The MulitUse LAB handles small batches of high-quality drugs in a sterile process. It offers development parameter settings for production equipment – without additional development for the production machines.
The latest addition to the MultiUse portfolio has it all. The MultiUse LAB is a particularly compact machine – and yet its integrated functions correspond exactly to those in higher performance ranges. With the MultiUse LAB, the production system settings can be set-up perfectly from the beginning.
With its special design, the MultiUse LAB is equally suitable for the commercial processing of particularly expensive and complex drugs in very small batches. The field of applications of the machine with an isolator also include the clinical phases.
Let’s first look at the development of the settings: The MultiUse LAB relieves existing MultiUse systems from recipe development tasks for which they were not originally intended. Determining new settings for a new drug or a new type of container can cause downtime for a production line, which could mean massive production interruption and revenue loss. Costs also arise when highoutput MultiUse systems are used for the development of settings in which multiple containers and materials are used. The use of a MultiUse LAB is a much more efficient option.
If system settings are to be set for laboratory use, a number of technical requirements must first be met. Technical equivalence is one of them: Like the other machines in the portfolio, the MultiUse LAB can handle three different container types - vials, pre-filled syringes and cartridges. Like the high-output MultiUse systems, the MultiUse LAB has all product saving functions, from sensors to vacuum filling and closing of the containers to ensure technical equivalence.
In order for the settings to be scaled-up successfully on a production line, not only the function scope has to be identical, but also the respective design. Therefore, Optima has transferred most functions from the large MultiUse systems to the LAB version. For example, the design of the drives, the software and processrelevant mechanical parts, like insertion rod are unchanged from the production machines.
The same applies to processing functions, such as filling, stoppering and crimping, all of which are carried out the same as in the production systems. For the individual stations and functions to correspond to the high-output machinery, the containers are processed individually and fully automatically. Product-saving functions have to be designed one-to-one, for example re-dosing, so they can be transferred from the MultiUse LAB into the larger systems.
For best parameter settings, high-speed cameras can be integrated into the MultiUse LAB to observe crucial processes. Additional sensors like pressure monitoring for the crimping process can be installed. With the extensive information - visual insights and measurement data - the parameter setting is much more targeted than on high-output production lines.
With the MultiUse LAB, the first CDMOs will even offer parametersetting development as an external service for pharmaceutical companies. Likewise, pharmaceutical companies that invest in a MultiUse LAB benefit from the precise scaling and transfer of the system settings to their larger lines.Everything for production: Cell and gene therapies
The MultiUse LAB is a complete production machine for high-quality drugs in small batches. For example, drugs from personalized medicine, cell and gene therapies, but also start-ups are among the target markets for the new machine type. The LAB version is designed for a reduced output.
For expensive drugs, users benefit from the integrated product saving functions. With particularly small batches, the product yield can be further maximized by switching to single-head dosing.
With the flexible combination-filling module from Optima, the common pump systems can be integrated into the system quickly. The appropriate filling system depends on the product properties.Sterile, gentle transport
The MultiUse LAB with isolator offers a fully automated transport and handling process from de-nesting to re-nesting under aseptic conditions. The containers are removed from the nest and transported between stations with an automatic handling system – hands-on work on the container is eliminated. After individual processing, the RTU containers are placed back into a nest. There is no glass-to-glass contact at any point, which is an important criterion in commercial processing, especially in the case of sensitive packaging like cryogenic packaging.
The handling system matches the low performance range and offers cost advantages compared to the transport systems of the production lines. To modify the container type only the format parts need to be exchanged – not the modules. No additional rebuild work is required. A welcome advantage: no modules have to be stored. Everything remains in the “3-in-1” machine for vials, pre-filled syringes and cartridges.
Depending on the drug type, it is conceivable that production batches will grow. There is already a qualified production process that can be transferred to a larger MultiUse system. Re-qualification or validation is now much easier because the processes are identical, apart from the transport.
The clinical phase is also an application area for the MultiUse LAB, when pharmaceutical liquids with APIs (Active Pharmaceutical Ingredients) are to be filled and closed as part of research and development. Pharmaceutical companies and universities reap benefits from the MultiUse LAB version. The implementation of media fills and stability tests of future drugs are additional areas of application from the laboratory area.
The isolator of the MultiUse LAB corresponds to INTISO technology. Even on a small scale, the Optima turnkey approach and Comprehensive Scientific Process Engineering (CSPE) are effective, because the isolator is already extensively synchronized with the MultiUse LAB in its design. The air handling system of the isolator is fully integrated, and there is no separate HVAC unit, therefore, no connection to the technical area is required. With integrated cooling, the heat load is not released into the clean room. In addition, the H2O2 used for decontamination is catalytically neutralized after the decontamination process is complete and can be discharged into the installation room as exhaust air. This isolator design saves time and costs during commissioning.
For commercial use, but also for research and development, the connection to a freeze-drying process is often important. The first MultiUse LAB commissioned is a turnkey project and will be connected to an Optima freeze-dryer featuring row-by-row loading. New types of freeze-dryers are currently in the design and implementation phase at Optima. This equipment is specially designed for the development of freeze-drying recipes, for laboratories and for the production of particularly small commercial batches.Fits everywhere
The MultiUse LAB needs very little space. Optima’s isolator technology contributes to the small footprint. In addition, the machine can be broken down for transport and is designed to fit in standard freight elevators, making it easier to bring into existing facilities.
Conclusion: The MultiUse LAB has been thought through to the detail – both for development of recipe setting for systems with higher outputs and for the production of small batches of very high-quality pharmaceuticals.
Highly flexible: MultiUse systems from OPTIMA
The MultiUse machine series is unique. Each MultiUse system can process three container types: Vials, pre-filled syringes and cartridges - without any module change. In order to maximize product yield, comprehensive product saving functions are integrated into MultiUse systems. Different product paths can also be installed in one system, for example for freeze-dried products, for RTU and bulk containers. The isolator and freeze-drying technology are designed and implemented turnkey in the OPTIMA CSPE process (Comprehensive Scientific Process Engineering). The MultiUse portfolio includes all performance areas up to highperformance systems with an output of up to 24,000 objects/h. The new MultiUse LAB is ideal for the development of recipe parameter settings for production systems, as well as for the commercial manufacturing of high-quality drugs in small batches and the clinical phases.