Pharma auto­ma­tion step by step: new mile­stones on the road to seri­al production 

From install­a­tion of equip­ment to Swiss­med­ic approv­al and ongo­ing val­id­a­tion, the pro­ject is mak­ing progress.

In early 2026, we repor­ted on the start of our pharma auto­ma­tion pro­ject, which involved the fully auto­mated ampule pack­aging line, includ­ing seri­al­iz­a­tion and aggreg­a­tion. Recent months have revealed just how many steps are needed before any such line is actu­ally ready for seri­al production.

What we have achieved so far

The seri­al­iz­a­tion sys­tem from Laetus and the pouch-mak­ing and car­ton­ing machine from Syn­t­e­gon have been installed and passed the site accept­ance test (SAT). Along­side this, the new pro­duc­tion room EV5 has been made ready and under­gone qual­i­fic­a­tion.
Swiss­med­ic has approved both room EV5 and the trans­fer of the seri­al­iz­a­tion sys­tem. These kinds of approvals are not mere form­al­it­ies. They call for orderly doc­u­ment­a­tion, close coordin­a­tion with the author­ity, and infra­struc­ture that reflects reg­u­lat­ory require­ments from the outset.

Where things cur­rently stand

The val­id­a­tion phase is under­way. In early June, four Line OQ runs will take place using new elec­tron­ic batch records, fol­lowed by six val­id­a­tion runs in late July. Of a total of 51 art­icles and pro­cess groups, the first six have been com­pleted.
At the same time, man­u­fac­tur­ing batch records (MBRs) are being pro­duced and val­id­ated in Batch­Line, SOPs are being devised, and QA cli­ent doc­u­ments are being approved. The pro­cess val­id­a­tion plan is also being worked on.
All this provides a good insight into what pharma con­tract pack­aging really entails, with tech­no­logy account­ing for part of it. The oth­er part relates to doc­u­ment­a­tion, qual­ity assur­ance, and reg­u­lat­ory work, which need to be imple­men­ted with sim­il­ar thor­ough­ness.
 

Inter­na­tion­al rol­lout: 22 new nation­al mar­kets

With val­id­a­tion ongo­ing, the scope of the pro­ject is already being widened. From Octo­ber onward, 22 new nation­al mar­kets are planned, each with its own seri­al­iz­a­tion require­ments and reg­u­lat­ory spe­cific­a­tions. The bulk ampules are expec­ted by the mid of June. This reflects the require­ments a con­tract pack­ager has to sat­is­fy when a product is rolled out world­wide.
Com­mer­cial pro­duc­tion is sched­uled to begin in October.The val­id­a­tion runs in the com­ing weeks are crit­ic­al to this, as they will demon­strate that the line is both in work­ing order and ready for reg­u­lat­ory approv­al in terms of seri­al production.

Früh expands pharma auto­ma­tion

With this pro­ject, Früh is fur­ther devel­op­ing its expert­ise with­in the pharma sec­tor. For pharma com­pan­ies look­ing for a part­ner who can provide end-to-end sup­port in a pack­aging pro­ject, from spe­cific­a­tions to seri­al pro­duc­tion, this is a good example of what Früh does and the way we go about things.