Pharmaceutical Technology Europe-06-01-2004

The American Society of Mechanical Engineers' Council on Codes and Standards established an ad hoc committee to examine whether a standard to create uniformity and consistency in the bioprocessing industry is needed. This article describes the goals and current activities of the standards committee and its subcommittees.

The FDA guidelines that stipulate the conditions for starting materials are currently being superseded. PhRMA and several European pharmaceutical manufacturers have already added their voices to the ongoing discussion and, as this editorial explains, the debate is far from over. Rules are important, but industry is looking to a future when health care authorities are less inclined to impart total control over every aspect of production.

The article describes the basic principles of blow-fill-seal (BFS) technology together with the advantages it offers. Although BFS technology is an ideal process for aseptic filling of liquid pharmaceutical products there is still a risk of contaminating the product inside the filling area. This, together with regulatory requirements for the microbiological control of critical areas in pharmaceutical production, makes microbiological monitoring a necessity.

The content and quality of information supplied with drug products are among the most specifically defined areas associated with the products for sale. For patient or drug user, the information is presented in patient information leaflets (PILs) placed in the package. The readability testing of PILs is an important stage in the process of making the texts contained in the summary of product characteristics comprehensible to users, as this article discusses.

This article introduces the application of high-resolution ultrasonic spectroscopy (HR-US) for the analysis of emulsions and suspensions. The authors outline the principles of the technique and illustrate its application for analysis of the crystallization of lysozyme and the formation of a microemulsion.