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Getinge ISOTEST User Manual

Sterility testing isolator
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ISOTEST
USER MANUAL

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Summary of Contents for Getinge ISOTEST

  • Page 1 ISOTEST USER MANUAL...
  • Page 2 GETINGE-LA CALHENE ISOTEST | User manual ISOTEST Title : User manual Document type : Customer reference : GLC reference: Customer : Number of pages : Version : Date: 07.07.2010 REVISION HISTORY Date Version Description Written by First issue (09/186) 22.12.2009 E.

  • Page 3: Table Of Contents

    GETINGE-LA CALHENE ISOTEST | User manual CONTENTS Page IDENTIFICATION........................ 5 1.1. ISOLATOR BRAND AND DESCRIPTION..............5 1.2. VERSION OF THE ISOLATOR AND THE SOFTWARE.......... 5 1.3. MANUFACTURER'S NAME AND ADDRESS ............6 COMPLIANCE REPORT ....................7 SAFETY NOTES......................... 8 3.1.
  • Page 4 GETINGE-LA CALHENE ISOTEST | User manual INSTRUCTIONS FOR THE TOOLS AND ACCESSORIES ..........56 9.1. DPTE-BETA BAG ....................56 9.2. TUBING SYSTEM..................... 56 OPTION LIST ........................59 10.1. CONTROL SYSTEM....................59 10.2. ACCESSORIES ......................59 10.3. CONSUMABLES ...................... 59 DEFINITION OF THE TECHNICAL TERMS ..............60 APPENDICES ........................

  • Page 5: Identification

    GETINGE-LA CALHENE ISOTEST | User manual IDENTIFICATION 1.1. ISOLATOR BRAND AND DESCRIPTION Rigid-wall isolator for the performance of sterility tests ISOTEST (European version) 1.2. VERSION OF THE ISOLATOR AND THE SOFTWARE The isolator is identified by its serial number and by the software version indicated on the operator panel (see technical manual, configuration chapter).

  • Page 6: Manufacturer's Name And Address

    GETINGE-LA CALHENE ISOTEST | User manual Isolator serial number Operator panel and PLC program version number 1.3. MANUFACTURER'S NAME AND ADDRESS 1, rue du Comté de Donegal 41102 Vendôme cedex – France GETINGE-LA CALHENE +33 (0)254 734 747 +33 (0)254 734 710 www.getinge-lacalhene.com...

  • Page 7: Compliance Report

    GETINGE-LA CALHENE ISOTEST | User manual COMPLIANCE REPORT EMC directive no. 89/336/EEC modified by directives 91/263/EEC, 92/31/EEC, 93/68/EEC, − 92/31/EEC. Low voltage directive no. 73/23/EEC. − Test voltage (standard test): as per EN 61 010-1, 2001 issue. − Overvoltage classification II, pollution level 2 −...

  • Page 8: Safety Notes

    GETINGE-LA CALHENE ISOTEST | User manual SAFETY NOTES 3.1. DEFINITIONS AND WARNINGS Means that failure to apply the correct safety measures will result in death or serious injury. DANGER Means that failure to apply the correct safety measures may result in death or serious injury.

  • Page 9: General

    Use of the The equipment should only be used for the applications equipment specified in the manual, with devices and components according to its recommended and approved by Getinge-La Calhène destination 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 9/74...

  • Page 10: General Operation And Range Of Applications

    ISOTEST | User manual GENERAL OPERATION AND RANGE OF APPLICATIONS The ISOTEST isolator is a sealed enclosure which allows its user to perform biodecontamination of various surfaces inside the isolator by chemical means in a closed circuit. The unit is designed and equipped so as to be able to be biodecontaminated using...

  • Page 11: Safety Information

    Do not use the ISOCYT isolator in an explosive atmosphere. Only use "HYDROCYDE" hydrogen peroxide with a concentration DANGER of 35 % as recommended by Getinge-La Calhène The ISOCYT isolator makes use of hazardous toxic products. The user must take all necessary steps before the proper authorities to have this new equipment included in their safety analysis study.
  • Page 12 GETINGE-LA CALHENE ISOTEST | User manual All maintenance operations must be performed after aerating the circuits that contain hydrogen peroxide in gaseous form and purging the circuits in which the sterilant is in liquid form. WARNING It is compulsory to rinse with water when removing a component on the injection circuit.

  • Page 13: Commissioning

    GETINGE-LA CALHENE ISOTEST | User manual COMMISSIONING Set the master switch to position 1. − Check that the operator panel switches on. The welcome view appears automatically: − 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 13/74...

  • Page 14: Equipment Description

    GETINGE-LA CALHENE ISOTEST | User manual EQUIPMENT DESCRIPTION 7.1. OVERVIEW Number Designation Work station Sleeves and gloves Quick biodecontamination airlock container Red/green LEDs for door opening authorisation Touch-sensitive operator interface 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 14/74...
  • Page 15 GETINGE-LA CALHENE ISOTEST | User manual Number Designation Ventilation / Filtration Control-command Biodecontamination airlock Built-in STERITRACE II hydrogen peroxide sterilizer 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 15/74...

  • Page 16: Operator Interface

    GETINGE-LA CALHENE ISOTEST | User manual 7.2. OPERATOR INTERFACE Number Designation Master power switch EMERGENCY AERATION push-button Touch screen 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 16/74...

  • Page 17: Work Station

    GETINGE-LA CALHENE ISOTEST | User manual 7.3. WORK STATION Number Designation Steritest pump DPTE® S transfer system Basket hanging bars Sleeve and glove Special precautions must be taken when opening the inner door. Consult chapter 5 – Information and Safety.

  • Page 18: Biodecontamination Airlock

    GETINGE-LA CALHENE ISOTEST | User manual 7.4. BIODECONTAMINATION AIRLOCK Number Designation Transfer trolley Biodecontamination airlock door Sealing gaskets Inner door Basket Inspection window To help when loading the baskets in the transfer trolley, a preparation IMPORTANT trolley can be placed in front of the airlock.

  • Page 19: Steritrace Ii Sterilizer Interface

    GETINGE-LA CALHENE ISOTEST | User manual 7.5. STERITRACE II STERILIZER INTERFACE Number Designation Needle-positioning lever (perforation of the cap of the vial) Vial container Hydrogen peroxide vial 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 19/74...

  • Page 20: Handling

    ISOTEST | User manual 7.6. HANDLING Before each sterilization cycle, Getinge-La Calhène recommends checking the integrity of the isolator gloves. The method consists of: − conducting a test by raising the oxygen level to assess glove performance (GLT testing device – operator manual NT 3020/1) If the result of the test is "not correct", the glove must be replaced.
  • Page 21 PVC-coated polyester. Before starting operations, it is compulsory to remove any objects that might damage the glove: watch, rings, etc. Getinge-La Calhène also recommends wearing under- CAUTION gloves (for hygiene) and over-gloves, which must be replaced frequently (to reduce cross-contamination).
  • Page 22 GETINGE-LA CALHENE ISOTEST | User manual PVC / Divetex sleeve Hypalon® sleeve Neoprene glove Hypalon® glove 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 22/74...

  • Page 23: Operation

    GETINGE-LA CALHENE ISOTEST | User manual OPERATION 8.1. TRANSFER SYSTEM The unit is equipped with two DPTE® ALPHA 190 transfer systems, one of which is fixed to the work top of the work station allowing the connection of a DPTE-DispoBagTM transfer system to ensure safe evacuation of liquid/solid waste.
  • Page 24 GETINGE-LA CALHENE ISOTEST | User manual The following is provided for the connection of a Beta part: DPTE-DispoBag or DPTE- Tubing This system is completely interlocked. It allows completely safe connection / disconnection of the Alpha and Beta parts. The door can only be opened using the lever when a Beta part is connected to the Alpha part and, likewise, the Beta part can only be disconnected if the door is closed.

  • Page 25: Process

    GETINGE-LA CALHENE ISOTEST | User manual 8.2. PROCESS After a power failure or when a user logs off, the following view appears: To access the user view, press the screen. 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 25/74...
  • Page 26 GETINGE-LA CALHENE ISOTEST | User manual User view To start a complete cycle, the operator must follow the instructions on the panel with the help of the block diagram. Number Designation Operator instructions Block diagram of a cross-section of the machine...
  • Page 27 GETINGE-LA CALHENE ISOTEST | User manual Number Designation Isolator control buttons. Halts an isolator cycle in progress (in the case of a biodecontamination, airlock automatically launches the emergency phase). Launches the isolator cycle. Launches a new batch (in production or waiting production phase).
  • Page 28 GETINGE-LA CALHENE ISOTEST | User manual 8.2.1. User password Operator mode requires the entry of a user password. − When any of the buttons are pressed, the following screen appears: − Enter the username (default "Oper") followed by the password (default "101").
  • Page 29 GETINGE-LA CALHENE ISOTEST | User manual 8.2.2. Cycle progress "The goal of steps 1 to 4 is to prepare the isolator during initial commissioning or after a cleaning or maintenance operation with breach of containment (operation recommended once per month). The isolator is not sterile at the start of this phase, and is sterile at the end.
  • Page 30 GETINGE-LA CALHENE ISOTEST | User manual Make sure the inner door of the biodecontamination airlock is open. Make sure a vial of HYDROCYDE is inserted in the container of the Steritrace II sterilizer and that the needle-positioning lever is in the bottom position.
  • Page 31 GETINGE-LA CALHENE ISOTEST | User manual Press the "Not ready" button and the following window appears. − All the locking parameters must be set to "YES" in order to begin the cycle. − Yes -> Condition met No -> Condition missing Press the enter key to return to the user view.
  • Page 32 GETINGE-LA CALHENE ISOTEST | User manual If the verification of the H bottle is correct, the following window appears. The − following phases then succeed one another automatically (see steps 3 and 4). If the cycle takes place without any faults and if the test is declared non- −...
  • Page 33 GETINGE-LA CALHENE ISOTEST | User manual If the verification of the bottle is not correct, the following window appears. − Note: Correct the missing condition and then restart the process from step 1. Three possible alarms: − quantity for next cycle fault,...
  • Page 34 GETINGE-LA CALHENE ISOTEST | User manual Step 5: If the biodecontamination phase is completed with no errors, the isolator − automatically enters the waiting production phase and the airlock enters the unloading phase. Step 6: To start a production phase, press button –...
  • Page 35 GETINGE-LA CALHENE ISOTEST | User manual The following animation appears: The operator can transfer the load (in the presence of a load) into the isolator and then close the door. Step 8: The isolator door is closed. The airlock is in loading phase.
  • Page 36 GETINGE-LA CALHENE ISOTEST | User manual Step 9: The airlock door is closed. The airlock is in loading phase. − The airlock is not sterile. The following animation appears: When the load is inserted, the operator can close the airlock door.
  • Page 37 GETINGE-LA CALHENE ISOTEST | User manual The "Start" button is displayed. − All the conditions required for beginning a cycle are met. Press this button to move on to step 9. The operator wants to select another recipe for the biodecontamination phase.
  • Page 38 GETINGE-LA CALHENE ISOTEST | User manual Step 11: The airlock begins to check the H bottle. − If the verification of the sensor is not correct, the following window appears. − Note: Correct the missing condition and then restart the process from step 7.
  • Page 39 Check the tightening of the clamps, cable glands and hose attachments. − Press "stop airlock" and return to step 7. − If the fault continues, consult the Getinge After-Sales Service Centre for your − region. 3015/78 C Approuvé informatiquement / Electronic signature...
  • Page 40 GETINGE-LA CALHENE ISOTEST | User manual Step 12: The test phase is correct. − If the leak test phase is correct, the biodecontamination cycle starts and the − following animation appears: Step 13: If the biodecontamination phase is completed with no errors, the airlock enters −...
  • Page 41 GETINGE-LA CALHENE ISOTEST | User manual The operator can transfer the load to the isolator. − After transferring the load to the isolator, the operator can close the door again. − Step 14: The isolator door is closed. The airlock is in loading phase.
  • Page 42 GETINGE-LA CALHENE ISOTEST | User manual Step 15: The airlock door is closed. The airlock is in loading phase. − The airlock is not sterile. The following animation appears: When the load is inserted, the operator can close the airlock door.

  • Page 43: Stopping A Cycle By The User

    GETINGE-LA CALHENE ISOTEST | User manual If the test phase is not valid, the following animation appears: − Perform the same steps for subsequent cycles. − 8.3. STOPPING A CYCLE BY THE USER The operator can halt a cycle by pressing the isolator or airlock "stop" button.

  • Page 44: Emergency Aeration

    GETINGE-LA CALHENE ISOTEST | User manual Premature halting of the aeration process will allow the outer door to be opened with a residual level of H in the machine which is higher than the minimum level defined for normal operation. This therefore represents a risk of...

  • Page 45: Printing

    GETINGE-LA CALHENE ISOTEST | User manual 8.5. PRINTING If the printing option is selected, a report is automatically generated at the end of each phase. The data from the preceding cycle are always stored in the memory and can then be printed from the user screen.
  • Page 46 GETINGE-LA CALHENE ISOTEST | User manual Select "current cycle" or "last cycle" − Press the button to scroll down the menu until the following window appears: − 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 46/74...
  • Page 47 GETINGE-LA CALHENE ISOTEST | User manual Press the button to scroll down the menu until the following window appears: − Press the button to print the report. − 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 47/74...
  • Page 48 GETINGE-LA CALHENE ISOTEST | User manual Perform the same steps for all the subsequent phases. − 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 48/74...
  • Page 49 GETINGE-LA CALHENE ISOTEST | User manual Procedure for printing the alarm log In the user view, press the "alarm" button and the following view appears: − Press the "print" button. − There are two options for printing the alarm log: −...
  • Page 50 GETINGE-LA CALHENE ISOTEST | User manual Alarm log − Alarm status Alarm time Date de l’alarme Alarm text Alarm status: – alarm appearing. – (A) D alarm disappearing and acknowledged. 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 50/74...

  • Page 51: Process Alarms

    GETINGE-LA CALHENE ISOTEST | User manual 8.6. PROCESS ALARMS Any error occurring during a cycle is displayed in the alarm view and must be − acknowledged. Alarm status: – A alarm appearing (in red). – (A) D alarm disappearing and acknowledged (in green).

  • Page 52: Recipe

    ISOTEST | User manual 8.7. RECIPE The parameters are defined and validated by Getinge-La Calhène. Any modification may cause a change in the cycle. The "recipe menu" can be accessed from the main view with at least "validation" access level.
  • Page 53 GETINGE-LA CALHENE ISOTEST | User manual Press the value to be modified. The following window opens: − Upper limit value Lower limit value Validation after entering value Press the button to print the recipe. − Recipe modification date and time...
  • Page 54 GETINGE-LA CALHENE ISOTEST | User manual Airlock biodecontamination recipe modification Select the airlock biodecontamination recipe. The following view appears: − Number Designation Allows the user to select a recipe Number of the selected recipe Name of the parameter to be changed...

  • Page 55: Cleaning

    GETINGE-LA CALHENE ISOTEST | User manual 8.8. CLEANING It is advisable prior to any cleaning operation on the isolator, to consult the leaflet NT 3015/12. Before beginning to use any other cleaning products, it is essential to check their chemical compatibility with the...

  • Page 56: Instructions For The Tools And Accessories

    GETINGE-LA CALHENE ISOTEST | User manual INSTRUCTIONS FOR THE TOOLS AND ACCESSORIES 9.1. DPTE-BETA BAG Safe waste disposal with DPTE-BetaBag The DPTE® 190 beta is fixed to a mixed bag (20-litre liquid – 100-litre solid). The overall system has been 100 % tested for leaks.
  • Page 57 GETINGE-LA CALHENE ISOTEST | User manual 9.2.1. Basket The baskets are made of 316 L stainless steel. − Dimensions (mm): 240 x 160 x 370 − Max. admissible load: 2 kg − 9.2.2. Basket (½ campaign) The basket is made of 316 L stainless steel.
  • Page 58 GETINGE-LA CALHENE ISOTEST | User manual 9.2.3. Welding machine The welding machine and its frame are made of 316L stainless steel. The welding machine consists of a double welding line and a cutting system. This machine makes it possible to isolate the product to be transferred while keeping the containment in the isolator.

  • Page 59: Option List

    GETINGE-LA CALHENE ISOTEST | User manual OPTION LIST 10.1. CONTROL SYSTEM PLC server traceability Printer (with PLC system) Printer (without PLC system) 10.2. ACCESSORIES Trolley for mixed waste 4 stainless-steel baskets metering system for the operator room 2 ergonomic seats 1 welding machine (Tubing™...

  • Page 60: Definition Of The Technical Terms

    GETINGE-LA CALHENE ISOTEST | User manual DEFINITION OF THE TECHNICAL TERMS Work station Sealed volume in which the work is performed. (or work isolator) STERITRACE II Hydrogen peroxide sterilizer (H The sterilizer only takes care of the sterilant intake, the outlet Open loop is provided by the isolator extractor.

  • Page 61: Appendices

    GETINGE-LA CALHENE ISOTEST | User manual APPENDICES (2 appendices) 3015/78 C Approuvé informatiquement / Electronic signature DEX | Page 61/74...
  • Page 62 Appendix 1 3015/78 C DEX | Page 1/1...
  • Page 63 Appendix 2 3015/78 C DEX | Page 1/11...
  • Page 64 Appendix 2 3015/78 C DEX | Page 2/11...
  • Page 65 3015/78 C Appendix 2 DEX | Page 3/11...
  • Page 66 Appendix 2 3015/78 C DEX | Page 4/11...
  • Page 67 Appendix 2 3015/78 C DEX | Page 5/11...
  • Page 68 Appendix 2 3015/78 C DEX | Page 6/11...
  • Page 69 Appendix 2 3015/78 C DEX | Page 7/11...
  • Page 70 Appendix 2 3015/78 C DEX | Page 8/11...
  • Page 71 Appendix 2 3015/78 C DEX | Page 9/11...
  • Page 72 Appendix 2 3015/78 C DEX | Page 10/11...
  • Page 73 Appendix 2 3015/78 C DEX | Page 11/11...
  • Page 74 COMPLETE SOLUTIONS FOR CONTAMINATION PREVENTION Getinge is the world’s leading provider of solutions for effective cleaning, disinfection and sterilization in the healthcare and life science sectors. We are dedicated to helping our customers provide maximum productivity in the most cost-efficient way.

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