环境监测回顾分析报告.docx
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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.
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