Materials

SPI: The Plastics Industry Trade Association is pleased to announce the publication of an update to its 2003 Guidelines for the Development of Type III Drug Master Files.  This manual, prepared by the SPI Pharmaceutical and Medical Device Applications Committee, is a guide to the regulatory considerations and procedures to be taken into account when establishing a Type III Drug Master File.  The new updates reflect procedural changes at the U.S. Food and Drug Administration and "best practices" amassed by the law firm of Keller and Heckman.

Medical device manufacturers are currently evaluating Eastman Tritan copolyester MP100 for a number of rigid medical packaging applications. Eastman’s main focus at its Medical Design & Manufacturing West 2011 press conference was its newest product in the Tritan copolymer family for renal devices. However, the company reported that packaging evaluations are underway on a number of fronts.

Topas cyclic olefin copolymer (COC) resins are carving out a role in drug delivery. Industry has valued COC’s properties while exploring plastic alternatives for vials and syringes. In another use, Topas has been adopted for delivering biomaterials in operating room skeletal procedures.

The new 16-oz PET bottle for T.N. Dickinson’s Witch Hazel replaced glass and PVC alternatives.

Now available in all-new 8- and 16-oz PET bottles is T.N. Dickinson’s Witch Hazel Astringent.