{"id":3932,"date":"2025-01-24T13:17:02","date_gmt":"2025-01-24T05:17:02","guid":{"rendered":"https:\/\/www.leakagetester.com\/?p=3932"},"modified":"2025-03-18T09:36:17","modified_gmt":"2025-03-18T01:36:17","slug":"ccit-test-in-pharma-usp-1207-vacuum-leak-test","status":"publish","type":"post","link":"https:\/\/www.leakagetester.com\/ja\/ccit-test-in-pharma-usp-1207-vacuum-leak-test\/","title":{"rendered":"\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b CCIT \u30c6\u30b9\u30c8\u306e\u7406\u89e3 | USP 1207 \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9"},"content":{"rendered":"

\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b CCIT \u30c6\u30b9\u30c8\u306e\u7406\u89e3 | USP 1207 \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h1>\n\n\n\n

\u533b\u85ac\u54c1\u5305\u88c5\u306e\u5b8c\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306f\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u4fdd\u5b58\u671f\u9593\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u305d\u306e\u305f\u3081 \u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u88fd\u85ac<\/strong> \u306f\u3001\u5bb9\u5668\u306e\u6f0f\u308c\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306e\u6700\u3082\u4fe1\u983c\u3067\u304d\u308b\u65b9\u6cd5\u306e\u4e00\u3064\u3067\u3042\u308b\u3002\u4ee5\u4e0b\u3092\u9075\u5b88\u3059\u308b\u3053\u3068\u3067 USP 1207<\/a><\/strong> \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u6d3b\u7528\u3057\u3001\u9ad8\u5ea6\u306a \u771f\u7a7a\u30ea\u30fc\u30af\u691c\u51fa\u6cd5<\/a><\/strong>, \u306a\u3069\u304c\u3042\u308b\u3002 \u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bCCIT\u8a66\u9a13<\/strong>, \u88fd\u9020\u8005\u306f\u3001\u533b\u85ac\u54c1\u5305\u88c5\u30b7\u30b9\u30c6\u30e0\u306e\u7121\u83cc\u6027\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3092\u640d\u306a\u3046\u53ef\u80fd\u6027\u306e\u3042\u308b\u6f5c\u5728\u7684\u306a\u9055\u53cd\u3092\u691c\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

\u533b\u85ac\u54c1\u5305\u88c5\u306b\u304a\u3051\u308b\u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306e\u91cd\u8981\u6027<\/strong><\/h2><\/div>\n\n\n\n

\u5305\u88c5\u306f\u3001\u533b\u85ac\u54c1\u3092\u74b0\u5883\u6c5a\u67d3\u304b\u3089\u5b88\u308b\u4e0a\u3067\u6975\u3081\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u3044\u308b\u3002\u5305\u88c5\u306e\u5c0f\u3055\u306a\u6f0f\u308c\u3067\u3055\u3048\u3001\u6c5a\u67d3\u3001\u533b\u85ac\u54c1\u6709\u52b9\u6210\u5206\uff08API\uff09\u306e\u52a3\u5316\u3001\u307e\u305f\u306f\u88fd\u54c1\u306e\u6709\u52b9\u6027\u306e\u640d\u5931\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u771f\u7a7a\u30ea\u30fc\u30af\u691c\u67fb\u306f\u3001\u5305\u88c5\u306e\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3057\u3001\u7c73\u56fdFDA\u3084\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306a\u3069\u306e\u5f53\u5c40\u304c\u5b9a\u3081\u308b\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u306e\u306b\u5f79\u7acb\u3064\u975e\u7834\u58ca\u691c\u67fb\u6cd5\u3067\u3059\u3002.<\/p>\n\n\n\n

\u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306f\u3001\u88fd\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3057\u3066\u7121\u83cc\u30d0\u30ea\u30a2\u3092\u7dad\u6301\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u7121\u83cc\u5305\u88c5\u306b\u3068\u3063\u3066\u7279\u306b\u91cd\u8981\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n

\u533b\u85ac\u54c1\u306b\u304a\u3051\u308bCCIT\u8a66\u9a13\uff08\u5bb9\u5668\u9589\u9396\u5b8c\u5168\u6027\u8a66\u9a13\uff09<\/strong><\/h2><\/div>\n\n\n\n

\u306e \u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308bCCIT\u8a66\u9a13<\/strong> (Container Closure Integrity Testing\uff09\u306f\u3001\u533b\u85ac\u54c1\u5305\u88c5\u306e\u4fe1\u983c\u6027\u3068\u5b89\u5168\u6027\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u91cd\u8981\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002\u3053\u306e\u8a66\u9a13\u306f\u3001\u5bb9\u5668\u304c\u305d\u306e\u5b8c\u5168\u6027\u3092\u7dad\u6301\u3057\u3001\u6c5a\u67d3\u3084\u52a3\u5316\u304b\u3089\u88fd\u54c1\u3092\u4fdd\u8b77\u3059\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3002CCIT\u3067\u306f\u3001\u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u3001\u30d8\u30ea\u30a6\u30e0\u30ea\u30fc\u30af\u691c\u51fa\u3001\u5727\u529b\u6e1b\u8870\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u65b9\u6cd5\u304c\u63a1\u7528\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u30c6\u30b9\u30c8\u306f\u3001\u5305\u88c5\u30b7\u30b9\u30c6\u30e0\u304c\u4ee5\u4e0b\u306b\u6982\u8aac\u3055\u308c\u308b\u53b3\u683c\u306a\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002 USP 1207<\/strong>, \u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3057\u3066\u3001\u898f\u5236\u8981\u4ef6\u3092\u9075\u5b88\u3057\u3001\u7121\u83cc\u6027\u3068\u54c1\u8cea\u3092\u5b88\u308b\u3002.<\/p>\n\n\n\n

\u4ee5\u4e0b\u306f\u305d\u306e\u4e3b\u306a\u3082\u306e\u3067\u3042\u308b\u3002 \u88fd\u85ac\u306b\u304a\u3051\u308bCCIT\u8a66\u9a13<\/strong> \u88fd\u85ac\u696d\u754c\u3067\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\uff1a<\/p>\n\n\n\n

1.\u771f\u7a7a\u30ea\u30fc\u30af\u691c\u77e5\u6cd5<\/strong><\/p>\n\n\n\n

\u306e \u771f\u7a7a\u6e1b\u8870\u6cd5<\/strong> \u306f\u3001\u88fd\u85ac\u696d\u754c\u3067\u6700\u3082\u5e83\u304f\u4f7f\u308f\u308c\u3066\u3044\u308b\u30ea\u30fc\u30af\u691c\u77e5\u6280\u8853\u306e\u3072\u3068\u3064\u3067\u3042\u308b\u3002\u3053\u306e\u65b9\u6cd5\u3067\u306f\u3001\u5305\u88c5\u3092\u5bc6\u9589\u30c1\u30e3\u30f3\u30d0\u30fc\u306b\u5165\u308c\u3001\u771f\u7a7a\u3092\u304b\u3051\u308b\u3002\u30c1\u30e3\u30f3\u30d0\u30fc\u5185\u306e\u5727\u529b\u306f\u7d4c\u6642\u7684\u306b\u30e2\u30cb\u30bf\u30fc\u3055\u308c\u308b\u3002\u30ea\u30fc\u30af\u304c\u5b58\u5728\u3059\u308b\u5834\u5408\u3001\u88c2\u3051\u76ee\u304b\u3089\u7a7a\u6c17\u304c\u5165\u308b\u305f\u3081\u3001\u30c1\u30e3\u30f3\u30d0\u30fc\u5185\u306e\u5727\u529b\u304c\u4e0a\u6607\u3059\u308b\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306e\u611f\u5ea6\u306f\u308f\u305a\u304b\u306a\u30ea\u30fc\u30af\u3082\u691c\u51fa\u3067\u304d\u308b\u305f\u3081\u3001\u7e4a\u7d30\u306a\u533b\u85ac\u54c1\u5305\u88c5\u306e\u5b8c\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u306e\u306b\u7406\u60f3\u7684\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n

\u3053\u306e\u65b9\u6cd5\u306f\u30b7\u30f3\u30d7\u30eb\u3067\u52b9\u7387\u7684\u3067\u3042\u308a\u3001\u900f\u660e\u3067\u306a\u3044\u30d1\u30c3\u30b1\u30fc\u30b8\u3084\u76ee\u8996\u691c\u67fb\u304c\u3067\u304d\u306a\u3044\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u6700\u9069\u3067\u3059\u3002\u771f\u7a7a\u6e1b\u8870\u8a66\u9a13\u306f\u3001\u30d0\u30a4\u30a2\u30eb\u3001\u30a2\u30f3\u30d7\u30eb\u3001\u30d6\u30ea\u30b9\u30bf\u30fc\u30d1\u30c3\u30af\u3001\u305d\u306e\u4ed6\u306e\u533b\u85ac\u54c1\u5bb9\u5668\u306b\u3088\u304f\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

2.\u30d8\u30ea\u30a6\u30e0\u6f0f\u308c\u691c\u77e5<\/strong><\/p>\n\n\n\n

\u30d8\u30ea\u30a6\u30e0\u30fb\u30ea\u30fc\u30af\u691c\u67fb\u306f\u3001\u533b\u85ac\u54c1\u5305\u88c5\u306e\u30ea\u30fc\u30af\u3092\u691c\u51fa\u3059\u308b\u305f\u3081\u306e\u3082\u3046\u4e00\u3064\u306e\u6b63\u78ba\u3067\u52b9\u679c\u7684\u306a\u65b9\u6cd5\u3067\u3042\u308b\u3002\u3053\u306e\u8a66\u9a13\u3067\u306f\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u771f\u7a7a\u30c1\u30e3\u30f3\u30d0\u30fc\u306b\u5bc6\u5c01\u3057\u3001\u30d8\u30ea\u30a6\u30e0\u30ac\u30b9\u3092\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u5c0e\u5165\u3059\u308b\u3002\u30d1\u30c3\u30b1\u30fc\u30b8\u304b\u3089\u6f0f\u51fa\u3059\u308b\u30d8\u30ea\u30a6\u30e0\u3092\u691c\u51fa\u3059\u308b\u305f\u3081\u306b\u8cea\u91cf\u5206\u6790\u8a08\u304c\u4f7f\u7528\u3055\u308c\u308b\u3002\u30d8\u30ea\u30a6\u30e0\u306f\u5c0f\u3055\u304f\u975e\u53cd\u5fdc\u6027\u306e\u5206\u5b50\u3067\u3042\u308b\u305f\u3081\u3001\u4ed6\u306e\u65b9\u6cd5\u3067\u306f\u7279\u5b9a\u304c\u96e3\u3057\u3044\u30ea\u30fc\u30af\u3092\u691c\u51fa\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>\n\n\n\n

\u30d8\u30ea\u30a6\u30e0\u30ea\u30fc\u30af\u691c\u77e5\u306f\u3001\u88fd\u54c1\u306e\u5305\u88c5\u306e\u5b8c\u5168\u6027\u3092\u6700\u9ad8\u306e\u7cbe\u5ea6\u3067\u691c\u8a3c\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u9ad8\u7cbe\u5ea6\u306e\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u7279\u306b\u6709\u76ca\u3067\u3059\u3002.<\/p>\n\n\n\n

3.\u67d3\u6599\u6d78\u900f\u6cd5\uff08\u30c8\u30ec\u30fc\u30b5\u30fc\u6db2\uff09<\/strong><\/p>\n\n\n\n

\u67d3\u6599\u6d78\u5165\u6cd5\u3067\u306f\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u5916\u5074\u306b\u67d3\u6599\u3092\u5857\u5e03\u3057\u3001\u771f\u7a7a\u72b6\u614b\u306b\u3059\u308b\u3002\u5305\u88c5\u306b\u6f0f\u308c\u304c\u3042\u308b\u5834\u5408\u3001\u67d3\u6599\u306f\u305d\u306e\u88c2\u3051\u76ee\u304b\u3089\u5305\u88c5\u306b\u5165\u308a\u3001\u691c\u67fb\u5b98\u306b\u898b\u3048\u308b\u3088\u3046\u306b\u306a\u308b\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u30dc\u30c8\u30eb\u3001\u74f6\u3001\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u5bb9\u5668\u306a\u3069\u3001\u76ee\u8996\u691c\u67fb\u304c\u5bb9\u6613\u306a\u5305\u88c5\u306b\u6709\u52b9\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n

\u52b9\u679c\u7684\u3067\u306f\u3042\u308b\u304c\u3001\u67d3\u6599\u6d78\u5165\u6cd5\u306f\u3001\u3059\u3079\u3066\u306e\u7a2e\u985e\u306e\u533b\u85ac\u54c1\u5305\u88c5\u3001\u7279\u306b\u7121\u83cc\u72b6\u614b\u3067\u5bc6\u5c01\u3055\u308c\u308b\u3082\u306e\u3001\u3042\u308b\u3044\u306f\u6c5a\u67d3\u304c\u554f\u984c\u3068\u306a\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u3082\u306e\u306b\u306f\u9069\u3055\u306a\u3044\u304b\u3082\u3057\u308c\u306a\u3044\u3002.<\/p>\n\n\n\n

4.\u5727\u529b\u6e1b\u8870\u6cd5<\/strong><\/p>\n\n\n\n

\u771f\u7a7a\u6e1b\u8870\u6cd5\u3068\u540c\u69d8\u306b \u5727\u529b\u6e1b\u8870\u6cd5<\/strong> \u5305\u88c5\u3092\u5bc6\u5c01\u3057\u3001\u5727\u529b\u3092\u304b\u3051\u308b\u3002\u305d\u306e\u5f8c\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u5185\u306e\u5727\u529b\u304c\u30e2\u30cb\u30bf\u30fc\u3055\u308c\u308b\u3002\u5727\u529b\u304c\u4f4e\u4e0b\u3059\u308c\u3070\u3001\u30ea\u30fc\u30af\u304c\u767a\u751f\u3057\u305f\u3053\u3068\u3092\u793a\u3059\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u5727\u529b\u8a66\u9a13\u306b\u8010\u3048\u3089\u308c\u308b\u88fd\u54c1\u3084\u3001\u8fc5\u901f\u306a\u8a66\u9a13\u304c\u5fc5\u8981\u306a\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u3088\u304f\u4f7f\u308f\u308c\u308b\u3002.<\/p>\n\n\n\n

\u5727\u529b\u6e1b\u8870\u8a66\u9a13\u306f\u3001\u30dc\u30c8\u30eb\u3084\u30d0\u30a4\u30a2\u30eb\u306a\u3069\u306e\u786c\u8cea\u5bb9\u5668\u306e\u8a66\u9a13\u306b\u3088\u304f\u7528\u3044\u3089\u308c\u3001\u591a\u304f\u306e\u533b\u85ac\u54c1\u7528\u9014\u306b\u9069\u3057\u3066\u3044\u308b\u3002.<\/p>\n\n\n\n

5.\u84cb\u306e\u305f\u308f\u307f\u6cd5<\/strong><\/p>\n\n\n\n

\u306e\u4e2d\u3067 \u30ea\u30c3\u30c9\u30fb\u30c7\u30a3\u30d5\u30ec\u30af\u30b7\u30e7\u30f3\u6cd5<\/strong>, \u5bc6\u5c01\u3055\u308c\u305f\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u771f\u7a7a\u3092\u304b\u3051\u3001\u84cb\u3084\u30ad\u30e3\u30c3\u30d7\u306e\u305f\u308f\u307f\u3092\u6e2c\u5b9a\u3059\u308b\u3002\u5305\u88c5\u304c\u7121\u50b7\u3067\u3042\u308c\u3070\u3001\u305f\u308f\u307f\u306f\u307b\u3068\u3093\u3069\u306a\u3044\u3002\u3057\u304b\u3057\u3001\u6db2\u6f0f\u308c\u304c\u3042\u308c\u3070\u3001\u305f\u308f\u307f\u306f\u9855\u8457\u306b\u306a\u308b\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u67d4\u8edf\u306a\u30b7\u30fc\u30eb\u3084\u84cb\u3092\u6301\u3064\u5bb9\u5668\u306b\u7279\u306b\u6709\u52b9\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n

6.\u30d8\u30c3\u30c9\u30b9\u30da\u30fc\u30b9\u30ac\u30b9\u5206\u6790\uff08HGA\uff09<\/strong><\/p>\n\n\n\n

\u30d8\u30c3\u30c9\u30b9\u30da\u30fc\u30b9\u30ac\u30b9\u5206\u6790\uff08HGA\uff09\u306f\u3001\u5bc6\u5c01\u3055\u308c\u305f\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u30d8\u30c3\u30c9\u30b9\u30da\u30fc\u30b9\u306e\u30ac\u30b9\u7d44\u6210\u3092\u6e2c\u5b9a\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u30ea\u30fc\u30af\u3092\u691c\u51fa\u3059\u308b\u65b9\u6cd5\u3067\u3042\u308b\u3002\u30ea\u30fc\u30af\u304c\u5b58\u5728\u3059\u308b\u5834\u5408\u3001\u30d1\u30c3\u30b1\u30fc\u30b8\u5185\u306e\u30ac\u30b9\u7d44\u6210\u306f\u5909\u5316\u3059\u308b\u3002\u3053\u306e\u65b9\u6cd5\u306f\u3001\u6ce8\u5c04\u5668\u3084\u30d7\u30ec\u30d5\u30a3\u30eb\u30c9\u30da\u30f3\u306a\u3069\u3001\u5185\u90e8\u306e\u96f0\u56f2\u6c17\u304c\u91cd\u8981\u306a\u533b\u85ac\u54c1\u5305\u88c5\u306b\u3088\u304f\u7528\u3044\u3089\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

\u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u306b\u304a\u3051\u308bUSP1207\u3078\u306e\u6e96\u62e0<\/strong><\/h2><\/div>\n\n\n\n

\u306e USP 1207<\/strong> \u306e\u305f\u3081\u306e\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002 \u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u88fd\u85ac<\/strong> \u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u5bb9\u5668\u9589\u9396\u5b8c\u5168\u6027\u8a66\u9a13\uff08CCIT\uff09\u6cd5\u3092\u542b\u3080\u3002USP1207\u306f\u3001\u533b\u85ac\u54c1\u5305\u88c5\u304c\u88fd\u54c1\u306e\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u7121\u83cc\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002.<\/p>\n\n\n\n

\u306e \u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u88fd\u85ac<\/strong> \u306f\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u5b8c\u5168\u6027\u3001\u6709\u52b9\u6027\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u306a\u65b9\u6cd5\u3067\u3059\u3002\u771f\u7a7a\u6e1b\u8870\u3001\u30d8\u30ea\u30a6\u30e0\u30ea\u30fc\u30af\u691c\u51fa\u3001\u67d3\u6599\u6d78\u5165\u3001\u5727\u529b\u6e1b\u8870\u8a66\u9a13\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u691c\u51fa\u65b9\u6cd5\u304c\u3042\u308b\u305f\u3081\u3001\u533b\u85ac\u54c1\u30e1\u30fc\u30ab\u30fc\u306f\u88fd\u54c1\u3084\u5305\u88c5\u30bf\u30a4\u30d7\u306b\u5fdc\u3058\u3066\u6700\u9069\u306a\u6280\u8853\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n

\u3088\u304f\u3042\u308b\u3054\u8cea\u554f<\/strong><\/h2>\n\n\n\n

1.\u771f\u7a7a\u30ea\u30fc\u30af\u30c6\u30b9\u30c8\u88fd\u85ac\u3068\u306f\uff1f<\/strong>
\u771f\u7a7a\u30ea\u30fc\u30af\u691c\u67fb\u6cd5\u306f\u3001\u771f\u7a7a\u3092\u4f5c\u308a\u3001\u7834\u308c\u3092\u793a\u3059\u5727\u529b\u5909\u5316\u3092\u76e3\u8996\u3059\u308b\u3053\u3068\u306b\u3088\u3063\u3066\u3001\u533b\u85ac\u54c1\u5305\u88c5\u306e\u30ea\u30fc\u30af\u3092\u691c\u51fa\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n

2.\u771f\u7a7a\u6f0f\u308c\u306e\u691c\u51fa\u65b9\u6cd5\u306f\uff1f<\/strong>
\u771f\u7a7a\u6e1b\u8870\u6cd5\u3067\u306f\u3001\u5bc6\u5c01\u3055\u308c\u305f\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u771f\u7a7a\u3092\u304b\u3051\u3001\u30c1\u30e3\u30f3\u30d0\u30fc\u5185\u306e\u5727\u529b\u3092\u30e2\u30cb\u30bf\u30fc\u3059\u308b\u3002\u5727\u529b\u306e\u4e0a\u6607\u306f\u30ea\u30fc\u30af\u3092\u793a\u3059\u3002.<\/p>\n\n\n\n

3.USP 1207\u3068\u306f\uff1f<\/strong>
USP 1207\u306f\u3001\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u898f\u5b9a\u3057\u3066\u3044\u308b\u3002 \u5bb9\u5668\u9589\u9396\u5b8c\u5168\u6027\u8a66\u9a13\uff08CCIT\uff09<\/strong>, \u771f\u7a7a\u30ea\u30fc\u30af\u691c\u67fb\u3092\u542b\u3081\u3001\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u7121\u83cc\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3002.<\/p>\n\n\n\n

4.\u5727\u529b\u6e1b\u8870\u6cd5\u3068\u771f\u7a7a\u6e1b\u8870\u6cd5\u306e\u9055\u3044\u306f\u4f55\u3067\u3059\u304b\uff1f<\/strong>
\u3069\u3061\u3089\u306e\u65b9\u6cd5\u3082\u5727\u529b\u5909\u5316\u3092\u30e2\u30cb\u30bf\u30fc\u3057\u3066\u6f0f\u308c\u3092\u691c\u51fa\u3059\u308b\u304c\u3001\u5727\u529b\u6e1b\u8870\u6cd5\u306f\u6b63\u5727\u3092\u304b\u3051\u308b\u306e\u306b\u5bfe\u3057\u3001\u771f\u7a7a\u6e1b\u8870\u6cd5\u306f\u8ca0\u5727\u3092\u533b\u85ac\u54c1\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u304b\u3051\u308b\u3002.<\/p>\n\n\n\n

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

\u88fd\u85ac\u306b\u304a\u3051\u308b CCIT \u30c6\u30b9\u30c8\u306e\u7406\u89e3 | USP 1207 \u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9 \u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u4fdd\u5b58\u671f\u9593\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u533b\u85ac\u54c1\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u5b8c\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u533b\u85ac\u54c1\u306e\u771f\u7a7a\u30ea\u30fc\u30af \u30c6\u30b9\u30c8\u306f\u3001\u5bb9\u5668\u306e\u6f0f\u308c\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306e\u6700\u3082\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u65b9\u6cd5\u306e 1 \u3064\u3067\u3059\u3002USP 1207 \u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u62e0\u3057\u3001\u533b\u85ac\u54c1\u306e CCIT \u30c6\u30b9\u30c8\u306a\u3069\u306e\u9ad8\u5ea6\u306a\u771f\u7a7a\u30ea\u30fc\u30af\u691c\u51fa\u65b9\u6cd5\u3092\u5229\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u533b\u85ac\u54c1\u30d1\u30c3\u30b1\u30fc\u30b8 \u30b7\u30b9\u30c6\u30e0\u306e\u7121\u83cc\u6027\u3001\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3092\u640d\u306a\u3046\u53ef\u80fd\u6027\u306e\u3042\u308b\u6f5c\u5728\u7684\u306a\u9055\u53cd\u3092\u691c\u51fa\u3067\u304d\u307e\u3059\u3002\u533b\u85ac\u54c1\u30d1\u30c3\u30b1\u30fc\u30b8\u306b\u304a\u3051\u308b\u771f\u7a7a\u30ea\u30fc\u30af \u30c6\u30b9\u30c8\u306e\u91cd\u8981\u6027 \u30d1\u30c3\u30b1\u30fc\u30b8\u306f\u3001\u533b\u85ac\u54c1\u3092\u74b0\u5883\u6c5a\u67d3\u304b\u3089\u4fdd\u8b77\u3059\u308b\u4e0a\u3067\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002\u30d1\u30c3\u30b1\u30fc\u30b8\u306e\u5c0f\u3055\u306a\u6f0f\u308c\u3067\u3082\u3001 [\u2026]","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-3932","post","type-post","status-publish","format-standard","hentry","category-test-method"],"yoast_head":"\nUnderstanding the CCIT Test in Pharma | USP 1207 Compliance<\/title>\n<meta name=\"description\" content=\"Discover effective vacuum leak test methods for pharmaceutical packaging. 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