Autoin­ject­or assembly and pack­aging: Früh builds new pro­duc­tion line for cold chain-depend­ent biologics

Assembly, labeling, car­ton­ing, seri­al­iz­a­tion, and case pack­ing – Früh is build­ing a com­plete pro­duc­tion line for an autoin­ject­or, which will meas­ure about 900 m² and fea­ture three pack­aging con­fig­ur­a­tions.
Since March 2026, Früh Ver­pack­ung­s­tech­nik AG has been work­ing on a new pro­ject to build a com­plete assembly and pack­aging line for an autoin­ject­or with a cold chain-depend­ent bio­lo­gic. The kick­off meet­ing with the cli­ent was held on April 16.

What hap­pens on the line
The autoin­ject­or con­sists of three main com­pon­ents, which are assembled on an assembly machine from SHL Med­ic­al in a fully auto­mated pro­cess. SHL Advantec is provid­ing both the autoin­ject­or and the pro­duc­tion plat­form. The assembly machine is dir­ectly con­nec­ted to a labeler, which prints, veri­fies, and applies labels – at a rate of up to 20 autoin­ject­ors a minute.
The next step is per­formed by the Dividella car­ton­ing line from Körber Pharma. Car­tons are auto­mat­ic­ally pre­pared and trans­por­ted via a con­vey­or belt, ready for any items to be inser­ted by hand. The machine then inserts the inform­a­tion leaf­let, closes the fold­ing box, and per­forms seri­al­iz­a­tion with a laser print­er. The pro­ject com­prises three pack­aging con­fig­ur­a­tions, designed to accom­mod­ate packs with single items, packs of four, and mul­tiple packs con­tain­ing 12 items. The Dividella plat­form from Körber Pharma is per­fect for this as it sup­ports format changes with little con­ver­sion work.

The clos­ing step is taken care of by a case pack­er from Christ in an auto­mated pro­cess where fold­ing boxes are packed into trans­port boxes, labeled, sealed, and aggreg­ated. Pal­let­iz­a­tion is per­formed manu­ally.
For this pro­ject, assembly and pack­aging have been delib­er­ately designed as sep­ar­ate lines. The Dividella car­ton­ing line from Körber Pharma runs at up to 45 units per minute twice as fast as the assembly machine. This cre­ates capa­city that Früh can also util­ize for oth­er orders. Togeth­er, the entire pro­cess from indi­vidu­al com­pon­ents to ready-to-ship trans­port boxes, includ­ing seri­al­iz­a­tion and aggreg­a­tion is part of the grow­ing phar­ma­ceut­ic­al port­fo­lio that Früh is stra­tegic­ally build­ing out.

The import­ance of cold chain con­di­tions

The product must be stored between 2 and 8°C through­out the pro­cess. The max­im­um hold time is 26 hours at below 30°C. These require­ments apply across the whole of the pro­duc­tion pro­cess and must be doc­u­mented and mon­itored in accord­ance with GMP. Früh has the neces­sary infra­struc­ture and pro­cesses for this.

Where the pro­ject cur­rently stands

The car­ton­ing line from Körber Pharma and the case pack­er from Christ have been ordered. As regards the assembly machine from SHL Med­ic­al, the final URS points are still being thrashed out – with site vis­its and reg­u­lar meet­ings at the supplier’s own premises. Mean­while, new test equip­ment for in-pro­cess con­trol of autoin­ject­ors is cur­rently being assessed The rough plan­ning phase for the pro­duc­tion room is complete.

Next steps before pro­duc­tion starts

Over the com­ing months, the rest of the equip­ment will be ordered, plan­ning of the room will be final­ized, pro­cesses will be defined, and onboard­ing will be arranged for the remain­ing sup­pli­ers. FAT and SAT tests for the assembly machine and Dividella are sched­uled for mid-2027, with pro­cess val­id­a­tion due by the end of 2027. Pro­duc­tion will start in Q2 2028. A fur­ther update will fol­low in the fall.