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Thomas Ruebekeil is vice-president of Project Management at Vetter Pharma-Fertigung GmbH & Co. KG and is responsible for investment projects and technical project management at Vetter in Ravensburg, Germany.
Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.
Today’s innovative pharma and biotech companies have been increasingly relying on external partnerships with solution providers such as contract development and manufacturing organizations (CDMOs) to help them reduce costs emanating from their supply chain, retain flexibility, and have the agility to react quickly to changing developments within the development, manufacturing, and packaging process. Reinforcing this trend, a 2017 CPhl report (1) notes that these outsourcing activities are being applied in an integrated way, with single-source CDMOs increasingly preferred in an effort to reduce complexity. Nonetheless, for CDMOs to effectively support their customers’ needs, facilities that can combine intelligent facility layout, start-of-the-art technologies, and innovative processes are necessary. Today, modular facilities that are designed to anticipate simple and gradual creation of more space without affecting ongoing operations are most desired as they allow for flexibility in terms of process development and technical equipment, while maintaining a high-quality standard.
The International Society for Pharmaceutical Engineering (ISPE)’s Facility of the Year Award (FOYA) recognizes facilities that demonstrate innovative facility design, construction, and operation. Recently, the award was granted to Vetter in the Facility of the Future category for its Center for Visual Inspection and Logistics.
Faced with increasing customer demand coinciding with the need to bundle all supply-chain processes within a single, innovative structure that stands ready to meet future requirements, Vetter’s concept was to create an autonomous site that could act as a central hub for all of the company’s logistical processes. In doing so, the facility had to include efficient processes, flexible use of space, and options for future expansion.
The facility combines state-of-the-art logistics with optimized processes for visual inspection, making the supply chain reliable, efficient, and flexible with all routes and processes designed for optimal material and staff flow. For example, the receiving area is directly connected to the high-bay storage area. From there, a lock leads to visual inspection and back. This considerably reduces warehousing and retrieval times, in particular when combined with an automatic pallet transportation system, an information-technology-controlled routing system, and a high-bay warehouse administered using enterprise resourcing planning software (SAP). The intelligent integration of the facility into the company’s overall logistics means that Vetter’s three production sites can be supplied quickly and at short notice.
With a modular design, two successive construction phases allowed for full integration following completion. The site was initially put into operation in 2012, and the expansion with the second construction phase was completed in 2017. Connecting pathways between the two sections for staff and material were opened up shortly after the second construction stage was finished and were part of the original blueprint. Technical equipment for power, climate control, and fire prevention had also been set-up for an increase in capacity. Due to the modular design concept, the facility can be successively enlarged in the event of customer demand, with no impact on running operations.
To ensure precise planning and control of the construction project, Vetter drew up a list of detailed guidelines, specification sheets, and delivery policies for all project partners. Other factors included integration of the approval agencies, clearly defined approval processes, quality and performance reviews at regular intervals, and stringent deadline control, which was crucial because the overall project involved a tight schedule with over 6000 connected processes. By consistently connecting interdependent aspects and regularly monitoring progress, Vetter was able to quickly intercede if a deadline could not be kept and immediately apply corrective measures. Working together with competent partner companies helped keep the project on schedule and meet the high quality standards demanded by Vetter. Thus, the two construction stages were finished within the set timetable and within the set budget.
The automated visual inspection (AVI) machines at Vetter can check up to 400 syringes per minute in fully-automated mode. The filled syringes pass through as many as 14 inspection stations that use high-resolution cameras, lighting systems, and specially developed sensors to measure absorption and refraction. Syringes that appear to be defective are removed from the machine and taken to a special area for a manual follow-up inspection. AVI ensures uniformly high quality due to an objective assessment of the product and lowers throughput times. It also allows Vetter to offer a higher inspection capacity if, and when, the volume of customer products increases at a later date.
Forward-looking facilities are crucial to a rapidly growing, highly regulated and competitive drug manufacturing industry. The continued increase in customer demand for more capacity will continue to play a key role in facility design. In the future, the most successful facilities will be those which have a modular design approach that allows for simple and gradual creation of more space without this expansion work affecting operations.
1. CPhI Pharma Insights, Prospects, Analysis, and Trends in Global Pharma, CPhI Annual Industry Report 2017 (October, 2017).
Thomas Ruebekeil is vice-president of Project Management atVetter Pharma-Fertigung GmbH & Co. KG and is responsible for investment projects and technical project management at Vetter in Ravensburg, Germany.