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Bioquell QUBE User Manual

Bioquell QUBE
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©Bioquell UK Ltd (2015). All rights reserved. USER MANUAL
TD069-O&M-001
REVISION 6
Bioquell UK Ltd
52 Royce Close
West Portway
Andover
Hampshire SP10 3TS
T:
F:
E:
W:
+44 (0)1264 835 835
+44 (0)1264 835 836
info@bioquell.com
www.bioquell.com
Page 1 of 80
Aseptic Processing Workstation
USER MANUAL

Table of Contents

Questions and Answers:

Bioquell QUBE Specifications

General IconGeneral
CategoryDesktop
ManufacturerBioquell
DecontaminationHydrogen Peroxide Vapor (HPV)
HEPA FiltrationH14 HEPA filters
Power Supply230V, 50/60Hz
AirflowUnidirectional
MaterialStainless steel
DimensionsVaries depending on configuration
WeightVaries depending on configuration
Noise Level<65 dB(A)
CertificationsISO 14644

Summary

SAFETY PROTOCOLS

Hydrogen Peroxide and HPV Cycle Safety

Safety instructions for handling Hydrogen Peroxide and HPV cycles.

General QUBE Safety Guidelines

General safety guidelines for operating and maintaining the QUBE system.

QUBE Warning Labels

Explains the warning labels found within the QUBE enclosure.

QUBE SYSTEM DESCRIPTION

Purpose of the QUBE System

Describes the intended use and applications of the QUBE workstation.

QUBE System Modules

Details the modular components that make up the QUBE system.

QUBE Module Types: QHPV, QEXT, QSDM

Describes the QHPV, QEXT, and QSDM modules.

QUBE Module Types: QMTD, QOCM, End Modules

Details QMTD, QOCM, and various end panel module types.

Optional Sub-systems: Glove Tester and Sterility Pump

Details optional accessories for glove testing and sterility pump integration.

Optional Sub-systems: Environmental Monitoring

Packages for Level 1, 2, 3, and 4 environmental monitoring.

Optional Sub-systems: Ports, Extract, Printer

Options for fluid connection, air extraction, and printing.

System Configurations, Control Panel, and Lighting

Covers system configurations, control panel, and lighting.

QUBE Modes of Operation

Details Processing Mode and Bio-decontamination Mode.

QUBE CONNECTIONS AND SET-UP

Positioning and Electrical Connections Overview

Guidelines for unit placement and connecting power supply.

External Electrical Connections

Details the external electrical connection points on the QUBE.

Internal Electrical Connections

Details the internal electrical connection points for accessories.

Door Control Mechanisms

Details door interlocks, pneumatic seals, and operation indicators.

Hydrogen Peroxide Supply Information

Information on using Bioquell approved 35% w/w Hydrogen Peroxide bottles.

QUBE OPERATION GUIDE

Control Panel Interface and Navigation

Explains the touch screen interface, icons, and navigation flow.

Logging ON and User Access

Procedures for logging into the system with different user access levels.

Loading the QHPV Chamber

Step-by-step guide to opening the chamber and loading items.

Opening QUBE Doors

Procedure for safely opening different types of QUBE doors.

Bio-decontamination Cycle Preparation

Steps for preparing the chamber and load before starting a decontamination cycle.

Loading a Hydrogen Peroxide Bottle

Instructions for correctly loading the H2O2 bottle into the module.

Running and Monitoring a Cycle

How to start, run, and monitor the progress of a decontamination cycle.

Cycle Phases Explained

Describes the different stages of the decontamination cycle (Conditioning, Gassing, etc.).

Pressure Test and Conditioning Phase

Details the optional pressure test and the system conditioning phase.

Gassing and Dwell Phase Details

Explains the gassing process and the dwell phase of the cycle.

Aeration Phase and Cycle Completion

Details the aeration phase and how to confirm cycle completion.

Aborting a Cycle

Procedure for aborting a decontamination cycle if necessary.

Cycle Printouts and Load Reports

Information included in cycle printouts and product transfer reports.

Cycle Recipes: Viewing and Management

How to view, create, and edit cycle recipes.

Pre-Loaded Cycles and Recipe Creation

Describes pre-programmed cycles and the process for creating custom recipes.

Pressure Testing and Leak Tests

How to perform chamber leak tests and optional glove leak testing.

Sterility Test Pump and Air Sampler Operation

Operating instructions for optional sterility test pumps and air samplers.

Aseptic Hold Period

Explains the validated time for maintaining aseptic conditions after a cycle.

SYSTEM ADMINISTRATION

System Information and Operator Functions

Viewing system details and operator-editable settings like language and light intensity.

Supervisor Functions

Functions editable by Supervisor, including mode suspension and time/date settings.

Administrator Functions: Pressure Setpoints

Allows Administrators to set pressure regimes for individual modules.

Administrator Functions: User Management

Manages aseptic hold periods, users, passwords, and access levels.

MAINTENANCE PROCEDURES

Operator Maintenance: Cleaning

Procedure for cleaning the QUBE exterior surfaces.

Operator Maintenance: Glove and Sleeve Replacement

Step-by-step guide for replacing gloves and fitting new sleeves.

Operator Maintenance: Printer Paper Replacement

Procedure for changing the printer paper.

Scheduled Maintenance and Servicing

Details scheduled maintenance intervals and service provider recommendations.

TROUBLESHOOTING AND ALARMS

Understanding and Managing Alarms

How to view, acknowledge, and clear system alarms and warnings.

Troubleshooting Common Faults

Troubleshooting guide for common issues like power loss or printer errors.

PARTS LIST

Consumables

List of consumable items for the QUBE system.

Replacement Parts

List of available spare parts for the QUBE system.

TECHNICAL SPECIFICATIONS

EC DECLARATION OF CONFORMITY

SCREEN NAVIGATION GUIDE

GLOSSARY OF TERMS

DEFAULT PASSWORDS