{"id":229,"date":"2026-07-10T05:28:01","date_gmt":"2026-07-10T05:28:01","guid":{"rendered":"https:\/\/industrialelectricmotor.net\/?p=229"},"modified":"2026-07-10T05:28:01","modified_gmt":"2026-07-10T05:28:01","slug":"stainless-steel-motor-for-pharmaceutical-gmp-manufacturing","status":"publish","type":"post","link":"https:\/\/industrialelectricmotor.net\/zh\/stainless-steel-motor-for-pharmaceutical-gmp-manufacturing\/","title":{"rendered":"\u7528\u4e8e\u5236\u836fGMP\u751f\u4ea7\u7684\u4e0d\u9508\u94a2\u7535\u673a"},"content":{"rendered":"
\n

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<\/div>\n
<\/div>\n
<\/div>\n
\n
\n
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\u97e9\u56fd\u6c38\u52a8\u529b\u00b7BXG\u7cfb\u5217\u00b7\u5236\u836fGMP\u9a71\u52a8\u6307\u5357<\/span><\/p>\n

<\/div>\n<\/div>\n

\u7528\u4e8e\u5236\u836fGMP\u751f\u4ea7\u7684\u4e0d\u9508\u94a2\u7535\u673a\uff1a
\nFDA 21 CFR\u3001\u6b27\u76df GMP \u548c EHEDG \u5408\u89c4\u6307\u5357<\/span><\/h1>\n

\u6309\u7167\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303 (GMP) \u8fd0\u884c\u7684\u5236\u836f\u751f\u4ea7\u8bbe\u65bd\u5fc5\u987b\u786e\u4fdd\u6240\u6709\u4e0e\u836f\u54c1\u63a5\u89e6\u6216\u4f4d\u4e8e\u836f\u54c1\u4e0a\u65b9\u7684\u8bbe\u5907\u4ee5\u53ca\u4e0e\u836f\u54c1\u63a5\u89e6\u7684\u8868\u9762\u5747\u91c7\u7528\u53ef\u9632\u6b62\u836f\u54c1\u6c61\u67d3\u7684\u7ed3\u6784\u3002\u5b89\u88c5\u5728 GMP \u533a\u57df\u7684\u7535\u673a\u5fc5\u987b\u5177\u6709\u5149\u6ed1\u3001\u8010\u8150\u8680\u3001\u6613\u4e8e\u6e05\u6d01\u7684\u8868\u9762\uff0c\u4e0d\u5f97\u6709\u4f1a\u6ede\u7559\u9897\u7c92\u7269\u6216\u6db2\u4f53\u7684\u6c34\u5e73\u51f8\u7f18\uff0c\u4e0d\u5f97\u6709\u4f1a\u6ecb\u751f\u5fae\u751f\u7269\u7684\u7f1d\u9699\uff0c\u5e76\u4e14\u5fc5\u987b\u6709\u8bb0\u5f55\u5728\u6848\u7684\u6e05\u6d01\u548c\u68c0\u67e5\u7a0b\u5e8f\u3002\u672c\u6307\u5357\u6db5\u76d6\u4e86\u4f7f\u7528\u97e9\u56fd Ever-Power BXG \u4e0d\u9508\u94a2\u7cfb\u5217\u7535\u673a\u7684 GMP \u539f\u6599\u836f\u548c\u5236\u5242\u751f\u4ea7\u7684\u7535\u673a\u89c4\u683c\u3002<\/p>\n

FDA 21 CFR \u7b2c 211 \u90e8\u5206<\/span>
\n\u6b27\u76dfGMP\u9644\u4ef61\/2<\/span>
\nIP69K SS316L<\/span>
\nRa \u2264 0.8 \u03bcm<\/span>
\n\u9002\u7528\u4e8e\u6d01\u51c0\u5ba4<\/span><\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
\n
316L<\/div>\n
\u6240\u6709\u5916\u8868\u9762<\/div>\n<\/div>\n
\n
IP69K<\/div>\n
\u5236\u836f\u5728\u7814\u4ea7\u54c1<\/div>\n<\/div>\n
\n
FDA<\/div>\n
21 CFR \u7b2c 211 \u90e8\u5206<\/div>\n<\/div>\n
\n
\u6b27\u76dfGMP<\/div>\n
\u9644\u4ef61\u548c\u9644\u4ef62<\/div>\n<\/div>\n
\n
Ra 0.8<\/div>\n
\u6700\u5927\u8868\u9762\u5149\u6d01\u5ea6\u5fae\u7c73<\/div>\n<\/div>\n
\n
H1<\/div>\n
NSF H1 \u836f\u7528\u6da6\u6ed1\u8102<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\"\u4e0d\u9508\u94a2\u7535\u673a\uff0c\u7b26\u5408\u5236\u836fGMP\u751f\u4ea7\u89c4\u8303\uff0cIP69K\u9632\u62a4\u7b49\u7ea7\uff0cSS316L\u4e0d\u9508\u94a2\uff0c\u97e9\u56fdBXG<\/p>\n
\u97e9\u56fdEver-Power BXG\u7cfb\u5217\u4e0d\u9508\u94a2\u7535\u673a\u2014\u2014\u9632\u62a4\u7b49\u7ea7IP69K\uff0c\u5916\u58f3\u91c7\u7528AISI 316L\u4e0d\u9508\u94a2\uff0c\u8868\u9762\u949d\u5316\u5904\u7406\uff0c\u8868\u9762\u7c97\u7cd9\u5ea6Ra\u22640.8\u03bcm\u3002\u8bbe\u8ba1\u7b26\u5408\u7f8e\u56fdFDA 21 CFR Part 211\u548c\u6b27\u76dfGMP Annex 2\u5bf9GMP\u751f\u4ea7\u533a\u5185\u5236\u836f\u8bbe\u5907\u536b\u751f\u8981\u6c42\u3002<\/div>\n<\/div>\n

<\/p>\n

\n
\u5185\u5bb9<\/div>\n
1. \u7535\u673aGMP\u76d1\u7ba1\u8981\u6c42<\/a>
\n2. GMP\u533a\u57df\u5206\u7c7b<\/a>
\n3. \u5236\u836f\u5382\u5728\u5236\u54c1\u548c\u539f\u4f4d\u5236\u54c1<\/a>
\n4. GMP\u8868\u9762\u548c\u7f1d\u9699\u8981\u6c42<\/a>
\n5. IQ\/OQ\/PQ \u9274\u5b9a\u6587\u4ef6<\/a>
\n6. BXG GMP\u9a71\u52a8\u5668\u89c4\u683c<\/a>
\n7. \u836f\u54c1GMP\u5e94\u7528<\/a>
\n8. \u5e38\u89c1\u95ee\u9898<\/a><\/div>\n<\/div>\n

<\/p>\n

\n

1. \u5236\u836f\u751f\u4ea7\u4e2d\u7535\u673a\u7684GMP\u76d1\u7ba1\u8981\u6c42<\/h2>\n

\u7f8e\u56fd\u548c\u6b27\u6d32\u7684\u826f\u597d\u751f\u4ea7\u89c4\u8303\uff08GMP\uff09\u6cd5\u89c4\u5bf9\u5236\u836f\u751f\u4ea7\u533a\u57df\u5185\u5b89\u88c5\u7684\u6240\u6709\u8bbe\u5907\u90fd\u63d0\u51fa\u4e86\u5177\u4f53\u8981\u6c42\uff0c\u5305\u62ec\u9a71\u52a8\u6405\u62cc\u673a\u3001\u8f93\u9001\u673a\u3001\u5305\u8863\u673a\u548c\u5236\u7c92\u673a\u7684\u7535\u673a\u3002GMP\u533a\u57df\u7684\u7535\u673a\u4e0d\u4ec5\u8981\u7b26\u5408\u7535\u6c14\u6807\u51c6\uff0c\u8fd8\u5fc5\u987b\u7b26\u5408\u5236\u836f\u8bbe\u5907\u536b\u751f\u6807\u51c6\u3002<\/p>\n

\n
\n
\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) 21 CFR \u7b2c 211 \u90e8\u5206<\/div>\n

21 CFR 211.65 \u8981\u6c42\u4e0e\u7ec4\u4ef6\u3001\u836f\u54c1\u52a0\u5de5\u539f\u6599\u6216\u836f\u54c1\u63a5\u89e6\u7684\u8bbe\u5907\u8868\u9762\u4e0d\u5f97\u5177\u6709\u53cd\u5e94\u6027\u3001\u6dfb\u52a0\u6027\u6216\u5438\u6536\u6027\uff0c\u4ee5\u514d\u6539\u53d8\u836f\u54c1\u7684\u5b89\u5168\u6027\u3001\u9274\u522b\u3001\u6548\u4ef7\u3001\u8d28\u91cf\u6216\u7eaf\u5ea6\uff0c\u8d85\u51fa\u65e2\u5b9a\u8981\u6c42\u300221 CFR 211.67 \u8981\u6c42\u8bbe\u5907\u5fc5\u987b\u6309\u9002\u5f53\u7684\u5468\u671f\u8fdb\u884c\u6e05\u6d01\u548c\u7ef4\u62a4\u3002\u5982\u679c\u5236\u836f\u52a0\u5de5\u5bb9\u5668\u4e0a\u65b9\u7684\u7535\u673a\u8868\u9762\u8150\u8680\u6216\u7c97\u7cd9\uff0c\u5219\u4e0d\u7b26\u5408 211.65 \u7684\u8981\u6c42\uff0c\u56e0\u4e3a\u8868\u9762\u9897\u7c92\u6216\u8150\u8680\u4ea7\u7269\u4f1a\u6c61\u67d3\u4e0b\u65b9\u7684\u836f\u54c1\u3002<\/p>\n<\/div>\n

\n
\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u9644\u4ef62\uff08\u751f\u7269\u836f\u54c1\uff09<\/div>\n

\u6b27\u76df\u751f\u7269\u836f\u54c1\u751f\u4ea7\u89c4\u8303\u9644\u4ef62\uff082020\u5e74\u4fee\u8ba2\u7248\uff09\u8981\u6c42\uff0c\u751f\u7269\u539f\u6599\u836f\u548c\u836f\u54c1\u751f\u4ea7\u4e2d\u4f7f\u7528\u7684\u8bbe\u5907\u5fc5\u987b\u7ecf\u8fc7\u7cbe\u5fc3\u8bbe\u8ba1\u548c\u5236\u9020\uff0c\u4ee5\u4fbf\u4e8e\u6e05\u6d01\u548c\u706d\u83cc\u3002\u6240\u6709\u4e0e\u4ea7\u54c1\u63a5\u89e6\u6216\u9760\u8fd1\u4ea7\u54c1\u7684\u8868\u9762\u5fc5\u987b\u5149\u6ed1\u3001\u65e0\u7f1d\u9699\u548c\u8fb9\u89d2\u3001\u6613\u4e8e\u6e05\u6d01\uff0c\u5e76\u4e14\u80fd\u591f\u8010\u53d7\u6240\u4f7f\u7528\u7684\u6e05\u6d01\u548c\u706d\u83cc\u5242\u3002\u5b89\u88c5\u5728C\u7ea7\u548cD\u7ea7\u6d01\u51c0\u5ba4\u533a\u57df\u7684\u7535\u673a\u5fc5\u987b\u7b26\u5408\u8fd9\u4e9b\u6750\u6599\u548c\u8868\u9762\u8981\u6c42\u3002<\/p>\n<\/div>\n

\n
\u6b27\u76dfGMP\u9644\u4ef61\uff08\u65e0\u83cc\u836f\u54c1\uff09<\/div>\n

\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\u9644\u4ef61\uff082022\u5e74\u4fee\u8ba2\u7248\uff09\u5bf9A\/B\u7ea7\u6d01\u51c0\u5ba4\uff08\u65e0\u83cc\u704c\u88c5\u533a\uff09\u7684\u8bbe\u5907\u536b\u751f\u6807\u51c6\u8981\u6c42\u6700\u9ad8\u3002A\u7ea7\u548cB\u7ea7\u6d01\u51c0\u5ba4\u7684\u8bbe\u5907\u5fc5\u987b\u8bbe\u8ba1\u7528\u4e8e\u539f\u4f4d\u706d\u83cc\uff08SIP\uff09\u548c\u539f\u4f4d\u6e05\u6d17\uff08CIP\uff09\uff0c\u5176\u8868\u9762\u5149\u6ed1\u3001\u4e0d\u6389\u6bdb\uff0c\u80fd\u591f\u8010\u53d7\u9ad8\u538b\u84b8\u6c7d\u706d\u83cc\u6e29\u5ea6\u548c\u6240\u6709\u4f7f\u7528\u7684\u6e05\u6d01\u5242\u3002\u8fd9\u4e9b\u533a\u57df\u7684\u7535\u673a\u5fc5\u987b\u4f5c\u4e3a\u6d01\u51c0\u5ba4\u8bbe\u8ba1\u7684\u4e00\u90e8\u5206\u8fdb\u884c\u4e13\u95e8\u8ba4\u8bc1\u3002\u6709\u5173A\/B\u7ea7\u6d01\u51c0\u5ba4\u73af\u5883\u7684BXG\u89c4\u683c\uff0c\u8bf7\u8054\u7cfb\u97e9\u56fd\u6c38\u529b\u52a8\u529b\u516c\u53f8\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

2. GMP\u533a\u57df\u5212\u5206\u548c\u7535\u673a\u89c4\u683c<\/h2>\n
\n\n\n\n\n\n\n\n\n\n
GMP\u7ea7<\/th>\n\u4ea7\u54c1\u533a<\/th>\n\u7535\u673a\u6750\u6599\u8981\u6c42<\/th>\nBXG \u5408\u9002\u5417\uff1f<\/th>\n<\/tr>\n<\/thead>\n
A\u7ea7<\/td>\n\u65e0\u83cc\u704c\u88c5\u3001\u5c0f\u74f6\u585e\u585e\u3001\u655e\u5f00\u7684\u5bb9\u5668\u5b58\u5728\u98ce\u9669<\/td>\n\u517c\u5bb9SIP\/CIP\u5de5\u827a\uff0c\u91c7\u7528SS316L\u4e0d\u9508\u94a2\uff0c\u5728\u67d0\u4e9b\u5e94\u7528\u4e2d\u8868\u9762\u7c97\u7cd9\u5ea6Ra\u22640.4\u03bcm<\/td>\n\u54a8\u8be2\u97e9\u56fd\u6c38\u529b<\/td>\n<\/tr>\n
B\u7ea7<\/td>\nA\u7ea7\u80cc\u666f\u533a\uff1b\u5c0f\u74f6\u6e05\u6d17\uff0c\u7ec4\u4ef6\u5236\u5907<\/td>\nSS316L\uff0c\u8868\u9762\u7c97\u7cd9\u5ea6Ra\u22640.8\u03bcm\uff0c\u517c\u5bb9CIP\u6e05\u6d17\uff0c\u65e0\u8131\u843d<\/td>\n\u662f\u7684\u2014\u2014BXG \u6807\u51c6<\/td>\n<\/tr>\n
C\u7ea7<\/td>\n\u6563\u88c5\u586b\u5145\u3001\u5236\u7c92\u3001\u538b\u7247\u3001\u5305\u8863<\/td>\nSS316L \u6216\u540c\u7b49\u6750\u8d28\uff0c\u53ef\u6e05\u6d17\uff0c\u65e0\u8150\u8680<\/td>\n\u662f\u7684\u2014\u2014BXG \u6807\u51c6<\/td>\n<\/tr>\n
D\u7ea7<\/td>\n\u4e00\u822c\u5236\u9020\u652f\u6301\uff0c\u96f6\u90e8\u4ef6\u5904\u7406<\/td>\n\u8868\u9762\u5149\u6ed1\u3001\u6613\u4e8e\u6e05\u6d01\u3001\u8010\u8150\u8680\u3002\u63a8\u8350\u4f7f\u7528SS316L\u4e0d\u9508\u94a2\u3002<\/td>\n\u662f\u7684\u2014\u2014BXG \u6807\u51c6<\/td>\n<\/tr>\n
\u975eGMP<\/td>\n\u4ed3\u5e93\u3001\u516c\u7528\u8bbe\u65bd\u3001\u672a\u5206\u7c7b\u533a\u57df<\/td>\n\u53ef\u63a5\u53d7\u7684\u6807\u51c6Y2\u7535\u673a<\/td>\nY2 \u6807\u51c6\u7535\u673a<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n

<\/p>\n

\n

3. \u5236\u836f\u8fc7\u7a0b\u4e2d\u4f7f\u7528\u7684\u6e05\u6d17\u5242\u548c\u539f\u4f4d\u6e05\u6d17\u5242<\/h2>\n

\u5236\u836f\u751f\u4ea7\u8bbe\u5907\u91c7\u7528\u7ecf\u8fc7\u9a8c\u8bc1\u7684\u6e05\u6d01\u7a0b\u5e8f\u8fdb\u884c\u6e05\u6d01\uff0c\u5305\u62ec\u55b7\u6dcb\u5f0f\u6216\u4eba\u5de5\u6e05\u6d17\u7684\u539f\u4f4d\u6e05\u6d17 (WIP)\uff0c\u4ee5\u53ca\u5bf9\u8fde\u63a5\u5de5\u827a\u8bbe\u5907\u8fdb\u884c CIP\u3002\u5236\u836f\u884c\u4e1a GMP \u4e2d\u4f7f\u7528\u7684\u6e05\u6d01\u5242\u4e0e\u98df\u54c1\u884c\u4e1a\u7684 CIP \u4e0d\u540c\uff0c\u524d\u8005\u9664\u4e86\u6c34\u6027\u6e05\u6d01\u5242\u5916\uff0c\u8fd8\u53ef\u80fd\u5305\u62ec\u6709\u673a\u6eb6\u5242\u51b2\u6d17\u6db2\u3001\u4e13\u7528\u6d17\u6da4\u5242\u548c\u6d88\u6bd2\u6db2\u3002<\/p>\n

\n
\n
\u6c34\u57fa\u6e05\u6d17\u5242\uff08C\/D\u7ea7\uff09<\/div>\n

\u6807\u51c6\u5236\u836fGMP\u6e05\u6d17\u91c7\u7528\u7eaf\u51c0\u6c34\uff08PW\uff09\u6216\u6ce8\u5c04\u7528\u6c34\uff08WFI\uff09\u4f5c\u4e3a\u6eb6\u5242\uff0c\u5e76\u4f7f\u7528\u78b1\u6027\u6e05\u6d01\u5242\uff08NaOH 0.5\u81f32%\uff0cpH 11\u81f313\uff09\u548c\u9178\u6027\u51b2\u6d17\u6db2\uff08\u78f7\u9178\u6216\u67e0\u6aac\u9178 0.5\u81f31%\uff09\u3002BXG SS316L\u4e0d\u9508\u94a2\u5b8c\u5168\u8010\u53d7\u8fd9\u4e9b\u6e05\u6d01\u5242\u3002\u7535\u673a\u6e05\u6d17\u91c7\u7528\u624b\u5de5\u64e6\u62ed\u6216\u7528\u6d78\u6709\u7eaf\u51c0\u6c34\/\u6ce8\u5c04\u7528\u6c34\u7684\u6e05\u6d01\u5e03\u55b7\u6dcb\u2014\u2014IP69K\u8ba4\u8bc1\u8bc1\u660e\u5176\u80fd\u591f\u627f\u53d7\u52a0\u538b\u55b7\u6dcb\u6e05\u6d17\u3002<\/p>\n<\/div>\n

\n
\u9152\u7cbe\u6d88\u6bd2\uff08B\/C\u7ea7\uff09<\/div>\n

\u5236\u836f\u6d01\u51c0\u5ba4\u5728\u751f\u4ea7\u6279\u6b21\u95f4\u4f7f\u7528 70% \u5f02\u4e19\u9187 (IPA) \u6216 70% \u4e59\u9187\u55b7\u96fe\u8fdb\u884c\u8868\u9762\u6d88\u6bd2\u3002BXG SS316L \u7535\u673a\u8868\u9762\u5b8c\u5168\u8010\u53d7\u8fd9\u4e9b\u6d53\u5ea6\u7684 IPA \u548c\u4e59\u9187\u3002FDA \u8ba4\u8bc1\u7684\u7845\u80f6\u8f74\u5c01\u548c NSF H1 \u8f74\u627f\u6da6\u6ed1\u8102\u4e5f\u4e0e\u5236\u836f\u7528\u6d53\u5ea6\u7684\u9152\u7cbe\u6d88\u6bd2\u5242\u517c\u5bb9\u3002\u55b7\u96fe\u5f0f IPA \u6d88\u6bd2\u4e0d\u4f1a\u5f71\u54cd BXG \u7684 IP69K \u9632\u62a4\u7b49\u7ea7\u3002<\/p>\n<\/div>\n

\n
VHP\u706d\u83cc\uff08A\/B\u7ea7\uff09<\/div>\n

\u6d53\u5ea6\u4e3a 150 \u81f3 750 ppm H\u2082O\u2082 \u7684\u6c14\u5316\u8fc7\u6c27\u5316\u6c22 (VHP) \u7528\u4e8e A\/B \u7ea7\u6d01\u51c0\u5ba4\u7ef4\u62a4\u540e\u6216\u4ea7\u54c1\u66f4\u6362\u540e\u7684\u6d88\u6bd2\u5faa\u73af\u3002VHP \u4e0e SS316L \u4e0d\u9508\u94a2\u4ee5\u53ca\u6240\u6709 BXG \u5bc6\u5c01\u4ef6\u548c\u6da6\u6ed1\u8102\u6750\u6599\u517c\u5bb9\uff0c\u6d53\u5ea6\u7b26\u5408\u5236\u836f\u706d\u83cc\u6807\u51c6\u3002\u5bf9\u4e8e\u9700\u8981\u4f7f\u7528 VHP \u7684 A\/B \u7ea7\u7535\u673a\u5e94\u7528\uff0c\u8bf7\u5411\u97e9\u56fd\u6c38\u529b\u7535\u529b\u516c\u53f8 (Korea Ever-Power) \u786e\u8ba4\u7535\u673a\u6587\u6863\u548c\u6750\u6599\u8bc1\u4e66\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

4. GMP\u8868\u9762\u3001\u7f1d\u9699\u548c\u6392\u6c34\u8bbe\u8ba1\u8981\u6c42<\/h2>\n
\n
\n
Ra \u2264 0.8 \u03bcm \u2014 \u5fae\u751f\u7269\u63a7\u5236<\/div>\n

\u6b27\u76dfGMP\u548cFDA\u6307\u5357\u5747\u5c06EHEDG\u8868\u9762\u7c97\u7cd9\u5ea6\u6807\u51c6Ra \u2264 0.8 \u03bcm\u4f5c\u4e3a\u6709\u6548\u6e05\u6d01\u7684\u9608\u503c\u3002\u4f4e\u4e8e\u6b64\u7c97\u7cd9\u5ea6\uff0c\u7ec6\u83cc\u7c98\u9644\u548c\u751f\u7269\u819c\u5f62\u6210\u5c06\u663e\u8457\u51cf\u5c11\uff0c\u4f7f\u7528\u6807\u51c6\u6e05\u6d01\u5242\u8fdb\u884c\u8868\u9762\u6e05\u6d01\u5373\u53ef\u8fbe\u5230\u836f\u54c1GMP\u6240\u9700\u7684\u5fae\u751f\u7269\u53bb\u9664\u7387\u3002BXG\u7535\u673a\u4ea4\u4ed8\u65f6\u6240\u6709\u5916\u8868\u9762\u5747\u5df2\u8fbe\u5230Ra \u2264 0.8 \u03bcm\u7684\u8868\u9762\u7c97\u7cd9\u5ea6\uff0c\u4e14SS316L\u6750\u6599\u5728\u6b63\u5e38\u7684GMP\u6e05\u6d01\u5faa\u73af\u4e0b\u4e0d\u4f1a\u51fa\u73b0\u7c97\u7cd9\u5316\u3002\u5728IQ\u9636\u6bb5\u9a8c\u8bc1\u8868\u9762\u5149\u6d01\u5ea6\uff0c\u5e76\u6309\u7167\u573a\u5730\u53d8\u66f4\u63a7\u5236\u7a0b\u5e8f\u4e2d\u89c4\u5b9a\u7684\u5468\u671f\u6027\u590d\u68c0\u95f4\u9694\u8fdb\u884c\u518d\u6b21\u9a8c\u8bc1\u3002<\/p>\n<\/div>\n

\n
\u6ca1\u6709\u6b7b\u89d2\u3001\u7f1d\u9699\u6216\u6c34\u5e73\u8fb9\u7f18<\/div>\n

GMP\u8981\u6c42\u6d88\u9664\u7535\u673a\u8868\u9762\u53ef\u80fd\u79ef\u805a\u4ea7\u54c1\u3001\u6e05\u6d01\u6db2\u6216\u5fae\u751f\u7269\u6c61\u67d3\u7269\u800c\u65e0\u6cd5\u901a\u8fc7\u6e05\u6d01\u7a0b\u5e8f\u6e05\u9664\u7684\u533a\u57df\u3002BXG\u673a\u67b6\u91c7\u7528\u503e\u659c\u5f0f\u6563\u70ed\u7247\u8bbe\u8ba1\uff0c\u53ef\u5b9e\u73b0\u81ea\u7531\u6392\u6c34\uff1b\u63a5\u7ebf\u76d2\u76d6\u4e3a\u51f8\u9762\u8bbe\u8ba1\uff08\u65e0\u5e73\u9762\uff09\uff1b\u91c7\u7528\u5149\u6ed1\u710a\u63a5\u7ed3\u6784\u800c\u975e\u673a\u68b0\u8fde\u63a5\u7684\u9762\u677f\uff1b\u5e76\u4f7f\u7528\u5149\u6ed1\u7684\u5185\u516d\u89d2\u87ba\u6813\u800c\u975e\u5341\u5b57\u5934\u6216\u5185\u516d\u89d2\u87ba\u6813\uff0c\u4ee5\u907f\u514d\u9897\u7c92\u7269\u6ede\u7559\u3002\u8fd9\u4e9b\u8bbe\u8ba1\u7279\u70b9\u5df2\u8bb0\u5f55\u5728BXG\u6280\u672f\u6587\u4ef6\u4e2d\uff0c\u5e76\u7eb3\u5165GMP\u8bbe\u5907\u9a8c\u8bc1\u6d41\u7a0b\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

5. GMP\u8bbe\u65bd\u4e2dBXG\u7684IQ\/OQ\/PQ\u9a8c\u8bc1\u6587\u4ef6<\/h2>\n

\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) 21 CFR \u7b2c 211 \u90e8\u5206\u548c\u6b27\u76df\u836f\u54c1\u751f\u4ea7\u89c4\u8303 (EU GMP) \u8981\u6c42\uff0c\u836f\u54c1\u751f\u4ea7\u4e2d\u4f7f\u7528\u7684\u8bbe\u5907\u5fc5\u987b\u5148\u7ecf\u8fc7\u9a8c\u8bc1\u624d\u80fd\u6295\u5165\u751f\u4ea7\u3002\u7535\u673a\u901a\u5e38\u4f5c\u4e3a\u8bbe\u5907\u7cfb\u7edf\u9a8c\u8bc1\uff08\u4f8b\u5982\u5305\u542b\u7535\u673a\u7684\u5236\u7c92\u673a\u3001\u5305\u8863\u673a\u6216\u8f93\u9001\u673a\uff09\u7684\u4e00\u90e8\u5206\u8fdb\u884c\u9a8c\u8bc1\uff0c\u4f46\u81f3\u5c11\u5fc5\u987b\u63d0\u4f9b\u7535\u673a\u6587\u6863\u5305\u4ee5\u652f\u6301\u5b89\u88c5\u9a8c\u8bc1 (IQ)\u3002<\/p>\n

\n
\n
\u667a\u5546\u6587\u6863<\/div>\n

\u7535\u673a\u578b\u53f7\u548c\u5e8f\u5217\u53f7\uff1b\u5236\u9020\u5546\u5408\u683c\u8bc1\u4e66\uff1bSS316L \u673a\u67b6\u6750\u6599\u8bc1\u4e66\uff08EN 10204 3.1 \u578b\u6750\u6599\u6d4b\u8bd5\u8bc1\u4e66\uff09\uff1b\u8868\u9762\u7c97\u7cd9\u5ea6\u6d4b\u91cf\u62a5\u544a\uff08Ra \u2264 0.8 \u03bcm\uff09\uff1bIP69K \u6d4b\u8bd5\u8bc1\u4e66\uff1b\u5bc6\u5c01\u4ef6\u548c\u6da6\u6ed1\u8102\u7684 FDA 21 CFR \u6750\u6599\u5408\u89c4\u6027\u58f0\u660e\uff1b\u8f74\u627f\u6da6\u6ed1\u8102\u7684 NSF H1 \u8bc1\u4e66\u3002<\/p>\n<\/div>\n

\n
OQ \u6587\u4ef6<\/div>\n

\u5b89\u88c5\u65f6\u7535\u673a\u989d\u5b9a\u8f6c\u901f\u3001\u626d\u77e9\u548c\u529f\u7387\uff1b\u8c03\u8bd5\u65f6\u7684\u632f\u52a8\u7279\u5f81\uff1b\u7535\u673a\u4fdd\u62a4\u7ee7\u7535\u5668\u8bbe\u5b9a\u8bb0\u5f55\uff1b\u5b89\u88c5\u5728\u7279\u5b9a\u4f4d\u7f6e\u7684\u7535\u673a\u7684\u6e05\u6d01\u7a0b\u5e8f\u8d44\u8d28\uff1b\u6e05\u6d01\u5242\u517c\u5bb9\u6027\u786e\u8ba4\uff1b\u9996\u6b21\u5b89\u88c5\u540e\u68c0\u67e5\u8bb0\u5f55\u3002<\/p>\n<\/div>\n

\n
PQ \u548c\u91cd\u65b0\u8ba4\u8bc1<\/div>\n

PQ\uff08\u6027\u80fd\u786e\u8ba4\uff09\u7528\u4e8e\u786e\u8ba4\u7535\u673a\u5728\u5546\u4e1a\u751f\u4ea7\u8fc7\u7a0b\u4e2d\u4f5c\u4e3a\u751f\u4ea7\u8bbe\u5907\u7684\u4e00\u90e8\u5206\u80fd\u591f\u6b63\u5e38\u8fd0\u884c\u3002\u53d8\u66f4\u63a7\u5236\u4e8b\u4ef6\uff08\u4f8b\u5982\u7535\u673a\u66f4\u6362\u3001\u7535\u673a\u7ef4\u4fee\u3001\u6e05\u6d01\u5242\u66f4\u6362\u6216\u8bbe\u5907\u91cd\u65b0\u914d\u7f6e\uff09\u4f1a\u89e6\u53d1\u91cd\u65b0\u9a8c\u8bc1\u3002\u97e9\u56fd\u6c38\u529b\u52a8\u529b\u516c\u53f8\u4f1a\u4e3a\u5236\u836f\u5ba2\u6237\u7684\u6bcf\u7b14 BXG \u8ba2\u5355\u63d0\u4f9b\u6240\u6709\u5fc5\u8981\u7684 IQ\uff08\u5b89\u88c5\u786e\u8ba4\uff09\u6587\u4ef6\u3002<\/p>\n<\/div>\n<\/div>\n

\n

\u97e9\u56fd\u6c38\u529b\u52a8\u529b\u516c\u53f8\u4e3a\u5236\u836f\u4f01\u4e1a\u63d0\u4f9b\u7b26\u5408GMP\u89c4\u8303\u7684BXG\u7535\u673a\uff0c\u5e76\u63d0\u4f9b\u4e00\u5957\u5b8c\u6574\u7684\u6587\u6863\u5305\uff0c\u5305\u62ec\uff1a\u5236\u9020\u5546\u7b26\u5408\u6027\u58f0\u660e\uff1b\u6750\u6599\u6d4b\u8bd5\u8bc1\u4e66\uff08EN 10204 3.1\uff09\uff1b\u8868\u9762\u7c97\u7cd9\u5ea6\u6d4b\u8bd5\u62a5\u544a\uff1bIP69K\u8ba4\u8bc1\u526f\u672c\uff1bFDA 21 CFR\u5408\u89c4\u58f0\u660e\uff1bNSF H1\u6da6\u6ed1\u8102\u8bc1\u4e66\uff1b\u4ee5\u53ca\u53d8\u66f4\u901a\u77e5\u7a0b\u5e8f\u3002\u8be5\u6587\u6863\u5305\u65e8\u5728\u652f\u6301\u8bbe\u5907\u9a8c\u8bc1\u7684IQ\u9636\u6bb5\uff0c\u65e0\u9700\u5236\u836f\u516c\u53f8\u8fdb\u884c\u989d\u5916\u7684\u6d4b\u8bd5\u3002<\/p>\n<\/div>\n<\/div>\n

<\/p>\n

\n

6. \u97e9\u56fd Ever-Power BXG \u5236\u836f GMP \u9a71\u52a8\u5668<\/h2>\n
\n
\n

\u97e9\u56fdEver-Power BXG\u7cfb\u5217\u7535\u673a\u662f\u7b26\u5408B\u3001C\u3001D\u7ea7\u836f\u54c1GMP\u751f\u4ea7\u533a\u57df\u7684\u5b8c\u6574\u7535\u673a\u89c4\u683c\u3002\u5b83\u96c6IP69K\u9632\u51b2\u6d17\u4fdd\u62a4\u3001SS316L\u4e0d\u9508\u94a2\u8010\u9178\u78b1\u7ed3\u6784\u3001Ra\u22640.8\u03bcm\u536b\u751f\u7ea7\u8868\u9762\u5149\u6d01\u5ea6\u3001FDA\u8ba4\u8bc1\u7845\u80f6\u8f74\u5c01\u3001NSF H1\u7ea7\u836f\u54c1\u7ea7\u8f74\u627f\u6da6\u6ed1\u8102\u548cH\u7ea7\u7edd\u7f18\u4e8e\u4e00\u4f53\u3002BXG\u6280\u672f\u6587\u4ef6\u5305\u542b\u836f\u54c1\u8bbe\u5907IQ\u6240\u9700\u7684\u6240\u6709\u6587\u6863\u3002\u5b8c\u6574\u4ea7\u54c1\u7cfb\u5217\u8bf7\u89c1\u4e0b\u6587\u3002 \u4e0d\u9508\u94a2\u7535\u673a\u4ea7\u54c1\u90e8<\/a>\u5982\u9700\u4e86\u89e3 A\/B \u7ea7\u65e0\u83cc\u751f\u4ea7\u73af\u5883\u89c4\u8303\u6216\u836f\u54c1\u9a8c\u8bc1\u652f\u6301\uff0c\u8bf7\u8054\u7cfb \u97e9\u56fd\u6c38\u529b\u6280\u672f\u56e2\u961f<\/a>.<\/p>\n<\/div>\n

\n
\n
BXG \u2014 \u836f\u54c1GMP\u6570\u636e<\/div>\n\n\n\n\n\n\n\n\n\n\n
\u6846\u67b6\u6750\u6599<\/td>\nAISI 316L \u5168\u5916<\/td>\n<\/tr>\n
\u8868\u9762\u5904\u7406<\/td>\nRa \u2264 0.8 \u03bcm\uff08\u5df2\u8ba4\u8bc1\uff09<\/td>\n<\/tr>\n
IP\u8bc4\u7ea7<\/td>\nIP69K<\/td>\n<\/tr>\n
\u8f74\u5c01<\/td>\nFDA 21 CFR 177.2600 \u7845\u80f6<\/td>\n<\/tr>\n
\u6da6\u6ed1\u8102<\/td>\nNSF H1 \u836f\u7528\u7ea7<\/td>\n<\/tr>\n
\u7edd\u7f18<\/td>\nH\u7ea7<\/td>\n<\/tr>\n
\u529f\u7387\u8303\u56f4<\/td>\n0.18\u201311\u5343\u74e6<\/td>\n<\/tr>\n
\u667a\u5546\u6587\u6863<\/td>\n\u6807\u51c6\u914d\u7f6e\u5305\u542b\u5168\u5957\u4ea7\u54c1<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

7. \u836f\u54c1GMP\u751f\u4ea7\u5e94\u7528<\/h2>\n\n\n\n
\"\u97e9\u56fd\u6c38\u52a8\u529b\uff08Ever-Power\uff09BXG<\/p>\n
\n
\u7247\u5242\u5236\u7c92\u673a\u548c\u538b\u7247\u673a<\/div>\n

C\u7ea7\u7247\u5242\u751f\u4ea7\u533a\u914d\u5907\u9ad8\u526a\u5207\u6e7f\u6cd5\u5236\u7c92\u673a\u548c\u8f8a\u538b\u5236\u7c92\u673a\u3002BXG 1.1\u81f35.5 kW\u56db\u6781\u7535\u673a\u901a\u8fc7\u5bc6\u5c01\u9f7f\u8f6e\u7bb1\u9a71\u52a8\u53f6\u8f6e\u8f74\u548c\u5207\u788e\u8f74\u3002C\u7ea7\u5236\u7c92\u5ba4\u8981\u6c42\u6240\u6709\u5916\u9732\u7535\u673a\u8868\u9762\u5747\u91c7\u7528SS316L\u4e0d\u9508\u94a2\u6750\u8d28\uff0c\u53ef\u4f7f\u7528\u5f02\u4e19\u9187\u548c\u6c34\u6027\u6e05\u6d01\u5242\u6e05\u6d17\uff0c\u4e14\u65e0\u6c34\u5e73\u51f8\u7f18\u3002C\u7ea7\u751f\u4ea7\u5ba4\u7684\u538b\u7247\u673a\u9a71\u52a8\u7535\u673a\uff1aBXG 0.75\u81f32.2 kW\u7535\u673a\u7528\u4e8e\u8f6c\u76d8\u5206\u5ea6\u548c\u538b\u7247\u529b\u9a71\u52a8\u3002<\/p>\n<\/div>\n<\/td>\n

\"\u97e9\u56fd<\/p>\n
\n
\u836f\u54c1\u8f93\u9001\u548c\u8f6c\u79fb\u7cfb\u7edf<\/div>\n

C\u7ea7\u548cD\u7ea7\u5236\u836f\u751f\u4ea7\u533a\u57df\u7684\u8f93\u9001\u7cfb\u7edf\u7528\u4e8e\u5728\u5de5\u827a\u6b65\u9aa4\u4e4b\u95f4\u8f93\u9001\u539f\u6599\u836f\u3001\u6210\u54c1\u6df7\u5408\u7269\u548c\u704c\u88c5\u597d\u7684\u521d\u7ea7\u5bb9\u5668\u3002\u8f93\u9001\u6bb5\u9a71\u52a8\u91c7\u7528BXG 0.18\u81f31.5 kW 4\u6781\u7535\u673a\u3002GMP\u8303\u56f4\u5185\u6240\u6709\u7535\u673a\u8868\u9762\u5fc5\u987b\u4e3aSS316L\u4e0d\u9508\u94a2\uff0c\u8868\u9762\u7c97\u7cd9\u5ea6Ra\u22640.8 \u03bcm\u3002\u8f93\u9001\u673a\u7535\u673a\u7684\u6e05\u6d01\u5fc5\u987b\u5305\u542b\u5728\u8f93\u9001\u7cfb\u7edf\u7ecf\u9a8c\u8bc1\u7684\u6e05\u6d01\u7a0b\u5e8f\u4e2d\u3002<\/p>\n<\/div>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\n
\n
\u6d82\u5c42\u76d8\u9a71\u52a8<\/div>\n

C\u7ea7\u6d01\u51c0\u5ba4\u4e2d\u7684\u7247\u5242\u5305\u8863\u9505\u4ee53\u81f325\u8f6c\/\u5206\u7684\u8f6c\u901f\u65cb\u8f6c\uff0c\u7528\u4e8e\u7247\u5242\u5e8a\u7684\u7ffb\u6eda\u3002\u91c7\u7528BXG 0.75\u81f32.2\u5343\u74e6\u56db\u6781\u7535\u673a\uff0c\u914d\u5907NMRV\u51cf\u901f\u673a\uff0c\u51cf\u901f\u200b\u200b\u6bd4\u4e3a40:1\u81f3100:1\u3002\u9505\u5185\u58c1\u4e0e\u836f\u54c1\u76f4\u63a5\u63a5\u89e6\u3002\u9505\u5916\u58c1\u7684BXG\u7535\u673a\u5fc5\u987b\u80fd\u591f\u4f7f\u7528\u4e0e\u9505\u5185\u58c1\u76f8\u540c\u7684\u6e05\u6d01\u5242\u8fdb\u884c\u6e05\u6d01\u3002<\/p>\n<\/div>\n

\n
\u751f\u7269\u53cd\u5e94\u5668\u6405\u62cc\u5668\u9a71\u52a8\u88c5\u7f6e<\/div>\n

C\u7ea7\u751f\u7269\u751f\u4ea7\u4e2d\u751f\u7269\u53cd\u5e94\u5668\u548c\u53d1\u9175\u7f50\u7684\u5916\u90e8\u6405\u62cc\u9a71\u52a8\u7535\u673a\u3002BXG 0.37\u81f32.2 kW\uff0c\u51cf\u901f\u6bd420:1\u81f360:1\u7684NMRV\u9f7f\u8f6e\u7535\u673a\u3002\u7535\u673a\u4f4d\u4e8e\u5bb9\u5668\u5916\u90e8\uff0c\u4f46\u4ecd\u5728C\u7ea7\u6d01\u51c0\u5ea6\u8303\u56f4\u5185\uff1b\u901a\u5e38\u6bcf\u65e5\u4f7f\u7528\u5f02\u4e19\u9187\uff08IPA\uff09\u6e05\u6d17\uff0c\u6bcf\u5468\u4f7f\u7528\u78b1\u6027\u6eb6\u6db2\u6e05\u6d17\u3002BXG SS316L\u4e0d\u9508\u94a2\u548cFDA\u8ba4\u8bc1\u7684\u7845\u80f6\u5bc6\u5c01\u4ef6\u80fd\u591f\u627f\u53d7\u8fd9\u79cd\u6e05\u6d17\u65b9\u5f0f\u800c\u4e0d\u4f1a\u53d1\u751f\u6027\u80fd\u4e0b\u964d\u3002<\/p>\n<\/div>\n

\n
\u51bb\u5e72\u673a\u88c5\u8f7d\u7cfb\u7edf<\/div>\n

B\u7ea7\u6d01\u51c0\u533a\u5185\uff0c\u6bd7\u90bbA\u7ea7\u65e0\u83cc\u704c\u88c5\u533a\uff0c\u914d\u5907\u7528\u4e8e\u51bb\u5e72\u673a\uff08\u51b7\u51bb\u5e72\u71e5\u673a\uff09\u7684\u81ea\u52a8\u5c0f\u74f6\u88c5\u5378\u7cfb\u7edf\u3002\u5c0f\u74f6\u8f93\u9001\u5e26\u9a71\u52a8\u529f\u7387\u4e3a0.18\u81f30.75\u5343\u74e6\u7684BXG\u4ea7\u54c1\u3002\u51bb\u5e72\u673a\u88c5\u6599\u533a\u5728\u88c5\u6599\u64cd\u4f5c\u671f\u95f4\u4e3aB\u7ea7\u6d01\u51c0\u533a\uff1bBXG VHP\u4ea7\u54c1\u5df2\u786e\u8ba4\u7b26\u5408GMP\u6d88\u6bd2\u5faa\u73af\u8981\u6c42\u3002<\/p>\n<\/div>\n

\n
WFI\u5faa\u73af\u6cf5<\/div>\n

\u7528\u4e8e\u5236\u836f\u7528\u6c34\u7cfb\u7edf\u7684\u6ce8\u5c04\u7528\u6c34 (WFI) \u5206\u914d\u56de\u8def\u6cf5\u9a71\u52a8\u88c5\u7f6e\u3002\u7535\u673a\u901a\u5e38\u4f4d\u4e8e GMP \u8f66\u95f4\u5916\u7684\u516c\u7528\u8bbe\u65bd\u533a\u57df\uff0c\u4f46\u5728\u7ef4\u62a4\u671f\u95f4\u53ef\u80fd\u4f1a\u53d7\u5230 WFI \u55b7\u6e85\u3002BXG 0.75 \u81f3 3.0 kW\uff0c2 \u6781\uff0c\u9002\u7528\u4e8e\u9700\u8981\u8010\u8150\u8680\u3001\u80fd\u591f\u627f\u53d7\u9ad8\u7eaf\u6c34\u8150\u8680\u548c\u6cf5\u623f\u84b8\u6c7d\u6e05\u6d17\u7684 WFI \u6cf5\u9a71\u52a8\u88c5\u7f6e\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n
\n

\"\u97e9\u56fd\u6c38\u529bBXG\u5236\u836f\u7535\u673a\u751f\u4ea7\"<\/p>\n

GMP\u6c7d\u8f66\u751f\u4ea7<\/div>\n<\/div>\n
\n

\"\u97e9\u56fd<\/p>\n

Ra \u6d4b\u91cf<\/div>\n<\/div>\n
\n

\"\u97e9\u56fdEver-Power<\/p>\n

CE \u548c ISO<\/div>\n<\/div>\n
\n

\"\u97e9\u56fd<\/p>\n

\u51fa\u53e3\u5305\u88c5<\/div>\n<\/div>\n<\/div>\n

<\/p>\n

\n

8. \u5e38\u89c1\u95ee\u9898<\/h2>\n
\n
\n
\n
\u5982\u679c\u5c06\u65e7BXG\u7535\u673a\u66f4\u6362\u4e3a\u76f8\u540c\u578b\u53f7\u7684\u65b0BXG\u7535\u673a\uff0c\u662f\u5426\u9700\u8981\u91cd\u65b0\u8fdb\u884c\u8ba4\u8bc1\uff1f<\/div>\n<\/div>\n
\n

\u5bf9\u5df2\u83b7\u8ba4\u8bc1\u7684\u5236\u836f\u8bbe\u5907\u8fdb\u884c\u7535\u673a\u66f4\u6362\u5c5e\u4e8e\u53d8\u66f4\u63a7\u5236\u4e8b\u9879\uff0c\u901a\u5e38\u81f3\u5c11\u9700\u8981\u8fdb\u884c\u4e00\u6b21\u5b89\u88c5\u786e\u8ba4 (IQ) \u590d\u6838\uff08\u786e\u8ba4\u65b0\u7535\u673a\u7b26\u5408\u539f\u5df2\u83b7\u8ba4\u8bc1\u7535\u673a\u7684\u76f8\u540c\u89c4\u683c\uff09\u548c\u4e00\u6b21\u8fd0\u884c\u786e\u8ba4 (OQ) \u590d\u6838\uff08\u786e\u8ba4\u5b89\u88c5\u65b0\u7535\u673a\u540e\u8bbe\u5907\u80fd\u591f\u6309\u89c4\u683c\u8fd0\u884c\uff09\u3002\u5982\u679c\u66f4\u6362\u7684\u7535\u673a\u662f\u76f8\u540c\u578b\u53f7\u548c\u529f\u7387\u7b49\u7ea7\u7684 BXG \u7535\u673a\uff0c\u4e14\u62e5\u6709\u540c\u7b49\u7684\u6587\u6863\u8d44\u6599\uff0c\u5219\u8be5\u53d8\u66f4\u63a7\u5236\u4e8b\u9879\u53ef\u5f52\u7c7b\u4e3a\u540c\u578b\u53f7\u66f4\u6362\uff0c\u4ec5\u9700\u8fdb\u884c IQ \u590d\u6838\u548c\u7b80\u77ed\u7684 OQ \u529f\u80fd\u6d4b\u8bd5\uff0c\u800c\u65e0\u9700\u8fdb\u884c\u5b8c\u6574\u7684\u91cd\u65b0\u8ba4\u8bc1\u3002\u5728\u66f4\u6362\u5df2\u83b7\u8ba4\u8bc1\u7684\u5236\u836f\u8bbe\u5907\u7684\u7535\u673a\u4e4b\u524d\uff0c\u8bf7\u68c0\u67e5\u8d35\u5355\u4f4d\u7684\u53d8\u66f4\u63a7\u5236\u7a0b\u5e8f\u5e76\u54a8\u8be2\u8d28\u91cf\u56e2\u961f\u3002\u97e9\u56fd\u6c38\u529b\u7535\u673a\u53ef\u63d0\u4f9b\u53d8\u66f4\u63a7\u5236\u652f\u6301\u51fd\uff0c\u786e\u8ba4\u66f4\u6362\u7684 BXG \u7535\u673a\u4e0e\u539f\u5df2\u83b7\u8ba4\u8bc1\u7535\u673a\u5728\u89c4\u683c\u548c\u6750\u6599\u65b9\u9762\u5b8c\u5168\u76f8\u540c\uff0c\u8fd9\u53ef\u4ee5\u51cf\u5c11\u540c\u578b\u53f7\u66f4\u6362\u7684\u8ba4\u8bc1\u5de5\u4f5c\u91cf\u3002<\/p>\n<\/div>\n<\/div>\n

\n
\n
\u5728\u5236\u836fGMP\u533a\u57df\u5185\uff0cBXG\u7535\u673a\u7684\u6700\u4f4e\u6e05\u6d17\u9891\u7387\u662f\u591a\u5c11\uff1f<\/div>\n<\/div>\n
\n

\u6e05\u6d01\u9891\u7387\u5fc5\u987b\u6839\u636e\u60a8\u5df2\u9a8c\u8bc1\u7684\u6e05\u6d01\u7a0b\u5e8f\u786e\u5b9a\uff0c\u8be5\u7a0b\u5e8f\u57fa\u4e8e\u7279\u5b9a\u7535\u673a\u4f4d\u7f6e\u7684\u6c61\u67d3\u98ce\u9669\u3001\u6240\u751f\u4ea7\u7684\u4ea7\u54c1\u4ee5\u53ca\u6e05\u6d01\u5242\u7684\u6709\u6548\u6027\u3002\u97e9\u56fd\u6c38\u529b\u516c\u53f8\u4e0d\u89c4\u5b9a\u6e05\u6d01\u9891\u7387\u2014\u2014\u8fd9\u7531\u5236\u836f\u516c\u53f8\u81ea\u884c\u51b3\u5b9a\uff0c\u5e76\u9700\u8fdb\u884c\u8d28\u91cf\u548c\u9a8c\u8bc1\u3002\u81f3\u5c11\uff0c\u7535\u673a\u5e94\u7eb3\u5165\u5176\u5b89\u88c5\u6240\u5728GMP\u533a\u57df\u7684\u623f\u95f4\u6e05\u6d01\u7a0b\u5e8f\u4e2d\u3002\u5728C\u7ea7\u533a\u57df\uff0c\u8fd9\u901a\u5e38\u610f\u5473\u7740\u5728\u6bcf\u6b21\u751f\u4ea7\u6279\u6b21\u524d\u540e\u4f7f\u7528\u5f02\u4e19\u9187\uff08IPA\uff09\u8fdb\u884c\u6e05\u6d01\u3002\u5728D\u7ea7\u533a\u57df\uff0c\u5df2\u9a8c\u8bc1\u7684\u7a0b\u5e8f\u53ef\u80fd\u662f\u6bcf\u65e5\u4f7f\u7528\u6c34\u6027\u6e05\u6d01\u5242\u6eb6\u6db2\u8fdb\u884c\u6e05\u6d01\u3002\u6e05\u6d01\u7a0b\u5e8f\u5fc5\u987b\u7ecf\u8fc7\u9a8c\u8bc1\uff0c\u4ee5\u8bc1\u660e\u4f7f\u7528\u6307\u5b9a\u7684\u6e05\u6d01\u5242\u3001\u7528\u91cf\u548c\u65b9\u6cd5\uff0c\u80fd\u591f\u5c06BXG\u7535\u673a\u5728\u5176\u5b89\u88c5\u4f4d\u7f6e\u7684\u8868\u9762\u6e05\u6d01\u81f3\u6240\u9700\u7684\u5fae\u751f\u7269\u548c\u5316\u5b66\u6b8b\u7559\u9650\u91cf\u3002<\/p>\n<\/div>\n<\/div>\n

\n
\n
BXG\u7535\u673a\u80fd\u5426\u7528\u4e8e\u7ec6\u80de\u6bd2\u6027\uff08OEB 4\/5\uff09\u836f\u7269\u751f\u4ea7\u533a\u57df\uff1f<\/div>\n<\/div>\n
\n

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<\/p>\n

\n
<\/div>\n

 <\/p>\n

\n
\u97e9\u56fd\u6c38\u529b\u7535\u673a \u00b7 BXG\u7cfb\u5217 \u00b7 IP69K\u9632\u62a4\u7b49\u7ea7\uff0cSS316L\u4e0d\u9508\u94a2\u6750\u8d28\uff0c\u7b26\u5408\u5236\u836fGMP\u89c4\u8303\u7684\u7535\u673a<\/div>\n

\u60a8\u7684\u5236\u836f\u5382\u9700\u8981\u7b26\u5408GMP\u89c4\u8303\u4e14\u5177\u5907IQ\u6587\u4ef6\u7684\u7535\u673a\u5417\uff1f<\/h2>\n

\u97e9\u56fd Ever-Power BXG\uff1aAISI 316L \u4e0d\u9508\u94a2\uff0cIP69K \u9632\u62a4\u7b49\u7ea7\uff0c\u8868\u9762\u7c97\u7cd9\u5ea6 Ra \u2264 0.8 \u03bcm\uff0c\u7b26\u5408 FDA 21 CFR \u6807\u51c6\u7684\u5bc6\u5c01\u4ef6\uff0cNSF H1 \u6da6\u6ed1\u8102\uff0cH \u7ea7\uff0c\u529f\u7387\u8303\u56f4 0.18\u201311 kW\u3002\u6807\u914d\u5b8c\u6574\u7684 IQ \u6587\u6863\u5305\u3002<\/p>\n

\u67e5\u770b BXG \u4e0d\u9508\u94a2\u7cfb\u5217<\/a><\/p>\n<\/div>\n<\/div>\n

\u7531 Cxm \u7f16\u8f91<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

Korea Ever-Power \u00b7 BXG Series \u00b7 Pharmaceutical GMP Drive Guide Stainless Steel Motor for Pharmaceutical GMP Manufacturing: FDA 21 CFR, EU GMP and EHEDG Compliance Guide Pharmaceutical manufacturing facilities operating under Good Manufacturing Practice (GMP) regulations must ensure that all equipment in contact with or above product and product-contact surfaces is constructed to prevent contamination […]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[28],"tags":[],"class_list":["post-229","post","type-post","status-publish","format-standard","hentry","category-industrial-electric-motor"],"_links":{"self":[{"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/posts\/229","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/comments?post=229"}],"version-history":[{"count":1,"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/posts\/229\/revisions"}],"predecessor-version":[{"id":230,"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/posts\/229\/revisions\/230"}],"wp:attachment":[{"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/media?parent=229"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/categories?post=229"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/industrialelectricmotor.net\/zh\/wp-json\/wp\/v2\/tags?post=229"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}