EVER Pharma Jena GmbH has invested a total of nearly 20 million Euros in construction of a new production building as well as a fully automatic high bay warehouse. This new construction project is a decisive milestone in implementing a master plan foreseeing consolidation of the production and logistic capacities at the newly developed location in Jena Lobeda. “With this investment at the highest technical level we are continuing our expansion activities in the area of parenteral production of pharmaceutical products for worldwide markets”, emphasized Dr. Friedrich Hillebrand, Proprietor of the Austrian EVER Pharmaceutics Group, on the occasion of the opening ceremonies on April 27, 2015.
The German affiliate of this internationally active pharmaceutical corporation employs a staff of approximately 280 in this Thuringian university city. Here the company is specialized in development, production and preparation of sterile medicinal products to help improve the health and vital quality of patients - particularly for people following a stroke, suffering from dementia or skull-brain trauma. The production capacities run up to 130 million units per year. EVER Pharma is certified according to the regulations of EU GMP, “Good Manufacturing Practice”, which requires the highest quality standards and carefully supervised, perfectly matched production processing under clean room conditions.
Functionality meets aesthetics and sustainability
After a construction time of nearly two years, the new central production and logistics location for Jena GmbH was officially dedicated the end of April 2015. Just a few months previously those responsible for the project received an accolade: specifically the “Special Energy Award” from the Jean Facade Award. The facade design of the new production tract was praised in context with the energetic efficiency achieved. The high bay warehouse is linked directly to this building structure and is integrated harmoniously into the landscape in spite of its height of nearly 38 meters. This was accomplished with an unusual color design, whose intensity decreases with increasing height. According to information from the responsible architecture office Heene + Pöbst, the upper limit of the storage building gradually merges visually into the sky regardless of weather or light conditions.
The processes inside this new landmark are also matched harmoniously to one another. The Swiss Intralogistic Provider Stöcklin Logistik AG is responsible. The work to be realized included the steel construction for the racks, the pallet conveying system, three full automatic stacker cranes, an new warehouse management system including material flow computer and visualization, equipment such as shelves, pallet wrapper and pallet changer, for the manual storage areas as well as further measures for adequate fire protection.
Implementation also required focusing on special temperature requirements, necessary for storage of sensitive pharmaceutical products.
“We decided in favor of passive cooling”
stated Dr. Adalbert Lembcke, Business Manager at EVER Pharma Jena GmbH.
“This is why, among other things, the concrete tanking for the high bay warehouse extends six feet into the ground, so that the low temperatures at this depth can be utilized in combination with other technical climatic features."
Pallet changer as central element in material flow
The goods to be stored are generally fed in on Euro-pallets and placed on the conveyor path by employees. These load carriers are logged in with hand scanners and the information is transferred directly to the warehouse management system. Since wooden pallets are not allowed inside the company’s own system circuit - for hygienic reasons - they are fed to a pallet changer. First an aluminum pallet is fed in, followed by the wooden pallet with cargo. The transfer operation is triggered by double pushing plates closing above the destination pallet forming an optimum sliding surface. The electric drive is started by the control, causing the goods to be surrounded tightly on three sides pushing it gently sliding onto the lowered destination.
A pallet dispenser is available for empty wooden pallets as well as aluminum pallets. Such a pallet collector can hold up to 12 load carriers simultaneously. Upon reaching this number, preceded by a height check, the pallet stack is moved automatic in the direction of the removal station. As soon as the dispenser is empty, a new stack of pallets is moved in. The aluminum pallets, which now form a load unit together with the goods, are identified by reading the bar code label permanently attached to the middle stay of each pallet with a scanner permanently installed on the conveying equipment. After clearly determining the values, they are passed on by the control to the material flow computer (MFR).
The goods are either transferred directly to the high bay warehouse (HRL) over the conveying path on the ground floor or travel first to the so-called manual storage area. In the manual storage area the pallets are stored and retrieved with the aid of claw stackers. A picking station is also located here, which is equipped with a scissors-type lift table to facilitate the removal procedure and make the workstation as ergonomic as possible.
Dynamics and safety in the pharmaceutical high bay warehouse
The 3 aisle high bay warehouse (HRL) built at a level of -5.0 meters is laid out for single depth storage, offering space for holding approx. 5,200 aluminum pallets (1,250 x 850 mm - LxW) with a permissible gross weight of up to 800 kilograms. The three fully automatic stacker cranes (RBG) from Stöcklin Logistik AG’s MASTer series take over the pallets from the infeed conveyors in the high bay warehouse (HRL) antechamber. Each of the 38 meter high, single mast units is equipped with a telescopic fork as load handling device and moves over a length of 43.5 meters.
The storage and retrieval operations in the high bay warehouse (HRL) are accomplished at level 0.00 m as well as 4.50 m. For this purpose, a platform is installed in the shelf area for the conveying equipment.
The dynamic performance values for the travel and elevating axes are not only matched to the dimensions of the storage facility, they are also defined by the software for the stacker cranes (RBG) before each individual movement, to ensure the maximum exchange of energy between the individual axes (intermediate circuit coupling). Each of the axes, which are not time-critical, are also operated only as fast as absolutely necessary. All totalled, the software ensures that the stacker cranes (RBG) are always operated at maximum energy efficiency without negatively influencing the pallet handling rates.
A separate fire zone was also provided in the antechamber to the high bay warehouse (HRL). These doors close automatically in the event of a fire alarm. The high-speed doors prevent unauthorized access to the warehouse and also serve as climatic sluices. Here each conveying path has its own door, which opens only to allow a pallet to pass through.
While the actual picking area as well as shipping is located on the ground floor, preparation and preliminary picking are accomplished on the second floor. The preparation lines are provided with three stations each consisting of six buffer or transfer positions designed as gravity feed roller tracks. The full aluminum pallets are transferred in and out by a shuttle on slightly inclined roller tracks. If all three stations are to be provided with goods in parallel, the shuttle moves over a total path of 28 meters, completing the run in 31.8 seconds. Pallet discharge is monitored by a sensor allowing the process to be reported directly to the material flow computer (MFR).
Documented quality thanks to GDP validation
"The actual challenge in this project was to ensure GDP compatible layout of the warehouse management system (WMS). This applied to the concept as well as development and validation”
reported Oliver Vujcic, responsible Stöcklin Project Manager, in addition to Matthias Föhner and Roland Eberhard. Background: The guidelines for “Good Manufacturing Practice” applying to pharmaceutical companies such as EVER Pharma Jena, that quality control of GMP regulated products include the entire chain of delivery, not just the production process. These special requirements are again documented in the GDP guidelines (“Good Distribution Practice”). It is therefore necessary to document and verify the required product quality level from production right up to the final customer.
This also includes logistic processes such as warehouse storage. “This virtually prescribed safety is absolutely necessary along the entire supply chain for protection of the patients”, said Oliver Vujcic. “It is essential to exclude any negative influences to the products which could possibly be harmful for humans.” Simultaneously implementation of a GDP compliant or validated warehouse management system is associated with enormous expenditures. Here test management is an important constituent of the quality management system covering the entire WMS development process. “Upon validation, we have achieved the objective of our application fulfilling all criteria”, continued Oliver Vujcic. The defined objectives were achieved. This includes complete fulfilment of requirements, constancy of system availability and guaranteed high reliability in every day operation.
“Right from the very beginning we were certain we selected the right partner with Stöcklin Logistics”, summarized Dr. Adalbert Lembcke. “Our expectations were fulfilled completely. In every single phase of the project, the assigned team under the management of Mr. Vujcic and Mr. Föhner, demonstrated their full commitment, competency and experience”,
continued EVER Pharma Jena GmbH’s business manager. Everything is go for growth and further expansion.
Author: Urs Grütter