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<h2>1. PURPOSE</h2>
<div>1.1 To verify and document the proper installation of the new ETO Sterilizer (Serial Number: 201346 and</div>
<div>Model: HMQ-100) and any ancillary items have been supplied and installed in accordance with their INSTALLATIONAL QUALIFICATION PROTOCOL</div>
<div>For HZBOCON&amp; Fengtai 98.6 M 3Size ETO Sterilizer (S/N: 201346)</div>
<div>Used to sterilize Medical Devices Products</div>
<div>&nbsp;</div>
<div>specification.</div>
<div>This protocol defines the Installation Qualification (IQ) requirements and the corresponding acceptance</div>
<div>criteria for the 98.6 m 3 ETO Sterilizers which installed at ETO sterilization facility of medical product</div>
<div>Co., LTD., which is located in XXX.</div>
<div>&nbsp;</div>
<div>
<h2>2. BACKGROUND</h2>
<div>2.1 In order to expand capacity, A new 98.6 m 3 ETO sterilizers is added and installed in ETO sterilization</div>
<div>facility of XXX Co., LTD , XXX . xxx will use it to sterilize medical products.</div>
<div>2.2 The sterilizer is a 98.6 cubic meter chamber manufactured by Hangzhou Bocon Mechanical &amp;Electrical</div>
<div>Equipment co.Ltd and Beijing Fengtai Yongding Disinfection Equipment Factory. It is water-jacketed</div>
<div>with gas circulation system, it use 100% ETO gas as sterilizing agent, The sterilizer hold thirty (30)</div>
<div>pallets of size L1000mm x W1200mm x H120mm and the inner size of chamber is L16600mm x</div>
<div>W2700mm x H2200mm.</div>
<div>2.2 IQ study</div>
<div>2.2.1 Safety review of all parameters and decisions to operate the chamber under any operating</div>
<div>conditions.</div>
<div>&nbsp;</div>
<div>
<h2>3. REFERENCE</h2>
<div>3.1 ISO11135-1:2007 Sterilization of health care products &mdash; Ethylene oxide &mdash; Part 1: Requirements for</div>
<div>development, validation, and routine control of a sterilization process for medical devices</div>
<div>3.2 ISO11135-2:2008 Sterilization of health care products &mdash; Ethylene oxide &mdash; Part 2: Guidance on the</div>
<div>application of ISO 11135-1</div>
<div>3.3 AAMI TIR15:2009 Physical aspects of ethylene oxide sterilization</div>
<h2>4. RESPONSIBILITIES</h2>
<div>4.1 Sterilization validation department</div>
<div>4.1.1 Sterilization Engineer will draft installation qualification protocol, gather supporting</div>
<div>documentation &amp; data and review, write final validation technical report.</div>
<div>4.1.2 QA director will review and approve validation protocol and final technical report.</div>
<div>4.2 Testing center</div>
<div>4.2.1 Responsible calibration personnel will prepare calibration procedure and complete calibration of</div>
<div>all relevant measuring device before installation qualification.</div>
<div>4.3 Equipment department</div>
<div>4.3.1 Install, set-up, and operate equipment for purposes of this study. Provide relevant equipment</div>
<div>information, documentation and drawing for IQ,</div>
<div>4.3.2 Inspect and accept sterilizer hardware and software according to purchase technical contract;</div>
<div>4.3.3 Provide technical support for any utility related issue.</div>
<div>4.4 ETO sterilization center</div>
<div>4.4.1 Technician: Provide process and equipment documentation, provide technical support.</div>
<div>4.4.2 Operator: Assist for inspect equipment and collect relevant evidence.</div>
<div>4.1.3 Vice general manager: Review and approve validation protocol and final technical report.</div>
<div>&nbsp;</div>
<div>
<h2>5. DEVIATION AND CHANGE CONTROL</h2>
<div>5.1 Deviation and/or change may happen during the qualification process. If it occurs, a corresponding</div>
<div>deviation form on Attachment A will be completed and submitted to the validation engineer for</div>
<div>disposition. The deviation form will describe the deviation / change, the impact to validation, resulting</div>
<div>investigation, and action. The deviation form will be reviewed for acceptability and approved by the</div>
<div>personnel responsible for protocol approval. The deviation form will be the part of the validation report</div>
<div>for final determination.</div>
<div>&nbsp;</div>
<div>
<h2>6. TEST INSTRUMENTS AND MATERIAL</h2>
<div>6.1 Sterilizer#17 (internal asset number: F2-EMJ-017) and ancillary system.</div>
<div>&nbsp;</div>
<h2>7. INSTALLATION QUALIFICATION PROCEDURE</h2>
<div>7.1 The following Installation Qualification sections will detail the documentation required to verify that the</div>
<div>installation of the EO sterilizer according to the manufacturer&rsquo;s recommendations and the approved</div>
<div>design specifications.</div>
<div>7.2 Equipment Documentation</div>
<div>7.2.1 List all of the documentation that drove the design, purchase and installation of the sterilizer in</div>
<div>Attachment B-1 &amp; B-2. Check the following requirements:</div>
<div>7.2.1.1 Drawings of the equipment installed, and other ancillary equipment. (System map of</div>
<div>sterilizer, installation sketch map of sterilizer, pipeline marking schedule, etc)</div>
<div>7.2.1.2 Building Drawings of equipment (show the installation location)</div>
<div>7.2.1.3 Purchase Orders</div>
<div>7.2.1.4 Manual (may include operating instruction, installation instruction, safe operation</div>
<div>regulation of sterilizer, maintenance guide of sterilizer, normal malfunctions and</div>
<div>troubleshooting of the sterilizer, etc)</div>
<div>7.2.2 Document the following information into attachment B-1 where applicable</div>
<div>7.2.2.1 Title</div>
<div>7.2.2.2 Document Number</div>
<div>7.2.2.3 Issue Date</div>
<div>7.2.2.4 Revision Number</div>
<div>7.2.2.5 Location</div>
<div>7.2.3 Acceptance Criteria: All drawings / Documents must accurately represent the machine as</div>
<div>installed. Make note in the following table if any changes were made to the individual drawings</div>
<div>or documents.</div>
<div>7.3 Standard Operating, Cleaning, Calibration and Maintenance Procedures</div>
<div>7.3.1 Allmed shall establish and implement procedure to assure the equipment operation and</div>
<div>maintenance under control.</div>
<div>7.3.2 The responsible personnel at Allmed will establish corresponding standard operating, cleaning,</div>
<div>calibration and maintenance procedures based on training, experience, and any</div>
<div>recommendations from the equipment supplier. List all SOP&rsquo;s in Attachment B-2. Document</div>
<div>the following where applicable.</div>
<div>7.3.2.1 SOP Number</div>
<div>7.3.2.2 Title</div>
<div>7.3.2.3 Version Number / Effective Date</div>
<div>7.3.2.4 SOP Location</div>
<div>7.3.3 Acceptance Criteria: All SOP&rsquo;s needed for the operation, cleaning, calibration and</div>
<div>maintenance of the chamber must exist.</div>
<div>7.4 Spare Parts List</div>
<div>7.4.1 The responsible personnel at Allmed will develop spare parts list, based on training,</div>
<div>experience, and any recommendations from the equipment supplier. Appropriate spare parts</div>
<div>shall be ordered. List the spare parts in Attachment B-3, or attach the equivalence report to</div>
<div>Attachment B-3 is also acceptable.</div>
<div>7.4.2 Acceptance Criteria: spare parts has been listed and ordered.</div>
<div>7.5 Calibration</div>
<div>
<div>7.5.1 All sterilizer monitor, controls, indicator or record parameters (time, temperature, humidity,</div>
<div>pressure, etc.) and test instruments shall be identified and criticality determined.</div>
<div>7.5.2 Non-critical instrumentation shall be identified and indication of labeling as &ldquo;Not Calibrated&rdquo;.</div>
<div>The following instrumentations shall be considered non-critical:</div>
<div>7.5.2.1 Steam Pressure Gauge, at steam generator, monitors the steam pressure</div>
<div>7.5.2.2 Compressed Air Pressure Gauge, at compressed air entrance piping, monitor the</div>
<div>Pressure of the compressed air.</div>
<div>7.5.2.3 EO Gas Pressure Gauge, at EO entrance pipe, monitors the pressure of the ETO gas</div>
<div>7.5.2.4 Hot Water Pressure Gauge, at hot tank entrance and exit, monitor water entrance</div>
<div>and exit pressure.</div>
<div>7.5.2.5 Nitrogen Pressure Gauge, at nitrogen stage tank, monitor nitrogen stage tank</div>
<div>pressure.</div>
<div>7.5.2.6 Vacuum pressure gauge, within wind circulation piping.</div>
<div>7.5.2.7 Other gauges</div>
<div>7.5.3 Critical instrumentation must be calibrated traceable to a national standards institute. All test</div>
<div>equipment used in IQ shall be calibrated before validation studies. The following</div>
<div>instrumentations are known and shall be considered critical:</div>
<div>7.5.3.1 Temperature sensors: Two (2) as a whole are within chamber, one (1) is within</div>
<div>vaporizer and one (1) is in EO gas injection inlet.</div>
<div>7.5.3.2 Humidity sensor: Two (2) are within circulation main piping.</div>
<div>7.5.3.3 Pressure sensor: Two (2) are within chamber.</div>
<div>7.5.3.4 ETO tank scale: One (1) is specially used for the sterilizer.</div>
<div>7.5.4 Verify and document that all critical instrumentation has been introduced into the calibration</div>
<div>program. List all critical instruments and devices with their accuracy, precision, range,</div>
<div>calibration due date into sheet Attachment B-4, or attach the equivalent report to Attachment</div>
<div>B-4 is also acceptable.</div>
<div>7.5.4.1 Instrument Name</div>
<div>7.5.4.2 Model Number</div>
<div>7.5.4.3 Serial Number</div>
<div>7.5.4.4 Range</div>
<div>7.5.4.5 Precision</div>
<div>7.5.4.6 Calibration Certificate No.</div>
<div>7.5.4.7 Calibration Due Date</div>
<div>7.5.5 Acceptance Criteria</div>
<div>7.5.5.1 Each instrument must be in compliance with the Calibration Program. Each critical</div>
<div>instruments must be within the calibration due date and the calibration should be</div>
<div>effective.</div>
<div>7.5.5.2 A response of &ldquo;Yes&rdquo; is required for items which require a Yes / No response.</div>
<div>7.5.5.3 Any response of &ldquo;No&rdquo; must be explained in the comments section.</div>
<div>7.6 Installation inspection</div>
<div>7.6.1 Complete Attachment C which defines the information of the sterilizer. Document the following</div>
<div>where applicable:</div>
<div>7.6.1.1 Manufacturer</div>
<div>7.6.1.2 Model Number</div>
<div>7.6.1.3 Serial Number</div>
<div>7.6.1.4 Asset Number</div>
<div>7.6.1.5 Location</div>
<div>
<div>7.6.1</div>
<div>Verify that equipment is compliance with installation specifications which described below and</div>
<div>document in Attachment C. Attach the drawings which show the installation location and</div>
<div>requirements of these parts.</div>
<div>7.6.2.1 Chamber construction: check the constructions materials of the inner wall of the</div>
<div>chamber, the material shall be made of stainless steel，the inner size of chamber is</div>
<div>L16600mm x W2700mm x H2200mm.</div>
<div>7.6.2.1 Load door and unload door: check the constructions materials of the inner wall</div>
<div>of the doors, the material shall be made of stainless steel, Doors are lifted by</div>
<div>Pneumatic jacks that are operated by pushbuttons mounted on the side of the</div>
<div>chamber. Once the doors have been lifted they can then be manually swung open.</div>
<div>7.6.2.2 Silicone gaskets with internal inflatable type are fitted between both the load and</div>
<div>unload door, a gaskets are equipped into groove of door frame for each door. when</div>
<div>start sterilizer, nitrogen gas inflate gasket, the door and chamber keep seal, when</div>
<div>complete run, deflate gasket, the seal is relieved, the door can be opened.</div>
<div>7.6.2.3 Temperature sensors: Two (2) as a whole are within chamber, one (1) is within</div>
<div>vaporizer and one (1) is in EO gas injection inlet.</div>
<div>7.6.2.4 Humidity sensors: Two (2) are within circulation main piping</div>
<div>7.6.2.5 Pressure sensors: Two (2) are within chamber</div>
<div>7.6.2.6 ETO cylinder scale: One (1) is specially used for the sterilizer</div>
<div>7.6.2.7 Infrared ETO gas analyzer: One (1) is within chamber</div>
<div>7.6.2.8 Compressed air supply piping: check the pressure of the compressed air, Check the</div>
<div>joint of the compressed air supply piping. The joint of the piping shall be integrated.</div>
<div>7.6.2.9 EO piping: check the construction materials of piping from EO steel cylinder to joint</div>
<div>piping inside the chamber, the pipe must be made of stainless steel. The joint of the</div>
<div>piping shall be integrated.</div>
<div>7.6.2.10 Humidifying piping: check the construction materials of piping from steam generator</div>
<div>to steam sprayer inside the chamber, the piping must be made of stainless steel. The</div>
<div>joint of the piping shall be integrated.</div>
<div>7.6.2.11 Electric control cabinet: used to control the sterilization process manually, the electric</div>
<div>Control cabinet shall be installed properly.</div>
<div>7.6.2.13 Frequency converter: used to control revolution speed of electric machinery of</div>
<div>vacuum pump so that control vacuum speed by frequency converting.</div>
<div>7.6.2.14 Steam generator: used to generate steam which add into the chamber and improve</div>
<div>chamber humidity, the steam generator shall be installed properly. The joint of the</div>
<div>piping shall be integrated.</div>
<div>7.6.2.15 EO vaporizer: used to vapor EO and maintain EO gas at a higher temperature, the</div>
<div>EO vaporizer shall be installed properly. The joint of the piping shall be integrated.</div>
<div>7.6.2.16 Hot water supply system: used to generate hot water which will flow through the</div>
<div>piping inside the jacket of the chamber, and heating sterilization chamber. The hot</div>
<div>water tank shall be installed properly. The joint of the piping shall be integrated.</div>
<div>7.6.2.17 HEPA filter: A filter to be used to filter air when air is injected into chamber, A filter to</div>
<div>be used to filter steam when steam is injected into chamber, the two filter meet</div>
<div>specific requirements of relevant standards（Brand: PALL, 0.3&mu;m or better）The joint</div>
<div>of the piping shall be integrated.</div>
<div>7.6.2.18 Vacuum system (including vacuum pumps, chiller and piping): used to vacuum the</div>
<div>chamber, the vacuum shall be installed properly. The joint of the pipes shall be</div>
<div>integrated.</div>
<div>
<div>7.6.2.19Gas circulation system, Two (2) fans (each single fan has the flow rate of 2500m3 /h)</div>
<div>to allow a gas circulation flow inside the chamber of 50 chamber volume/hour. The</div>
<div>fans are explosion-proof.</div>
<div>7.6.2.20Exhaust system, A exhaust fan is installed the top of chamber which near to load door,</div>
<div>when unload door is opened, the exhaust fan start, draw out air with residual EO gas</div>
<div>within chamber to protect operator. The joint of the piping shall be integrated.</div>
<div>7.6.2.21There are two (2) main circulation wind piping on top of chamber, each main wind</div>
<div>piping have a flow rate switch, each main wind piping connect a circulation fan, fan</div>
<div>connect chamber circulation wind inlet, each main wind piping have four (4) outlet</div>
<div>which connect chamber circulation wind outlet, so the chamber have two (2)</div>
<div>circulation wind inlet and eight (8) circulation wind outlet, the joint of the piping shall</div>
<div>be integrated.</div>
<div>7.6.2.22EO exhaust, emission control and abatement systems: use acid to treat EO gas, the</div>
<div>joint of the piping shall be integrated.</div>
<div>7.6.2.23Notrigen generator is installed and the joint of the piping from sterilizer to nitrogen</div>
<div>storage tank shall be integrated</div>
<div>7.6.2.24There are forty-nine (49) water jacket distributed in chamber and five (5) water jacket</div>
<div>distributed in each door.</div>
<div>7.6.2.25There are three(3) pump installed in the top of chamber, one(1) is vacuum pump</div>
<div>which is used to chamber vacuum; one(1) is hot water circulation pump which is used</div>
<div>to promote circulation of water within chamber and door water jacket; one(1) is</div>
<div>gasification pump which is used to promote circulation of water within vaporizer.</div>
<div>7.6.2.26Process automation computer system: the installation of two (2) computer shall meet</div>
<div>the requirements; each computer has a citect software keys，one is as control</div>
<div>computer and the other is as monitor computer.</div>
<div>7.6.2.27In-touch software is used to control sterilizer run and MES software is used to collect</div>
<div>date derived from PLC to generate form, software is validated and authorized to</div>
<div>Allmed and Backup.</div>
<div>7.6.2.28Physical damage and integrity: The sterilizer and all auxiliary equipments shall be</div>
<div>inspected to ensure that it is intact with no visible signs of loose parts or physical</div>
<div>damage. Document all findings on the documentation form.</div>
<div>7.6.2.29Electrical power: check the electrical power supply for the chamber and all ancillary</div>
<div>items. The power voltage shall comply with requirements from the equipment supplier.</div>
<div>Document the findings on Attachment C.</div>
<div>7.6.2.29.1 Electric control cabinet: AC 380V, 50Hz</div>
<div>7.6.2.29.2 Frequency convertor: AC 380V, 50Hz</div>
<div>7.6.2.29.3 Computer system: AC 220V, 50Hz</div>
<div>7.6.2.29.4 Vacuum pump: AC 380V, 50Hz</div>
<div>7.6.2.29.5 Steam generator: AC 380V, 50Hz</div>
<div>7.6.2.29.6 Chiller: AC 380V, 50Hz</div>
<div>7.6.2.29.7 Nitrogen generator: AC 380V, 50H</div>
<div>7.6.2.29.8 EO gas abatement system: AC 380V, 50Hz</div>
<div>7.6.2.29.9 Hot water circulation pump: AC 380V, 50Hz</div>
<div>7.6.2.29.10 Gas circulation fan: AC 380V, 50Hz</div>
<div>7.6.2.29.11 Exhaust fan：AC 380V, 50Hz</div>
<div>7.6.2.29.12 Gasification pump: AC 380V, 50Hz</div>
<div>7.6.3 Acceptance Criteria</div>
<div>7.6.3.1 Instrument should be compliance with the specification.</div>
<div>&nbsp;</div>
<div>
<div>7.6.3.2 All utilities necessary for system operation must be connected to the machine and must</div>
<div>be present at the levels required to operate the machine.</div>
<div>7.6.3.3 A response of &ldquo;Yes&rdquo; is required for items which require a Yes / No response.</div>
<div>7.6.3.4 Any response of &ldquo;No&rdquo; must be explained in the comments section.</div>
<div>7.7 Sub-system of Sterilizer Environment Installation Check</div>
<div>7.7.1 Check the environment of the sterilizer according to attachment D and record the result onto</div>
<div>Attachment D.</div>
<div>7.7.2 Check the installation of all sun-systems for the sterilizer according to Attachments E1~E5, and</div>
<div>record the result onto Attachments E1~E5.</div>
<div>7.7.3 Check the job qualification of operators attend this validation follow the requirements in</div>
<div>Attachment F and document the result onto it also.</div>
<div>8 INSTALLATION QUALIFICAITON REPORT</div>
<div>8.1 Installation report will be written, clearly showing how the acceptance criteria of this protocol were met.</div>
<div>If there were any deviations from the protocol, then the completed deviation forms must be included in</div>
<div>the report. The report will be reviewed and approved by Allmed.</div>
<div>&nbsp;</div>
<div>&nbsp;</div>
<div>
<p>Attachment A<br>Protocol Deviation Form<br>(Use additional sheets if needed)<br>Protocol # and Title:<br>Section of Protocol Deviated from:<br>Machine# involved in the Deviation:<br>1. &nbsp;Describe the deviation:</p>
<p><br>2. &nbsp;Describe how the deviation impacts the qualification:</p>
<p><br>3. &nbsp;Investigation of the deviation:</p>
<p><br>4. &nbsp;Corrective action taken:</p>
<p>&nbsp;</p>
<p>Deviation Form completed by / Date:<br>Deviation Reviewed by / Date:<br>Deviation Approved by / Date:</p>
</div>
</div>
</div>
</div>
</div>
</div>
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Installational Qualification Protocol For 100m3 Eto Sterilizer

Publish Time：2023-11-07