PROSYS - Isolator - Model 6003

PROSYS ISOLATOR, MODEL 6003

Year of construction: 2020

Aseptic Isolator System for Formulation

Never used after the FAT.

The unit is a high quality sterile isolator capable of meeting Iso 5 conditions with VHP sterilization capability.

Single pass Uni Directional Air Flow (UDAF).

Unit can be used for process batch manufacturing or can be set up for filling operation if needed.

The isolator system consists of one chamber with a H2O2 (Hydrogen peroxide) vapour generator (ProSGen).

The Main chamber is the principal working area where product processing occurs. It has integrated centrifuge. The Centrifuge is bio-decontaminated with the main chamber as part of isolator H202 cycle.

A ventilation system ensures controlled positive pressure vs. the surrounding room, as well as constant fresh-air renewal. The incoming air is supplied from the surrounding lab at a high level and extracted to the room at a low level; it is a single pass system. Non-viable and viable particle monitoring systems are provided by the customer. ProSys to provide mechanical integration of the sampling head.

A central PLC (Programmable Logic Controller) based control the isolator, with HMI (Human Machine Interface) centralizing all commands and monitoring data.

A H2O2 vapor generator will be integrated into the isolator. Pipe work will connect to a manifold directing the vapor from the generator to the isolator. H2O2 residuals consecutive to bio-decontamination cycle are directed to the exhaust system which are equipped with Catalytic Converter which removes the H2O2 Vapour from the exhaust air. The H2O2 Generator (ProSGen) is a standalone system provided by ProSys and interfaces with the isolator PLC via the machine network over ProfiNet.

The Isolator also is equipped with a High H2O2 monitoring sensor.

The Isolator will be supplied with a glove test kit in order to detect glove leaks. The glove test kit includes the following parts:

1 large diameter test plugs

1 Laptop PC for interfacing with the glove test plug

Glove test plug Charger

The HMI clock is set up for 24H format.

UDAF Description

The Isolator Main Chamber will have a positive operating pressure (Adjustable HMI parameter) with respect to the surrounding room.

The Main Chamber UDAF is achieved by two inlet fans. These fans operate at the same fixed speed setpoint (Adjustable HMI parameter) and will be configured to so that the UDAF inside the chamber has a velocity of 0.45 m/s +/- 20 %.

Idle Control Description

The pressure is controlled by an inlet and extract fans. The Inlet fan is a fixed speed setpoint (Adjustable HMI parameter) and the extract is automatically adjusted speed control to achieve the required chamber pressure.

With the Isolator air inlet and extract valves opened, the inlet and extract fans running, a PID (proportional–integral–derivative) loop will adjust, when required, the speed of the extract fans with relation to the pressure detected by the Isolator pressure transmitter to maintain the pressure at the required set point value (HMI Parameter).

If the chamber pressure falls outside the set limits for operation, the fans will continue to operate, and an alarm will be activated indicating that an operating pressure fault has occurred. The chamber sterile indication will be deactivated, and the chamber will be placed back into Idle mode and a new H2O2 cycle will have to be completed to recreate a sterile environment.