ASTM International Reaches Out to European Packagers
ASTM International invites medical device packaging professionals in Europe to participate in advanced standards development. The group will hold a workshop on ASTM test methods October 6–8 in Prague, Czech Republic. Participating in the meeting is Committee F02 on Flexible Barrier Packaging, and several of the planned presentations focus on medical device packaging test methods and standards.
“This meeting is one of the first ASTM standards committee meetings being held in the European community and in the eastern European region,” says Curt Larsen, a member of the executive board of Committee F02 and a principal of Spartan Design Group. “There are no consensus standards–writing organizations of this kind for European medical device packagers to participate in.” The committee especially hopes to attract members of the CEN Technical Committee 102 Sterilization, Working Group 4, Packaging (CEN/TC 102/WG 4), and the CEN TC102 member companies. continued
Control from the Top
With complete process control in mind, Sigpack Systems, a Bosch Packaging Technology (Switzerland) company, has introduced its Pharma Toploader for combining pharmaceutical vials, syringes, and needle holders with product literature in boxes. Using bar-code verification and camera systems, the system checks packages at each process step for any incomplete or damaged contents. A simple tool change enables it to switch to a different set of products.
“Faulty items are immediately separated out without any disruption to the packaging process,” explains Rene Kummer, sales support manager, Sigpack Systems, Bosch Packaging Technology. “Rejected and misplaced products are dropped into drawers and can therefore be easily documented. This is a stringent requirement, especially for expensive or toxic pharmaceuticals. Users can be sure that no products are left in the system and that all packaged contents are fully accurate and undamaged.”
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Respiratory Study Finds Inhaler Trigger OK for Ill Patients
On World Asthma Day, Valois Pharma revealed the results of a clinical study with patients suffering from asthma and chronic obstructive pulmonary disease (COPD) using its proprietary Dry Powder Inhaler, Prohaler. Patients use the Prohaler by opening the device, inhaling the powder dose, and closing it. Inhaling triggers the release of a dose of medication, and a dose counter reminds the patient how many doses are left in the device.
The hospital-based study was carried out from December 2007 to April 2009 at the CHRU (Tours, France). It was led by Professor Patrice Diot, a respiratory physician and president of ISAM (the International Society for Aerosols in Medicine), and Dr. Steve Newman, an expert consultant in inhaled dosage forms and founder of Pharmaceutical Profiles Ltd. Sixty patients suffering from asthma or COPD took part in the two-phase study. Some of these patients had very poor lung capacity, as low as 30% of that of a normal healthy person. continued