Overview
PBL Pharma division has design a customizable and highly innovative isolator able to completely automate different ATMPs production processes, which are, up to now, only manually performed by research institutes and pharmaceutical workshops.
The 100% class A system, completely sterilizable through VHP (or similar), can be provided with loading cells with weight and dosing control, centrifuge, incubation systems, microscope, environmental monitoring, robotic handling and visual inspection.
The inner set-up of the isolator, based on an easy-to-use automated wall warehouse, allows to organize all the consumables and reagents to save space.
The high flexibility allows to reproduce the production steps required for ATMPs. It is possible to easily modify the process steps and/or to insert tools and instrumentations for cellular selection, electroporation, activation, viral transduction, expansion and formulation.
“Pass Box” and Continuous Liner Systems, allow to insert and remove materials from the isolator in every step of the process without disrupting the sterility, preserving product quality and saving time and resources.
Main features
⦁ Modular class A isolator, sterilizable through automated systems (e.g. VHP);
⦁ Customizable system for filling and liquid transferring (from 10 µL a 50 L);
⦁ Customizable robot tool and format change, in line with specific requirements;
⦁ Liner system for samples and waste ejection in sterile environment;
More features
⦁ Variety of handled containers, both rigid and flexible;
• Wall automatized warehouse customizable according to process requirements;
⦁ HMI system for potential manual control and operator monitoring (CFR 21 part 11 compliant);
⦁ Environmental monitoring systems (Temperature, humidity, CO2, O2, particles and microbiological) and controlled ventilation;
⦁ Positive and/or negative pressure potential environment;
⦁ Possibility to insert/integrate:
– Load cells with dose calibrator for controlled filling of containers;
– AI-aided vision tools for sampling and dosage control;
– Internal microscopy inspection systems;
– Integrated centrifuge for cellular samples isolation and handling;
– Incubators, connected through Rapid Transfer Port Systems to manage different production batches, minimizing cross-contamination risk;
– Refrigerators, connected through Rapid Transfer Port System or integrated in the isolator hardware;
– Customizable “Pass Box” module to enter third parties’ instrumentation or other materials which are not directly placeable in the main module;
– Tools for cellular selection, electroporation, activation, viral transduction, expansion and formulation.
Machine Output
2 to 20 PpM
Compatible containers
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