Automation and digitalization are entering massively in the pharmaceutical industry, which faces the challenges of customized medicine, small batches and traceability. In this sense, Stäubli offers its innovative modular robots designed specifically for medical and pharmaceutical applications. In particular, the TX60 clean room robot is capable of aseptically filling and closing syringes and automating cell cultures.
The pharmaceutical industry is currently going through what is seen to be the biggest change in its history. The growth in world population, the universal desire for higher living standards, the expiry of patents and the subdued forecasts for the economy are forcing the industry to take action. This is underscored by the trend towards personalized medicine, with ever smaller batch sizes and more diverse packaging materials, as well as the whole issue of counterfeiting. Pharmaceutical manufacturers are seeking more automation for a variety of reasons, for example to facilitate cleanroom production entirely without human intervention, to respond to competitive pressure with even higher production speeds and to offer the markets even more flexible batch sizes. Stäubli robots support all protocols that have been defined as an international standard. The robot specialist offers its customers all options for digital transformation and guarantees maximum flexibility in process integration and operation, regardless of which bus generation, protocol or interface a customer wants to operate with.
Stäubli has adapted to the current dynamics and challenges of the future in its next-generation modular robot series such as the TS40, TS60, TS80 TX40, TX90, TX60 e TX60L cr models. The company provides standardized communication protocols all the way through to real-time Ethernet and its compatibility with a wide range of connected systems such as MES or ERP. The resulting high-performance communication offers greater flexibility within drug production for rapid adaptation to changing production parameters while guaranteeing secure traceability within the supply chain.
They ensure speed and asepticity
The manufacture of aseptic drugs poses unique challenges – foremost among them contamination by the operator. As part of their Advanced Aseptic Processing (AAP) systems, pharmaceutical companies are increasingly implementing isolator-barrier technologies to restrict operator access. Stäubli’s TX series stericlean 6-axis robot arms were developed specially for safe integration into critical aseptic areas, enhancing AAP systems and product safety overall. A German player in technology for processing pharmaceutical solutions uses two TX90 stericlean robots in its new line for the aseptic filling of infusion bags, which work fully automatically and can be completely sterilized. The TX stericlean robot system made it possible to keep the entire filling room sterile and guarantee aseptic filling. Stericlean robots can be put to constant use in vaporous hydrogen peroxide environments while fulfilling the highest demands in product hygiene and economic viability. At a Belgian health and life sciences company specializing in radioisotopes, a TX40 stericlean robot works at the sterile bank, minimizing the risk of contamination. The SCARA robots TS40, TS60 e TS80 are ones of the fastest in their class. In line with the Stäubli motto: “Modern automation solutions for the working world”, the ultra-fast TS80 has recently taken over part handling at B. Braun Melsungen – another player in the healthcare marketplace. Bringing high speed to Class D standard room environments, Stäubli’s new SCARA robot delivers high precision in the range of 0,1 mm.
Precise dosage of drugs
Large quantities of individual drug doses are prepared every day in hospital pharmacies to be administered to patients. To improve the quality of this delicate task, while excluding any risks of skin contact with potentially toxic substances, the Canadian company Intelligent Hospital Systems has developed a robotic system capable of filling syringes and infusion bags with the correct drug doses. The RIVA system has been designed in a flexible way and is compatible with normal bottles, disposable syringes and commercial infusion bags. In addition, you can quickly switch from individual dosage for individual patients to mass preparation of large quantities of the same type. A Stäubli robot, TX60L cr model with high precision, fills the syringes and infusion bags with doses of the selected drugs. The robot, which thanks to its integral coating and small footprint can be used optimally in clean rooms, is installed with all its accessories in a 4.5 m2 cell. TX60L cr is equipped with a Schunk gripper to pick up the bottles and syringes from the cell loader, collect the desired dose from the aspiration station and expel the syringes labeled through a well. Alternatively, dosage can also take place inside an infusion bag. It is also possible to prepare powdered medicines. In this case, the powder is placed in a bottle together with a diluent. The bottle is then subjected to stirring in a mixing station, and the liquid thus obtained is introduced into the syringes.
The innovative process and plant control system, combined with the robot extreme speed and precision, allows for cycles of less than a second. The high rigidity of the mechanical structure totally closed by casing and the JCM gearmotors (Stäubli patent) make it possible to obtain very high acceleration values on all axes. The TX60 cr model can automatically fill and close the syringes even in aseptic conditions, always with maximum speed, precision and reliability. The key element is the fact that the double gripper is used simultaneously for filling and closing the syringes. The simultaneous filling and closing procedure makes it possible to minimize plant cycles. While filling the syringes, the precise drug dosage plays a key role: in order to ensure it, the machine has been equipped with a no-valve dosing unit which reaches an accuracy level of ± 0.05%. Filling and closing are performed under vacuum to avoid contamination and bubble formation.
Automated cell cultures
Cellmate is able to grow cells without process changes from the laboratory to mass production. It is a system developed by TAP biosystem (a company of the Sartorius Stedim Biotech group), which automates all phases of cell culture in roller bottles and flasks. This system is suitable for cultivation processes from the laboratory to mass production. The latest generation of the Cellmate system features software that simplifies the validation of processes pursuant to the 21 CFR Part 11 standard. Thanks to the Stäubli TX60 clean room robot model, Cellmate can automate the following processes: cell insemination; enzymatic and mechanical collection; washing of cell trays; vehicle replacement; temporary transfection; mechanical removal; filling of bottles with gas. Cellmate systems, originally developed for the needs of a GMP environment, have been installed in 90 plants intended for cell culture in the production and research sectors. Examples of applications include: therapeutic proteins, vaccines for animals, genetic and cellular therapies.