Small batch production of medical products
Phase III

Small series and pilot series

Your PLUS with Gerresheimer

Development and construction of small series molds and special-purpose machines

Contract manufacturing pharmaceutical primary packaging
Two-cavitiy mold for a disposable primary drug container made of plastics for injection without needles

Our experts in mold design and automation technology develop the small series molds and special-purpose machines. Mold and automation solutions are thus not first formulated for series production, but instead first in the prototype and pilot series phase to save time.

Development and construction of the measuring equipment

Mass production medical products
Multi-sensor coordinate measuring machine

Quality Planning develops the measuring equipment used in the quality lab for quality assurance. In the process, the testing requirements specific to the component are considered in detail, and the surveying of all relevant measurements is thus enabled. The correct function in large series production, the reduction of rejects, and the early detection of deviations are thus assured.

Tests in the quality lab

Measurement of injection molding parts of the mass production
Computer tomograph for measurement and testing without destruction

In our TCC-internal quality lab, injection molded parts or modules can be measured highly precisely in the product creation process. With the Zeiss Metrotom 800 computer tomograph, complex individual parts and complete modules can be examined without destruction and evaluated with regard to their dimensions and functionality. In addition to plastic components, thin-walled metal components, such as springs, can also be measured. The computer tomograph allows a look into the interior of objects or entire modules without them having to be, like otherwise, disassembled or even destroyed. A three-dimensional image of the examined object, in which fluctuations in dimensions or hidden errors, such as cavities, can be read and measured, is created in a single pass.

Production of clinical samples

Small series production of medical products
Small batch production has a room with a vacuum for the filling of toxic substances

When needed, we produce development samples, clinical samples, or stability batches and small series in our small batch production with clean room according to ISO 14644-1 classes 7 and 8 or GMP classes C and D. In the process, we guarantee that the products are safe and provide the promised functions, so that you can collect the clinical data. This is checked in the context of a design verification.

Design verification

Small batch production point of care tests
Fully automatic, PCR-based real time molecular diagnostics system

The design verification takes place at the end of product development. The development history of the product was carefully documented and can now be checked to determine whether the requirements of the product defined in the design input, and thus of the design output, have been fulfilled. The planning and execution of the design verification takes place on the basis of functional requirements and of the criticality of the functions, using the integrated risk management. Production in large numbers is also statistically assured in the process.

Contact
Contact us!
Alexander Schiessl
Sales Europe
Phone
+49 9431 639 6292
Mail
Aron Haber
Sales North America
Phone
+1 770 688 5000
Mail
Rafael Kollofrath
Sales South America
Phone
+49 9431 639 6162
Mail
Mike Nie
Sales Asia
Phone
+86 769 8851 7100 317
Mail