October 16, 2002
To: All members of The Pharmaceutical BFS International Operators Association
Re: Points to Consider document revision 2001/2002
As the Global Technical Officer of the BFS IOA, I have had the ultimate responsibility to run the revision process of our guidance document, called “Points to Consider for Pharmaceutical B/F/S Manufacturing”. Besides myself, many others have participated and contributed in the process. I would particularly like to thank Eric Dewhurst of IVAX Pharmaceutical and Martin Haerer of Holopack, Germany.
The decision to start this revision process was taken at the AGM 2001 in Luzern, Switzerland. Since then, there has been a lot of debate as to the role of this document.
Since the last revision from 1996, new regulatory guidelines and other guidance documents have been issued. Still, however, very few mention BFS technology specifically and if they do, often very briefly. Therefore it was felt, that the PTC-document still has a function in pointing out issues which is specific to BFS processing and which is not covered by guidelines written for traditional aseptic processing, utilizing pre-formed containers and closures. In an effort to make the document easier to read, we have tried to remove at least some sections where we felt sufficient guidance is given by other official documents. Many parts of BFS manufacturing (e.g. filter validation) is basically the same whether one deals with traditional aseptic processing or BFS and such sections were therefore removed in the current revision. Other parts (such as Part two, covering general validation) was kept and updated, since it was felt that many issues specific to BFS was part of this text, although the section to a large extent also applies to traditional aseptic processing.
I would urge you to read through the document and appendices until we meet at the AGM in New Orleans, where a voting to approve or not approve the document will take place. If you have any comments or questions, please feel free to contact me. Looking forward to meet with you all in New Orleans.
To read or download Points to Consider document revision 2001/2002 in PDF format, please klick below links:
Anders Löfgren, Ph.D.
Global Technical Officer, BFS IOA
c/o AstraZeneca R&D
S-151 85 Södertälje, Sweden