Flexible and High Performance
Flexible and High Performance
Many biotech start-ups became notable companies or an interesting takeover candidate. The ratio of pharmaceutical produced drugs in Germany is more than a third(1). At the same time, specialized CDMOs (Contract Development and Manufacturing Organizations) for complex pharmaceutical drugs developed into larger enterprises. New drugs receive additional approval for supplementary therapeutic applications and reach new markets. Conclusion: A dynamic and growing market demands MultiUse applications with a high-performance ratio.
The latest generation of MultiUse systems combines 10-laned processes and the specific characteristic concept of individual packaging. The output can reach up to 24,000 containers per hour. All features like 100% in-process control for vials, ready-to-use syringes and cartridges, as well as product savings are still available with a high output. The MultiUse portfolio includes all performance categories for small, medium and large batches.
Optima Pharma places great emphasis on process transfer to all new systems and for all concepts. Scale up is easier when processes can be “inherited” by the next generation of high-performance MultiUse systems. This includes guidelines for system adjustments in the millimeter range, homing function and more support processes. Validation of identical machine functions is possible and already validated processes are the basis for new systems.
Currently, Optima Pharma is designing a MultiUse machine complementary to the single-lane MultiUse machine for laboratories and for batches up to 2,000 containers, typically used for experimental purposes and stability tests. With this MultiUse version Optima offers identical functions that can be used within an isolator, but with a very small footprint. The processes can be transferred to the MultiUse production system later. Users benefit from the laboratory version by relieving the production machinery and using its potential to its fullest.
Highly precise dosing system, exact filling volume: If a fill volume is inaccurate, the container is immediately refilled instead of rejected – the so-called “re-dosing on request”
The MultiUse portfolio provides the option to configure different processes within one machine. For example, a bulk path for non-sterile vials that are transported from the washing machine and sterilizing tunnel to the filling station. Parallel a RTU-path for pre-sterilized syringes, cartridges and nested vials or vials in trays can be integrated leading to the same filling station. A freeze dryer can follow and lead to a joint crimping station that processes both liquid and lyophilized vials.
The MultiUse portfolio adapted with the CSPE (Comprehensive Scientific Process Engineering) approach for different combined processes in one system is especially profitable. Machines are completely integrated and tested before the FATs (iFATs) with isolators and loading and unloading systems in the CSPE center. Subsequently, Optima Pharma performs a cycle development in-house, in order to save the customer time until production start.
To comply with pharmaceutical requirements, Optima Pharma selected a different, innovative approach for automation. Depending on the assignment, a typical six-axle robot can be a disadvantage for pharmaceutical systems. Robotic arm movements, particularly, above open containers has to be avoided to maintain pharmaceutical integrity. In addition, the large space requirements of the robot, the possible disturbance of the laminar air flow, as well as lower speeds during the transport through the machine, call for specific robotic and pharmaceutical solutions.
For these reasons, the MultiUse system contains different robotic types and kinematics and in part, newly designed robots. This highlights the fully automatic linear transport with a format-free design and ensures the gentle transport of containers throughout the entire machine: from de-nesting to re-nesting containers without any glass-to-glass contact.
Third-party robots can be used for de-nesting and feeding containers into the transport system. The free-programmable oval transport can also be reviewed as part of this process. Together with “conventional” robots, the oval transport offsets potential empty spaces in the nest and is part of the flexible re-nesting process. All robot functions reduce operator involvement to a minimum.
An additional benefit: Optima Pharma programs all continuous core processes, including all transport systems in-house – this is more than “just” an integration of third-party components. Each MultiUse machine is controlled by central logistics. This full synchronization forgoes manufacturer specific software sub-systems and reduces the software’s complexity enormously. This is especially vital if the standard process has to be changed. For example, if an individual stopper is added, all machine components stop and will be automatically married again to the process. A process that is easily controlled, specifically if coherent software controls the machine operation.
Highly precise weighing systems are one of MultiUse system’s most beneficial features. The transport system’s impact on the weighing precision should not be underestimated. Optima’s sophisticated transport and weighing technology achieves precise weighing results, avoiding potential errors due to oscillation.
Highly precise weighing results require a certain time to be completed. Optima succeeded in implementing these requirements into the new MultiUse high-performance machinery. In addition, individual weighing cells simplify the acquisition of spare parts.
Smart production assistance services from Optima have proven extremely useful for highly flexible systems. Digital technology supports systems during size part changes or the changeover to a new product. All tasks that need to be performed by an operator can be accessed with augmented reality glasses, a tablet or HMI and can be uploaded visually into the machine system, and information immediately implemented by the operator.
A re-printing function to maximize the product yield is a new feature. The vials or tubs can be reprinted, if they are classified as incorrectly labeled by the camera system. This assists bringing pharmaceutical production per batch even closer to the 100% mark. In addition, processing of pre-crimped individual cartridges was accomplished 100% air bubble free using a multi-staged filling process in combination with vacuum stopper insertion. This means the stopper is always in the correct position, for the final pen application.
This machine design has an additional benefit. Different bio-pharmaceutical products require different handling. The individual handling of the object is the ideal requisite to fulfill individual requirements.
The bold decision to establish a new MultiUse machine system proved correct. Since the first customer bought a MultiUse in 2014 (they have since purchased a second MultiUse machine), the demand has continuously grown, especially since 2019. Today, MultiUse machines are very well established on the market. From laboratory to high-performance machines, the systems are in daily use in the pharmaceutical industry. Several customers, including international CDMOs and well-known companies, use the portfolio and operate MultiUse equipment with different outputs.
- Continuous MultiUse portfolio from R&D to high performance applications with identical, transferable processes.
- New: High output up to 24,000 containers/hour, including complex fill & finish requirements
- Flexibility to process different container types: ready-to-use syringes, cartridges and vials (bulk or RTU in tubs or trays)
- Unique process varieties with turnkey options: combination of different process paths in one system, including freeze-drying.
- Pharmaceutical optimized robotic and best in-process safety for minimized operator interference.
- Comprehensive functions for maximum product yield.
- Smart Production Assistance Services provide production and format change support.