Monday, 2 September 2013

Design considerations for container closures


Parenteral products (products that are administered to the body by injection) are designed, formulated and packaged to be sterile and to maintain sterility. One of the most important parts of the packaging of the sterile drug product is the container-closure mechanism. This article examines the use of closures, intended for injection, in the pharmaceutical industry. The article considers the most important aspects relating to the manufacture of closures and the different physical and biological tests required in order to assess that closures are ‘fit for purpose.’ The article does not address caps or other types of seals.

Tim Sandle has explored the design and validation requirements for the use of container closures for medicinal products in a peer reviewed article for BioPharm International. This has been published in a recent edition.

Here is an extract:

“A review of industry practices suggests that failures occur with container-closure seals for a variety of reasons. These include poor quality starting materials; an improper fir of the container-closure combination; the lack of sufficient inspection as part of batch release; insufficient process monitoring or process control; the use of unreliable manual or visual inspection techniques; the use of methods that produce subjective results and the lack of proper process validation. This latter point is addressed through the tests described below.”

The reference is:

Sandle, T. (2012). Container Closures for Pharmaceutical Preparations: A review of Design and Test Considerations, BioPharm International, Vol. 25, No. 12, pp32-36

For further details, see BioPharm International

  Posted by Tim Sandle