The REMOIN Preparation Room with Isolator is designed for the production of sterile solutions intended for oncological and injectable drugs, ensuring a controlled environment compliant with Class A, B and C requirements.
The system integrates isolators configurable in positive or negative pressure, fixed or mobile preparation tanks and all process utilities, including WFI, pure steam, sterile air, nitrogen and product transfer lines.
Manufactured in AISI 316L stainless steel according to ASME BPE standards, the system features automatic welds tested by borescope inspection, components passivated according to ASTM 967, and VHP sterilization.
The installation can be equipped with SCADA control and fully complies with CFR 21 Part 11, USP, EMA and FDA requirements.
Sterile environment with isolators for Class A / B / C applications.
Positive or negative pressure configuration depending on product requirements.
HEPA H14 filters on inlet and outlet.
Integrated preparation tanks mounted on skid.
VHP sterilization with advanced monitoring systems.
Automatic welds verified by borescope inspection.
Passivation according to ASTM 967 standards.
HEPA H14 filters on inlet and outlet.
Integrated exhaust system.
Inflatable gasket control system.
Pressure regulation for chamber and pre-chamber.
Filter clogging monitoring.
PMMA transparent doors (other materials available).
Oval flanges for improved operational ergonomics.
SCADA integration for continuous supervision.
Every component is manufactured using AISI 316L stainless steel, with controlled surface finishes and complete qualification documentation, ensuring long-term reliability and full regulatory compliance.
A dedicated team of experts is always available to provide consulting, maintenance services and technological upgrades, supporting the system at every stage of its operational life.
Advanced automation solution designed for real-time monitoring and management of industrial processes.
Complete Systems for PW, WFI and Pure Steam
We design and build turnkey water systems, from pre-treatment to final distribution.
Our engineering ensures constant purity, continuous digital monitoring and complete traceability.
Complete Preparation Rooms, Automated Systems and Sterile Processes
Remoin develops turnkey Preparation Rooms for the pharmaceutical, cosmetic, chemical and food industries.
Solutions include preparation vessels, transfer lines, filtration systems, CIP/SIP units and thermo-regulation modules — all designed according to FDA, EMA and cGMP standards.
The goal is simple: repeatability, purity and total control of critical parameters.
Request a personalized quotation or contact us to evaluate the most suitable solutions for your production workflow.
With Remoin, you have a reliable technical partner offering continuous support and expertise in the management of critical systems.
