NEWS

 VDI/VDE Working Group on Medicine and Technology at Fraunhofer IIS      

Hops, malt and the FDA    

What should you consider if you want to brew FDA-compliant medicinal beer?

After a brewery recalls, how can you immediately determine whether a purchased beer comes from a contaminated malt shipment? Assuming the brewery has the appropriate technical infrastructure, all you would need to do is scan a barcode on the crate or bottle with your smartphone to trace the entire „product creation process.“

Craft Beer meets Industry 4.0    When brewing beer on an industrial scale, there is another similarity with the medical technology/pharmaceutical industry: a lot of data

are not recorded manually, but rather automatically using sensors. FDA-compliant validation of such interfaces is another sensitive issue that not only brewmasters who wish to comply with GBBBP („Good Bavarian Beer Brewing Practice“) must address.

The lively discussion following the lecture

What do the production of computer tomography scanners, the manufacture of tablets, and artisanal beer brewing have in common? Well, quite a lot, as Jürgen Dallner and Marc Holfelder of Erlangen-based LA2 GmbH vividly illustrated in their presentation on July 16 at the Fraunhofer IIS in Tennenlohe. The evening’s hosts were Christian Weigand and Christian Graf, heads of the Medicine and Technology Working Group.

Making the dry liquid    Starting with the fictitious business idea of ​​placing a medicinal beer on the US market, the two

In the form of a dialogue between a master brewer and an FDA consultant, we navigate the maze of regulatory requirements that manufacturers of medical devices or pharmaceutical products must comply with. These range from requirements for staff training, production facilities, and batch control to the so-called product development file, electronic signatures, archiving, and the so-called audit trail, a type of time stamp that completely and immutably records all changes to the relevant data records.

Many of these points are no longer handled on paper, but can be covered by appropriate software, which itself, however, must be specified, developed and operated according to appropriate guidelines.

To add color to the gray theory, Marc Holfelder and Jürgen Dallner demonstrated how the complete brewing process, from malt milling and mashing to lautering and hop boiling to fermentation and maturation of the green beer, can be modeled and documented from a regulatory perspective using the „doq“ software.

On the other hand, many work steps were carried out live on site and the audience could look at, smell (hops) or even taste (malt and wort) samples of the intermediate products.

The extent to which this has to do with the production of computer tomographs became clear during the dialogue between the

„Braumeister“ and the consultant are becoming increasingly clear: Brewing beer also involves a complex, batch-oriented process, a lot of measurement data, and high traceability requirements. The importance of the last point is particularly easy to understand: Who wants to

Discussions covering as many regulatory as brewing-related issues showed that meeting the growing number of regulatory requirements is becoming increasingly important to affected producers. The question of pragmatic processes and suitable tools was a central focus of the discussions.

How this can be done relatively simply and yet still comply with regulatory requirements has become somewhat clearer today. This demonstrates once again that the Medicine and Technology Working Group succeeds in explaining even relatively dry topics clearly and, in the truest sense of the word, „fluently.“ „The speakers not only managed to convince with their expertise in both regulatory and beer-brewing matters, but they also managed to captivate the audience with their acting,“ said Christian Weigand, head of the Medicine and Technology Working Group.

PS: Anyone interested is cordially invited to taste a fresh “doq Dunkel” at LA2 – guaranteed to be brewed in compliance with 21 CFR Part 11.

Christian Weigand

Fraunhofer IIS,

Jürgen Dallner, Marc Holfelder

LA2

Technology in Bavaria 06/2015