Harro Höfliger produced a labeling and packaging line for Pharma Stulln – a GMP-compliant production line – within a very tight deadline. The limited space available required special line planning.
Dr. Susanne Koschatzky sits at her desk with the phone in one hand and a pen in the other. Concentrating, she takes down notes on her pad. She explains with a laugh: “Irregularities between different interfaces can be best dealt with over the phone. Inhouse developed risk assessment for handling good parts in the event of faults provides an additional safeguard, precluding any confusion between good and bad parts.” The Head of Qualification/Validation at Pharma Stulln took on project management for developing a system that produces eye drops in single – dose containers 15 months ago. As central point of contact she has since coordinated internal departments and external suppliers, convened meetings and kept an eye on scheduling. “Holistic project planning is a lot of fun – but also a lot of work.”
The blow-fill-seal production process has been part of Pharma Stulln’s core business for many years. What was new to the company headquartered in the region of Upper Palatinate was the planning of a fully automated process flow. As Dr. Koschatzky describes the task: “Our requirements could only be satisfied by continuous highly automated line production from sterile filling through to boxing.” And the deadline was extremely tight: just 15 months lay between the initial meeting and system commissioning. As Dr. Koschatzky assumed the role of central coordinator, she was able to smooth the way and clarify matters, for instance when defining product orientation for machine-to-machine conveying.
However every bit as important to success were proven suppliers like Harro Höfliger. “There was no time for experiments”, stresses Dr. Koschatzky. “We have been working with Harro Höfliger for six years, so we knew that we would be getting fast and good solution approaches to state-of-the-art standard.” Their Allmersbach partner was also able to help Pharma Stulln with the assembly situation. As the existing production facilities were working to full capacity, the warehouse was converted into a clean room area.
We had no time to experiment, which was why we opted for a proven partner like Harro Höfliger.
Dr. Susanne Koschatzky
Head of Qualification/Validation, Pharma Stulln
The labeling and packaging line was optimally planned to suit the space available
State-of-the-art technology: cartining machine, type MKT
Line balancing belt for synchronizing the blow-fill-seal strips
The bulk packer ensures serialization and identification in the system
Folding carton, package leaflet and two blow-fill-seal strips with eye drop ampules
Harro Höfliger designed several assembly versions for individual machines and thus helped to make the most of available space. Harro Höfliger delivered a complete labeling and packaging line consisting of a high speed labeling machine with camera inspection and picker cell for transferring products to the packaging line. Plus a cartoning machine, serialization device and bulk packer. Dr Koschatzky adds: “That left us with a minimum of interfaces on the packing line – with virtually everything from one supplier.” The packaging expert developed the labeling machine specifically for the job. It consists of a redundant system with two label dispensers connected in parallel. If one label roll is finished, the dispenser switches to the other system. The operation continues while an operator changes the roll for the first dispenser. The bulk packer ensures serialization and identification in the system. Every product can be fully traced over the track & trace process - enhancing forgery protection.
An additional bypass function in front of the labeling machine allows the manual introduction of acceptable parts. The system produces 33,000 ampule strips per hour or 3,300 folding cartons. “Only our own product is produced on the system, our proven Stulln Mono eye drops”, comments Dr. Koschatzky. They are used to treat asthenopia, a weakness of the ciliary muscles.
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