Isolators and smart units
Learn more about salamanderU's synthetic resin isolators and smart units.
salamanderU is a technology company made up of a multidisciplinary team of business experts in the life sciences industry, pharmaceutical engineering and IT. We enhance your competitive advantage by increasing the robustness of your operational processes, especially aseptic ones, and by saving you time and costs.
Our solutions improve the efficiency of your manufacturing, filling and quality control processes, accelerate your harmonized deployment anywhere in the world and give you better control over subcontractors. Your operators can focus on what really matters: manufacturing and testing medicines properly and getting them to patients on time.
Our experts help you optimize your many processes in order to bring your products to market as quickly as possible. For instance, through a design analysis of your GMP manufacturing equipment and premises, user training and GMP accreditation by health authorities.
Learn more about salamanderU's synthetic resin isolators and smart units.
Watch the demo of salamanderU's voice-controlled electronic Batch Record SmartReg.
We support you by integrating innovative solutions, accelerating the commercialization of your products and propelling you into Pharma 4.0. Our solutions are both technical and digital: technical with acrylic resin isolators, digital with our voice-controlled electronic Batch Record and our software for remote data collection and control. Together they can be deployed as a remote-controlled smart operational unit.
We custom-make your isolators according to your needs and available space. They are built to house all your production and environmental monitoring equipment. The use of a highly resistant acrylic resin improves the ergonomics of your operations, and ensures that the isolators retain their integrity and can withstand many years of H2O2 cleaning.
Grades D to A
Our isolators are designed so that you can work in cleanliness conditions that meet grades D to A (ISO 8 to ISO 5) requirements.
Our electronic Batch Record (eBR) system SmartReg, with voice recognition and a voice synthesizer, is the world's first to be patented. Operators can simply tell SmartReg what they are doing instead of writing everything down.
Personal assistant
SmartReg is the infallible pilot that guides the operator through each step, does the calculations and offers many more options, such as optimized reporting features.
IP-cProtect is our software for the remote collection and control of operational data. It includes the voice-controlled eBR system, which collects operational and equipment data, and an Environmental Monitoring System (EMS).
Real-time remote control
We enable you to remotely control your operational processes in real time, whether they are being carried out by you or by Contract Manufacturing Organizations (CMOs), no matter the location, or whether in fixed or mobile production units.
salamanderU's production units are designed for GMP grade A operations. They house all the equipment needed for manufacturing or filling your end products and for controlling environmental parameters. They are resistant to intensive decontamination.
Mobile
Our smart production units can be mobile. So you can formulate the medication anywhere and deliver it to patients as soon as it has been approved by the Qualified Person (QP).
Your operations are performed in aseptic environments with grade A cleanliness level, if necessary. Our innovative solutions are fully compliant with major health regulatory requirements worldwide, such as those laid down in cGMP (current Good Manufacturing Practices) and EudraLex Volume 4.
Our innovative solutions increase the robustness of your operational processes and greatly simplify your operators’ work. This accelerates the deployment of your products while reducing costs.
Our innovative solutions give you strict and real-time control over your operational processes anywhere in the world, whether the operations are being carried out by you or CMOs, or whether in fixed or mobile production units.
We custom-make all our solutions so that they perfectly fit your needs and available space. Our digital solutions are designed to accurately reflect your own operational processes.
