One-stop pharma auto­ma­tion: fully auto­mated ampule pack­aging with Früh

From line integ­ra­tion to seri­al­iz­a­tion and aggreg­a­tion – struc­tured, com­pli­ant and scalable

Phar­ma­ceut­ic­al pack­aging is more than just pack­ing up products: it’s about pro­cess-reli­able auto­ma­tion, trace­able data flows, val­id­a­tion-enabled pro­ced­ures – and a setup that func­tions reli­ably in a reg­u­lated envir­on­ment. This is pre­cisely where Früh Ver­pack­ung­s­tech­nik AG is cur­rently bol­ster­ing its expert­ise: togeth­er with a cus­tom­er from the phar­ma­ceut­ic­al sec­tor, we are imple­ment­ing a pro­ject for the fully auto­mated pack­aging of ampules, includ­ing car­ton­ing, tamper-evid­ent seals as well as seri­al­iz­a­tion and aggregation.

From the spe­cific­a­tion to the line: integ­ra­tion in a reg­u­lated environment

The pro­ject com­menced in Octo­ber 2024 with the sign­ing of the cooper­a­tion agree­ment. At this point, only a pro­vi­sion­al ver­sion of the specifications/​requirements doc­u­ment was avail­able. Nev­er­the­less, the equip­ment was ordered at an early stage – an approach that only makes sense in com­plex phar­ma­ceut­ic­al pro­jects if the meth­od­o­logy, coordin­a­tion and engin­eer­ing clar­ity are right. At the same time the equip­ment was ordered, the doc­u­ment­a­tion was gradu­ally refined and open points were cla­ri­fied as part of ongo­ing dis­cus­sions between the cus­tom­er, equip­ment sup­pli­er and Früh.

The added value was found in the pre­dict­ab­il­ity and speed, with an eye on qual­ity and com­pli­ance at all times. This allowed fol­low-up pro­cesses, resources and tim­ings to be estab­lished at an early stage – a decis­ive factor when new lines are being introduced.

Auto­ma­tion that thinks for itself: flex­ible, trace­able, efficient

At the heart of all this is a fully auto­mated pack­aging pro­cess, includ­ing car­ton­ing in two dif­fer­ent pack­age sizes. The pro­cess is sup­ple­men­ted by key phar­ma­ceut­ic­al functions:

• Tamper-evid­ent seals
• Seri­al­iz­a­tion
• Aggreg­a­tion

The res­ult is a trace­able, flex­ible pack­aging solu­tion that sim­ul­tan­eously reduces manu­al effort. For phar­ma­ceut­ic­al cus­tom­ers, this means robust pro­cesses, clear data chains and line logic that can be integ­rated into exist­ing sup­ply chain and com­pli­ance requirements.

Pro­ject expert­ise as the key: inter­faces, dis­cip­line, clear milestones

A fully auto­mated line is also invari­ably a pro­ject that involves mul­tiple inter­faces: mech­an­ics, soft­ware, data, qual­ity require­ments, doc­u­ment­a­tion – and mul­tiple part­ners that have to work in step with each oth­er. The fact that Früh and the sup­pli­er were able to achieve a key mile­stone exactly as agreed was the res­ult of close, struc­tured coordin­a­tion between all three parties. Our intern­al pro­ject man­agers ensured that require­ments were con­stantly aligned, decisions were made in good time and dead­lines were con­sist­ently adhered to.

“Just in time” infra­struc­ture: new pro­duc­tion space for chal­len­ging lines

Along­side the line, the appro­pri­ate envir­on­ment was also real­ized: a new pro­duc­tion space of just under 400 m², delivered on time and ready for install­a­tion and com­mis­sion­ing. This was made pos­sible thanks to pre­fab space solu­tions, con­fig­ur­able accord­ing to the spe­cif­ic pro­ject. The advant­age is that there is no idle time between com­ple­tion of con­struc­tion and equip­ment install­a­tion – just a quick trans­ition into the next phases of the project.

Next step: com­mis­sion­ing, SAT and qualification

With deliv­ery com­plete, a key step has been taken – now it’s time for com­mis­sion­ing, the SAT (site accept­ance test) and qual­i­fic­a­tion runs. Here too, it is clear what the phar­ma­ceut­ic­al envir­on­ment depends upon: clean han­dovers, con­sist­ent doc­u­ment­a­tion, defined test logic and a team that not only car­ries out pro­cesses, but under­stands them as well.
As part of the cur­rent test­ing and qual­i­fic­a­tion phase, the seri­al­iz­a­tion and aggreg­a­tion pro­cess steps will be imple­men­ted in the com­ing weeks.

Früh is expand­ing its pharma auto­ma­tion expertise

This pro­ject exem­pli­fies the expan­sion of our expert­ise: Früh is com­bin­ing expert­ise in pack­ing mater­i­als and con­tract pack­ing with line integ­ra­tion and pro­ject man­age­ment – to give cus­tom­ers a solu­tion that boasts impress­ive tech­no­logy and also per­forms reli­ably in the reg­u­lated day-to-day environment.