Gerresheimer to expand small batch production of plastics in Wackersdorf
Gerresheimer Regensburg is increasing its small batch product chapters in the Technical Competence Middle (TCC) Wackersdorf. To this purpose, the already existing production surface area has been converted into cleanroom space, and a new building with additional clean room and role infinite 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 earlier 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 foursquare 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 product chapters in the plastics segment to the growing number of projects. Produced here are, for instance, 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 product infinite was converted into a 500 square meter clean room of the ISO-14644-i classes eight and 7. This cleanroom is already in operation. In a second step, an extension building is now existence built, which, in addition to 245 square meters of office space, likewise provides 1,200 square meters of the additional cleanroom area.
Up to now, small batch production had a total of 1,800 foursquare meters of product 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 foursquare meters, more than double the cleanroom area of ISO classes vii and 8 are available for plastic production. The total product area of Small Batch Product at present amounts to two,900 square meters.
Through the manufacture of medical devices, such as, for case, patch pumps with internally adult micro pumps, in small-scale batch production, Gerresheimer Regensburg opens up a new business area as an Original Equipment Manufacturer (OEM). Therefore, the classification of the visitor in the commercial register is supplemented by the signal "Manufacture of medical and dental apparatuses and materials."
The expansion of production capacity in Pocket-size Batch Product is required due to the growing number of development projects for pharmaceutical and medical technology products. Earlier batch production, these products are subjected to a protracted development and blessing process, for which pocket-size numbers of units are often required every bit samples. Small Batch Production thereby ensures the required product quality and complete batch documentation at the level of subsequent big batch production. The experiences can also be transferred directly to subsequent production on a large calibration when establishing large batch production.
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