Smart units

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Remote-controlled and flexible production

Fully equipped

salamanderU designs, builds, installs and maintains your smart production units consisting of: isolators with all the necessary equipment (such as microscopes, centrifuges, incubators, bioreactors, etc.), voice-controlled eBR systems, local controllers and centralized computer units that give an overview of the operations being carried out. Our smart production units enable you to remotely control your production processes in real time, anywhere in the world, regardless of whether your operations are performed by yourself or by CMOs.

GMP grade A

If needed, our smart units are designed in such a way that all operations are performed in a GMP grade A environment and they house all the equipment necessary for manufacturing or filling your end products. They also hold all the equipment required to control process and environmental parameters. Moreover, the units are resistant to the intensive use of decontamination products.

Flexible

Our smart units are flexible, so they can be easily and quickly adapted to constantly changing production processes. Flexibility is also built into the integrated decontamination units: you can decontaminate one specific section of the unit while continuing to work within the other sections.

Mobile

In some cases, flexibility means being mobile. For instance, when medications used in clinical phase trials have a short shelf life, or their active duration is unknown, the drug must be administered to the patient within a few hours of its final formulation. salamanderU’s smart cGMP mobile unit (with changing room, operation room and technical area) makes this possible, as it enables you to perform your aseptic operations at your patient’s bedside, so to speak.

Why you need a smart unit

Production optimization

salamanderU’s smart unit is fully integrated, meaning that the different elements of the unit – the isolator, voice-controlled eBR system, equipment, disinfection systems, Environmental Monitoring System, local controller, and real-time remote-controlled centralized computer unit – are linked together for an optimal production process.

Safety and ergonomics

The smart unit is made of a highly resistant acrylic resin, which means it maintains its integrity and can withstand many years of H2O2 disinfection cycles. Ergonomics are important too, as the operators should feel comfortable when working with the unit. Thanks to the flexibility of the material used, the unit’s shape can be changed on request, for instance to integrate new equipment because some operations need to be changed or automated.

Easy transportation with a mobile unit

Thanks to salamanderU’s mobile smart units, you can run clinical trials at several hospital sites, even if they are located far apart. The team working in the GMP truck is always connected to its company through the GPS system and mobile communication.

Custom-made

salamanderU’s smart units are custom-made, so a perfect fit for your needs and available space is always guaranteed.

cGMP and other health regulations

Our smart units are compliant with cGMP and other important health regulations. We install and validate your production unit in compliance with the standards in force.

High quality and compliance

salamanderU provides a practical response to the major challenge of guaranteeing a uniform high-quality standard when manufacturing in multiple units around the world. Our smart units collect all data in real time in a protected cloud environment, giving you complete remote control over all manufacturers.

Custom-built for your operations

salamanderU can custom-make a mobile unit that takes into account each step of your aseptic operations. Here’s an example of a mobile unit we designed for one of our customers who develops cell therapy products.

One of their products had to be administered to the patient in a medical setting within 6 hours after its final formulation. The customer had a single plant for performing the aseptic and temperature-controlled formulation process, but by transplanting this process to a mobile unit parked near the clinical site, they were able to deliver the product within the set time.

A closed formulation system, in which the product does not come into contact with the environment, was designed and validated to aseptically prepare the final product in a non-aseptic environment. A temperature-controlled production room was designed and fitted on a truck frame. This was used to both transport the equipment required to the clinical site and to formulate the product on-site.

This innovation has enabled the delivery of the cell therapy products to remote patients who could not have been treated within 6 hours of completing the formulation at our client’s premises. The formulation process and equipment have been inspected and approved by the Belgian Health Authorities, the Federal Agency for Medicines and Health Products (FAMHP).

The closed system’s ability to maintain aseptic conditions in a grade D environment at the back of the unit has been fully demonstrated and, as part of the validation process, specification-compliant batches of the product were successfully formulated in the mobile unit in the UK. Several patients were then treated with the products formulated in the mobile unit in Belgium and France.