环境监测回顾分析报告.docx

1、宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., LtdEnvironmental Monitoring Annual Summary Report for year 20182018年度环境监测回顾分析报告NO.: HG18-009.00Page No.:1 / 63Environmental Monitoring AnnualSummary Report for year 20182018年度环境监测回顾分析报告Category 类另UDepartment部门Name姓名Signature/ Date签名/日期Compiled by 起草人质量

2、控制部王雪洁Checked by审核人质量控制部杜胜质量保证部黄锋莉Approved by批准人质量负责人赵婕宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., LtdEnvironmental Monitoring Annual Summary Report for year 20182018年度环境监测回顾分析报告NO.: HG18-009.00Page No.:2 / 63TABLE OF CONTENTS目录1 Introduction 介绍32 Purpose目的： 33 Scope 范围：34 Abbreviations 缩略语35 Co

3、ntent 内容36 Summary 总结57 Attachment 附件： 5Environmental Monitoring Annual Summary Report for year 20182018年度环境监测回顾分析报告NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., LtdPage No.:3 / 631 Introduction 介绍对2018年度环境监测情况（包括悬浮粒子数、沉降菌、浮游菌）进行回顾分析汇总。2 Purpose目的：清楚了解2018年度洁净区环境的洁净程度。3 Scope 范围：适用

4、于宜昌天仁药业有限责任公司内洁净区环境监测数据的汇总（监测时间为2018年01月01日2018年12月31日）。4 Abbreviations 缩略语Abbreviation缩写Full Description 全称NANA5 Content 内容5.1 洁净区悬浮粒子数判定标准洁净级别ABCD悬浮 粒子 数最 大元 许数 /立方 米静态0.5(im标准规定352035203520003520000警戒指标70425002500002500000纠偏指标14083000300000 5 pm标准规定2029290029000警戒指标420200020000纠偏指标82525000.5标准规定3

5、520 352000 3520000警戒指标70470400704000纠偏指标1408140800 5 pm标准规定2029029000警戒指标45805800纠偏指标8116011600监测频率1次/3个 月NA1次/6个月大修开班前；平时监测1次/3个月Environmental Monitoring Annual Summary NO.： HG18-009.00宜昌天仁药业有限责任公司RepoR for year 2018Yichang Tianren2018年度环境监测回顾分析报告Page No.:4 / 63Pharmaceutical Co., Ltd5.2 洁净区浮游菌判定标准

6、及检测频率洁净度级 别浮游菌平均菌落数（CFU/m3）标准规定警戒指标纠偏指标监测频次AV 1NANA1次/1个月B0 1068NAC& 100 200 401次/6个月D 2000 40 80大修开班前；平时 监测1次/3个月5.3 洁净区沉降菌判定标准洁净度级 别沉降菌平均菌落数（CFU/皿4小时）标准规定警戒限度纠偏限度监测频次A10.60.8每周一次C工 500 10 201次/3个月D& 1000.5 pm悬浮粒子（个/M3）微生物限度实验室2018.06.212018.12.152018.12.162018.12.17静态警戒限静态纠偏限静态限度微生物检测室94-117653777

7、1105901376725000030000035200094-1776684727766217725000030000035200094-128246707317770625000030000035200094-2282438831765776625000030000035200094-217650353176525000030000035200094-228240044478250000300000352000内毒素检测室94-3141270614123847725000030000035200094-3211803531412025000030000035200094-388253533

8、5370625000030000035200094-495313530025000030000035200094-47413021533025000030000035200094-412708067070250000300000352000缓冲走廊94-5529549773109431306125000030000035200094-5091784589388325000030000035200094-6060012824458925000030000035200094-6776670670635325000030000035200094-760010141224712500003000003

9、5200094-7529510590353250000300000352000This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Phar

10、maceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:9 / 63监测区域取样点编号0.5 pm悬浮粒子（个/M3）阳性对照实验室2018.06.212018.12.152018.12.162018.12.17静态警戒限静态纠偏限静态限度缓冲走廊94-87060109431412882525000030000035200094-81270898841059388325000030000035200094-8811998840105925000030000035200094-96707494270670625000030000035200094-93883353

11、0035325000030000035200094-98825353052956707250000300000352000阳性菌对照室94-10247191787061023725000030000035200094-10529560011059458925000030000035200094-1035324712824317725000030000035200094-1128249884105935325000030000035200094-1110597413353025000030000035200094-1102824141220827250000300000352000This Do

12、c. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:10

13、 / 63监测区域取样点编号5.0 pm悬浮粒子（个/M3）微生物限度实验室2018.06.212018.12.152018.12.162018.12.17静态警戒限静态纠偏限静态限度微生物检测室94-1010590020002500290094-100070620002500290094-100706020002500290094-2000020002500290094-270600020002500290094-2000706200025002900内毒素检测室94-3000141220002500290094-3000020002500290094-3000020002500290094

14、4000020002500290094-435300020002500290094-4706000200025002900缓冲走廊94-500035320002500290094-5000020002500290094-600035320002500290094-670600020002500290094-7000020002500290094-70000200025002900This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd.

15、 is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:11 / 63监测区域取样点编号5.0 pm悬浮粒子（个/M3）阳性对照实验室2018.06.212018.12.152018.12.162018.12.17静态警戒限静态纠偏限静态限度缓冲走廊94-800

16、035320002500290094-800070620002500290094-803530020002500290094-9000020002500290094-9000020002500290094-90000200025002900阳性菌对照室94-100353035320002500290094-1007060020002500290094-10000020002500290094-11000020002500290094-11000020002500290094-11000706200025002900This Doc. is strictly confidential. Any

17、use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:12 / 632018年度微生物限度实验室沉降菌趋势图2018年度阳性

18、对照实验室沉降菌趋势图3.5监测日期535251503 2 10 结果单位I CF U /皿4小时微生物限度室94-1微生物限度室94-2内毒素检测室94-3内毒素检测室94-4缓冲走廊94-5缓冲走廊94-6警戒限：10CFU/皿.4小时纠偏限：20CFU/皿.4小时限度：50CFU/皿.4小时果单位IC FU /皿4小时缓冲走廊 94-8缓冲走廊94-9阳性菌室94-10阳性菌室94-11警戒限：10CFU/皿.4小时纠偏限：20CFU/皿.4小时限度：50CFU/皿.4小时This Doc. is strictly confidential. Any use and copy unaut

19、horied by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝监测日期缓冲走廊94-6100CFU/M3Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:13 / 63微生物限度室94-1微生物限度室94-2内毒素检测

20、室94-3内毒素检测室94-4缓冲走廊94-5警戒限：20CFU/M 纠偏限：40CFU/M 限度：This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang T

21、ianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:14 / 632018年度阳性对照实验室学.0师悬浮粒子趋势图个监测日期方 米 )悬 浮 粒 子 数94-894-894-894-994-994-994-1094-1094-1094-1194-1194-11静态警戒限:2000 个/m3静态纠偏限:2500 个/m3静态限度：2900 个/m3This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutica

22、l Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:15 / 6360000500002018年度微生物限度实验室 0.5m悬浮粒子趋势图悬浮粒子数 1 个/立方米400003000020000100002018.06.21 2018.

23、12.15 2018.12.16 2018.12.1794-194-194-194-294-294-394-294-3-94-394-494-494-494-594-694-794-594-694-7静态警戒限：250000个/m 静态警戒限：300000个/m 静态警戒限：352000 个/m监测日期This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得

24、使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:16 / 63AT-HG18-009-02 一线洁净区监测数据分析汇总一线洁净区沉降菌监测结果单位（CFU加4小时）监测区域取样点编号2018.02.052018.04.192018.07.032018.09.032018.11.222018.11.302018.12.06警戒限纠偏限

25、限度精制问3-12131691581620401003-221718723520401003-3131219512151220401003-40717417111120401003-51181851171320401003-60416229620401003-70116453220401003-81261616135720401003-9358113132040100干燥问3-1015414040320401003-110319112120401003-120414445020401003-132818819020401003-140811920420401003-15231701402040

26、100This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitoring Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告P

27、age No.:17 / 63一线洁净区沉降菌监测结果单位（CFU加4小时）监测区域取样点编号2018.02.052018.04.192018.07.032018.09.032018.11.222018.11.302018.12.06警戒限纠偏限限度粉碎总 混内包 问3-16090901020401003-17232600020401003-180001500020401003-190001412020401003-200111720020401003-21011160102040100洁净走 廊3-22003212020401003-2308151830020401003-241351743

28、020401003-251251834720401003-262381947320401003-273781905020401003-2810080632040100内包材 暂存问3-29000000120401003-3000000012040100This Doc. is strictly confidential. Any use and copy unauthoried by Yichang Tianren Pharmaceutical Co., Ltd. is forbidden.仅限宜昌天仁药业有限责任公司内部使用。未经授权，不得使用或拷贝Environmental Monitor

29、ing Annual Summary Report for year 2018NO.: HG18-009.00宜昌天仁药业有限责任公司Yichang Tianren Pharmaceutical Co., Ltd2018年度环境监测回顾分析报告Page No.:18 / 63一线洁净区浮游菌监测结果单位（CFU/M）监测区域取样点编号2018.02.052018.04.192018.07.032018.09.052018.11.222018.11.302018.12.06警戒限纠偏限限度精制问3-1040201040401040802003-22030103010102040802003-3030100200040802003-402020202002040802003-504030200101040802003-60010010