on the packaging line and much more, all within the context of forcing the industry—some of which may already be in compliance—to adopt the kind of CGMPs that the FDA has prescribed for food and drugs.
Based in Las Vegas, Med-Health is a combination of three independent businesses where Enterprise Resource Planning (ERP) technology from SAP will play a key role. Currently operating is a Med-Health business that sells medical supplies like gowns, gloves, sutures, and other "consumables." Opening this summer was a pharmaceutical drug wholesaler. And some time around January of 2008 will be the opening of a Med-Health pharmaceutical repackaging arm.
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.
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.
“Advances in online package inspection and integrity testing are exciting,” exclaims Dana M. Guazzo, Ph.D., president of consulting firm RxPax LLC. “These include high-speed, noncontact ultrasound inspection technologies, light reflection technologies, and gas tracer techniques.”
David Rudd, a senior engineering specialist with Cardinal Health, doesn’t “anticipate any breathtaking advances. I do expect continual incremental improvements facilitated by increased application of servo motors, improved control software, and a drive to reduce costs. I’d like to see lower-cost machines that will allow users to buy more machines for increased scheduling flexibility.”
On the materials side, Rudd says, “I expect that the development and acceptance of a better microbial barrier test will allow medical device manufacturers to make more informed decisions about materials used for sterilization vents.”
Gas prices continue to climb. A good survival strategy for truckers is waiting for trailer loads to be full before hauling. Unless, of course, the trailer contains sensitive pharmaceuticals.
Clearly, the implications are that the packaging of temperature- and humidity-sensitive drugs and the monitoring of their shipping conditions are becoming key issues.
Sandy Cook, engineer and president of Thermal Packaging Solutions, an independent consulting firm in New Jersey, agrees. Cook is seeing changes brought on by the high cost of transportation in general. He has been asked to look into shipping pharmaceutical products by ocean-going vessels, a slow, but cost-effective method for United States suppliers to make the product in Europe or Asia and transport it back to the U.S. for sale.
“Big Pharma” continues to be a healthy target for unhealthy criticism. The front-page story in the Chicago Tribune’s February 8 issue, for example, reported that Illinois Attorney General Lisa Madigan’s office sued 48 drug makers, “accusing them of defrauding the state by overcharging government programs and Illinois Medicare customers out of hundreds of millions of dollars.”
