Practical fundamentals of glass, rubber, and plastic sterile packaging systems.
Sterile product packaging systems consist of glass, rubber, and plastic materials that are in intimate contact with the formulation. These materials can significantly affect the stability of the formulation. The interaction between the packaging materials and the formulation can also affect the appropriate delivery of the product. Therefore, a parenteral formulation actually consists of the packaging system as well as the product that it contains. However, the majority of formulation development time only considers the product that is contained in the packaging system. Little time is spent studying the interaction of the packaging materials with the contents. Interaction between the packaging and the contents only becomes a concern when problems are encountered. For this reason, there are few scientific publications that describe the available packaging materials, their advantages and disadvantages, and their important product attributes. This article was created as a reference for product development and describes some of the packaging materials and systems that are available for parenteral products.
Sacha
Gregory A
GA
Research and Development, Baxter BioPharma Solutions, Bloomington, Indiana 47404, USA. gregory_sacha@baxter.com
Saffell-Clemmer
Wendy
W
Abram
Karen
K
Akers
Michael J
MJ
D004349:Drug Packaging; D005898:Glass; D010969:Plastics; D011189:Potassium Chloride / Q000737:chemistry; D012408:Rubber; D012995:Solubility
D010969:Plastics; D011189:Potassium Chloride; D012408:Rubber