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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.
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.
The Technical Report is designed to be an industry reference document in which science supports the use of BFS technology. “Our goal is to present harmonized blow-fill-seal procedures for the US, Europe, and others based on the scientific data that has been obtained to date,” observes Reed. Topics will include, for example, risk analysis, validation protocols, selection of BFS systems for particular types of products, and quality assurance.
Making real progress
At this point, a table of contents for the PDA BFS Technical Report has been developed and each Task Force member has been assigned specific sections/topics to address. The group has scheduled regular face-to-face and web-based meetings, and the expectation is that a final draft will be ready around the time of the PDA Annual Meeting in April 2014. At that point, there will be an internal PDA committee and staff review, followed by a review by the relevant regulatory agencies. The document will then be available for open review, and input from other interested industry participants will be solicited. Reed anticipates that this open-review period will commence sometime in late 2014, with a hope to publish by year-end. “The review process takes a while; the value of these PDA Technical Reports lies in the fact that they are science-based and peer-reviewed. It is therefore necessary to ensure that the document is thoroughly and appropriately reviewed before being issued for general use,” Reed asserts.
Background on the PDA BFS Interest Group
The BFS Interest Group (IG) is an active part of the PDA interaction process and meets three to four times per year during relevant PDA meetings and conferences, according to Reed. Joint BFS IG meetings are also occasionally held with the Sterile Processing IG because there are cross-over topics of interest to both groups. Membership in the BFS IG is open to anyone who is a current PDA member and/or conference attendee and includes representatives from all of the major pharmaceutical companies and contract manufacturers that use BFS technology.
The most recent IG meeting was held in September at the 2013 PDA/FDA Joint Regulatory Conference, where much of the discussion focused on FDA-related issues that should be included in the new BFS Technical report. The next formal meeting of the IG is scheduled for the PDA Parenteral Packaging Conference in Brussels in March 2014 while the next domestic meeting will be held at the PDA Annual Meeting in April 2014 in San Antonio. “Topics vary at these meetings and are driven both by industry trends and the particular interests of the attendees at the meeting. Over the course of the next several months, updates on the progress of the BFS Technical Report Task Force will be one of the main discussion points.