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.
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.
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.
Our modular container system is innovative and allows for a quick installation. The containers are adaptable to your environment, so they fit next to your existing building.
This type of infrastructure is part of salamanderU’s mission to provide qualitative industrial infrastructures that are innovative and quickly available. Moreover, you can have them at a very good price.
The inside of the container offers a BL2 (Biosafety Level 2) laboratory. It has outdoor inflatable joints to ensure containment. Its HVAC system is designed for a maximum flexibility, compliant with the cleanroom classification ISO 7, and contains fluid filters for air and water with a pore size of 0,22 µm. You can manage and split the contaminated from the uncontaminated effluents. The container is integrated into the central techniques of the existing building.
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. Our mobile smart unit is a truck with a standard production room on board with an LAF system (Laminar Air Flow) or a grade A isolator.
Transportation and formulation
It both brings the equipment, materials and technicians to the clinical site, and provides a suitable facility for formulation and the subsequent fill and finish process. The rear technical area hosts an air flow system with black and clean utilities, keeping the room at 15-25°C. This area maintains a class D environmental cleanliness. The closed manufacturing process and the mobile smart unit are approved by various European authorities.
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.
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.
Thanks to salamanderU’s mobile smart units, used to both transport the material and manufacture the product, 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.
salamanderU’s smart units are custom-made, so a perfect fit for your needs and available space is always guaranteed.
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.
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.
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.
Delivering the product within the set time
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.
Transportation and formulation
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.
Inspected and approved
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.
When effective and rapid containment is necessary, for example when immediate protection against contagious infections is needed, the “CLEANBUBBLE” proposed by salamanderU proves to be particularly advantageous.
The “CLEANBUBBLE” is a depressurized room which can be installed in less than half an hour and which prevents pathogens from spreading in the adjacent environment. It consists of flexible walls that are attached to an aluminum frame, polyester piping, a HEPA filter and a UV-C germicidal lamp.
Hospitals which must treat patients suffering from contagious diseases and that don’t wish the pathogenic agent spreading within the hospital institution can for example install the “CLEANBUBBLE” in an outside container.
Watch our video on "CLEANBUBBLE" »