Thursday, July 10, 2014

Science-Based Technical Report Being Developed to Ensure Effective Use of Blow-Fill-Seal Technology

The Parenteral Drug Association has established a task force to develop a peer- and regulatory agency-reviewed Technical Report that will serve as a science-based industry reference document.

Pharmaceutical Sciences, Manufacturing & Marketplace Report

Blow-fill-seal (BFS) aseptic processing in parenteral manufacturing enables the automated formation of a plastic container, aseptic filling of the container with a liquid, and the hermetic sealing of the container, all in a few seconds using one machine. Because packaging of the formulated drug takes place under aseptic conditions without any human intervention, it provides increased product safety. The automated nature of the process leads to lower energy consumption, reduced waste generation, and a lower carbon footprint. In addition, the resins used to form the plastic containers are recyclable, and plastic containers do not shatter like glass. Furthermore, with most advanced BFS systems, numerous different container shapes can be produced, and today premolded, presterilized inserts can be added once the container is filled, allowing for more delivery options. “These advanced aseptic BFS containers and ampuls can deliver precise dosing in disposable formats. The incorporation of a sterile tip-and-cap, a rubber stopper, or a multi-entry insert into the BFS package offers added flexibility in container design and drug delivery methods, as well as enhanced sterility safety,” observes Chuck Reed, director of sales and marketing with Weiler Engineering and leader of the US Parenteral Drug Association (PDA) Blow-Fill-Seal Interest Group.
Today, in fact, FDA characterizes modern BFS technology as an "advanced aseptic process," indicating its use as a preferred technology, according to Reed, director of sales and marketing with Weiler Engineering and leader of the US Parenteral Drug Association (PDA) Blow-Fill-Seal Interest Group. As leader of the PDA BFS Interest Group, and a member of the PDA Task Force, Reed is involved in the development of the BFS Technical Report that will provide science-based support for the use of BFS technology in the pharmaceutical industry.
Cooperation with the BFS International Operators Association (IOA)
The BFS IOA, founded as a meeting forum for users of BFS technology to get together and discuss topics of interest specifically to users, is celebrating its 25th anniversary in 2013.  This group’s BFS Points to Consider is a template and reference document for its members to use when establishing BFS processes for their products. “The BFS IOA and the PDA have signed a memorandum of understanding (MOU) so that the BFS Technical Report Task Force of the PDA can use the BFS Points to Consider as the basis for development of the PDA BFS Technical Report,” Reed explains.
Need for a Technical Report
Interest in the development of a BFS Technical Report was initiated by subject-matter experts on the PDA Science Advisory Board. “Technical Reports have already been developed on filtration and sterilization processes for parenterals, and it was a natural fit to provide the pharmaceutical industry with a similar document on BFS technology since it is increasing in use as its benefits are realized,” Reed says.
The PDA Task Force was created to develop the report and consists of approximately 20 people, most of whom are current active users of the technology. Two of the invited members, however, are representatives from the European Medicines Agency and FDA. “We felt that this size of a group would be able to work effectively and efficiently to develop a first draft. Involving the key regulatory agencies throughout the process ensures that the document will be in accordance with existing regulations,” explains Reed.

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