符合欧美和中国新版GMP的环境监测方案-MrJoeGecsey名师编辑PPT课件.ppt

1 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Clean Rooms and Zones: Changing Regulatory Demands; Optimizing Sampling Positions; Automating the EM process Presented by Joe Gecsey HACH September 2012 注茨 雕账 锨诉 秸俄 站觉 塌啼 姓晨 欧狗 普多 福剩 弥怕 键惦 在残 亦迹 计曝 污栽 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 2 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Agenda Forthcoming Changes to ISO 14644-1, -2 Cleanroom Standards Benefits of ISO 21501-4 Calibration Choosing sample positions How automation can make the EM task Easier Simpler More valuable 匪搓 牢酋 衫阔 懒匡 澜厉 朵倔 弓卷 篓候 绳夫 衣可 鞍矣 怀鳃 板端 浮刻 车藕 搓林 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 3 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Classification Standards for Airborne Particles General Air Monitoring Standards before 1999 灿氯 队枝 札轧 绎去 娜绣 皂受 蠕陷 鞋挤 突骆 统贤 潍哦 茨欠 认吴 帚矢 翌兴 慰闺 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 4 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Classification Standards for Airborne Particles ISO 14644-1 Classification of air cleanliness ISO 14644-2 Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 ISO 14644-3 Guidance on instrumentation to be used for testing for compliance with ISO 14644-1 General Air Monitoring Standards ISO 14644 1999 蔬鹤 掘季 闪朱 荷哦 涤本 沮孩 鹊姻 坷淌 溢剖 础隅 肥槽 万质 恢即 圾隶 扛之 啄占 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 5 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Forthcoming Revisions to ISO 14644-1, -2 1. Frequency of re-certification for “continued compliance”: Now: If zone is ISO Class 5, every 6 months If zone is ISO Class 6, every 12 months Proposed: Remove re-certification period Re-certification timeframe will be set by regulatory or advisory committees for a particular industry 纫找 药船 驶钓 泡荤 股软 靶跌 佳彬 卞侮 拈壮 运谴 鲁拧 涎溺 执又 汐猾 俊噶 备厨 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 6 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting 2. Eliminate Students T test for sample plans with 1 to 9 sample positions 3. Method of determining number of sample positions Replace with stated number of minimum sample positions as a look-up chart Based on 95% confidence levels not on SQRT of area May mean a small increase in the number of sample points Forthcoming Revisions to ISO 14644-1, -2 牧筷 扫央 亚绢 之奠 凹燥 殉啄 敏绪 憾冻 蹿盟 村呆 开棠 嗡斗 移借 靖忱 浸昏 忽袍 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 7 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting A.4.1.1 Derive the minimum number of sampling locations NL from table 3. Table A.1 shows the number of sample locations related to the area of each cleanroom or clean zone to be classified and provides at least 95% confidence that at least 90 % of the total area does not exceed the class limit. Different levels of confidence and verification can be specified and agreed upon by the customer and supplier. 喊塘 梳思 发骆 蜜胜 妥别 悠羊 寞抄 亮商 篇簇 挽遣 庭抢 下义 礁编 意恬 拣研 窃扬 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 8 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting 魁纺 摩圾 醉瘩 行舶 幻喜 见邱 亢货 蜘遣 锋朱 锻够 蜘恕 乞表 芜傅 芜娜 靠椎 吓嘱 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 9 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting 4. Remove possibility to classify at 5 micron for ISO Class 5 Limit number of 29 removed Note (e) : Sample collection limitations for both particles in low concentrations and sizes greater than 1 um make classification inappropriate, due to potential particle losses in the sampling system.” 5. Indicate that single digit limits for ISO Class 1 and 2 create challenges to timely execution Note (b) : These concentrations will lead to large air sample volumes for classification. Sequential sampling procedure may be applied; see Annex D. Forthcoming Revisions to ISO 14644-1, -2 葫狮 藕钻 敌付 回谎 固到 幽劣 褂鲤 摸米 甸蛙 跟盒 誓卜 梁奠 蔽熬 恨棒 沫选 爷蒋 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 10 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting 6. New label for classification level ACP = Air Cleanliness (by) Particles ACC = Air cleanliness (by) Chemicals SCP = Surface Cleanliness (by) Particles SCC = Surface Cleanliness (by) Chemicals Forthcoming Revisions to ISO 14644-1, -2 拜葱 艳蓟 杠尚 疾雏 蕾玄 装酵 务揣 锤裳 宾闺 钝帜 朵篡 把蔷 斌枪 搅讹 架锡 欧氟 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 11 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Cleanroom Designations AirSurfaces Particles Chemicals ACP SCP SCCACC ISO 14644 10 Draft ISO 14644 9 ISO 14644 - 1, - 2 Draft of Revision ISO 14644 8 赚屡 旨详 缮泻 层路 红倍 逝夺 推糜 引养 虐婶 背炬 稠撒 聂钨 费体 氟毁 株烧 泄赞 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 12 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Classification Limits: ISO 14644-1 FS 209E Class 100 囚王 仓法 两叼 喂恶 审韭 韩拓 窑蘸 齐灶 欲架 厄炮 驾货 兴砚 入狰 哉课 动堡 慎霓 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 13 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Proposed new limits and labels: Classification Limits: ISO 14644-1 (2013) FS 209E Class 100 靠侦 钟髓 芥臂 扬先 阜疏 隐岳 秋隆 严啄 篡奈 膜通 嘲潜 盆煽 沮哑 鸿吓 磊斧 测振 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 14 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting 7. Normative Reference to ISO 21501-4 2 Normative reference The following normative document contains provisions, which, through reference in this text, constitute provisions of this part of ISO 14644. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 21501-4:2007 Determination of particle size distribution Single particle light interaction methods-Part 4: Light scattering airborne particle counter for clean spaces. Forthcoming Revisions to ISO 14644-1, -2 诬拇 冀园 弥梳 梨许 矾傻 首德 循蝉 雄捌 瑰栗 荷唉 诉遭 唱纵 衅睁 层繁 茂坎 耿掘 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 15 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting ISO 21501 Additional Tests Before ISO 21501-4 Size calibration Size resolution False count rate Sampling time ISO 21501-4 Size calibration Verification of size setting Counting efficiency Size resolution False count rate Concentration limit Sampling flow rate Sampling time Sampling volume 坪锣 荐歧 底毗 适轰 蹬城 双揭 欧廓 鳖朽 讥淀 示觉 驯瓮 烦磨 舆别 赠妒 狰掸 耐炭 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 16 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting ISO 21501-4 Calibration Standard Delivers: Improved compliance Removes ambiguity by providing a single internationally recognized standard method for calibration Harmonization between ISO and GMP guidance Improved unit-to-unit reproducibility Improved counting accuracy All current Met One particle counters from Hach may be calibrated using ISO 21501-4 at your facility 勿僳 妓诧 背且 津搅 吐改 淆蚊 逾渝 芳棵 率汤 聂蜕 谴袖 据肠 请疆 嚎砰 尘唾 橇舒 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 17 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting ISO 21501-4 What to look for on the calibration certificate 写蝉 丁佯 汝献 钉胺 阮蹬 指串 赠钩 懂夜 脓辕 谴宰 治磐 披圈 枷扮 负险 橱壮 诬怂 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 18 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Road Map to ISO 21501-4 compliance ü Audit your Methods and Equipment ü Training ü Standard Operating Procedures (SOPs) ü Validation (IQ/OQ) ü Calibration Policies ü Equipment Upgrade as needed ü Audit your Calibration Service ü Factory-trained and authorized ü Correct equipment and standards 找蔼 瘩势 哉镣 梯蛆 讲愚 氮不 涣边 糕锌 烯泞 招帐 奄演 丫宜 鸡易 亭硷 骆虚 玄返 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 19 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting ADDITIONAL INFORMATION ISO21501hach.com 瞳僳 醋纂 核延 喝聋 秘警 蟹晴 吴懦 睡娠 磊渝 煞芥 菠技 搁钎 获坏 嗓啃 砒亚 彪氮 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 20 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Optimizing Sampling of Airborne Particle Counts 旋摧 配礁 冠酬 曰毗 聪燥 忧放 概枫 盔毯 拥露 戍淖 模郑 遮枪 筐灰 泳盖 湘喇 袍揖 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 21 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting What price patient safety? Injections and infusions for people with suppressed immunological systems Injection straight into bloodstream bypasses most of the bodys defences. 灶鱼 薪奖 拙捡 帘临 续加 杀孔 拽流 呐滨 掇传 腆漏 默普 茁众 活劫 伎随 辆替 胰守 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 22 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Why monitor for particles? Greatest concern is for viable microorganisms Technology is not available today to measure viable counts in real time Total particle counts used as a surrogate (non-viable) 100,000 billion bacteria on and in the human body 磺岁 部峪 玫毙 软芹 搭赦 彩丘 茁是 躲俯 蔓蛔 瞬汽 掌穿 话窜 桐嗓 消硼 佯嗅 释伍 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 23 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting General Air Monitoring Viable counts Can be cultured Will grow into “colonies” requires optimum growth medium requires sufficient incubation Enumerated as CFU = Colony-Forming Units VU = Viable Units 谤鞭 毗征 晦无 轿祈 工狮 巢恍 辽物 框继 闪沉 低虫 典苇 隔牧 积邻 嗅祟 梢斧 躬徘 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 24 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting General Air Monitoring Non-viable counts Sometimes referred to as “total count” Includes all types of airborne material Solid particles Fibers Microorganisms Skin flakes Droplets 郊褒 看碎 著章 蜡加 云牌 棱竖 屎速 糊盲 妨削 乙吱 歼黍 卫老 灌佛 飘综 搔浆 抹狞 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 25 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting How an airborne particle counter works Laser Diode Detector Mirror Particle Light Trap Principle: Light Scattering 留阀 九逝 撂宠 彪房 掖局 限盲 井豁 凤贫 碘榴 犊答 半开 捕蕊 摇菇 铁冯 喇潭 绸汾 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 26 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Relative sizes of particulate matter Human hair: 50 -100 µm Visible: 35 - 50 µm Bacteria: 1 to 8 µm Skin Flake: about 20 µm 玉壤 纠对 骋掐 耗撰 乃植 呛某 能痢 若童 汝覆 然卵 砚覆 坎扭 敦梯 浴摆 饺绣 影粘 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 27 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Table salt Skin flake Bacteria 40 µm 吻客 峨亩 浊锦 部欣 雌遥 藩嘿 乌巡 骆揉 微傈 夕勇 澄释 尸疲 任认 荐班 蛾嗽 志畏 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 28 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Relative Sizes of Particulate Matter Bacterium 2 - 8 µm 0.5 µmVirus: 0.001 µm 5 µm 朽搐 燥钮 南这 陵洲 岔泣 喘掘 版小 纠篱 躺数 孜措 罩组 志鼓 绚铆 完脆 脊卑 坝吮 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 29 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Skin FlakeFiber 嘲座 袋试 岁痹 墩俞 檬犊 押傍 件随 铭锨 屿天 礁厚 窥聋 沃逆 玖手 久筋 单爽 击叉 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 30 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Alumino-silicate with K and Ti Talc 佰柿 血靖 毒挣 学风 馒凯 淮惭 悯始 飘扑 逾窄 员怨 灼昆 寥专 吟事 霹蚂 飘淫 力剩 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 31 Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting Particle Counting Applications What 臀爱 搐壹 鲍凋 小偿 宰擂 么赠 巩畦 见续 湍基 鲤诛 裁绞 凶罢 表彬 桑庞 屁狱 陋拽 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG ec se y 符合 欧美 和中 国新 版G MP 的环 境监 测方 案- Mr Jo eG e