FDA recognizes comments from BFS IOA on the new aseptic processing guideline, Appendix 2

Recently, on Sept 29th 2004 the FDA published their long-awaited update of their 1987 guidance on aseptic processing. As we are sure you are aware, the BFS IOA have been active in discussing this document. Below we give a quick update on the work and results.

Ever since the FDA, published the first preliminary concept paper in Sept 2002, the Pharmaceutical Blow-Fill-Seal International Operators Association (BFS IOA) has worked with the Parenteral Drug Association (PDA) and the FDA to comment upon and revise the text. Naturally, the focus of our attention and comments were on the Appendix 2, covering Blow-Fill-Seal Technology. To be frank, the text in the preliminary concept paper left a lot to be desired from a BFS-technology standpoint.

Our comments on the guidance have been presented on numerous occasions as oral presentations and panel discussions at major PDA meetings, such as the PDA annual meeting in New Orleans 2002, the Prague meeting in 2003 and the SciTech Summit meeting in Orlando 2004. FDA Officers such as Richard Friedman and Brenda Uratani have both participated at BFS IOA conferences and dinners where more relaxed discussions around the topic have been held. Besides these discussions, formal written comments have been submitted directly to the FDA, both for the concept paper and the subsequent draft guidance.

As members of the board with responsibility for the comments, it is with great satisfaction and pride we recognize that practically all our major concerns with the Appendix 2 on BFS technology have been listened to, and implemented into the final document. It is clear that without the hard work the BFS IOA put into compiling comments, presentations, panel discussions and the aseptic BFS survey data, the FDA guidance would not be have looked as it does today. One of the major comments, which did not get changed when going from concept paper to draft guidance, was the requirement to operate aseptic BFS processing in class 10,000 clean rooms. This differed from the EU-GMP where class 100,000 has been the standard. In the final guidance, the FDA has changed position and now harmonizes their guidance to EU-GMP, in line with our comments.

To access the updated aseptic processing guideline from the FDA published September 29, 2004, please go to FDA webpage at

This is maybe the clearest evidence that PDA and FDA now acknowledge BFS IOA as the expert industry organization in BFS processing. It is also evident that the FDA has high confidence in the high quality of BFS processes when they are operated by knowledgeable companies.

We would like to take the opportunity to thank all members of BFS IOA for their help in providing input to the BFS aseptic survey, which formed a part of the comments. Thanks also to the dedicated appointed Officers, especially in the US, and former board members, Svend-Axel Laursen and Götz Reiner who helped in our discussions and preparations at the conferences. Hard work and persistence pays off! We will request all members (especially our Asian members) to continue to support the BFS IOA with further media fill data in the future so we can raise the confidence level of the survey data even higher.

I would also like to acknowledge the FDA for being open and responsive to constructive criticism and for the interesting and sometimes challenging discussions we have had during the past two years.

The BFS IOA is seen as an industry association with real impact and the board believes that the results we now see are an effect of the scientifically sound arguments we are raising. Let us continue in this direction to further strengthen the position of BFS technology as an excellent choice in the future production of sterile pharmaceutical products.

Officers of BFS IOA Board:

Anders Löfgren,                         Eric Dewhurst
Chairman of the Board               Technical Officer

Martin Haerer                            Jesper Laursen
Officer of Training/Education       Officer of Operation