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related_results_labels({"version":"1.0","encoding":"UTF-8","feed":{"xmlns":"http://www.w3.org/2005/Atom","xmlns$openSearch":"http://a9.com/-/spec/opensearchrss/1.0/","xmlns$blogger":"http://schemas.google.com/blogger/2008","xmlns$georss":"http://www.georss.org/georss","xmlns$gd":"http://schemas.google.com/g/2005","xmlns$thr":"http://purl.org/syndication/thread/1.0","id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515"},"updated":{"$t":"2023-12-16T21:31:21.011+05:30"},"category":[{"term":"SOP"},{"term":"Education"},{"term":"Quality Control"},{"term":"Microbiology"},{"term":"Production"},{"term":"GMP"},{"term":"Quality Assurance"},{"term":"Test"},{"term":"Validation"},{"term":"Sterile"},{"term":"Engineering"},{"term":"Calibration"},{"term":"Audit"},{"term":"Regulatory"},{"term":"GLP"},{"term":"Equipment"},{"term":"T-BP304"},{"term":"Water"},{"term":"Reagents"},{"term":"Cleaning"},{"term":"T-BP402"},{"term":"GDP"},{"term":"Obsolete"},{"term":"T-BP203"},{"term":"STP"},{"term":"HPLC"},{"term":"Sterilization"},{"term":"Stores"},{"term":"T-BP303"},{"term":"T-BP401"},{"term":"T-BP202"},{"term":"T-BP101"},{"term":"T-BP103"},{"term":"Protocol"},{"term":"T-BP201"},{"term":"T-BP204"},{"term":"T-BP102"},{"term":"T-BP302"},{"term":"HVAC"},{"term":"T-BP104"},{"term":"Checklist"},{"term":"T-BP403"},{"term":"T-BP205"},{"term":"T-BP301"},{"term":"Pharmacology"},{"term":"Troubleshooting"},{"term":"Safety"},{"term":"T-BP105"},{"term":"T-BP404"},{"term":"Article"},{"term":"Stability"},{"term":"Non-sterile"},{"term":"Standard"},{"term":"T-BP206"},{"term":"Questions"},{"term":"Cleaning Validation"},{"term":"Sterility"},{"term":"Administration"},{"term":"Interview"},{"term":"Pharmaceutics"},{"term":"IT"},{"term":"Companies"},{"term":"Data Integrity"},{"term":"COVID-19"},{"term":"ETP"},{"term":"OOS"},{"term":"Ointment"}],"title":{"type":"text","$t":"Pharmaguideline"},"subtitle":{"type":"html","$t":"Pharmaguideline provides all pharmaceutical regulatory guidelines including quality control, quality assurance, microbiology, and production departments. Get all SOPs of these all departments. Calibration and operating procedures of all quality control instruments and operating procedures of all production equipment are also provided on the website. All GMP topics are also covered for quality assurance."},"link":[{"rel":"http://schemas.google.com/g/2005#feed","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/posts\/default"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/-\/Sterile?alt=json-in-script\u0026max-results=5"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/search\/label\/Sterile"},{"rel":"hub","href":"http://pubsubhubbub.appspot.com/"},{"rel":"next","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/-\/Sterile\/-\/Sterile?alt=json-in-script\u0026start-index=6\u0026max-results=5"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"generator":{"version":"7.00","uri":"http://www.blogger.com","$t":"Blogger"},"openSearch$totalResults":{"$t":"102"},"openSearch$startIndex":{"$t":"1"},"openSearch$itemsPerPage":{"$t":"5"},"entry":[{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-2344258421139798915"},"published":{"$t":"2023-09-26T22:51:00.000+05:30"},"updated":{"$t":"2023-09-26T22:51:48.029+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Protocol"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Validation"}],"title":{"type":"text","$t":"Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals"},"content":{"type":"html","$t":"\u003Cdiv dir=\"ltr\" trbidi=\"on\"\u003E\n\u003Ch2\u003E\n1.0 OBJECTIVE\u003C\/h2\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E1.1 \u0026nbsp;To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system\/facility\/equipment.\u003C\/span\u003E\u003Cbr \/\u003E\n\u003Ch2\u003E\n2.0 SCOPE\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E2.1 \u0026nbsp;This procedure applies to all aseptically filled sterile products intended for human use.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga1\u003E\u003C\/ga1\u003E\n\n\u003Ch2\u003E\n3.0 RESPONSIBILITY\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.1 \u0026nbsp;The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.2 \u0026nbsp;Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cdiv class=\"separator\" style=\"clear: both; text-align: center;\"\u003E\n\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/08\/aseptic-filling-process-media-fill.html\" style=\"clear: right; float: right; margin-bottom: 1em; margin-left: 1em;\"\u003E\u003Cimg alt=\"Media Fill Validation Test for Sterile Manufacturing\" border=\"0\" src=\"https:\/\/1.bp.blogspot.com\/-f45IK4CqRZs\/VpFWiF_l0WI\/AAAAAAAAFEA\/qijJPPRrKkI\/s1600\/media-fill.jpg\" title=\"Media Fill Validation Test for Sterile Manufacturing\" \/\u003E\u003C\/a\u003E\u003C\/div\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.3 \u0026nbsp;QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E3.4 \u0026nbsp;QC personnel to perform the testing and assist with the monitoring required for each sterile media fill.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch2\u003E\n4.0 ACCOUNTABILITY\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E4.1 \u0026nbsp;Manager QA\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch2\u003E\n5.0 REFERENCE (S)\u003C\/h2\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E5.1 \u0026nbsp;In- house.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"text-align: left;\"\u003E\n\u003Cspan style=\"text-align: justify;\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E5.2 \u0026nbsp;\u003C\/span\u003E\u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2010\/10\/pics-pharmaceutical-inspection.html\" target=\"_blank\"\u003EPharmaceutical Inspection convention Guideline.(PIC)\u003C\/a\u003E\u003C\/div\u003E\n\u003Ch2\u003E\n6.0 PROCEDURE\u003C\/h2\u003E\n\u003Cdiv\u003E\n\u003Ch3\u003E\n6.1 EXIT AND ENTRY PROCEDURE\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.1.1\u0026nbsp;\u0026nbsp;All Operators and Supervisors enter department as per Defined Gowning procedure.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga2\u003E\u003C\/ga2\u003E\n\n\u003Ch3\u003E\n6.2 AMPOULE FILLING MEDIA\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.1 \u0026nbsp;The media fill run shall be performed for approximately the same duration as required for filling of a normal production batch (approx. 12 hours).\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.2 \u0026nbsp;Batch (Media) manufacturing shall be done in the initial hours of the 1st shifts, followed by other processing steps normally followed.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.3 \u0026nbsp;Nitrogen flushing shall not to be done during media filling.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4 \u0026nbsp;The filling of media shall be done in the following sequence:-\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.2.4.1\u0026nbsp;\u0026nbsp;The media (\u003C\/span\u003E\u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/02\/culture-media.html\" target=\"_blank\"\u003ESoybean Casien Digest Madium\u003C\/a\u003E\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E) batch shall be manufactured in the manufacturing area. The bulk is then aseptically filtered into a sterile holding tank (under LAF) in the sterile area. The tank containing the filtered solution is then connected sterile silicon pipeline and filling done in\u0026nbsp;\u003C\/span\u003Eampule\u003Cspan style=\"font-family: inherit;\"\u003E\u0026nbsp;without employing the use of on-line cartridge filters\/filter housing on the machine.\u003C\/span\u003E\u003C\/span\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.2\u0026nbsp;\u0026nbsp;Fill volume of media as per the protocol. (The fill volume of media in units need not equal the fill volume of finished product units, the quantity filled shall be sufficient to wet all the inner surfaces of the unit \u0026amp; to enable an inspection to detect positives.)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.3\u0026nbsp;\u0026nbsp;Filling activity is performed in the filling room (especially the filling zone) under LAF.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.4\u0026nbsp;\u0026nbsp;\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2013\/08\/three-consecutive-batches-for-validation.html\" target=\"_blank\"\u003EConsecutive first three runs\u003C\/a\u003E will be validated with sterile media solution.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.5\u0026nbsp;\u0026nbsp;Simulate the adverse condition testing of the system (details of adverse conditions given separately in step 6.4) after filling approximately 10,000 units.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.2.4.6 \u0026nbsp;\u0026nbsp;Filling to be planned in a manner such that the operator covers the activities during the shift change over.\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n\u003Ch3\u003E\n6.3 VIAL FILLING MEDIA:\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.1 \u0026nbsp;The media fill run shall be performed for approximately the same duration as required for filling of a normal production batch (approx. 12 hours).\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.2 \u0026nbsp;Batch (media) manufacturing shall be done in the initial hours of the 1st shifts, followed by other processing steps normally followed.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.3 \u0026nbsp;Nitrogen flushing shall not be done during media filling.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.4 \u0026nbsp;The filling of the media to be done in the following sequence-\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.4.1\u0026nbsp; The media (Soybean Casien Digest Madium) batch is manufactured in the manufacturing area. The bulk is then aseptically filtered into a sterile holding tank (under LAF) in the sterile area. The tank containing the filtered solution is then connected with is sterile silicon pipeline and filling done in vials without employing the use of on-line cartridge filters\/filter housing on the machine and then dosing of sterile lactose in vials.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.3.4.2 \u0026nbsp;Transfer the sterile lactose through material airlock into the sterile area and transfer the sterile lactose aseptically into the previously\u0026nbsp;\u003C\/span\u003Esterilized\u003Cspan style=\"font-family: inherit;\"\u003E\u0026nbsp;hopper of the vial filling machine. Three runs will be validated with 250 mg sterile lactose and 5 ml media solution, 500 mg sterile lactose with 5 ml media solution and 1000 mg sterile lactose with 10 ml media solution to validate the weight range from 250 mg to 1000 mg.\u003C\/span\u003E\u003C\/span\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.4.3 \u0026nbsp;Fill volume of media or weight of Powder as per the protocol. (The fill volume of media filled units need not equal the fill volume of finished product units, the quantity filled shall be sufficient to wet all the inner surfaces of the unit \u0026amp; to enable an inspection to detect positives.)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.5 \u0026nbsp;Filling activity is performed in the filling room (especially the filling zone) under LAF.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.6\u0026nbsp;\u0026nbsp;Simulate the adverse condition testing of the system (details of adverse conditions given separately in step 6.4) after filling approximately 10,000 units.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.3.7 \u0026nbsp;Filling to be planned in a manner such that the operator covers the activities during the shift change over.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga3\u003E\u003C\/ga3\u003E\n\n\u003Ch3\u003E\n6.4 ADVERSE CONDITIONS: (AMPULE\/ VIAL)\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.1 \u0026nbsp;Filling machine OFF:\u003C\/span\u003E\u003C\/b\u003E F\u003Cspan lang=\"EN-GB\"\u003Eor 60 minutes (The filtered air supply in the filling zone not to be put off. Imitate maintenance activities that are likely to take place during routine filling process, after restarting approx. 1,000 units to be filled)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.2 \u0026nbsp;LAF Filtration OFF:\u003C\/span\u003E\u003C\/b\u003E F\u003Cspan lang=\"EN-GB\"\u003Eor 5 minutes (filling to be done when LAF is OFF)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.3 \u0026nbsp;Air Handling Units power OFF:\u003C\/span\u003E\u003C\/b\u003E F\u003Cspan lang=\"EN-GB\"\u003Eor 5 minutes (ALL the AHU’s of the sterile and the adjoining areas to be switched OFF, filling to be done when AHU’s are OFF).\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.4 \u0026nbsp;Total Power OFF for 2 minutes:\u003C\/span\u003E\u003C\/b\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E(ALL the AHU’s of the sterile and the adjoining areas, filling m\/c, LAF’s etc to be switched OFF, after restarting approx. 1,000 units to be filled)\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.4.5 \u0026nbsp;Highest (250\u0026nbsp;\u003C\/span\u003Eampule\u003Cspan style=\"font-family: inherit;\"\u003E\/vial min.) speed of machine:\u003C\/span\u003E\u003C\/span\u003E\u003C\/b\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003Eapprox. 1,000 units to be filled\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E6.4.6 \u0026nbsp;Change in tubing’s:\u003C\/span\u003E\u003C\/b\u003E A\u003Cspan lang=\"EN-GB\"\u003Epprox. 1,000 units to be filled \u0026nbsp;\u0026nbsp;\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cb\u003E\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.4.7 \u0026nbsp;\u003C\/span\u003EAmpule\u003Cspan style=\"font-family: inherit;\"\u003E\/Vial Sterilizing tunnel OFF:\u003C\/span\u003E\u003C\/span\u003E\u003C\/b\u003E\u003Cspan style=\"font-family: inherit;\"\u003E F\u003C\/span\u003E\u003Cspan lang=\"EN-GB\" style=\"font-family: inherit;\"\u003Eor 5 minutes (total power supply of the tunnel is to be switched OFF, after restarting tunnel all the units from the cooling zone to be filled).\u003C\/span\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch3\u003E\n6.5 STORAGE OF FILLING UNITS (AMPULE\/VIAL)\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.5.1\u0026nbsp; Collect all units in a tray or suitable container, Store in previously maintained temperature defined area or incubator.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.5.2 \u0026nbsp;First Store at temperature 20 -25 ° C for seven days.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.5.3 \u0026nbsp;After that Store at temperature 30 -35 ° C for seven days.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga4\u003E\u003C\/ga4\u003E\n\n\u003Ch3\u003E\n6.6 RESULT\u003C\/h3\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E1. After the incubation period of the media-filled containers, they are visually examined for microbial growth. Contaminated containers should be examined for evidence of container\/closure damage which might compromise the integrity of the packaging system. Damaged containers should not be included as failures (positives) when evaluating results.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E2. The number of containers used for media fills should be sufficient to enable a valid evaluation. For small batches, the number of containers for media fills should at least equal the size of the product batch. The target should be zero growth and the following should apply:\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv class=\"MsoNormal\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E•\u0026nbsp; When filling fewer than 5000 units, no contaminated units should be detected.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E•\u0026nbsp; When filling 5,000 to 10,000 units,\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Ea) One (1) contaminated unit should result in an investigation, including consideration of a repeat media fill;\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Eb) Two (2) contaminated units are considered cause for revalidation, following an investigation.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E•\u0026nbsp; When filling more than 10,000 units:\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Ea) \u0026nbsp;One (1) contaminated unit should result in an investigation;\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin-bottom: .0001pt; margin: 0in;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003Eb) \u0026nbsp;Two (2) contaminated units are considered cause for revalidation, following an investigation.\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003EAbstracted from:\u003Cspan class=\"apple-converted-space\"\u003E\u0026nbsp;\u003C\/span\u003EPIC 007-5 dated 01 July 2009\u003Cspan class=\"apple-converted-space\"\u003E\u0026nbsp;\u003C\/span\u003ERecommendation on the Validation of aseptic processes\u003Cb\u003E.\u003C\/b\u003E\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cbr \/\u003E\n\u003Cga5\u003E\u003C\/ga5\u003E\n\n\u003Ch3\u003E\n6.7 DESTRUCTION OF MEDIA:\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.7.1 \u0026nbsp;After 14 days media shall be destructed as per sop or procedure.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Ch3\u003E\n6.8 FREQUENCY OF MEDIA FILLS (AMPULE\/VIAL):\u003C\/h3\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.1 \u0026nbsp;Initial Three consecutive Successful Run(all container size employed for filling on the machine) before start production for qualified area or equipment.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.2 \u0026nbsp;Then after once in 6+1 month of Single run any suitable volume for re-qualification of area or equipment.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.3 \u0026nbsp;If any change or modification of critical equipment or area then goes for single run media for any suitable volume before starting production.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cspan lang=\"EN-GB\"\u003E6.8.4 \u0026nbsp;If critical equipment or area is not in use for about one month then go for single run media for any suitable volume before starting production.\u003C\/span\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E6.8.5 \u0026nbsp;As and when required.\u003C\/span\u003E\u003C\/span\u003E\u003Cspan lang=\"HI\" style=\"font-family: \u0026quot;calibri\u0026quot; , sans-serif;\"\u003E\u003Co:p\u003E\u003C\/o:p\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003E\u003Cbr \/\u003E\u003C\/span\u003E\u003C\/span\u003E\u003C\/div\u003E\n\u003Cdiv style=\"margin: 0in 0in 0.0001pt; text-align: left;\"\u003E\n\u003Cspan lang=\"EN-GB\"\u003E\u003Cspan style=\"font-family: inherit;\"\u003EAlso see:\u0026nbsp;\u003C\/span\u003E\u003C\/span\u003E\u003Ca href=\"http:\/\/www.pharmaguideline.com\/2011\/01\/media-fill-test.html\" target=\"_blank\"\u003EMedia Fill Validation Test in Sterile Pharmaceuticals\u003C\/a\u003E\u003Cbr \/\u003E\n\u003Cbr \/\u003E\u003C\/div\u003E\n\u003C\/div\u003E\n"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/2344258421139798915\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2011\/08\/aseptic-filling-process-media-fill.html#comment-form","title":"18 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2344258421139798915"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/2344258421139798915"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2011\/08\/aseptic-filling-process-media-fill.html","title":"Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-f45IK4CqRZs\/VpFWiF_l0WI\/AAAAAAAAFEA\/qijJPPRrKkI\/s72-c\/media-fill.jpg","height":"72","width":"72"},"thr$total":{"$t":"18"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-4167202282650972442"},"published":{"$t":"2023-08-01T22:39:00.000+05:30"},"updated":{"$t":"2023-08-01T22:39:21.780+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Engineering"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Microbiology"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"}],"title":{"type":"text","$t":"Smoke Study in Cleanroom Areas"},"content":{"type":"html","$t":"The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the final product is free from \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2018\/06\/prevention-of-microbial-contamination-in-manufacturing.html\" target=\"_blank\"\u003Econtamination\u003C\/a\u003E in a processing company. The smoke study in cleanroom area is conducted to visually confirm unidirectional airflow exiting \u003Ca href=\"https:\/\/www.pharmaguideline.com\/2012\/03\/high-efficiency-particulate-air-hepa.html\" target=\"_blank\"\u003EHigh Efficiency Particulate Air\u003C\/a\u003E (HEPA) or Ultra Low Particulate Air (ULPA) filters in a manufacturing clean room.\u003Cbr\u003E\n\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2018\/09\/smoke-study-in-cleanroom-area.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/4167202282650972442\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2018\/09\/smoke-study-in-cleanroom-area.html#comment-form","title":"1 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4167202282650972442"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4167202282650972442"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2018\/09\/smoke-study-in-cleanroom-area.html","title":"Smoke Study in Cleanroom Areas"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/2.bp.blogspot.com\/-TKXUhKJhj8Y\/W5lQqqrom8I\/AAAAAAAAHmc\/V4XjNw4ss1gMYwOoMrdYM-b3TCZKVEnMwCLcBGAs\/s72-c\/smoke-test.jpg","height":"72","width":"72"},"thr$total":{"$t":"1"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-1591390556947764870"},"published":{"$t":"2023-03-26T21:57:00.008+05:30"},"updated":{"$t":"2023-06-16T10:57:37.333+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"HVAC"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Microbiology"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"}],"title":{"type":"text","$t":"Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas"},"content":{"type":"html","$t":"Aseptic area is used to manufacture sterile products in pharmaceuticals. The aseptic area is maintained by following strict cleaning and disinfection procedures. Maintenance of aseptic conditions in the sterile area can be challenging. Various aspects of aseptic area maintenance are discussed in this article.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/03\/maintenance-of-aseptic-conditions.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/1591390556947764870\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/03\/maintenance-of-aseptic-conditions.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1591390556947764870"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1591390556947764870"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/03\/maintenance-of-aseptic-conditions.html","title":"Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/1.bp.blogspot.com\/-qqriZV17TOw\/W4MA4sCin2I\/AAAAAAAAHiI\/iB8PCrHrYpEIvYfCPRqo0v_r5zpO-6-MACLcBGAs\/s72-c\/aseptic-area.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-4193024671909065607"},"published":{"$t":"2023-03-23T21:28:00.011+05:30"},"updated":{"$t":"2023-06-16T10:57:26.828+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"Engineering"},{"scheme":"http://www.blogger.com/atom/ns#","term":"HVAC"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"}],"title":{"type":"text","$t":"Air Handling Unit and Its Working Process"},"content":{"type":"html","$t":"Air handling in pharmaceutical manufacturing is important to maintain the safety and quality of the products. In this article, we shall understand the working of air handling units in pharmaceuticals to produce safe and effective products.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2023\/03\/air-handling-unit-and-its-working.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/4193024671909065607\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/03\/air-handling-unit-and-its-working.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4193024671909065607"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/4193024671909065607"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2023\/03\/air-handling-unit-and-its-working.html","title":"Air Handling Unit and Its Working Process"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEhKqiedrtIilX0WEvM3i4KdV-QKDIGprETRegtwGedTlbj561G4kW2_x-0YrnWYiu3HL8TzVPe44MNA0MF5fgT-DBBaXW03Zxh2TWEosP1FwzDd8Qy21_01Nn0gl_pKlhgbETOehfiJscTCo5QoQL_yS4S0pZ0gvQ4RCp01Dnnt6ul27nSf8MTKFNw4lg\/s72-w640-h344-c\/AHU-diagram-HVAC.png","height":"72","width":"72"},"thr$total":{"$t":"0"}},{"id":{"$t":"tag:blogger.com,1999:blog-2032508520370173515.post-1066913447316051619"},"published":{"$t":"2022-08-13T12:00:00.022+05:30"},"updated":{"$t":"2023-06-16T10:46:27.481+05:30"},"category":[{"scheme":"http://www.blogger.com/atom/ns#","term":"GMP"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Quality Assurance"},{"scheme":"http://www.blogger.com/atom/ns#","term":"Sterile"}],"title":{"type":"text","$t":"Contamination Control Strategies for Manufacturing Area"},"content":{"type":"html","$t":"Contamination Control for Pharmaceutical Manufacturing is an essential factor in the overall success of a pharmaceutical product. This article reviews some contamination control strategies for controlling microbial growth, including environmental control, personnel protection, and medical waste management.\u003Cspan\u003E\u003C\/span\u003E\u003Ca href=\"https:\/\/www.pharmaguideline.com\/2022\/08\/contamination-control-strategies-for-manufacturing-area.html#more\"\u003EContinue reading »\u003C\/a\u003E"},"link":[{"rel":"replies","type":"application/atom+xml","href":"https:\/\/www.pharmaguideline.com\/feeds\/1066913447316051619\/comments\/default","title":"Post Comments"},{"rel":"replies","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2022\/08\/contamination-control-strategies-for-manufacturing-area.html#comment-form","title":"0 Comments"},{"rel":"edit","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1066913447316051619"},{"rel":"self","type":"application/atom+xml","href":"https:\/\/www.blogger.com\/feeds\/2032508520370173515\/posts\/default\/1066913447316051619"},{"rel":"alternate","type":"text/html","href":"https:\/\/www.pharmaguideline.com\/2022\/08\/contamination-control-strategies-for-manufacturing-area.html","title":"Contamination Control Strategies for Manufacturing Area"}],"author":[{"name":{"$t":"Ankur Choudhary"},"uri":{"$t":"http:\/\/www.blogger.com\/profile\/13017110634151977121"},"email":{"$t":"noreply@blogger.com"},"gd$image":{"rel":"http://schemas.google.com/g/2005#thumbnail","width":"31","height":"32","src":"\/\/blogger.googleusercontent.com\/img\/b\/R29vZ2xl\/AVvXsEgNClN3RTa7EsnxCU-cdUVaGyvB6DpC1Q4P9TZcFmSeaEKDDoxxY19aCofuB_T9QotdwXw5IuPkdx2-z-kmRgFaR5q6FFCuizQ5XlYe4No2v1X7rIaM37DnG4EQHiJ2FQ\/s220\/ankur-img.jpg"}}],"media$thumbnail":{"xmlns$media":"http://search.yahoo.com/mrss/","url":"https:\/\/4.bp.blogspot.com\/-jYuA05jSXbs\/XJS2pPRkiMI\/AAAAAAAAH8M\/IXFEbV3mcvg-aU21uKuMwu1aITQJtoiMQCLcBGAs\/s72-w640-h240-c\/contamination-control.jpg","height":"72","width":"72"},"thr$total":{"$t":"0"}}]}});