Robotics for the preparation of ready-to-administer parenterals in hospital pharmacies
4 October 2021I. Krämer (Mainz, Germany)
Batch production of ready-to-administer (RTA) medicinal products encompasses the preparation of patient individual products as well the preparation of identical products prepared in series or prepared by filling a bulk solution. Even batches prepared for stock in hospital pharmacies are small compared to industrial manufactured batches. However, current and future hospital pharmacy practices demand digitalization and automation. Automated preparation is ideally based on an electronic prescription and the preparation instructions are send without media discontinuity to compounders, semi-automated or fully automated robotic system. The fully integrated workflow leads to increased quality and productivity. Compared to manual preparation, the main advantages are highly standardised preparation processes and reduced manual variability, diminished physical stress and repetitive motion injuries, reduced risk of occurrence of human errors, decreased risk of microbial contamination of the products, optimum process documentation and in-process controls (gravimetric verification, barcoding, photographic recognition), full traceability of the operations, as well as increased production capacity and working efficiency. In addition, by automated preparation of antineoplastic-parenterals, the exposure of healthcare personnel to hazardous substances in the working area and on the outer surfaces of the RTA products is diminished. Depending on the type of preparation different features of the robotic systems are especially relevant, i.e. safety of the working staff, safety of the process, accuracy or high production speed. Mostly licensed medicinal products are used as starting material and plastic syringes, empty or prefilled plastic infusion bags are used as primary containers. Size and packaging of the source material and devices is a critical issue to be regarded when selecting a robotic system. Shortages of supply or downtimes of the systems may lead to disadvantageous production shutdowns.
We are still in the beginning of automated RTA preparation in hospital pharmacies and look for further improvement of robotic solutions according to different needs. At the same time pharmaceutical industry is also struggling with small batch manufacturing of ATMPs what may result in a joined effort of robotic industry, pharmaceutical industry, and hospital pharmacy to exchange experience for optimal use and implementation of robotic technology.