Isolators

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salamanderU's innovative synthetic resin isolators

Why use isolators?

With isolators, you avoid any disruption to the containment of manufactured products and protect them from microbiological contamination originating from human operators or production environments. They ensure enhanced protection of products and operators, a considerably higher guarantee of sterility, and reduced costs for work, clothing and other cleanroom-related expenses.

Why are salamanderU’s isolators so innovative?

What makes salamanderU’s cell culture and filling isolators so innovative is that we use a highly resistant acrylic resin – polymethyl methacrylate or PMMA – to build isolators tailored to your needs and available space. Isolators are usually made of stainless steel, which corrodes when subjected to frequent H2O2 decontamination cycles. Furthermore, stainless steel is not the best solution for optimal ergonomics or easy to shape in manufacturing processes.

Integrity guaranteed over time

salamanderU’s PMMA isolators maintain their integrity, no matter the number of decontamination cycles. The isolators are designed for operating in cleanliness conditions of grades D to A (ISO 8 to ISO 5) of cGMP requirements, meaning they are perfectly suited to aseptic manufacturing.

Optimal ergonomics and flexibility

By using PMMA we can design isolators that best suit your production process, house all your equipment and optimize the ergonomics. The material is highly flexible, so the isolator can easily be adapted to changes in your manufacturing process if necessary.

salamanderU's isolators

Why our isolators are perfect for your operations

Custom-built

salamanderU’s isolators are shaped according to your aseptic operations. They house all your equipment to better guarantee sterility. Whatever your needs or available space, we will make an isolator that improves the ergonomics of your manufacturing process unit. Want to change your processes? No problem, your isolator can easily be adapted thanks to PMMA.

Efficient disinfection

Our isolators enhance automated bio-decontamination operations. They are easy to clean and disinfect. Working sections, material airlocks (MAL) and security airlock systems (SAS) can each be provided with an independent decontamination unit. These separate systems mean that some sections can go through a decontamination cycle, while you continue using others. Made of PMMA, they are highly resistant to decontamination products.

Easy to control

With their Human Machine Interface (HMI) touch screen, salamanderU’s isolators are easy to control. The touch screen manages the decontamination cycles in each section and verifies the status of the decontaminated sections. It also shows in real time whether doors are opened or closed, the status of filters, whether the valves of the decontamination and HVAC systems are opened or closed, and whether the HVAC systems have the correct flow rate.

Clear supervision

The HMI touch screen can display several critical parameters such as temperature, pressure and relative humidity, which may affect your products’ characteristics. The parameters are shown for each section of the isolator and for the equipment connected, such as incubators and bioreactors.

Features of your choice

You decide on the features you want. As an example, here is what one of our customers asked of a grade D environment. He wanted the isolator to contain four independent but interconnected main sections, each with an independent vaporized hydrogen peroxide (VHP) bio-decontamination system:

  • A MAL IN, a material airlock allowing all materials to enter, such as reagents, raw materials and small equipment to help perform the aseptic operations within the isolator. A watertight door for connecting the MAL IN to the isolator’s bench.
  • A grade A working section for all aseptic operations, connected on both sides to a SAS, safety airlock system, accessible through a watertight door. The working section also needed to have a DPTE Transfer Port System for sterile equipment to enter the isolator, and waste and samples to exit.
  • One SAS equipped with a microscope and a centrifuge, to transfer samples to a connected incubator.
  • A second SAS, also with a microscope, to transfer samples to a second incubator.

For another customer, we developed a full case study that compared the process costs of our customized isolator with those of a standard aseptic environment.

The final results overwhelmingly favoured our customized isolator:

  • More accurately defined and robust manufacturing process
  • Improved conditions for aseptic operations
  • Automated bio-decontamination
  • A decrease in OPEX of 36%, with a return on investment of less than 3 years
  • FTE reduction

Contact us for a copy of the study presentation we made or to talk to one of our experts (hello@salamanderu.com).