{"id":7846,"date":"2024-12-18T18:04:01","date_gmt":"2024-12-18T10:04:01","guid":{"rendered":"https:\/\/chimebiologics.com\/?p=7846"},"modified":"2025-06-12T10:57:58","modified_gmt":"2025-06-12T02:57:58","slug":"dp-quality-control-how-to-control-visible-particulates-in-injections-2-2","status":"publish","type":"post","link":"https:\/\/chimebiologics.com\/ja\/dp-quality-control-how-to-control-visible-particulates-in-injections-2-2\/","title":{"rendered":"(English) DP Quality Control: How to Control Visible Particulates in Injections\uff1f2\/2"},"content":{"rendered":"<p class=\"qtranxs-available-languages-message qtranxs-available-languages-message-ja\">\u7533\u3057\u8a33\u3042\u308a\u307e\u305b\u3093\u3001\u3053\u306e\u30b3\u30f3\u30c6\u30f3\u30c4\u306f\u305f\u3060\u4eca\u3000<a href=\"https:\/\/chimebiologics.com\/zh\/wp-json\/wp\/v2\/posts\/7846\" class=\"qtranxs-available-language-link qtranxs-available-language-link-zh\" title=\"\u4e2d\u6587\">\u4e2d\u6587<\/a>\u3000\u306e\u307f\u3067\u3059\u3002 For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.<\/p><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8\">\n.flex_column.av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-iwqe2-97bb6aa3783a5420eb8a707e0ad897c8 av_two_third  avia-builder-el-0  el_before_av_one_third  avia-builder-el-first  first flex_column_div av-zero-column-padding '     ><section  class='av_textblock_section av-k6j2pxor-09272cddfdcc1afe6211303b3b3d55e0'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><div class=\"mceTemp\"><\/div>\n<p><\/p>\n<h1><strong>\u751f\u7269\u5236\u5242\u8d28\u91cf\u63a7\u5236\uff1a\u5982\u4f55\u63a7\u5236\u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\uff1f\uff08\u4e0b\u7bc7\uff09<\/strong><\/h1>\n<p>\u53ef\u89c1\u5f02\u7269\u7684\u4ea7\u751f\uff0c\u539f\u56e0\u662f\u591a\u65b9\u9762\u7684\u3002\u73b0\u884c\u7684\u201c\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u6cd5\uff08\u901a\u5219 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free of visible particulates\u201d\u57fa\u672c\u4e0a\u4e0d\u542b\u53ef\u89c1\u5f02\u7269\uff0cEP\u5efa\u8bae\u7684\u662f\u201cpractically free of visible particles\u201d\u51e0\u4e4e\u6ca1\u6709\u53ef\u89c1\u5f02\u7269\u3002<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-7847 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1.png\" alt=\"\" width=\"1648\" height=\"208\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1.png 1648w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1-300x38.png 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1-1030x130.png 1030w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1-768x97.png 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1-1536x194.png 1536w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1-1500x189.png 1500w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe1-705x89.png 705w\" sizes=\"auto, (max-width: 1648px) 100vw, 1648px\" \/><\/p>\n<p style=\"text-align: center;\">\u88681 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\u751f\u7269\u5236\u54c1\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u53ef\u80fd\u5b58\u5728\u7684\u98ce\u9669\u548c\u6311\u6218<\/strong><\/p>\n<p>2.1 \u751f\u4ea7\u8bbe\u5907\u8bbe\u65bd<\/p>\n<p>\u6ce8\u5c04\u5242\u7684\u751f\u4ea7\u8bbe\u5907\u548c\u76f8\u5e94\u751f\u4ea7\u8bbe\u65bd\u5e94\u7b26\u5408\u6211\u56fd\u7684\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/p>\n<p>\uff08Good Manufacturing Practices\uff0cGMP\uff09\u8981\u6c42\u3002\u82e5\u751f\u4ea7\u8bbe\u65bd\u548c\u8bbe\u5907\u4e0d\u7b26\u5408GMP\u8981\u6c42\uff0c\u751f\u4ea7\u7ebf\u4f1a\u4ea7\u751f\u65b0\u7684\u6c61\u67d3\u6e90\uff0c\u76f4\u63a5\u6c61\u67d3\u6216\u589e\u52a0\u836f\u54c1\u751f\u4ea7\u53d7\u5230\u6c61\u67d3\u7684\u53ef\u80fd\u6027\u3002\u4f7f\u7528\u6750\u8d28\u4e0d\u5408\u9002\u7684\u751f\u4ea7\u8bbe\u5907\uff0c\u8bbe\u5907\u8001\u5316\u8131\u843d\u9897\u7c92\u4f1a\u589e\u5927\u53ef\u89c1\u5f02\u7269\u5f15\u5165\u7684\u53ef\u80fd\u3002\u4f8b\u5982\uff0c\u751f\u4ea7\u8bbe\u5907\u4e2d\u4e0e\u836f\u6db2\u63a5\u89e6\u7684\u7ba1\u8def\u548c\u50a8\u6db2\u7f50\u5e94\u4f7f\u7528\u89c4\u5b9a\u7684\u4e0d\u9508\u94a2\u6216\u7845\u80f6\u7ba1\u8def\uff0c\u5982\u679c\u4f7f\u7528\u5176\u4ed6\u6750\u6599\u5c06\u5927\u5927\u589e\u52a0\u6ce8\u5c04\u5242\u6210\u54c1\u4e2d\u53ef\u89c1\u5f02\u7269\u589e\u591a\u7684\u53ef\u80fd\u3002\u5f53\u524d\uff0c\u56fd\u5185\u8bbe\u5907\u5728\u751f\u4ea7\u5236\u5242\u5de5\u827a\u548c\u5236\u9020\u76f8\u5e94\u6750\u8d28\u4e0a\u53c2\u5dee\u4e0d\u9f50\uff0c\u8d28\u91cf\u4e0a\u4f1a\u56e0\u4e3a\u4ea7\u5546\u7684\u4e0d\u540c\u800c\u4e0d\u540c\u3002<\/p>\n<p>2.2\u751f\u4ea7\u5de5\u827a<\/p>\n<p>\u751f\u7269\u5236\u54c1\u591a\u4e3a\u975e\u6700\u7ec8\u706d\u83cc\u4ea7\u54c1\uff0c\u751f\u4ea7\u5de5\u827a\u4e3b\u8981\u5305\u62ec\u79f0\u91cf\u3001\u914d\u6db2\u3001\u9664\u83cc\u8fc7\u6ee4\u3001\u704c\u88c5\u3001\u8f67\u76d6\u3001\u706f\u68c0\u548c\u5305\u88c5\u3002\u5176\u4e2d\uff0c\u914d\u5236\u548c\u704c\u88c5\u4e24\u5927\u7cfb\u7edf\u662f\u53ef\u80fd\u4ea7\u751f\u53ef\u89c1\u5f02\u7269\u7684\u4e3b\u8981\u6765\u6e90\u3002\u4e00\u6b21\u6027\u7cfb\u7edf\u6c61\u67d3\u3001\u751f\u4ea7\u8bbe\u5907\u4e0d\u5e72\u51c0\u3001\u4eba\u5458\u64cd\u4f5c\u4e0d\u89c4\u8303\u7b49\u539f\u56e0\u90fd\u4f1a\u52a0\u5927\u836f\u54c1\u4e2d\u7684\u53ef\u89c1\u5f02\u7269\u589e\u52a0\u7684\u98ce\u9669\u3002\u4e0d\u5f53\u7684\u751f\u4ea7\u5de5\u827a\uff0c\u4f8b\u5982\u5904\u65b9pH\u8bbe\u8ba1\u4e0d\u5f53\u3001\u6ee4\u819c\u578b\u53f7\u4f7f\u7528\u4e0d\u5f53\u7b49\u90fd\u5c06\u5f15\u8d77\u53ef\u89c1\u5f02\u7269\u7684\u589e\u591a\u3002<\/p>\n<p>2.3 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loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-7848 aligncenter\" src=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe2.jpg\" alt=\"\" width=\"1280\" height=\"855\" srcset=\"https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe2.jpg 1280w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe2-300x200.jpg 300w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe2-1030x688.jpg 1030w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe2-768x513.jpg 768w, https:\/\/chimebiologics.com\/wp-content\/uploads\/2024\/12\/1218-\u56fe2-705x471.jpg 705w\" sizes=\"auto, (max-width: 1280px) 100vw, 1280px\" \/><\/p>\n<p>\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u662f\u5236\u836f\u4f01\u4e1a\u5e38\u6001\u5316\u7ba1\u7406\u7684\u91cd\u4e2d\u4e4b\u91cd\u3002\u8d28\u91cf\u98ce\u9669\u7ba1\u7406\u8d2f\u7a7f\u4e8e\u836f\u54c1\u751f\u547d\u5468\u671f\u7684\u59cb\u7ec8\uff0c\u5176\u6982\u5ff5\u3001\u76ee\u6807\u548c\u7ba1\u7406\u8981\u6c42\u5728\u4e2d\u56fdGMP 2010\u5e74\u7248\u4e2d\u6709\u660e\u786e\u89c4\u5b9a\u3002\u7136\u800c\uff0c\u76ee\u524d\u56fd\u5185\u884c\u4e1a\u5bf9\u4e8e\u6ce8\u5c04\u5242\u4e2d\u53ef\u89c1\u5f02\u7269\u7684\u63a7\u5236\u5e76\u672a\u5f97\u5230\u8db3\u591f\u91cd\u89c6\uff0c\u8fc7\u5ea6\u4f9d\u8d56\u6210\u54c1\u68c0\u9a8c\uff0c\u5ffd\u89c6\u4e86\u5bf9\u53ef\u89c1\u5f02\u7269\u7684\u98ce\u9669\u8bc4\u4f30\u548c\u5168\u751f\u547d\u5468\u671f\u7ba1\u7406\uff0c\u5f88\u5c11\u7ed3\u5408\u4ea7\u54c1\u7279\u6027\u3001\u53ef\u89c1\u5f02\u7269\u7279\u5f81\u53ca\u4e34\u5e8a\u98ce\u9669\u7b49\u5236\u5b9a\u6709\u9488\u5bf9\u6027\u7684\u63a7\u5236\u7b56\u7565\u3002\u76ee\u524d\u5728\u53c2\u7167ChP\u6807\u51c6\u8fdb\u884c\u751f\u4ea7\u548c\u5ba1\u8bc4\u7684\u57fa\u7840\u4e0a\uff0c\u4ec5\u4f9d\u8d56\u6210\u54c1\u68c0\u9a8c\u7ed3\u679c\u7b26\u5408\u836f\u5178\u6807\u51c6\u89c4\u5b9a\u5df2\u96be\u4ee5\u6ee1\u8db3\u6ce8\u5c04\u5242\u4e2d\u53ef\u89c1\u5f02\u7269\u7684\u63a7\u5236\u8981\u6c42\u3002\u5efa\u8bae\u7ed3\u5408FDA\u6307\u5357\u8349\u6848\u5e76\u9075\u5faaICH 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GMP\u7684\u8981\u6c42\u6765\u751f\u4ea7\u6db2\u4f53\u65e0\u83cc\u4ea7\u54c1\u3002\u751f\u4ea7\u8fc7\u7a0b\u4e2d\uff0c\u6211\u4eec\u7684\u751f\u4ea7\u64cd\u4f5c\u4ee5\u53ca\u8bbe\u5907\u8bbe\u65bd\u76d1\u6d4b\u90fd\u662f\u201c7x24hrs \u201d\uff0c\u706f\u68c0\u8fc7\u7a0b\u91c7\u75282\u6b21100%\u4eba\u5de5\u706f\u68c0\uff0c\u4e4b\u540e\u8fdb\u884cAQL\u53d6\u6837\uff0c\u786e\u4fdd\u706f\u68c0\u8fc7\u7a0b\u7684\u6709\u6548\u6027\u3002<\/p>\n<p>1. \u5c0f\u5bb9\u91cf\u6ce8\u5c04\u5242\uff082mL\u30016mL\u300110 mL\u300115 mL\u300120 mL\u300150mL\uff09\uff1a\u91c7\u7528\u5148\u8fdb\u7684\u8fdb\u53e3\u751f\u4ea7\u7ebf\uff0c\u5177\u5907100%\u5728\u7ebf\u79f0\u91cd\u529f\u80fd\u3002<\/p>\n<p>2. \u51bb\u5e72\u7c89\u9488\u5242\uff082mL\u30016mL\u300110mL\u300120mL\uff09\uff1a\u914d\u5907\u5168\u81ea\u52a8\u8054\u52a8\u7ebf\u548c25\u5e73\u65b9\u7c73\u51bb\u5e72\u673a\uff0c\u5177\u5907100%\u5728\u7ebf\u79f0\u91cd\u529f\u80fd\u3002<\/p>\n<p>3. \u9884\u704c\u5c01\u6ce8\u5c04\u5242\uff081mL\u30012.25mL\uff09\uff1a\u914d\u5907\u81ea\u52a8\u62c6\u5305\u673a\u5668\u548cPFS\u704c\u88c5\u673a\uff0c\u5177\u5907\u673a\u68b0\u81c2\u81ea\u52a8\u53d6\u6837\u79f0\u91cd\u529f\u80fd\u3002<\/p>\n<p>\u53c2\u8003\u6587\u732e\uff1a<\/p>\n<p>[1] \u5f20\u82b8,\u738b\u4e9a\u654f.\u6ce8\u5c04\u7528\u51bb\u5e72\u5236\u5242\u65b0\u836f\u7533\u62a5\u4e2d\u7684\u836f\u5b66\u5e38\u89c1\u95ee\u9898\u548c\u57fa\u672c\u8003\u8651[J].\u836f\u7269\u8bc4\u4ef7\u7814\u7a76, 2023, 46(9):1848-1853.<\/p>\n<p>[2] \u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u4ea7\u751f\u7684\u539f\u56e0\u548c\u68c0\u67e5\u65b9\u6cd5(https:\/\/www.ouryao.com\/blog-719835-47381.html\uff09<\/p>\n<p>[3] \u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u63a7\u5236\u6307\u5bfc\u539f\u5219 \u9644\u4ef6 1\uff1a\u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u63a7\u5236\u6307\u5bfc\u539f\u5219\uff08\u65b0\u589e\uff09\u516c\u793a\u7a3f\uff08\u7b2c\u4e00\u6b21\uff09<\/p>\n<p>[4] \u4e2d\u56fd\u836f\u51782020 \u7248 \u4e09\u90e8\u901a\u5219 0904 \u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u6cd5<\/p>\n<p>[5] \u9646\u4ed5\u534e,\u674e\u6749,\u848b\u660e\u8273,\u7b49.\u6ce8\u5c04\u5242\u7c7b\u836f\u54c1\u751f\u4ea7\u98ce\u9669\u9632\u63a7\u68c0\u67e5\u7684\u5206\u6790\u4e0e\u6539\u8fdb\u5bf9\u7b56[J].\u4e2d\u56fd\u533b\u836f\u5de5\u4e1a\u6742\u5fd7, 2022, 53(10):1516-1521.DOI:10.16522\/j.cnki.cjph.2022.10.020<\/p>\n<p>[6] \u674e\u8d8a,\u8463\u6b66\u519b,\u5f20\u8000,\u7b49.\u7f8e\u56fdFDA\u300a\u6ce8\u5c04\u5242\u53ef\u89c1\u5f02\u7269\u68c0\u67e5\u884c\u4e1a\u6307\u5357(\u8349\u6848)\u300b\u4ecb\u7ecd\u4e0e\u89e3\u8bfb[J].\u4e2d\u56fd\u65b0\u836f\u6742\u5fd7, 2023, 32(13):1309-1314.<\/p>\n<p>[7] \u6768\u534e,\u738b\u6709\u82b3.\u5236\u836f\u5de5\u827a\u9879\u76ee\u8d28\u91cf\u63a7\u5236\u5b58\u5728\u7684\u95ee\u9898\u53ca\u5b8c\u5584\u63aa\u65bd[J].\u4e2d\u6587\u79d1\u6280\u671f\u520a\u6570\u636e\u5e93(\u5f15\u6587\u7248)\u533b\u836f\u536b\u751f, 2022(4):3.<\/p>\n<p><strong>\u5173\u4e8e\u9f0e\u5eb7\u751f\u7269<\/strong><\/p>\n<p>\u9f0e\u5eb7\u751f\u7269\u662f\u4e00\u5bb6\u5168\u7403\u9886\u5148\u7684CDMO\u516c\u53f8\uff0c\u7387\u5148\u5f15\u8fdb\u4e86\u5168\u7403\u9996\u4e2a\u6a21\u5757\u5316\u751f\u7269\u5236\u836f\u5de5\u5382KUBio\uff0c\u8d4b\u80fd\u751f\u7269\u5236\u54c1\u4ece\u7ec6\u80de\u682a\u5f00\u53d1\u5230\u5546\u4e1a\u5316\u751f\u4ea7\u7684\u5168\u8fc7\u7a0b\u3002\u6211\u4eec\u4f4d\u4e8e\u4e0a\u6d77\u7684\u521b\u65b0\u4e2d\u5fc3\u805a\u7126\u9ad8\u6548\u7684\u7ec6\u80de\u682a\u5f00\u53d1\u548c\u5148\u8fdb\u7684\u6280\u672f\u5f00\u53d1\uff0c\u4e0e\u62e5\u6709\u591a\u56fd\u4e34\u5e8a\u8bd5\u9a8c\u7533\u8bf7\u548c\u65b0\u836f\u4e0a\u5e02\u6210\u529f\u7ecf\u9a8c\u7684\u6b66\u6c49\u5236\u9020\u5de5\u5382\u76f8\u7ed3\u5408\uff0c\u9f0e\u5eb7\u751f\u7269\u6b63\u5728\u4e3a\u5168\u7403\u751f\u7269\u533b\u836f\u5ba2\u6237\u63d0\u4f9b\u4e00\u7ad9\u5f0f\u7684CMC\u89e3\u51b3\u65b9\u6848\u3002\u5728\u9f0e\u5eb7\u751f\u7269,\u6211\u4eec\u6709\u4e00\u4e2a\u5171\u540c\u7684\u76ee\u6807, \u81f4\u529b\u4e8e\u63d0\u9ad8\u524d\u6cbf\u751f\u7269\u533b\u836f\u5bf9\u5168\u7403\u60a3\u8005\u7684\u53ef\u53ca\u6027\uff0c\u5c65\u884c\u6211\u4eec\u5bf9\u4eba\u7c7b\u5065\u5eb7\u7684\u627f\u8bfa\u3002\u5982\u9700\u4e86\u89e3\u66f4\u591a\u4fe1\u606f\uff0c\u8bf7\u8bbf\u95ee: <a href=\"http:\/\/www.chimebiologics.com\" target=\"_blank\" rel=\"noopener\">www.chimebiologics.com<\/a>\u3002<\/p>\n<p><\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2d3l4o-9301d0cdc14489efa114080353995aa9\">\n.flex_column.av-2d3l4o-9301d0cdc14489efa114080353995aa9{\n-webkit-border-radius:0px 0px 0px 0px;\n-moz-border-radius:0px 0px 0px 0px;\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class='flex_column av-2d3l4o-9301d0cdc14489efa114080353995aa9 av_one_third  avia-builder-el-2  el_after_av_two_third  el_before_av_two_third  flex_column_div av-zero-column-padding '     ><\/div><\/p>\n<div class='flex_column 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