velidation of fluid bed druer

Information about velidation of fluid bed druer

Published on July 14, 2014

Author: savajbhadresh

Source: authorstream.com

Content

PowerPoint Presentation: Validation of equipment Fluid bed dryers 2. Tray dryers Prepared by : savaj bhadresh Shree dhanvantry pharmacy college, kim PowerPoint Presentation: Parts of Equipment Validation Equipment Validation Installation Qualification ( I Q ) Operational Qualification (OQ)   Performance Qualification ( P Q ) Design Qualification(DQ) PowerPoint Presentation: Validation of fluid bed dryers PowerPoint Presentation: Fluid Bed Dryer (FBD) Your text here PowerPoint Presentation: Your text here Fluid Bed Dryer (FBD) PowerPoint Presentation: Your text here FBD control parameter PowerPoint Presentation: DESGINE QUALIFICATION OF FBD LIST BELOW recommendeds steps that should be considerd in inclusion in a desgine qualification Description of intended use of equipment Description of intended environments Preliminary selection of the functional and performance specification CONT….: Prelimary selection of supplier. Final selection of equipment. Final selection of supplier and equiment . Development and documentation of final functional and operational specification. CONT…. Installation qualification of FBD: following parameter should be measured. Purchase details : verify approved purchase orderd check manufacturer and supplier. details of equipment : Verify model no. and serial no. check for any physical damage confirm location and installation requirments per recommendetion of manufacturer. Installation qualification of FBD Cont…. : installation shell be conducted per instruction provided in i nstallation manual. appratus /sensors for measuring temperature, humidity, time, air velocity, pressure as recording devices for those variables should be calibreted . Cont …. Acceptence criteria for installation of FBS: Fulfill the selection criteria and its purpose of application. the equipment shell be as per purchase order. accessories recived shell be as per purchase order. should meet pre-selected desgine parameters, manufacturer/supplier shell provide complete equipment manual. material of construction shell be as per purchase order. Acceptence criteria for installation of FBS Operational qualification of FBD: Operational qualification of FBD Ensure machine operating within specification Check the OQ parameter Observ controls availabel Record and report Cont……: operate equipment at low, medium and high speed per operation manual to verify the operating control. verify that all switches and push buttons. establish procedures for operations, maintenance and calibration, Establish trainig programmed for relevent staff, verify alarm control. Cont …… Critical parameter tested during OQ: adjustment inlet air temperature. adjustment inlet air quantity. adjustment spray rate. adjustment atomizing air. Critical parameter tested during OQ Performance qualification of FBD: 3 betches / lots of any products will be tekan for PQ of FBD heat disribution : checked by placing 10 thermocouples in geometric pettern and empty product container without any load to ensure heat ditribution in during chember . for FBD: heat distribution study will be performed at 65 ± 5° C for two hour after achieving t he temperature on the controlling sensore to ensure proper heat distribution. Performance qualification of FBD Acceptance criteria for PQ of FBD : temperature difference between all thermocouple and set temperature should not differ by more than ± 5 °c. the reduction in moisture content after drying should be as per the specification in BMR. % RSD of LOD should not more than 6%. the equipment should produce intended outputs with respect to quantity and quality consistency. Acceptance criteria for PQ of FBD Revelidation criterial : equipment shell be revelideted if : location of equipment is changed there is change in spare parts , major maintenace or breckdown that have a direct on the performance of equipment. at normal revelidation schedule. Revelidation criterial Velidation of Tray Dryer: Velidation of Tray D ryer Tray dryer: Tray dryer Tray dryer control parameter: Tray dryer control parameter Fixed Veriable ( monitoer ) Response (test) Trays inlet/ exshaust temperature product temperature drying time air volume humidity of incoming air humidty of exshaust air Particle size distribution density lose on drying assay Installation qualification: procedure : selection criteria shell be defined and base on specific function to be carry out by machine and its efficacy requirement of accessories shell be decided and listed out. supplier and manufacturer selection. Installation qualification Cont…..: puechase detaile the purchase order no. and date shell be checked the accessories and their spare parts if any shell be checked as per purchase order delivery period shell be as per purchase order suppleir or manufacturer name and address shell be check any deviation observed should be inform to supplier or manufacture Cont ….. Cont….: details of equipment equipment name, make and model no. shell be noted down in- house identification no. shell be allocated location for installation shell be decided utilities required shell ne listed down Cont …. Cont…: installation procedure after checking all the specifications as mentioned in the selection criteria, service engineer of the manufacturer shell be called for commissioning , if necessary authorizes validation team shall carry out installation Department Head of production, QA & engineering shall evaluate installation report Cont … cont…: acceptance criteria for IQ Fulfill the selection criteria & its purpose of Application The equipment shall be as per purchase order Accessories received shall be as per purchase orde r Should meet pre-selected design parameters Manufacturer/supplier shall provide complete equipment manual Material of construction shall be as per purchase order cont … Performance Qualification: To check Heat Distribution by placing 10 thermocouples in geometric pattern with the TD Shell and empty Product Container without any load to ensure heat distribution in the drying chamber Heat distribution study will be performed at +45 °C and +105°C for one hour after achieving the temperature on the controlling sensors to ensure proper heat distribution. Performance Qualification Cont….: Procedure After completion of OQ initiate the PQ of TD The effectiveness of drying will be qualified by determining reduction of % moisture content in drying process . 3 batches/ lots of any product will be taken for PQ of TD At least 2.0 gm of sample is sampled for % MC check from the top, middle and bottom trays and will be reported Cont …. PowerPoint Presentation: Suggested locations for thermocouples on a single shelf for heat - distribution. Cont…: In case of any deviation inform to department head for necessary action Document the deviation details Deviation is acceptable or not will be decided -if yes -if not Cont … Cont…: Acceptance criteria Temperature difference between all thermocouples and set temperature should not differ by more than  5 °C . The reduction in moisture content after drying should be as per the specification in the BMR % RSD of LOD should not be more than 6 % The equipment should produce intended outputs with respect to quality & quantity consistently Cont … reference: Berry I.R., and Nash R.A., ”Pharmaceutical Process validation” second edition, revised and expanded; Marcel Dekker series; 83-110. reference PowerPoint Presentation: Thank you

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