Blow-Fill-Seal Machine Qualification/Validation

Until some years ago, Blow-Fill-Seals machines were pre-accepted on the manufacturing site in an almost informal test procedure. It was only required to demonstrate that the indicated capacity could be reached and that the equipment was in conformity with the scope of supply.

There is probably no other sector within this industry which has seen such a dramatic change in respect to requirements and specifications.

Abbreviations such as FAT, IQ, OQ, PQ are widely used today and implemented in many cases. For suppliers, these requirements have presented a considerable challenge, particularly where non-standard equipment is involved. The impression was for some time, and to a certain extent still exists, that there is no clear and mutual understanding in the industry as to what is required for each individual stage.

We know what that means as it relates to the BFS technology. We can work with you and assist you with all your DQ, IQ, OQ needs.

Therefore, we have decided to offer our customers a package of different qualification documents. This includes a full report together with material specification documentation. This lists the history of one single piece of the aseptic system from the steel works until the part is built into the machine in accordance to authorities' requirements.

In order to comply with US and European regulations and to be able to CE-mark the machines, all necessary steps, from design to the finished machine, are being undertaken.

We also offer a complete software validation package. If needed, we can also supply a TÜV Certification of the software.

We can supply standard FAT and SAT protocols enabling you to prepare your project specific protocols.

Our experience has shown that company demands seem to be quite different from one company to another. Therefore, individual pricing for the documentation work needs to be established, based on the client's specific requirements.