The steady rise in demand for smaller batches, as a result both of the growing number of projects requiring fewer units and those requiring fewer end products for development, approval, and industrialisation purposes has led Gerresheimer to embark on a new capacity expansion for its plastics segment at the Technical Competence Center (TCC) in Wackersdorf.
Prior to taking pharmaceutical and medical technology products into batch productions, these must undergoes extensive development and approval process, for which small numbers of units are often required as samples.
Small Batch Production ensures the required product quality, as well as complete batch documentation at the level of subsequent large batch production. This can be transferred directly to subsequent large-scale production on setting up large batch production.
The company had previously invested a comparable sum at the site in 2018, when it added 900 square meters dedicated to the development and industrialisation of glass products such as syringes and carpules.
To accommodate the increasing number of the Small Batch Production unit’s plastics projects, existing production space has been converted into ISO-14644-1 classes 8 and 7 clean rooms and a new building with additional clean room and office space is being completed.
The products produced here include 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.
The new clean room space has already been taken into operation. The company is also adding 245 square meters of new office space and 1,200 square meters of additional clean room area in the new extension which is under construction. Small Batch Production now covers a total area of 2,900 square meters.
This is allowing the company to open up a new business area and to become an Original Equipment Manufacturer (OEM) manufacturing small medical devices, such as, patch pumps with internally developed micro pumps, in Small Batch Production. The company’s entry in the commercial register therefore now also includes: “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. Prior to 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, as well as 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.