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Applikon ez-Control User Manual

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ez-Control for
In Situ sterilizable Bioreactors
OPERATOR MANUAL
Project 310420; PS 70L, IST (AU)

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Applikon ez-Control Specifications

General IconGeneral
BrandApplikon
Modelez-Control
CategoryLaboratory Equipment
LanguageEnglish

Summary

1 GENERAL SAFETY

1.1 SAFETY SYMBOLS

Explains symbols used in the manual for warnings and information.

1.2 SAFETY WARNINGS

Details general safety precautions and warnings related to equipment operation and potential hazards.

2 GENERAL

2.1 INTRODUCTION

Introduces the Applikon In Situ sterilizable Bioreactor Systems and their main components.

2.2 SYSTEM OVERVIEW

Presents the ez-Control system combined with the Pilot System 70L, including a diagram.

2.3 HOME SCREEN

Describes the Synoptic and Bar Graph screens displayed after system initialization.

2.4 ICONS

Lists and describes various icons used on the ez-Control interface for navigation and status indication.

2.5 KEYPAD AND KEYBOARD

Explains the numeric and alphanumeric keypads for data entry, calibration, and password protection.

2.6 BAR GRAPH AND TREND VIEW SCREENS

Details the Bar Graph screen for parameter overview and Trend View screens for historical data visualization.

2.7 SET-POINTS

Explains how to change set-points, noting that Operator authorization is required.

2.8 CONFIGURABLE OUTPUTS

Describes how to edit actuator assignments and rename actuators according to specific demands.

2.9 RELATED MANUALS

Lists other relevant manuals for the ez-Control system, such as Hardware and PID Control manuals.

3 GENERAL PREPARATIONS

3.1 GENERAL

Covers initial procedures like unpacking, cleaning, and assembly before preparing for a new process.

3.2 PREPARING FOR A NEW PROCESS

Outlines the essential steps for preparing the bioreactor for a new cultivation or fermentation process.

3.2.1 CALIBRATE THE pH SENSOR

Details the procedure for calibrating the pH sensor, including 1-point and 2-point calibration methods.

3.2.2 CHECK THE DO SENSOR

Explains the calibration of the DO sensor after sterilization and its potential maintenance needs.

3.2.3 OTHER SENSORS

Provides instructions for mounting level sensors and general notes on other sensors like temperature and pressure.

3.2.4 OTHER HARDWARE

Covers preparation steps for push-valves, tubing, bottles, and other external connections to the reactor.

3.2.5 PREPARE SUPPLIES

Lists necessary verifications for steam, cooling water, and gas supplies before proceeding to pressure testing and sterilization.

4 PRESSURE TEST AND STERILIZATION

4.1 PRESSURE HOLD TEST

Describes the manual procedure for performing a pressure hold test to ensure the reactor is airtight.

4.2 STERILIZATION ROUTINE

Outlines the discrete steps involved in the sterilization routine and the operator's required actions.

4.3 STERILIZATION SETTINGS

Presents the specific settings and durations for both empty and full sterilization routines.

4.4 ACTUATOR ACTIVITY MATRIX

Details the activity matrix for various actuators during different stages of empty and full sterilization.

4.5 EXECUTION OF THE STERILIZATION ROUTINE

Guides the operator through the step-by-step execution of the sterilization process from start to finish.

5 CULTIVATION

5.1 PREPARING FOR CULTIVATION

Details the steps required to prepare the bioreactor for cultivation after the sterilization process is complete.

5.1.1 PREPARE THE SENSORS

Covers height adjustment of the level sensor and calibration procedures for the DO sensor.

5.1.2 CONNECT ADDITION FLUIDS

Explains how to connect acid and base fluids using the contained addition assembly and push valves for aseptic operation.

5.1.3 ACTIVATE THE CONTROL LOOPS

Instructs on activating all control loops in the ez-Control system to achieve optimal process conditions for cultivation.

5.2 START CULTIVATION BY ADDING INOCULUM

Details the aseptic "Tube Welding" technique for adding inoculum to initiate the cultivation process.

5.3 DRAIN VALVE

Explains the function and operation of the bottom drain valve for taking samples and harvesting the system.

6 CLEANING

6.1 CLEANING THE SENSORS

Provides procedures for draining the reactor and cleaning pH and DO sensors after cultivation.

6.2 CLEANING THE BIOREACTOR

Outlines two cleaning steps for the bioreactor using specific solutions and temperatures for thorough cleaning.

6.3 CLEANING AUXILIARIES AND TUBING

Details disassembly and cleaning of tubing and auxiliaries using the same cleaning solutions as for the reactor.

6.4 MAINTENANCE

Refers users to Maintenance Data Sheets from Applikon-Biotechnology for detailed maintenance instructions.

7 SYSTEM WARNINGS

7.1 POWER FAILURE DURING OPERATION

Describes how the system detects power failures, the resulting messages, and options for restart or halt.

7.2 EMERGENCY STOP DURING OPERATION

Explains the immediate effect of the Emergency Stop button and the procedures for removing the cause and restarting the system.