Primary_Barrier__Exhibit_Minidox-M_Systems_Operations_Guide_Rev_3-30_.pdf

Minidox-M Decontamination System

System Operations Guide www.clordisys.com

PO Box 549

Lebanon, NJ USA 908-236-4100

Minidox-M Decontamination System Operations Guide 2

Minidox-M Decontamination System System Operations

Guide 07-020 V3.30

ClorDiSys Solutions, Inc.

PO Box 549

Lebanon, NJ 08833 USA

(1-908-236-4100) www.clordisys.com

©2007 ClorDiSys Solutions, Inc.. All rights reserved. Other products mentioned in this publication are trademarked by their respective corporations. Reproduction, adaptation or translation of this publication without prior written permission is prohibited. Printed in the USA.

Minidox-M Decontamination System Operations Guide 3

Contents Contents

Chapter 1. Introduction 7 Overview About the Minidox-M Decontamination System

• Benefits Of The Minidox-M Decontamination System

Chapter 2. Safety 11 Overview Safety

• Oxidizer and Corrosive Exposure

• Safe Operation of the System

• Safe Handling of Consumables

• Safe Installation and Maintenance

• Use Only Approved Parts Additional Information

Chapter 3. General Operating Information 17 Overview The Decontamination Process

• Ambient Chambers Cycle Steps

• Pre-Condition

• Conditioning

• Charge

• Exposure

• Aeration Operating Parameters Equipment Description

• Gas Generator Section

• Sensing Section

• Steam Injection Module

• Control and Monitoring System User Displays

• Main Display

• Cycle Select

• Cycle Edits

• Cycle Development

• Configurable Parameters 1-99, 100-999 and 1000 and Up

• Global Configurable Parameters

• System Status

• System Status Activate

• Engineering System Status

• Administration Functions

• Operator and Supervisor Passwords

• Terminate Aeration

Minidox-M Decontamination System Operations Guide 4

• Disable Exposure Pressure Fault

• Time, Date and Contrast Adjust

• Trend RH

• Trend CD

• Print Functions

• Option DataLog

• Alarms Pressure Relief

• Ambient Pressure Relief

Chapter 4. Day-to-Day Operation 63 Initial Operation Caution

• Attachment to Chamber

• Installation Guideline for Rooms Creating a Cycle Starting A Cycle

• Loading, Starting and Ending a Cycle

Chapter 5. Troubleshooting 71 Overview

• Resetting Alarms

• Alarms Miscellaneous Troubleshooting Information

Chapter 6. Routine Maintenance 79 Overview Maintenance Schedule

• User Maintenance

• Yearly Maintenance Changing Consumables

• Preparing to Change Consumables

• Changing the Gas Cylinders

• Changing the Cartridges Relieve Cylinder Pressures Chamber Leak Testing Photometer Lens Cleaning Regulator Setup Regulator Purge Regulator Purge Extended Disconnect Re-zero Photometer

Appendix A. Specifications 97 Physical Specifications Space Requirements Environmental Operating Conditions Electrical Requirements

Appendix B. Microbiocidal Activity of Gaseous Chlorine Dioxide 99 Background and Process Fundamentals Guidance on Development of Sterilization Processes

• Moisture Conditioning

Minidox-M Decontamination System Operations Guide 5

• Exposure Time/Gas Concentration

• Aeration Examples of CD Process Development

Appendix C. Passwords 105 Operator Level Supervisor Level

Appendix D. Warranties 107 Service Warranty Commercial Warranty

Appendix E. Configurable Parameters Worksheets 109 Configurable Parameters Chlorine Replacement Cartridge Replacement

Appendix F. Training Certification Sheet 117

Appendix G. Configurable Relays Worksheet 119 Relay Output Worksheet

Appendix H. Conversion Charts 123 Conversion Charts

Appendix I. Spare Parts 127 Spare Parts

Appendix J. Example Chamber Connections 133 Chamber Connections

Appendix K. Specialized Applications 151 Background and Process Fundamentals Guidance on Development of Sterilization Processes

• Tubers:

• Microbial Food Spoilage Organism List:

Appendix L. Example SOP 154

SOP

Minidox-M Decontamination System Operations Guide 7

Chapter 1.

Introduction in this chapter . . .

• overview

• about the system

Introduction 1

Minidox-M Decontamination System Operations Guide 8

Overview This guide is designed to provide detailed information on the functionality and the proper operation and maintenance of the Minidox-M Decontamination System. The operation and maintenance of the system includes operating the user interface; setting passwords/security levels for various users; and changing consumables. In addition, system function details are included in this guide. This functional information is designed for use by operators at the supervisory level.

Because you are using chlorine dioxide and other chemicals, you should read, understand and use the information in “Chapter 2. For Your Safety.”

The guide is divided into 6 chapters and 7 appendices. These chapters provide information on using the system, routine maintenance, troubleshooting, password generation and maintenance, and system details.

The chapters are:

• Chapter 1. Introduction-the first chapter of the guide has important details about the Minidox-M Decontamination System, and the Sterilization process.

• Chapter 2. For Your Safety-this may be the most important chapter in the guide. You should read it thoroughly, understand the information, and follow all the safety procedures in this chapter. These safety procedures include safe handling of consumables, and information regarding possible chlorine dioxide exposure.

• Chapter 3. General Operating Information-this chapter provides a brief description of the system processes, equipment description, operational parameters and a description of the controls.

• Chapter 4. Day-to-Day Operation-this chapter gives you detailed information on how to use the system, how to use the control panel, how to run cycles and how to set security levels for other operators.

• Chapter 5. Routine Maintenance-the routine maintenance of the system is very important.

This chapter contains information on changing the consumables which include the gas cylinders.

• Chapter 6. Troubleshooting-the system displays a number of messages to tell you what the system status is at any given moment. Many of these messages do not require any action from you. Others require that you call Support for maintenance.

• Appendix A. Specifications- this appendix details the technical specification information for Minidox-M Decontamination System.

• Appendix B. Microbiocidal Activity of Gaseous Chlorine Dioxide-this appendix provides guidance on choices of moisture conditioning and gas exposure conditions when developing gaseous CD Decontamination processes.

• Appendix C. Passwords-this appendix contains the pre-defined login passwords for all levels.

• Appendix D. Service and Warranty Information-this appendix contains the detailed system warranty and our guarantees to you regarding your Minidox-M Decontamination System.

Minidox-M Decontamination System Operations Guide 9

• Appendix E. Configurable Parameters Worksheet-this appendix contains specific information on Configurable Parameters, what they mean, and recommended values.

• Appendix F. Training Certification Sheet–this appendix contains the training sheet that must be signed by a ClorDiSys Solutions, Inc. personnel or representative

• Appendix G. Configurable Relay Worksheet-this appendix contains a worksheet to document the electrical connections to the field configurable.

• Appendix H. Conversion Charts-this appendix conversions from English units to metric

• Appendix I. Spare Parts-this appendix contains a list of spare parts for the Minidox-M.

• Appendix J. Example Chamber Connections-this appendix contains diagrams for connections of the generator to different types of chambers.

• Appendix K. Specialized Applications – this appendix contains instructions on how to use the generator in special circumstances.

• Appendix L. Example SOP – this appendix contains an example SOP for the proper operation of the Minidox-M system.

About the Minidox-M Decontamination System The Minidox-M Decontamination System is a general purpose, chlorine dioxide gas generator. Chlorine dioxide gas is an effective sterilant which, when delivered to chambers at ambient temperatures and 60- 75% relative humidity, rapidly inactivates microorganisms within the chamber.

The Sterilization process proceeds in the following manner:

• The items, if any, to be decontaminated are placed in the chamber and the chamber is sealed.

• The chamber is humidified to a selected level. This relative humidity is maintained for a period of time you select.

• A charge of gas is produced in the gas generator and introduced into the chamber to achieve the concentration you selected. This atmosphere of gas remains in the chamber for a selected period of time, sterilizing items within the chamber and/or the chamber itself.

• When exposure is completed, the atmosphere of the chamber is flushed to the atmosphere (local air quality regulations should be verified).

When the Sterilization process is completed, items can be removed from the chamber and used, and/or the chamber is decontaminated and ready for use.

Benefits of the Minidox-M Decontamination System

Minidox-M Decontamination System Operations Guide 10

• Chlorine dioxide, a true gas, is a rapid and effective Sterilizing agent with a visible green-yellow color. Chlorine dioxide is nonflammable and non-carcinogenic. It has a faster processing time and more rapid aeration compared to other sterilants. The gas is produced within the system only when required, and only in the amounts required. The system contains an integral sterilant monitoring and feedback control system.

• Chlorine dioxide works well at atmospheric pressures, and operates at ambient temperature throughout the cycle. It does not require an exceptionally dry environment and, in fact, works most rapidly when humidity is present. It is not, however, dependent on condensation levels.

• Chlorine dioxide is microbiocidal at the allowable range of 1-30 mg/liter. The 0.1 ppm odor threshold is self-alerting and coincides with the 0.1 ppm 8-hour TWA.

Minidox-M Decontamination System Operations Guide 11

Chapter 2.

Safety in this chapter . . .

• important safety information

For Your Safety 2

Minidox-M Decontamination System Operations Guide 12

Overview Your safety is of primary concern. This section provides information on safely using the Minidox-M Decontamination System. You must read, understand and follow the information in this chapter before operating the unit. The equipment must never be used in a manner not specified in this manual.

Also, always pay attention to the warnings, cautions and notes throughout this guide. This information is for your safety and to ensure that you receive the most benefit from the safe operation of your Minidox-M Decontamination System. Only trained, experienced technicians, who are fully acquainted with the unit, should repair or adjust the system.

Safety It is the system operator’s responsibility to verify that the system is in a safe state when changing consumables. You must read, understand, and follow the procedures featured in the Routine Maintenance Chapter. These procedures detail safe handling of the chlorine cylinders, flex line disconnection and reconnection, use of the safety cap, and cylinder replacement.

WARNING! YOU MUST READ, UNDERSTAND, AND

FOLLOW THE EXPOSURE CAUTIONS BELOW

BEFORE REPLACING THE CYLINDERS.

Oxidizer and Corrosive Exposure

• The gas cylinder contains dilute chlorine in nitrogen (2% chlorine gas in nitrogen) under pressure (2000 PSIG). Damage to the gas cylinder can result in the rapid release of chlorine gas.

• CHLORINE IS A STRONG OXIDIZER, AND IS IRRITATING TO THE SKIN, EYES,

LUNGS, NOSE, THROAT, AND GASTROINTESTINAL SYSTEM. Exposure to the vapors can cause coughing, discomfort, and difficulty breathing, particularly in persons with respiratory disorders. If inhaled, immediately move to fresh air and call a physician.

• The system produces chlorine dioxide. Care must be exercised when servicing and using the system.

• CHLORINE DIOXIDE IS A STRONG OXIDIZER, AND IS IRRITATING TO THE

SKIN, EYES, LUNGS, NOSE THROAT AND GASTROINTESTINAL SYSTEM.

Exposure to the vapors can cause coughing, discomfort, and difficulty breathing, particularly in persons with respiratory disorders. If inhaled, immediately move to fresh air and call a physician.

• AVOID EXCESSIVE HEAT, CONTAMINATION OR CONTACT WITH ANY

MATERIALS (SOLID, LIQUID OR VAPOR) NOT COMPATIBLE WITH OXIDIZERS.

• Read the Material Safety Data Sheet of any other material to be used in conjunction with this device to ensure that it is compatible with oxidizers.

Minidox-M Decontamination System Operations Guide 13

Safe Operation of the System

• ALWAYS PERFORM A LEAK TEST on the chamber according to the chamber manufacturer’s instructions, prior to sending any sterilant into a chamber. If the chamber is not sealed, chlorine dioxide gas could escape during the cycle. The chamber must be leak free before operation.

• Before setting pressure differentials for the chamber, VERIFY (REFER TO THE

MANUFACTURER’S RECOMMENDATIONS) THAT IT CAN WITHSTAND THE

PRESSURE BEING PROGRAMMED. Failure to do so could cause the chamber to rupture. As a result, chlorine dioxide gas could escape.

• VERIFY THAT BOTH PRESSURE CONNECTIONS ARE MADE BETWEEN THE

CHAMBER AND THE MINIDOX-M. ALSO VERIFY THAT THE CHAMBER’S

PRESSURE RELIEF IS FUNCTIONAL AND ELECTRICALLY CONNECTED TO

THE MINIDOX-M.

• Before starting the generator, MAKE SURE THE CHAMBER IS COMPLETELY

SEALED. HARMFUL CHLORINE DIOXIDE GAS CAN ESCAPE IF ALL

CONNECTIONS, VENTS AND PORTS ARE NOT PROPERLY SEALED.

• Before running a cycle, ALWAYS VERIFY THAT THE SYSTEM IS PROPERLY

CONNECTED TO THE SEALED CHAMBER TO ENSURE COMPLETE

CONTAINMENT OF THE CHLORINE DIOXIDE GAS. CHECK ALL

CONNECTIONS AND MAKE SURE ALL CHAMBER VENTS/PORTS ARE

SEALED. Post warning signs on and around the chamber to prevent accidental entry. Do not attempt to open the chamber until the gas generator has completed the entire cycle, and chlorine dioxide gas has been aerated from the chamber. You MUST verify that the chlorine dioxide gas has been aerated with a Dräger Detector or similar device.

• When in the Charge or Exposure steps and until Aeration has been completed HARMFUL

STERILANT GAS IS PRESENT WITHIN THE CHAMBER. DO NOT OPEN,

ENTER, OR IN ANY WAY ACCESS THE CHAMBER. If it is ever necessary to gain access to the chamber before the chlorine dioxide is completely evacuated, wear a self-contained breathing apparatus (if concentration is greater than 0.3 ppm), chemical splash goggles and full-cover vinyl or neoprene protective clothing.

• Chlorine dioxide gas is normally vented to the atmosphere to aerate the chamber. All local laws and regulations must be followed concerning such emissions and the appropriate permits obtained.

• At the end of the aeration phase and before entering a chamber, use a Dräger Detector tube or other monitoring device to verify the chamber concentration. THE CHLORINE

DIOXIDE CONCENTRATION SHOULD BE AT OR BELOW THE OSHA PEL (AS

OF JANUARY 1998 0.1 PPM, 8 HOUR TWA) BEFORE THE CHAMBER IS

OPENED, ENTERED, OR ACCESSED.

• Warning labels are displayed on the Minidox-M Decontamination System warning of potentially hazardous areas. These labels are shown below:

Minidox-M Decontamination System Operations Guide 14

This label signifies that a potential electrical hazard exists in the area.

Safe Handling of Consumables

• WHEN HANDLING CONSUMABLES, WEAR SAFETY GOGGLES AND VINYL OR

NEOPRENE GLOVES.

• USE ONLY CSI CD CARTRIDGES, WHICH HAVE BEEN SPECIALLY

FORMULATED, TESTED AND APPROVED FOR USE IN THIS GENERATOR. Failing to do so invalidates the warranty. Non-approved consumables could impair equipment operation and result in costly repairs, could result in a non-sterile chamber and could void the equipment warranty. Read the cartridge label for warnings and safety monitoring.

• BEFORE INSTALLING A CARTRIDGE, CHECK THE EXPIRATION DATE. Do not use if it is beyond its expiration date, or if the cartridge will not be fully used before its expiration date. Installation instructions are included in Chapter 6.

• DISPOSE OF CSI CD CARTRIDGES IN A SAFE MANNER. This material may be considered a hazardous waste. Dispose of it in accordance with federal, state, and local regulations

• DO NOT DISPOSE OF CSI CD CARTRIDGES IN LOCAL REFUSE OR WITH WASTE

FOR INCINERATORS. Cartridges cannot be safety subjected to temperatures greater than 52º C (126º F). Disposal of the cartridge should be handled through your local chemical waste treatment facility.

• CSI CD Cartridges should not be stored at temperatures greater than 30º C (85º F).

• Check with local authorities to confirm appropriate cartridge storage requirements and quantities.

• DO NOT USE CHLORINE IN HIGHER (NOMINAL 2%) CONCENTRATION. SUCH

USE IS DANGEROUS AND CAN RESULT IN AN OPERATIONAL HAZARD and will void system warranties. Only 2% chlorine in nitrogen mixtures is suitable for use in the system.

• Do not transport Minidox-M Decontamination Systems with the cartridges installed.

Safe Installation and Maintenance

• UNPACKING AND MOVING THE SYSTEM REQUIRES MORE THAN ONE PERSON.

The unit weighs approximately 400 pounds.

• MOVE THE MINIDOX-M DECONTAMINATION SYSTEM GENERATOR ONLY ON

FLAT SURFACES. Use an elevator to move the unit from one floor to another.

• REPAIRS AND ADJUSTMENT TO THIS EQUIPMENT SHOULD BE MADE ONLY BY

TRAINED SERVICE PERSONNEL. Non-routine maintenance performed by unqualified personnel or installation of unauthorized parts could cause personal injury, invalidate the

Minidox-M Decontamination System Operations Guide 15 warranty, or result in costly damage. CONTACT YOUR SERVICE REPRESENTATIVE

REGARDING SERVICE OPTIONS.

• Regularly scheduled planned maintenance is required for safe and reliable operation of this equipment. CONTACT YOUR SERVICE REPRESENTATIVE TO SCHEDULE

MAINTENANCE

• USE NONABRASIVE CLEANERS WHEN CLEANING THE EXTERIOR OF THE UNIT.

Abrasive cleaners can damage the stainless steel surfaces. Follow directions on the container and rub in a back-and-forth motion (in the same direction as the surface grain). Cleaner rubbed in a circular motion or applied with a wire brush or steel wool can damage the stainless steel surfaces.

Use Only Approved Parts

• USE OF UNAUTHORIZED PARTS MAY BE DANGEROUS AND VOIDS THE

WARRANTY. Use of unauthorized parts for maintenance or repair could cause personal injury and result in costly damage or unit malfunction.

Minidox-M Decontamination System Operations Guide 16

Additional Information The information in this chapter is repeated where appropriate throughout this guide for your safety and use. This information is subsequently labeled: WARNINGS, Cautions or Notes as appropriate.

• WARNINGS are shown in the text in all bold upper case letters. They indicate events or conditions that can result in serious injury or death. All safety precautions must be strictly followed.

• Cautions are shown in the text in bold letters, and they indicate events or conditions that can result in damage to equipment.

• Notes are shown in the text with a check mark . Notes highlight specific information about the proper use and maintenance of the system.

Minidox-M Decontamination System Operations Guide 17

Chapter 3.

General Operating

Information in this chapter . . .

• the Sterilization process

• equipment description

• User Displays

• operational parameters

• description of controls

General Operating Information 3

Minidox-M Decontamination System Operations Guide 18

Overview When the power is turned on, the following conditions occur and/or are monitored:

• The system interface monitor is energized, and displays the main screen.

• The unit monitors all process values, including:

» Pressure in each compressed gas cylinder.

» Pressure up stream of the gas generating cartridges.

» Air temperature in the chamber (when connected).

» Relative humidity in the chamber (when connected).

» Pressure in the chamber (when connected).

» Chlorine dioxide gas concentration in the chamber (when connected).

• The unit monitors all safety interlocks.

• The control system monitors and displays the key process parameters as described above, any process or system alarms, equipment status and cycle step and time.

Minidox-M Decontamination System Operations Guide 19

The Decontamination Process The system provides a simple and reliable method for decontaminating pre-cleaned, sealed ambient chambers using chlorine dioxide gas as the decontamination agent.

Ambient Chambers First, the system conditions the atmosphere of the chamber, raising the relative humidity to the pre-selected level. Chlorine dioxide gas is then introduced to a selected concentration and held for a defined period of time. After the Exposure step, the gas is removed and vented to external exhaust.

The Supervisor creates cycles for selected chambers by specifying the parameters of pressure, humidity, conditioning duration, gas concentration, exposure duration, and aeration duration.

Minidox-M Decontamination System Operations Guide 20

Cycle Steps The steps in the cycle are as follows:

• Pre-Condition

• Conditioning

• Charge

• Exposure

• Aeration

Pre-Condition During Pre-condition, chamber leak testing and/or RH Condition charge may occur. If leak testing is selected prior to beginning the RH Condition charge, the chamber is brought to the pressure test set point and, after the selected time, looks for a pressure drop (ambient application) or pressure increase (vacuum applications).

• If the chamber is not able to hold the selected pressure for the specified time, the process shuts down due to probable leaks.

• If the pressure maintains the level within the specified limits, the unit proceeds to the Condition step.

After leak testing, steam (optional equipment is required) is introduced into the chamber to raise the humidity to the specified set point.

• If a steam injection module is installed, steam is introduced until the set point is reached.

Conditioning Once the humidity is at the proper level the cycle advances to the condition step. Relative humidity (RH) is maintained in the chamber for the selected amount of time.

• If the RH drops 2% below the set point, more steam/humidity is added. If the RH drops by 5% RH below set point the condition time is paused until the RH is again in range.

• If all parameters are acceptable, the process continues to the charge operation.

Charge During Charge, chlorine dioxide gas is generated and introduced into the chamber to achieve a set concentration of gas (approximately 0.1 mg/L [global parameter 77] above the selected set point.)

• The system calculates the required charge time from the operating parameters:

chamber volume and gas concentration selected.

Minidox-M Decontamination System Operations Guide 21

• The feed gas valves open.

When the calculated charge time of chlorine dioxide gas is reached:

• The feed gas valve closes.

• The gas concentration from the chamber is monitored.

If the concentration is below the predetermined setting, gas is again introduced into the chamber. This may occur due to gas loss when pressure in the chamber is relieved, or if materials in the chamber absorb chlorine dioxide. When gas concentration reaches the predetermined level, the unit proceeds to the Exposure step.

Exposure During Exposure, the concentration of chlorine dioxide gas is monitored. If the gas concentration falls below the set point, gas makeup is activated and chlorine dioxide is added to the system. If the gas concentration falls below the set point, the exposure timing is paused until the gas concentration is again at the proper levels.

If a significant drop in chamber pressure occurs, indicating a leak, the cycle alarms. This occurs if pressure drops by 50 Pa from the initiation of Exposure.

If you wish to interact with the chamber during exposure, click Disable Exposure Pressure Alert on the Administration Functions pop-up to disable the alert. If the alert is disabled by the user the following warning is displayed:

Expose Pressure Alert DISABLED

At the end of the cycle the Alert automatically re-enables. The alert can also be re-enabled by clicking Enable Exposure Pressure Alert.

If you determine there is a problem or malfunction, for example, a chlorine dioxide gas leak is detected, you can manually abort the cycle by pressing the Stop button.

When gas has been present for the preset exposure time period, an audible signal MAY sound to alert you to end of Exposure depending on the type of aeration selected during cycle development.

Humidity is additionally controlled during exposure.

Aeration The aeration step allows the chlorine dioxide gas to be removed from the chamber. This is accomplished by allowing clean air into the chamber and the removal of chlorine dioxide from the chamber. When the aeration time has elapsed, an audible signal sounds to alert you to end the cycle (on for 1 second then off for 1 second and repeat until Ack is pressed). The aeration step continues until End Cycle is pressed. To provide maximum flexibility, the cycle can be developed utilizing either type of aeration (automatic or manual).

Minidox-M Decontamination System Operations Guide 22

• Automatic aeration allows the cycle to proceed from exposure directly to aeration without an audible signal, and with no user intervention. Field Configurable (FC’s) relay outputs located in the unit can be automatically energized after exposure. These FC’s would need to be connected to user aeration inlet and outlet valves, motors, blowers, etc., at installation, which controls aeration. This process, when properly installed, allows air into the chamber and out.

• Chlorine Dioxide Generator aeration allows the cycle to proceed from exposure directly to aeration without an audible signal and with no user intervention. This method differs from automatic and manual by supplying air from the pressure add valve and exhausting the chamber through the pressure relief valve. This necessitates connecting compressed air to the unit prior to starting a cycle.

This method provides a way to aerate chambers which do not have inlet and outlet ducts.

• Manual aeration causes the cycle to pause at the end of exposure to prompt the user, by audible signal (on for 1 second then off for 1 second and repeat until Ack is pressed) and a pop-up, to manually open the aeration valves. When Begin Aeration is pressed, the exposure step ends and the aeration step begins.

Upon completion of Aeration, you MUST ensure, via Dräger sampling or other acceptable methods, that the chamber environment is free from or at safe levels of chlorine dioxide before ending the cycle.

Click End Cycle to signify the cycle is completed and the chamber can be safely entered.

Minidox-M Decontamination System Operations Guide 23

Operating Parameters Chamber Parameters

Volume of chamber (cu ft.)

Chlorine dioxide generator pressure relief set point (Pa)

Chamber In Cycle High Pressure Alarm (Pa)

Chamber Leak Test Setup parameters

Leak Test set point (Pa)

Allowable pressure drop (Pa)

Pressure hold time (min)

Condition

Relative Humidity set point (% RH)

Length of Conditioning cycle (min)

Charge

Concentration of chlorine dioxide gas required during Exposure (mg/L)

Control by PPM-Hrs On/Off

Exposure

Length of Exposure Cycle (min)

Control Humidity during Exposure On/Off

Aeration

Use Automatic Aeration Control Selector

Use Manual Aeration Control Selector

CD Generator Aeration Selector

Aeration time (min)

Equipment Description The Minidox-M Decontamination System is portable in design and is comprised of a gas generation section and a sensing/controls section. A steam inject module is available as an optional method of providing humidity. These are used in conjunction with an operator control and monitoring system. The steam inject module delivers steam to raise relative humidity to within a specified range. The PLC (Programmable Logic Control) system controls and monitors pressures, temperatures, and relative humidity during the operating cycles.

Minidox-M Decontamination System Operations Guide 24

Gas Generator Section The gas generation system is designed to supply chlorine dioxide gas to a chamber as required by the process parameters. The gas generator module consists of 2 cylinders of compressed gas (2% chlorine in nitrogen), and a CSI CD Cartridge (active ingredient, sodium chlorite). The cartridge is a self-contained source of a reactant essential for the production of the chlorine dioxide gas. The gas generator takes the chlorine gas mixture from cylinder 1 or 2 then passes the gas through the generator to convert it to chlorine dioxide.

Sensing Section The sensor / electronic section will sample the atmosphere of the chamber. Instruments in this section will provide monitoring for the process variables: relative humidity, pressure, and temperature.

Steam Injection Module The steam injection module provides humidity to the chamber. It consists of a stainless steel steam injection nozzle and associated control valves. It is specially designed to improve steam quality by passing it through its internal heat exchanger in order to minimize condensate from entering the chamber.

Control and Monitoring System The control system automates the gas generation cycle and controls the key process parameters. It also provides feedback via the user interface. The control system consists of a Programmable Logic Controller (PLC) with its associated software and an Operator Interface. The PLC controls all of the functionality of the unit through its analog and digital I/O modules.

The functions of this system are:

• Provide for operator input: The operator enters set points including: chamber volume, gas concentration required, chamber pressure relief required, humidification and exposure time periods.

• Monitor operating conditions: chamber pressure, temperature, relative humidity, cylinder pressure, and chlorine gas pressure down stream of the gas regulating valve.

• Calculate and/or control: steam required to raise humidity from ambient to set point; gas flow to raise gas concentration within the chamber.

• Interlocks: chlorine gas availability and equipment functionality.

User Input Device

• Operator Interface. Allows starting a cycle, aborting a cycle, cycle development, etc.

• Stop button. Aborts the cycle.

User Output Device

• Operator Interface – Displays all process parameters, the process mode, the current cycle step, alarms, and consumables status.

Minidox-M Decontamination System Operations Guide 25

• Horn-An audible alarm that alerts you when new alarms are generated or operator intervention is required.

• USB memory – This will allow the run data to be recorded to a text file. Plug in any memory stick and the data will be run data (CD concentration, RH, Temperature, Pressure and accumulated PPM-Hrs) recorded.

• Printer – During each decontamination cycle a printout is printed if printing is selected on the Print Functions Screen.

Minidox-M Decontamination System Operations Guide 26

User Displays The Operator Interface shows information used to run cycles, develop cycles, monitor the system, and perform various other tasks.

Communications with the chlorine dioxide system are accomplished using the keypad to enter data and clicking buttons.

When you click a field, keypad pop-up appears for entering text and/or numbers. Click the individual keys to type information. Click OK or Enter to accept the information entered.

Main Display The Main display is the first display shown at power up. This is the starting point for beginning a cycle and monitoring the process.

The following system variables are displayed on the Main display.

Field Information Displayed ClO2 (mg/L) Chlorine dioxide concentration in the chamber in milligrams per liter.

PPM-Hrs Displays the accrued ppm-hours during a decontamination cycle. For example 1mg/L = 362 ppm so 1mg/L for 1 hour = 362ppm-hrs

Temperature (º C) Temperature of the chamber in degrees Centigrade.

RH (%) Relative humidity of the chamber displayed in percent.

Pressure (Pa) Pressure of the chamber, above atmosphere, displayed in Pascals.

Loaded Cycle Cycle 1, 2, 3, 4, 5 or 6 is displayed as being loaded.

Time in Cycle Elapsed Hours and Minutes of the current cycle. This counter increments during all cycle phases.

Step The current cycle step: Pre-condition, Condition, Charge, Exposure, Aeration or Not In Cycle.

Minidox-M Decontamination System Operations Guide 27

Field Information Displayed Time in Step Elapsed Minutes of the current step. This counter increments during each step (Pre-condition, Condition, Charge, Exposure and Aeration.) It resets at the beginning of each step. It does not increment when Not In a Cycle.

Cycle in Progress This indication is visible when any cycle is in progress.

Exposure Pressure Fault Disabled

This indication is visible when the Exposure Pressure Fault is Disabled.

Not Enough Cartridge Life

This indication is visible when not enough cartridge life is left for the cycle that was selected. Another cycle with lower concentration must be selected or the cartridges must be replaced.

Not Enough Chlorine This indication is visible when not enough chlorine is available for the cycle that was selected. Another cycle with lower concentration must be selected or the chlorine cylinder must be replaced.

Chamber Volume = 0 Cycle did not load properly. Reload cycle.

PPM-hrs Reached This indication is visible when control by ppm-hrs is on and the ppm-hrs has exceeded the number set in global parameters.

PPM-Hrs = 0 This indication if visible when control by ppm-hrs is on and the global parameter 81 Max PPM-Hrs is 0

Begin Aeration This indication if visible when it is time to begin aeration

End Cycle This indication if visible when it is time to end the cycle

Start Cycle After a cycle has been developed, loaded and verified, click this button to start the cycle.

Abort Cycle After is cycle is in progress, this button will abort or stop the cycle.

Cycle Parameters Displays the cycle parameters that are currently loaded and used.

Cycle Select Displays screen allowing you to choose which cycle to run.

Admin Functions Displays screen to allow user access to all administration functions.

Ack Acknowledges the alarm and silences the horn.

Alms Provides access to the alarm display to view alarms and to reset alarms after the alarm condition has been corrected.

Minidox-M Decontamination System Operations Guide 28

Cycle Select This feature enables you to load pre-developed cycles. Only an operator or supervisor can access the Cycle select. Within this display, you can select a cycle to run.

The following system variables are displayed on the Cycle Select display.

Load Cycle 1 Loads the parameters for Cycle 1 to be loaded and used next time the cycle is started.

Load Cycle 2 Loads the parameters for Cycle 2 to be loaded and used next time the cycle is started.

Load Cycle 3 Loads the parameters for Cycle 3 to be loaded and used next time the cycle is started.

Load Cycle 4 Loads the parameters for Cycle 4 to be loaded and used next time the cycle is started.

Load Cycle 5 Loads the parameters for Cycle 5 to be loaded and used next time the cycle is started.

Load Cycle 6 Loads the parameters for Cycle 6 to be loaded and used next time the cycle is started.

Not Enough Cart Life for Sel Cycle

This indication is visible when not enough cartridge life is left for the cycle that was selected. Another cycle with lower concentration must be selected or the cartridges must be replaced.

Not Enough Chlorine for Selected Cycle

This indication is visible when not enough chlorine is available for the cycle that was selected. Another cycle with lower concentration must be selected or the chlorine cylinder must be replaced.

Chamber Volume = 0 The cycle did not load properly. Reload cycle.

Minidox-M Decontamination System Operations Guide 29

Field Information Displayed PPM-Hrs = 0 This indication if visible when control by ppm-hrs is on and the global parameter 81 Max PPM-Hrs is 0

Main Displays the main screen.

Admin Functions Displays screen to allow user access to all administration functions.

Cycle Parameters Displays the parameters of the cycle selected.

Ack Acknowledges the alarm and silences the horn.

Minidox-M Decontamination System Operations Guide 30

Cycle Edits This feature allows access to edit the Cycles. Only a supervisor access password can access the Edit Cycles.

The following system variables are displayed on the Cycle Select display.

Edit Cycle 1 Displays the Cycle 1 edit screen.

Edit Cycle 2 Displays the Cycle 2 edit screen.

Edit Cycle 3 Displays the Cycle 3 edit screen.

Edit Cycle 4 Displays the Cycle 4 edit screen.

Edit Cycle 5 Displays the Cycle 5 edit screen.

Edit Cycle 6 Displays the Cycle 6 edit screen.

Edit 1-99 cut Ft. Ch Param

Displays the 1-99 cubic foot chamber parameters.

Edit 100-999 Cu Ft.

Ch Param

Displays the 100-999 cubic foot chamber parameters.

Edit 1000 and up Cu Ft. Ch Param

Displays the 1000 and Up cubic foot chamber parameters.

Edit Global Parameters

Displays the Global Configurable Parameters.

Cycle in Progress This indication is visible when any cycle is in progress.

Main Displays the main screen.

Admin Functions Displays screen to allow user access to all administration functions.

Minidox-M Decontamination System Operations Guide 31

Field Information Displayed Ack Acknowledges the alarm and silences the horn.

Minidox-M Decontamination System Operations Guide 32

Cycle Development This screen enables the user to modify Cycle number 1. This screen is only accessible to the supervisor

The following system variables are displayed on the Load Cycle Ambient Display:

Field/Button Description

Chamber Setup

Cham Volume (cu-ft 1-70000) Volume (space to be decontaminated) of the chamber in cubic feet.

Parameter ranges are from 1-70000 cubic feet.

Pressure Relief SP (Pa, 0-600) Pressure set point in Pascal above atmospheric pressure, of the chamber.

Chamber Leak Test Setup Note: If any Leak Test parameters are 0 then leak testing is skipped.

Leak Test Set point (Pa, 0-500) Chamber leak test pressure set point.

Allowable Drop (Pa, 0-500) Pressure drop allowed by system without an alarm condition being sounded.

Hold Time (min, 0-100) Time in minutes the chamber is to wait for leak test to occur.

Condition Setup Note: If condition time parameter is 0 then RH Conditioning is skipped.

RH SP (% 40-100) Relative humidity set point of the chamber displayed in percent.

Cond Time (min, x-600) The time, in minutes, that the load is conditioned. This parameter cannot be lower than Step 1020 Cool time (Parameter 7). If you enter a number lower than Parameter 7 then it will automatically change to a value equal to Parameter 7.

Charge Setup Note: If charge concentration parameter is 0 then Charge and Exposure are skipped.

CD SP (mg/L 0-20) Concentration set point of chlorine dioxide for the chamber.

Minidox-M Decontamination System Operations Guide 33

Field/Button Description

Exposure Setup

Exposure Time (min, 0-600) The time, in minutes, that the load is exposed to chlorine dioxide.

If control by PPM-Hrs is On then the charge or exposure can end if the Max PPM-Hrs is reached. Whichever parameter is reached first (PPM-Hrs or Exposure Time) will determine the exposure time.

RH in Exp This is on if the user wants humidity maintained during exposure.

If turned on the RH level will be maintained to the RH set point entered above.

PPM-Hrs This is on if the user wants to end the cycle when the PPM-Hrs entered on the Global Parameters (81) Max PPM-Hrs is reached. If this is Off then the cycle ends on the exposure time is completed.

Aeration Setup

Automatic Aeration PB This is selected to allow the control system to automatically open the customer aeration valves. This should be selected if the system has automated aeration valves.

Manual Aeration PB This is selected to alert the operator the aeration valves must be manually opened.

CD Gen Aeration PB This is selected to aerate the chamber by adding compressed air to the chamber and relieving the pressure buildup.

Aeration Time (min, 0-600) Time in minutes for aeration.

Additional information

High Pressure SP (0-2400 Pa) The chamber maximum pressure alarm.

Configurable Parameters

• 1-99 CuFt

• 100-999 CuFt

• 1000+ CuFt

Chooses which set of configurable parameters to use. These parameters are in 3 separate groups. 1-99 cu ft, 100-999 cu ft and 1000 and up.

Cycle Edits Displays the Cycle edits screen.

Main Displays the main screen.

Admin Functions Displays screen to allow user access to all administration functions.

Leak Test Parameters Displays the leak test parameters screen

Cycle Edits Returns to the Cycle edits screen

Cycle 1 Returns to the cycle 1 edits screen

Ack Acknowledges the alarm and silences the horn.

Alms Provides access to the alarm display to view alarms and to reset alarms after the alarm condition has been corrected.

NOTE: Cycle number 2, 3, 4, 5 and 6 are identical to Cycle number 1 screen.

Minidox-M Decontamination System Operations Guide 34

Configurable Parameters 1-99, 100-999 and 1000 and Up Only persons having Supervisor access level can modify the configurable parameters. The Configurable Parameters screen is usually reserved for process scientists or engineers. The supervisor modifies the parameters to configure the system to specific chambers. This allows for more customized cycles to maximize efficiencies when the Minidox is connected to different types of chambers such as flexible wall isolators, rigid wall isolators, rooms or processing tanks. The “Cycle Development Configurable Parameters 1” table details the fields and the information, which must be provided by the supervisor.

NOTE: Configurable Parameters 100-999 and 1000 and up are identical to configurable parameters 1-99.

Main Returns the user to the Main display.

Load Default Loads default parameters for the displayed screen.

Cycle Edits Display the Cycle edits screen.

Ack Acknowledges the alarm and silences the horn.

Alms Provides access to the alarm display to view alarms and to reset alarms after the alarm condition has been corrected.

Next Displays the next set of configurable parameters.

Minidox-M Decontamination System Operations Guide 35

The table below details the Configurable Parameters screen 1.

Config Parameter

Number Description

Suggested

Value (1-99 cu ft)

(100-999cu ft)

(1000 & up cu ft)

Step 30 Leak Test Pause for Pressure to Settle.

When the chamber has pressurized for leak testing there is a pause prior to starting the dwell time specified in the Cycle. This allows the chamber pressure to settle before starting countdown.

3 sec 3 sec 3 sec

Step 50 Humidification Heat Up Time. If the CSI steam injector is used then this allows the steam injector to heat up for the time specified before steam in injected. If this value is too low or the quality is steam is poor, condensate may be injected into the chamber along with steam.

150 sec 1 sec 1 sec

Step 60 Humidification Add to SP-X. When the system does the initial RH injection it injects to the specified amount minus this value. For larger chambers (greater than 500 cu ft.) this number can be smaller (1-2%) and for small chambers (8-20 cu ft.) the number should be larger (10- 20%)

5% RH 5% RH 1% RH

Step 70 & 100 & 1050 Pause for RH to settle.

There are several steps in which RH may be injected into the chamber. This value is the time after the inject that allows the RH to distribute before the RH is measured to determine if it is in tolerance.

5 sec 5 sec 10 sec

Step 80 At Condition SP RH for x sec. RH must be at the desired set point for this amount of time before the cycle goes from Pre-Condition to Condition.

60 sec 5 sec 5 sec

Step 90 & 1040 add RH Burst Time. This value is the length of the inject time, after the initial RH injection.

5 sec 5 sec 1 sec

Step 1020 Injector Cool Time Before CD Add. If the CSI steam injector is used, this is the time that allows the steam injector to cool before CD is added.

5 min 1 min 1 min

Step 1010 Injector Cool Time Before RH Add. If the CSI steam injector is used, this value represents the time that the steam injector would be considered to have cooled while in Condition time. If the steam injector has cooled and more steam is required then the system determines how long to heat up the injector for (see next parameters).

60 sec 60 sec 60 sec

Minidox-M Decontamination System Operations Guide 36

Config

(1000 & up cu ft)

Step 1030 Heat Up Injector if Cooled Time. Time to heat up the injector if the time in parameter 8 was exceeded.

120 sec 120 sec 120 sec

Step 1030 Heat Up Injector if NOT Cooled Time.

Time to heat up the injector if the time in parameter 8 was NOT exceeded.

10 sec 10 sec 10 sec

Step 2030 & 2070 & 3030 & 4030 Generator Pressure Relief Time. This value is the time given to relieve pressure in the generator after CD gas injections. The step is just based on time and not pressure readings.

5 sec 5 sec 5 sec

Step 2040 & 2080 & 3040 pause for CD to settle.

There are several steps in which CD may be injected into the chamber. This value is the time after the inject that allows the CD to distribute before the CD is measured to determine if it is in tolerance. The CD Settle time can be made up of this value and the Generator Pressure Relief Time, since they are back to back steps.

5 sec 10 sec 15 sec

CD Minimum Inject Time. If the calculated charge time is less than this value then this value is used for the charge time.

3.0 sec 3.0 sec 3.0 sec

14 Not Used N/A N/A N/A

Step 3020 Exposure CD Inject Time. This value is the CD inject time during Exposure if makeup CD is required to keep that concentration at set point.

Parameter 33 “CD at SP for x sec” will add to time entered.

0.8 sec 1.5 sec 1.5 sec

Step 4010 Ambient Cycle Aerate Time (for # minutes). Initial aeration reduction time.

120 sec 120 sec 120 sec

17 Not Used N/A N/A N/A 18 Not Used N/A N/A N/A

Step 4040 Reduce CD Concentration to SP in 1/10 mg/L. This is the value in which the CD must be lowered to before the Aeration time entered in the Cycle is started.

0.5 mg/L 0.5 mg/L 0.5 mg/L

20 Not Used N/A N/A N/A

Minidox-M Decontamination System Operations Guide 37

Load Default Loads default parameters for the displayed screen.

Cycle Edits Display the Cycle edits screen.

Ack Acknowledges the alarm and silences the horn.

Alms Provides access to the alarm display to view alarms and to reset alarms after the alarm condition has been corrected.

Previous Displays the previous set of configurable parameters.

(1000 & up cu ft) 21 Not Used N/A N/A N/A

Pressure Relief Close Valve. PR SP – #. This value is used if Pressure Relief is chosen in the Cycle. This value tells the pressure relief valve when to close, i.e. pressure relieved.

5 Pa 5 Pa 5 Pa

23 Not Used N/A N/A N/A 24 Not Used N/A N/A N/A

Pressure Control Add Lowest Pressure SP. If Pressure Add Control is selected then this value is the low pressure set point for the chamber where pressure will be triggered to be added.

40 Pa 40 Pa 40 Pa

Pressure Control Add Pressure Stop Add (Low SP + X). If Pressure Add Control is selected then this value is the point, above parameter 25, when the pressure add valve is closed, i.e.

pressure is greater than the Lowest Pressure SP

10 Pa 10 Pa 10 Pa

Minidox-M Decontamination System Operations Guide 38

Config

(1000 & up cu ft)

Use Pressure Add Control. Select this for ON to keep the chamber over a minimum pressure value. This is typically required for sterility applications.

Off Off Off

Step 90 Inject RH to SP. If turned on RH will be injected until the RH is at set point instead of time.

Off On On

Step 1040 Inject RH to SP. If turned on RH will be injected until the RH is at set point instead of time.

Off On On

Step 2020 Inject CD to SP. If turned on CD will be injected until the CD is at set point instead of time.

Off On On

Step 2060 Inject CD to SP. If turned on CD will be injected until the CD is at set point instead of time.

Off On On

Step 3020 Inject CD to SP. If turned on CD will be injected until the CD is at set point instead of time.

Off On On

CD at SP for X sec. This value allows the CD injecting valves to stay open for x seconds after concentration is reached. This is used to speed up charge when concentration is reached then drops quickly before exposure starts.

1.0 3.0 10.0

Chrg/ Exp PrsRel. If turned on the Charge and exposure pressure relief is used to relieve the pressure in the generator during charge and exposure. Pressure is always relieved during the aeration step.

Off On On

Minidox-M Decontamination System Operations Guide 39

Field/Button Description

Main Returns the user to the Main display.

Load Default Loads default parameters for the displayed screen.

Cycle Edits Display the Cycle edits screen.

Ack Acknowledges the alarm and silences the horn.

Alms Provides access to the alarm display to view alarms and to reset alarms after the alarm condition has been corrected.

Previous Displays the previous set of configurable parameters.

The table below details the Chamber Parameters Alarm screen.

(1000 & up cu ft)

Step 20 Chamber Pressurization Alarm Time.

This is the alarm time for chamber leak testing pressurization. If the time exceeds this value for chamber pressurization then this alarm occurs.

120 sec 240 sec 600 sec

Step 60 Excessive humidification time alert.

This alarm time is for chamber humidification time. If the chamber is not up to the Cycle RH value in this time then this alarm occurs.

5.0 min 10.0 min 15.0 min

Condition RH Alarm. If during Condition, RH drops below the RH SP - # then this alarm occurs.

5% RH 5% RH 5% RH

Excessive Condition Time Alarm. If the Condition Time exceeds the Condition time * # then this alarm occurs.

2 2 2

Slow Charge time. This value determines the time to check if there is a problem with charging CD. The time is determined by dividing the calculated charge time by this value. If after this time the concentration is not at a calculated value, then the Slow Charging Fault occurs. If 0 is entered the alarm is disabled (alarm 57).

4 3 2

Slow Charge CD Concentration set point. This value determines the concentration set point to verify the CD concentration in the chamber is at a minimum level after the Slow Charge Time (previous parameter) has elapsed. If the concentration is not at the target concentration divided by this value after the Slow Charge Time, then the Slow Charging Fault occurs. If 0 is entered the alarm is disabled (alarm 57).

10 10 10

Minidox-M Decontamination System Operations Guide 40

Config

(1000 & up cu ft)

Excessive charge time. If the actual charge time exceeds the…