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 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.
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;
⦁ 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;
– Tools for cellular selection, electroporation, activation, viral transduction, expansion and formulation.
Machine Output
2 to 20 PpM
Compatible containers
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