{"id":982,"date":"2025-06-28T06:46:22","date_gmt":"2025-06-28T06:46:22","guid":{"rendered":"https:\/\/pharmacoguide.com\/?p=982"},"modified":"2025-11-15T05:28:18","modified_gmt":"2025-11-15T05:28:18","slug":"title-operation-and-cleaning-of-tablet-and-capsule-hand-counter","status":"publish","type":"post","link":"https:\/\/pharmacoguide.com\/?p=982","title":{"rendered":"SOP Title: Operation and Cleaning of Tablet and Capsule Hand Counter"},"content":{"rendered":"

Title:<\/u><\/strong> Operation and Cleaning of Tablet and Capsule Hand Counter\u00a0<\/strong><\/u><\/p>\n

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

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

    To define procedure for Operation and Cleaning of Tablet and Capsule Hand Counter.<\/p>\n

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

      This SOP is applicable to all Hand Counters used for counting of tablets\/capsules during bulk \u00a0\u00a0packing in packing section.<\/p>\n

       <\/p>\n

        \n
      1. Responsibility:<\/strong>\n
          \n
        • Production Department:<\/strong> To prepare and review the SOP. To follow the procedure for operation and cleaning of Tablet and Capsule Hand Counter.<\/li>\n
        • Quality Assurance Department: <\/strong>To provide line clearance prior to operation. To collect the swab\/ rinse sample. To review and approve the SOP and Annexure.<\/li>\n
        • Quality Control Department: To analyse and report of the swab\/rinse samples.<\/li>\n<\/ul>\n<\/li>\n
        • Accountability:<\/strong><\/li>\n<\/ol>\n

          Head, Production Department. Head, Q.A. Department.<\/p>\n

            \n
          1. Procedure:<\/strong>\n
              \n
            • Definition:<\/strong>\n
                \n
              • Production Associate: Executive or Operator of Production 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
              • Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.<\/li>\n
              • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,\n
                  \n
                • Remove the previous batch residue.<\/li>\n
                • During end of the shift.<\/li>\n
                • Before starting the next batch of the same product.<\/li>\n
                • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.<\/li>\n<\/ul>\n<\/li>\n
                • Type B Cleaning: Wet cleaning by using soap solution in the following cases.\n
                    \n
                  • Removal of traces of the previous product, and is ensured by testing rinse \/swab sample of the cleaned equipment.<\/li>\n
                  • Change in product.<\/li>\n
                  • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.<\/li>\n
                  • After continuous five batches of the same product.<\/li>\n
                  • After seven days of cleaning before use, if equipment is not in use.<\/li>\n
                  • After replacement or repair of any product contact part.<\/li>\n
                  • Monthly, if it is not in use after cleaning.<\/li>\n<\/ul>\n<\/li>\n
                  • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v\/v)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n

                     <\/p>\n

                      \n
                    • Procedure<\/strong><\/li>\n<\/ul>\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
                       <\/td>\nPrecautions:<\/strong><\/td>\n<\/tr>\n
                      5.2.1<\/td>\nVisually check and ensure that, the hand counter is clean.<\/td>\n <\/td>\n<\/tr>\n
                      5.2.2<\/td>\nDuring filling of counted tablets in container, ensure that, the tablet should not miss in counter or should not drop outside the container.<\/td>\n <\/td>\n<\/tr>\n
                      5.2.3<\/td>\nAll the personnel involved in counting operation should wear the hand gloves and nose mask.<\/td>\n <\/td>\n<\/tr>\n
                      5.3<\/strong><\/td>\nProcedure<\/strong><\/td>\n <\/td>\n<\/tr>\n
                      5.3.1<\/td>\nEnsure that, the equipment is cleaned and line clearance is taken as per line clearance checklist on the BPR.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.2<\/td>\nCheck that the temperature and relative humidity (25o<\/sup>C \u00b1 2o<\/sup>C and 55% \u00b1 5% RH) are within the limit at all stages of manufacturing and packing.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.3<\/td>\nEnsure that the Hand Counter is used as per product shape\/ size by putting the tablets \/capsules in the Hand Counter.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.4<\/td>\nPress the lever and ensure that the hand Counter flap is working properly.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.5<\/td>\nFill the tablets \/capsules in the individual cavity of the Hand Counter tray.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.6<\/td>\nThen shake the counter to drop the over-filled extra tablets from the Hand Counter to the tablet container.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.7<\/td>\nOpen the flap of the Hand Counter and pour the Tablets \/ Capsules from the counter tray slowly to the packing container.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.8<\/td>\nInitially cross check the tablets\/capsules manually, counted by Hand Counter \u00a0to assure correctness as per number of cavities.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.9<\/td>\nAfter completion of counting activity label the Hand Counter as \u201cTo be type A cleaned\u201d or To Be Type B cleaned\u201d as applicable.<\/td>\n <\/td>\n<\/tr>\n
                      5.3.10<\/td>\nRecord the usage activity in \u201cEquipment log book.<\/td>\n <\/td>\n<\/tr>\n
                      5.4<\/strong><\/td>\nCleaning<\/strong><\/td>\n<\/tr>\n
                      5.4.1<\/strong><\/td>\nFor Type A (Batch to Batch ) Cleaning: <\/strong><\/td>\n<\/tr>\n
                      5.4.1.1<\/td>\nRemove all tablets\/ documents of previous batch from the area.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.1.2<\/td>\nInitially, remove the dust accumulated on Hand Counter by using dry duster.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.1.3<\/td>\nClean the outer, inner surface and cavity of Hand Counter by wiping with clean dry duster.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.1.4<\/td>\nAfter ensuring cleanliness, affix \u201cType A Cleaned\u201d label to the Hand Counter.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2<\/strong><\/td>\nFor Type B (Product to Product) Cleaning:<\/strong><\/td>\n<\/tr>\n
                      5.4.2.1<\/td>\nRemove all tablets\/ documents of previous batch from the area.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.2<\/td>\nInitially, remove the dust accumulated on Hand Counter by wiping with dry duster.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.3<\/td>\nCover the Hand Counter with poly bag and transfer to wash area on trolley for cleaning.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.4<\/td>\nWash the Hand Counter with 10-15 litres of potable water to remove the powder.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.5<\/td>\nApply 0.1% soap (teepol) solution to the Hand Counter, and then wash with 10-15 litres of potable water to remove the traces of soap solution. Finally rinse with 10-15 litres of purified water.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.6<\/td>\nFill the Swab \/ Rinse Sample Intimation Slip and submit to QA department to collect the samples.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.7<\/td>\nRecord the activity in equipment log book.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.8<\/td>\nCollect the Swab\/Rinse sample result from QA. If the result is complying, label the equipment as \u201cType B Cleaned\u201d. If the result is not complying repeat the steps 5.4.2.4 to 5.4.2.6<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.9<\/td>\nDry the Hand Counter with the help of clean dry duster\/in tray dryer.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.10<\/td>\nAfter successful completion of cleaning process, mention on the area status board as \u201cType B Cleaned\u201d.<\/td>\n <\/td>\n<\/tr>\n
                      5.4.2.11<\/td>\nCover \u00a0the Hand Counter with fresh poly bag and keep in to the spare parts room.<\/td>\n <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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

                        \n
                      1. Abbreviation:<\/strong><\/li>\n<\/ol>\n\n\n\n\n\n\n\n\n\n
                        Abbreviation<\/strong><\/td>\nExpansion<\/strong><\/td>\n<\/tr>\n<\/thead>\n
                        ml<\/td>\nMilliliter<\/td>\n<\/tr>\n
                        BPR<\/td>\nBatch Packing Record<\/td>\n<\/tr>\n
                        \u00b1<\/td>\nPlus or Minus<\/td>\n<\/tr>\n
                        o<\/sup>C<\/td>\nDegree Centigrade<\/td>\n<\/tr>\n
                        %<\/td>\nPercent<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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

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

                        Title: Operation and Cleaning of Tablet and Capsule Hand Counter\u00a0 \u00a0 Objective: To define procedure for Operation and Cleaning of Tablet and Capsule Hand Counter. Scope: This SOP is applicable to all Hand Counters used for counting of tablets\/capsules during bulk \u00a0\u00a0packing in packing section.   Responsibility: Production Department: To prepare and review the SOP. […]<\/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":[9],"tags":[],"class_list":["post-982","post","type-post","status-publish","format-standard","hentry","category-production"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/982","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=982"}],"version-history":[{"count":2,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/982\/revisions"}],"predecessor-version":[{"id":1536,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/982\/revisions\/1536"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=982"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=982"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=982"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}