Gerresheimer Regensburg is increasing its small batch production capacity in the Technical Competence Center (TCC) Wackersdorf. To this purpose, the already existing production area has been converted into cleanroom space, and a new building with additional clean room and office space has been completed. The company is reacting with the expansion of production space in keeping with the growing number of projects that require smaller numbers of units or for which a smaller number of complete products are already required before large batch production for development, approval, and industrialization.
Gerresheimer had already invested a double-digit sum in the millions in the expansion of small batch production in Wackersdorf in 2018. In the context of the company’s plastic and glass competence, 900 square meters of the additional area were created to develop and industrialize glass products like syringes and capsules.
A double-digit sum in the millions is invested in adapting small batch production capacity in the plastics segment to the growing number of projects. Produced here are, for example, patch pumps for administering medication, drug containers for injection without needles, point-of-care tests, infusion sets for X-ray contrast agents, syringes, and much more. To this purpose, the existing production space was converted into a 500 square meter clean room of the ISO-14644-1 classes 8 and 7. This cleanroom is already in operation. In a second step, an extension building is now being built, which, in addition to 245 square meters of office space, also provides 1,200 square meters of the additional cleanroom area.
Up to now, small batch production had a total of 1,800 square meters of production area for the plastics segment in the ISO classes 7 and 8 and rooms of the GMP classes C and D for pharmaceutical glass production. Following the conversion, with 2,200 square meters, more than double the cleanroom area of ISO classes 7 and 8 are available for plastic production. The total production area of Small Batch Production now amounts to 2,900 square meters.
Through the manufacture of medical devices, such as, for example, patch pumps with internally developed micro pumps, in small batch production, Gerresheimer Regensburg opens up a new business area as an Original Equipment Manufacturer (OEM). Therefore, the classification of the company in the commercial register is supplemented by the point “Manufacture of medical and dental apparatuses and materials.”
The expansion of production capacity in Small Batch Production is required due to the growing number of development projects for pharmaceutical and medical technology products. Before batch production, these products are subjected to a protracted development and approval process, for which small numbers of units are often required as samples. Small Batch Production thereby ensures the required product quality and complete batch documentation at the level of subsequent large batch production. The experiences can also be transferred directly to subsequent production on a large scale when establishing large batch production.