{"id":570,"date":"2025-04-23T05:02:56","date_gmt":"2025-04-23T05:02:56","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=570"},"modified":"2025-04-23T05:02:56","modified_gmt":"2025-04-23T05:02:56","slug":"sop-title-cleaning-and-operation-of-sampling-booth-2","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=570","title":{"rendered":"SOP Title: Cleaning and Operation of Sampling Booth"},"content":{"rendered":"

SOP Title:<\/u><\/strong> Cleaning and Operation of Sampling Booth<\/u><\/strong><\/p>\n

    \n
  1. Objective:<\/strong><\/li>\n<\/ol>\n

    To lay down the procedure for Cleaning and Operation of Sampling Booth.<\/p>\n

     <\/p>\n

      \n
    1. Scope:<\/strong><\/li>\n<\/ol>\n

      This procedure is applicable for Cleaning and Operation of Raw Material Sampling Booth \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0used for Raw Material Sampling.<\/p>\n

        \n
      1. Responsibility:<\/strong><\/li>\n<\/ol>\n
          \n
        • Quality Control Department: To prepare and review the SOP. To follow the procedures laid down for Cleaning and Operation of Raw Material Sampling Booth in Quality Control Department as per this SOP.<\/li>\n
        • Quality Assurance Department: To review and approve the SOP and Annexures.<\/li>\n
        • Engineering Department: To carry out preventive maintenance as per schedule and procedure defined.<\/li>\n<\/ul>\n
            \n
          1. Accountability:<\/strong><\/li>\n<\/ol>\n

            Head Quality Control Department, Head Quality Assurance Department<\/p>\n

              \n
            1. Procedure:<\/strong><\/li>\n<\/ol>\n

              \u00a0<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
              Sr. No.<\/strong><\/td>\nProcedure<\/strong><\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/strong>\u00a0<\/strong><\/td>\nSafety Precautions:<\/strong><\/td>\n<\/tr>\n
              5.1.1\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAlways use personal protective equipments such as nose masks and hand gloves while sampling, operation and cleaning of sampling booth.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.1.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nNever stand in front of the RLAF when Ultraviolet light is ON as UV exposure can cause damage to eyes, cell damage, skin itching etc.<\/td>\n <\/td>\n<\/tr>\n
              5.1.3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nDo not perform cleaning activity when UV light is ON.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              \u00a0\u00a0 5.2<\/strong><\/td>\nOperation of Sampling Booth:<\/strong><\/td>\n<\/tr>\n
              5.2.1<\/td>\nEnsure the cleaning of sampling booth is satisfactory and AHU is in running condition. Use 70% IPA for cleaning before starting the activity.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.2\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nSwitch \u2018ON\u2019 the RLAF unit after cleaning the unit and then switch \u2018ON\u2019 UV light of the sampling RLAF and pass box. Run them for minimum 30 minutes for disinfection.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.3\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAfter 30 minutes, switch OFF the UV light of the sampling RLAF and Pass box and note down burning hours in annexure. Start the air flow and check the differential pressure of RLAF on magnehelic gauge is between 10 mm – 20 mm as well as check the temperature and humidity maintained at 25\u00b12o<\/sup>C and 55\u00b15% in the area respectively.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.4\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nIn case, if the differential pressure or Temperature\/Humidity conditions are not meeting the requirements, then intimate the Engineering Department and Head Quality Control.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.5\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nPerform sampling of raw materials as per SOP \u2018Sampling of Raw Materials\u201d under RLAF.<\/p>\n

               <\/td>\n

              		\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.6\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nTransfer all the containers\/bags\/drums from the quarantine area or Under Test area one at a time through the pass box into the sampling booth, draw the sample and return to the Under Test area after completion of sampling.<\/td>\n <\/td>\n<\/tr>\n
              5.2.7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nAll the used equipment\u2019s; accessories shall be removed from the sampling booth after use for cleaning.<\/td>\n <\/td>\n<\/tr>\n
              5.2.8\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nSwitch off the RLAF after 15 minutes of completion of sampling activity.<\/td>\n <\/td>\n<\/tr>\n
              5.2.9\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\n\u00a0Update the \u201cUsage and Cleaning Record of Raw material Sampling Booth\u201d as per define Annexure.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.2.10\u00a0\u00a0\u00a0 \u00a0<\/strong><\/td>\nLabel the sampling booth as \u201cTo be Cleaned\u201d or if cleaning activity is going on, then label as \u201cUnder Cleaning\u201d and start the cleaning activity.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              \u00a0\u00a0 5.3<\/strong><\/td>\nCleaning Procedure of Sampling Booth:<\/strong><\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.1<\/td>\nSwitch \u2018OFF\u2019 the RLAF before starting the cleaning activity.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.2\u00a0\u00a0 \u00a0<\/strong><\/td>\nEnsure that all documents and labels and accessories of previous material are removed from sampling booth.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.3\u00a0\u00a0 \u00a0<\/strong><\/td>\nClean spilled dry powder or waste with soft brush or vacuum cleaner and collect in the waste bin.<\/td>\n <\/td>\n<\/tr>\n
              5.3.4<\/td>\nWipe the inside part as well as outside parts of the sampling booth properly in each and every corner with soft clean lint free dry cloth followed by wet cloth with water and finally wipe with wet cloth dipped in 70% IPA solution.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.5<\/td>\nWipe the floor and walls of sampling booth and pass box with clean soft lint free cloth, followed by wet cloth with water and finally with disinfectant solution such as dettol\/savlon.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.6<\/td>\nClean the UV light and ordinary tube lights with soft lint free cloth.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.3.7<\/td>\nAfter completion of the cleaning activity update the \u201cUsage and Cleaning log of Sampling Booth\u201d as per format and label the sampling booth as follows:<\/p>\n

              \u00a0<\/strong><\/p>\n

              Cleaned <\/strong><\/p>\n

              Date: \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Sign<\/td>\n

              		 <\/td>\n<\/tr>\n
              5.3.8<\/td>\nAfter completion of the cleaning activity, switch \u2018ON\u2019 the UV light of Both Sampling RLAF and pass box for 30 minutes. Record in Annexure.<\/td>\n <\/td>\n<\/tr>\n
              5.3.9<\/td>\nCleaning of sampling booth shall be carried out at the start of the shift and after completion of sampling activity.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4<\/strong><\/td>\nValidation of RLAF:<\/strong><\/td>\n<\/tr>\n
              5.4.1<\/td>\nFrequency: <\/strong>Once in a year<\/td>\n<\/tr>\n
              5.4.2<\/td>\nValidation of RLAF shall be performed by external agency.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.4.3<\/td>\nFor validation refer SOP \u201cProcedure for validation of LAF\/RLAF\u201d for parameters and acceptance criteria.<\/td>\n\u00a0<\/strong><\/td>\n<\/tr>\n
              5.5<\/strong><\/td>\nUV Efficacy Study of UV light tube in Sampling RLAF and Pass box<\/strong><\/td>\n<\/tr>\n
              5.5.1<\/td>\nFrequency: <\/strong>Half Yearly<\/td>\n <\/td>\n<\/tr>\n
              5.5.2<\/td>\nPerform Efficacy test of UV light Study as per define SOP<\/td>\n <\/td>\n<\/tr>\n
              \u00a0\u00a0\u00a0\u00a0 5.6<\/strong><\/td>\nPreventive Maintenance:<\/strong><\/td>\n<\/tr>\n
              5.6.1<\/td>\nPerform the preventive maintenance as per define frequency.<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

               <\/p>\n

                \n
              1. Definitions \/ Abbreviations : <\/strong><\/li>\n<\/ol>\n
                  \n
                • Definitions :<\/strong><\/li>\n
                • Quality Control Associate: Analyst, Supervisor, Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.<\/li>\n
                • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.<\/li>\n
                • Engineering Associate: Officer, Executive of Engineering Department or any personnel trained to perform duties as per this SOP.<\/li>\n
                • Breakdown: Any activity leading to operation of instrument other than the set parameters or unusual sound or vibration observed in the instrument.<\/li>\n
                • Preventive Maintenance: Maintenance activity performed to ensure that the instrument will function smoothly and to avoid breakdowns. These activities are performed as per predefined frequency.<\/li>\n
                • Principle of Sampling booth:<\/li>\n<\/ul>\n

                  Sampling booth is used to control hazardous emissions of powder, dust or vapour during sampling, without risk to the operator or environment. They are constructed from stainless steel in fully ducted designs. The reverse laminar flow booth is made from stainless steel. A negative pressure inside the booth prevents the escape of fine powder from the work area towards the external environment. Downward airflow provides full protection to operator and product. It minimizes the risk of contaminating the work zone ensuring health and safety of people working with the chemical\/powder. Reverse laminar air flow operates on the principle of providing containment of contaminated air by air movement. Pre filters capture airborne contaminants in the rear of the room or hood, and the velocity of the air entering the filters is accelerated to reduce the number of particles that recirculation into the room.<\/p>\n

                   <\/p>\n

                   <\/p>\n

                   <\/p>\n

                   <\/p>\n

                   <\/p>\n

                   <\/p>\n

                    \n
                  • Abbreviations :<\/strong><\/li>\n<\/ul>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
                    Abbreviation<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n
                    QC<\/td>\nQuality Control<\/td>\n<\/tr>\n
                    QA<\/td>\nQuality Assurance<\/td>\n<\/tr>\n
                    SOP<\/td>\nStandard Operating Procedure<\/td>\n<\/tr>\n
                    PVC<\/td>\nPoly Vinyl Chloride<\/td>\n<\/tr>\n
                    RLAF<\/td>\nReverse Laminar Air Flow<\/td>\n<\/tr>\n
                    LAF<\/td>\nLaminar Air Flow<\/td>\n<\/tr>\n
                    \u00b1<\/td>\nPlus or minus<\/td>\n<\/tr>\n
                    %<\/td>\nPercentage<\/td>\n<\/tr>\n
                    o<\/sup>C<\/td>\nDegree Celsius<\/td>\n<\/tr>\n
                    mm<\/td>\nmillilitre<\/td>\n<\/tr>\n
                    AHU<\/td>\nAir Handling Unit<\/td>\n<\/tr>\n
                    UV<\/td>\nUltra Violet<\/td>\n<\/tr>\n
                    IPA<\/td>\nIsopropyl Alcohol<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

                     <\/p>\n

                     <\/p>\n

                    *Note – Ready to use SOP available in \u201cDOWNLOAD\u201d Section.<\/u><\/em><\/strong><\/p>\n

                     <\/p>\n","protected":false},"excerpt":{"rendered":"

                    SOP Title: Cleaning and Operation of Sampling Booth Objective: To lay down the procedure for Cleaning and Operation of Sampling Booth.   Scope: This procedure is applicable for Cleaning and Operation of Raw Material Sampling Booth \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0used for Raw Material Sampling. Responsibility: Quality Control Department: To prepare and review the SOP. To follow the procedures […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"templates\/template-full-width.php","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-570","post","type-post","status-publish","format-standard","hentry","category-qc-sop"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/570","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=570"}],"version-history":[{"count":2,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/570\/revisions"}],"predecessor-version":[{"id":572,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/570\/revisions\/572"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=570"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=570"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=570"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}