Plastics in Cell Therapy Medicine

What requirements must GMP-compliant components satisfy?

The distinction between GMP and non-GMP products is important, because if a sample carrier is contaminated with particles in the laboratory, a test series may fail and have to be repeated. Contamination of a component used in therapy, on the other hand, can have serious consequences such as additional, life-threatening infections for patients who are already immunocompromised. GMP-compliant components must be manufactured in accordance with the ISO 7 cleanroom standard or GMP-C. Trained specialist staff at RKT adhere strictly to the hygiene specifications and are aware of the high level of responsibility involved in the manufacture of components used in therapy.

Which plastic components are manufactured for cell therapy?

RKT manufactures various components for cell therapy applications, including multi-well plates consisting of multiple tiny wells and larger cartridges used for therapy. Experiments involving pipetted cell material are carried out in the multi-well plates, with some of them having 384 wells. Larger quantities of liquid containing cell material are processed in the cartridge using the flow-through method to produce a sufficient quantity of modified cells for therapy.

Expertise in multi-component injection molding

A plastic mixture is required for all components, which RKT manufactures using two-component injection molding. First, a transparent, non-conductive plastic is poured into the respective mold, followed by a conductive plastic as the second component, via which the pulse of electric current can be applied. Conductive plastics are not an easy material to handle, as they cause increased wear in the molds, requiring increased maintenance and attention.

Another challenge is the integration of metal pins in some modules that act as connectors to establish connectivity to a device that supplies the power. These must be inserted into the mold and then overmolded with plastic.

Blistering process step

After plastic injection molding, the parts are assembled into the finished product in another cleanroom, where they are blister-packed in primary packaging with a film. This film must be impermeable to contamination yet permeable to gases because the components are sterilized directly in the primary packaging. The purpose of sterilization is to eliminate microbes to a level of 10^-6.