Sterile processing of high quality pharmaceuticals

OPTIMA MultiUse LAB: One machine, two application areas

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.

Important for you

MultiUse LAB: Perfect parameter development for MultiUse production systems, eliminating the need for additional development for production machines
Flawless commercial processing of small batches of high-quality drugs, such as cell and gene therapies, under isolator
Highly flexible: Different container types, functions, product paths, filling systems, formats and installation locations
All product saving functions and technologies, like sensor filling, vacuum filling and closing are identical to the production systems
Suitable isolator technology and freeze-dryers with loading systems as turnkey systems

The MultiUse LAB fully covers two application scenarios: Producing small batches of highquality pharmaceuticals and parameter development for high output equipment. Development tasks are completed for production systems.

System settings to go

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.

Product saving functions from filling to capping: Individual processing opens up the possibility to repeat a processing operation instead of discarding a container. The MultiUse LAB is suitable for parameter development for MultiUse systems with high deployment and for processing of expensive drugs in smallest batches:

Technically identical

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.

The OPTIMA MultiUse LAB is designed on processing RTU containers.

Parameter settings – a service

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.

From plants with low output to a flexible high performance plant

Use in research & development

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.

Isolator and freeze-dryer

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.

From plants with low output to a flexible high performance plant

Identical processes and functions from laboratories to high-performance. The highest product yield and flexibility, variable processing paths and turnkey implementation including isolators and freeze-drying systems - all combined in the unique MultiUse machine concept. The MultiUse LAB completes Optima’s portfolio of turnkey filling machines for batches of any size and container type.

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.

Like every MultiUse machine, the LAB version is a 3-in-1 machine: vials, pre-filled syringes and cartridges are processed without module changes.