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Pharm Sem -II Roll no:13 Department of Quality Assurance Guided By : Mr. Jignesh Shah S.J.Thakkar Pharmacy College, Rajkot . 1Contents: Contents Introduction Validation 2.1 Installation qualification 2.2 Operational qualification 2.3 Performance qualificationIntroduction: Introduction 2 types of steam system in pharmaceutical industries: 1.House steam- contains steam generator and distribution system made of iron or steel. Constructed with rusting material. This system is usually treated with various substances like amines, hydrazine or other boiler additives to arrest corrosion . 2. Clean steam - It established when steam is used for directly treating the product or product contact surfaces. Constructed with non-rusting material. E,g . stainless steel. This system use either purified or distilled water as feed water .Validation: Validation Steam system validation include the following steps: Make a process diagram and identify major process steps Define major equipment in the process Carry out IQ, OQ, PQ.Process outline of clean steam: Process outline of clean steamInstallation Qualification: Installation Qualification 1. For clean steam generator It is acc. To purchase specification Connect the generator to the reqired utilities and verify on to their correctness Tighten flanges or other fittings, clean generator chemically and passivate generator after installation . Label the utilities feeding the generator Carry out pressure testing and record the results. Check and calibrate all critical processes instruments.Slide 7: 2. Distribution system Confirm that material of construction of distribution system is as per the specification of the company Compare the design drawing and make note of the modification carried out in the design drawing at the tie of construction and also record reason. All branches of the system should be appropriately labeled. Clean the distribution system before start up and record it. Carry out the pressure test and record the results.Operational Qualification: Operational Qualification Clean steam generator Acc. To SOP, start up and run the clean steam generator . Record normal operating parameter of the system. Check that all instruments and alarms are working correctly . Record their status. Check that the generated steam meet the specifications and can be produced in quantities required.Slide 9: 2. Distribution system Test all the use points of the system for adequate supply of steam under maximum load or other production condition. Quality of steam should be tested at all the use points. Use point should also be tested to find out that excess condensate is not present under operating conditions.Performance Qualification: Performance Qualification I t required testing specified in the protocol Several tests under defined load conditions. Testing consist of condensensing steam at various use points and subject condensate to testing for WFI.Compressed Air system: Compressed Air systemIntroduction: Introduction 2 types of compressed air system are used in the pharmaceutical industry . Conventional oil lubricated compressors for operating instruments and machinery where no contact with product or the environment, where product is being mfg. is involved. An oil free compressed air system used in clean room areas. It contains mainly compressor, dryer, storage tank and distribution system.Installation Qualification : Installation Qualification Oil free compressor Check specification on purchase order and actual delivery specification Verify that no oil or other lubricant is used in the compressor Check that all required utility requirements have been met and connected properly Check whether pre-start up procedures were performed Check whether all critical instruments have been calibrated Document above allSlide 14: 2. Compressed air storage tank Confirm that the material of construction is as per specification Check the capacity of the tank against purchase specification Carry out a pressure hold test to determine whether the leak rate is within specification Examine the cleaning procedure adopted for the tank and observation made at the time of cleaning Check all pressure rates for tank against the purchase specification Calibrate all critical instrumentation on storage tankSlide 15: 3. Distribution system Confirm the material of construction and design parameter specified by the company Compare the drawing of the system with “as-built” drawing to show whether any modification have been made and note the modifications . Pressure test the system to confirm its integrity and record the result Examine the cleaning procedures after installationOperational Qualification: Operational Qualification Check all the use points for the tests mentioned below and record the results. Identity Nonviable particle count Microbial count Check several worst-case locations for purity and dew point Test all instrument and alarms for their operational status and record Test the compressor output for hydrocarbonsPerformance qualification: Performance qualification It consist of completing the documentation from various steps mentioned above and repeating operational testing as specified in the validation protocol. In case of the system PQ can be considered as validationReferences: : References: Validation in pharmaceutical industry ”; edited by P.P. sharma ;first edition 2007 ; 193-220Slide 19: Thank s… You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.