1Q/0Q Protocol Installation Qualification/ Operation Qualification Vacuum Drying Oven DP63C Yamato No: 199505 Rev. -2 SINCE 1889 Yamato Yamato Scientific Co., Ltd. Haseman Bldg. SF 2-11-6, Tomioka, koto-ku Tokyo 135-0047 tel: 481-3-5639-7076 fax:481-3-5639-6031Yamato Scientific Co., Ltt, 19/0Q Protocol #199505 Revision -2 Purpose and Scope IQ and OQ This Qualification Protocol is solely intended to be used with new or relocated Yamato Vacuum Drying oven DP63C. Models: Vacuum Drying oven DP23C, DP33C DP43C_ ‘DP63C * It is written to assist the end-user in validation of predetermined specifications. The protocol begins with planning the site for the piece of equipment and therefore is of value prior to receipt of product. The use of this document does not replace the need for Vacuum Drying oven DP63C User's ‘Manual. information with in the User’s Manual is required to complete this 10/0@ Protocol. If the manual has been misplaced, copies can be obtained from the manufacturer or down- loaded from their website, www.yamato-net.co,jp. Responsibilities End-User ~ The ultimate user or otherwise appointed personnel in the lab is responsible to ensure the Drying oven is installed and operating properly. This document can assist in that validation, This document cannot however anticipate every application or unique situation encountered with the installation and operation. It is therefore essential that users, lab managers and safety officers work together to broaden the scope of this document through careful forethought. End-User Employer ~ The employer is responsible for supporting the validation through adequate resources and training. The organization shall also ensure the validation process has been fully carried out prior to applying the Vacuum Drying oven. Records should be stored in a safe, easily retrievable location. The location of the equipment and required validation should be included in the company’s quality system. Manufacturer - Yamato Scientific Co., Ltd, certified ISO-9001, Is responsible to fully test each Vacuum Drying oven prior to shipment. The manufacturer must retain these records. Yamato Scientific staff of Product Service Representatives and Product Specialists can assist with information on the purchase, delivery and installation. Yamato Scientific is not responsible for the actual installation or validation processes. 1 Yamato Scientific Co.,Ltd. 1:481-3-5639-7076._f. +81-3-35639-6031Yamato Scientific Co., Ltd., 10/0@ Protocol #199505 Revision -2 Performance Qualification Once the Drying oven has been checked for proper installation and basic operation, it may be decided to validate its performance. Yamato Scientific Co., Ltd can not recommend specific procedures to do this. The performance validation should be designed to meet the specifications and accuracy required of the application, In general this requires establishing acceptance criteria, making several runs and testing the results with calibrated equipment and qualified personnel. A. Installation Qualification | Description | Specification or Acceptance Criteria Result Step Yes | NO 1 Site Planning la | Space Refer to part “Requirements for installation” |v) | N Requirements | in User’s Manual for dimensions of the model(s) you have chosen. Has adequate counter space been provided for placement of the equipment? 1b | Electrical Refer to the User's Manual for alist of model |(¥) | N Service numbers and their corresponding electrical requirements. Are services available for the equipment to be connected to an electrical circuit of adequate size and the proper voltage? 230V models are shipped with a power N cord plug. (It may require replacement.) Is one available to match the service outlet at the installation site? te | exhaust Refer to the User's Manual. Hav O N Requirements | accommodations been made to vent the Dryin Oven safely? ( hose is provided.) ad | Air/nitrogen | Have accommodations been made to have a @) N Supply supply of dry ait/nitrogen? See User’s Manual for an estimate of air/nitrogen consumption. 2 Yamato Scientific Co.,Ltd. 1¥81-3-5639-7076 fz +81-3-35639-6031Yamato Sclentifie Co., Ltd., 1Q/0Q Protocol #199505 Revision -2 Supply Gas supply MUST be regulated to less than J(¥) | Regulator for | 101kPa. Has a regulator equipped with gauge Air/Nitrogen | to accommodate this installation? Prior to Operation Damage Have the delivered products been inspected | Y | Claims for any signs of damage that may have occurred while in transit? Keep packaging ‘materials until inspection is complete, If damaged, refer to the User’s Manual for information on shipping damage claims. Air/nitrogen | Has the, regulated to less than aoakPa, |(Y) | N Connections Air/Nitrogen connection been made to the Drying Oven? ‘Sample pouch | Does the sample pouch in baskets match the IC {NN In baskets size of chamber you wish to use in this Drying oven? Has the baskets been placed into the ((y) | Drying Oven chamber? Handling Has the Safety Officer, or equivalent, reviewed [(v.) | Solvents the safe handling, venting and disposal of solvents oven? Yamato Scientific Co.,Ltd. 1.281-3-5639-7076 2 +81-3-35639-6031Yamato Scientific Co., Ltd., 10/0Q Protocol #199505 Revision -2 B. Operation Qalification Description i tep 7 Specification of Acceptance Criteria yes | NO 1 vacuum Drying Y N oven ta | Preheat Activate the Preheat feature. With thelic Oo N closed, does the chamber heat up? tb | HeatandRun | select any program and set a higher than O N ambient temperature and set the Run Time to 1 minute to check operation ac | Run Timer | pid the unit stop after one minute? io N id | Temperature | With aluminum tape attach @ thermocouple | y N Control wire to the top of the round temp probe disc Temperature | located in the center of the chamber floor. Display ‘Tape the sample probe next to the thermocouple wire. With the air/nitrogen OFF, close the lid. With the Temp. Control set} at 50 °C, press Preheat. Once the temperature stabilizes: Drying Oven BLOCK Display Temperature: Ui (Display should be between 48 and 52 °C) Drying oven sample Display Temperature: 54°C (Display should be between 48 and 52 °c) Reference Device Temperature: 51°C. (Display should be between 44 and 56 °c) te Pause Cycle Repeat the one-minute cycle, except this N time, presses the PAUSE button to interrupt the cycle. Did the Air/Nitrogen flow stop? When RESTART is pressed, did the cycle resume? Yamato Scientific Co.,Ltd. 1+ B1-3-5639-7076 fos +81-3-35639-6031Yamato Scientific Co., Ltd., 1Q/0Q Protocol #199505 Revision -2 {at | Manual mode | Vacuumizing: Oye Turna the purge valve CW to its end (close) Be sure the pump valve close, turn on the vacuum pump. Turn the pump valve CCW to Its end, the exhaust speed is max here. Air intake: Turna the pump valve CW to its end (close) Be sure the purge valve CCW to its end, the intake speed is max here. j 2 | Personnel Training 2a | User Training | Have personnel to use the Drying Oven been [Cy )| adequately trained? ‘Are personnel familiar wi Volume limits of samples in pouch; Loading of pouch in heated block; Safe handling of solvents and vapors; Programming time and temp. parameters; Cleaning and maintenance of the Drying Oven? Yamato Scientific Co.,Ltd. 1 481-3-5639-7076 fs +81-3-35639-6031Yamato Sciemtific Co., Ltd., 1Q/0Q Protocol #199505 Revision -2 Cc. Summary Yamato Vacuum Drying oven DP63C 10/0Q Document 199505 Revision-2 Equipment Location JAG CDIVA vacuum prying oven ser.no. )YOSI2C moet wo 2S 3C User Protecl Vacuum Dyyune Oven RPEBC, Reon or Date ublshed) May 26,2014 Contact (print nama) =A ELEY AAT Title: the deficiency or unacceptable results. Those deficiencies are to be followed with an instruction for “Corrective Actions.” Once acceptable results are obtained, the deficiency is “accepted” by initialing the Corrective Action. Step Deficiency followed by Corrective Action Yamato Sciemifie Co, Ltd. 1481-3-5639-7076. f: +81-3-35639-6031