Advanced aseptic processing – How does BFS fit in?
August 2005 - Letter from Chairman
At my latest conference in May-05, the 36th R3-Nordic & 5th European Parenteral Conference in Linköping, Sweden, several of the presentations concerned aseptic processing and how to mitigate risks. Among the presenters were well-known names like Russell Madsen, Gordon Farquharson, Didier Meyer and Jim (James) Akers.
As a response to the recent FDA and EMEA initiatives, where there has been a lot of focus on a risk-based approach, many of the presenters now start to challenge how aseptic processing is made. I became especially intrigued by Jim Akers presentation, titled “Mitigation of risk in aseptic processing through automation and on-line monitoring”
In his talk, Jim referred to a recent work in Japan where he had helped in developing a complete aseptic filling line without critical interventions. Taking a risk-based approach, Jim correctly pointed out that the central focus in risk mitigation in aseptic processing must be complete elimination of human borne contamination. Traditionally, human contamination has been controlled by use of proper ventilation and appropriate gowning. The fact remains, however, that humans still are present. Recent RABS (Restricted Access Barrier) technology which is seen as an advancement over traditional aseptic filling is often designed to facilitate human interventions. But to achieve the complete elimination of human borne contamination, one should not facilitate human interventions; one should take them away. The Japanese company described had taken this step. They had constructed a filling line completely enclosed by isolators and operated by robots. This system was now finally validated and had successfully filled some 4 billion units without incidents.
While the system described by Jim is impressive in many ways, the presentation which followed Akers was equally interesting. A Master Thesis student from AstraZeneca by the name of Stefan Sundström described his measurements of particulate contamination in Blow-Fill-Seal filling suites. It was evident that the hot-knife cutting of the parison from the extruder generates large amounts of particles, but it was also pointed out that such particles are non-viable and do not constitute a risk from a sterility point of view. Also in this case, the risk to mitigate is connected to human operators. However, in normal BFS filling, humans are not present in the filling suite, and if any critical interventions are made into the critical zone, the machine is stopped and resterilised via SIP.
What we have is effectively an aseptic filling line where we have taken a similar step as the Japanese company; we have eliminated critical human interventions from the process, but without the use of isolators and robots (unless you view the BFS machine as a robot in itself). True, we are still forced to enter a microbiologist into the filling suite by the end of the batch to extract sterility test samples, and this step is probably the most critical one in a BFS process.
The massive media fills made without contamination among most member companies indicates what we can achieve when operating BFS lines in a proper way.
Running a BFS filling line to the highest of standards has been and is still one of the safest and most efficient ways of running an aseptic filling process. We can perfect it even further and it is our hope that our US-meeting in Napa Valley will help in initiating such discussions. Join us for this outstanding meeting with interesting presentations, discussions and a remarkable social event in the wine cellars of Napa. We hope to have the major BFS machine manufacturers tell us about their view on future developments to meet future requirments in advanced aseptic processing.
Looking forward to see you all in US!
Anders Löfgren, Ph.D.,
Chairman of the Board, BFS IOA