With SAPUI5 applications developed by DATAGROUP according to the Fiori design paradigm, the pharmaceutical service provider Vetter digitized the optical control in production, thus saving thousands of working hours every year.
In hardly any other branch of industry are there such distinctive regulations and documentation requirements as in the pharmaceutical industry. Where elsewhere production is only controlled on a random basis, a company like Vetter Pharma-Fertigung GmbH & Co. KG from Ravensburg must subject each of its products manufactured on behalf of a customer to a separate visual inspection.
At Vetter, the quality inspection of aseptically pre-filled syringes, cartridges and vials is therefore a step that is on an equal footing with the other three production stages – preparation, filling and packaging. The finished syringe is tested to ensure that it is flawless and meets the requirements of authorities, customers and the market. More than 800 people are employed at Vetter every day to carry out these checks – almost a fifth of the total workforce! They document rejects and record good parts.
For a long time, Vetter’s results recording and batch evaluation were paper-based. Approximately 60,000 manufacturing specifications (= a kind of tally sheet) were printed out from SAP every year and made available to the employees of the optical inspection department (OC). They documented possible errors. A shift coordinator manually transferred these results to a batch evaluation and then to the inspection lot of the process order in SAP. A batch evaluation took about 2.5 hours for each shift coordinator and two media breaks had to be overcome.
The OC area at Vetter was facing fundamental changes. Following a management workshop, a specially established project team conducted a feasibility study and examined whether replacing the previous paper-based variant with a mobile app was feasible and economical. The result spoke for itself and so the decision was made to digitalize the process. Each OC workstation received a tablet and has since been entering its results directly into the ERP system via a SAPUI5 app.
The measure was part of a strategic initiative in which the pharmaceutical service provider is looking at factory processes of the future. The goal: to make current and future individual processes more efficient and smarter.
The feasibility study delivered promising results: The 60 testers recording the results digitally were convinced by the simple operation of the devices. An interdisciplinary, eight-person core project team at Vetter was then commissioned with an implementation project. With the support of DATAGROUP, a digital landscape was set up that integrates all results recording and batch evaluation processes.
DATAGROUP already accompanied the feasibility study and received the order to develop the apps in the follow-up project. A total of 28 different apps are now available for five process variants of optical inspection, including manual and semi-automatic OC. The OC employee logs on to the tablet with his SAP account, loads the corresponding app and enters his data into it. The production specifications for results recording and batch evaluation are thus automatically created in SAP, printed and attached to the process order papers.
“Digitization in the pharmaceutical industry is a particular challenge because the effects of new technologies on pharmaceutical processes must be analyzed in great detail,” explains Fatih Kaya, team leader IT Business Applications and project manager at Vetter. For example, can the ceiling lighting be reflected on the tablet displays in such a way that it becomes more difficult to see possible errors? Can the display tolerate being disinfected with cleaning agent after each test procedure? “DATAGROUP has familiarized itself very intensively with our process-related requirements.”
The project is a prime example of digitization and ranks high in Vetter’s internal project ranking. Since November 2017, the employees have been trained in the use of the tablet devices. In order to integrate the new digitized processes or apps into existing systems and processes, further useful applications were developed. Malte Steinicke, Team Manager OC and Department Project Manager: “Using the programmed applications, the shift coordinators can, for example, easily assign an order to a specific room or create batch analyses – processes that used to be performed manually and were very time-consuming”.
Vetter is convinced that further digitization topics will follow in order to further increase productivity and efficiency in business processes.
Vetter is a leading global Contract Development and Manufacturing Organization (CDMO) with headquarters in Ravensburg and production facilities in Germany and the USA. With its many years of experience, the company provides support from early drug development to clinical and commercial filling and a wide range of packaging solutions for vials, syringes and cartridges. Vetter’s customers include small and large pharmaceutical and biotech companies. As a provider of innovative solutions, the pharmaceutical service provider has set itself the task of developing injection systems together with its clients to continuously improve patient safety, comfort and compliance.