害虫控制管理程序 Pest control
quarantine pest 名词解释
quarantine pest 名词解释Quarantine pest is a noun phrase that refers to a type of organism that is harmful to plants and can cause significant damage to agricultural crops. These organisms are typically regulated and subjected to strict quarantine measures to prevent their entry or spread to new areas.1. The agricultural inspector identified a quarantine pest in the shipment of imported fruits.农业检查员在进口水果的货物中发现了一种检疫害虫。
2. The presence of a quarantine pest on the farm has led to a decrease in crop yields.农场上的一种检疫害虫的存在导致了作物产量的下降。
3. The authorities have imposed a ban on the movement of plants and plant products to control the spread of quarantine pests.当局已经禁止植物和植物产品的流动，以控制检疫害虫的传播。
4. Farmers must regularly monitor their crops for any signs of quarantine pests and report them immediately.农民们必须定期监测作物，以发现任何检疫害虫的迹象并立即报告。
3. Pest Control Management虫害控制
卷帘门 – 害虫有可能的进入点
6
IPM 的管理
检查
有的时候并不是硬件方面的问题
符合食品安全 要求的
标准IPM服务
IPM服务的文件要求：
综合虫害管理计划
如服务外包，必须签署合同（除非工厂明确 放弃要求），内容应包括：
– 工厂名称；– 虫害控制设施及物品的储存
Ecolab China
3
如何防护老鼠入侵室内？
Solution
ProGuard Pest Exclusion
如何防护老鼠入侵室内？
Solution Pest Exclusion
1/4 “ gap
老鼠尾巴
IPM的实际运用
IPM的实际运用
不仔细, 看不 出问题。
这里就是为什么我们称之为苍蝇生产基地的地方
IPM服务的操作要求：
• 定期的 虫害问 题的分 析及改 善建议 及措施；
IPM服务的化学药剂要求：
所有杀虫剂和灭鼠剂都必须有登记证明、MSDS、 标签
Ecolab China
9
IPM服务的化学药剂要求：
所有杀虫剂必须是卫生类药剂
问答时间
对IPM有任何疑问
T 021-62371000 M 13901603009 E heng.su@
定期的服务
定期的检查、监控，在必 要时采取处理措施
参与方
虫害控制服务商
虫害控制服务商和客户 的关键负责人
全员参与
Ecolab China
2
IPM虫害管理的 基本原理
IPM基本原理
栖息环境
• 设备老化时的渗水 • 清洁产生的积水 • 下水道的堵塞 • 冷凝水
《害虫管理程序》
《害虫管理程序》1、目的：更好地控制厂区内的害虫，保证药品生产区域、食品储藏区域、包装物料储藏区域内无虫、蚊蝇和鼠害，消除包括啮齿类、昆虫、以及猫、狗等对食品卫生造成的危害。
2、定义：害虫。
在食品加工厂，害虫类是以多种形式作孽的，包括鸟类、大量的飞虫及爬行类昆虫如蟑螂、蚊蝇、蛾；以及猫、鼠和各种啮齿类动物。
3、职责：办公室负责联系卫生防疫站对蝇虫进行消杀，并对消杀结果进行评估；办公室负责捕鼠点的控制，并对捕鼠点的每半年位置进行评价；办公室负责对厂区内猫、狗等有害食品卫生的动物的驱除。
4、程序：4.1蝇虫的控制4.1.1生产车间入口处及外界相连的排水通风口和车间卫生间设置窗纱、塑料门帘、地漏网等防蝇虫设施，并要经常检查维修，保证其状态良好。
4.1.2厂区内的垃圾暂存器采用带盖密闭容器，每天由专人进行清理，以免蚊蝇孳生。
4.1.3由办公室跟区消杀服务站签订蝇虫消杀协议，由消杀服务站对工厂的厕所、室内、垃圾点、污水沟、绿化带、室内、环境等处进行定期消杀。
（详见卫生消杀协议书）4.1.4在更衣室过道处悬挂灭蝇灯并每天开启，由卫生人员每周对灭蝇灯进行清理，检查灭蝇数量，并记录于《厂区环境卫生、防蝇、防害检查记录》中。
4.1.5由办公室负责分析，当前蝇虫控制状况是否符合要求。
4.2鼠害的控制4.2.1由办公室负责根据工厂的实际情况和经验在厂区内确定捕鼠点。
4.2.2由厂区卫生员负责放置粘鼠板并检查粘鼠板处于良好状态。
每星期两次检查捕鼠数量，并记录于《防鼠记录表》中。
4.2.3由厂区卫生员将所捕老鼠杀死并焚烧。
4.2.4在车间入口处设置挡鼠板，防止老鼠从门口窜入车间。
4.2.5由办公室每半年根据实际发生捕鼠数量对捕鼠点进行的位置、分布进行评价。
并对鼠害控制效果进行评估。
4.3其他有害动物的控制4.3.1由厂区卫生员负责驱除闯入厂区内的猫狗等有害食品卫生的动物。
查找有害动物来源和闯入通道并消除。
5、相关记录：《厂区环境卫生、防蝇、防害检查记录》《防鼠记录表》第二篇：绿色害虫控制管理计划程序绿色害虫控制管理计划程序xx-10-0317：131.目的为工厂能充分控制虫害提供导向。
害虫控制程序
害虫控制程序害虫防治方法（一）害虫防治方法一般来说，害虫控制的操作分为3个阶段：（1）除去害虫藏身地及诱饵。
（2）将害虫从企业中驱逐除去。
（3）消灭那些进入厂区的害虫。
首先，企业应对厂房进行一次预先检查，以便了解其执行上述3项工作的现有能力，以及在减少可能导致食品安全危害方面的不足，然后制定从企业中清除害虫的措施，例如“关闭门窗并密封以阻止害虫侵入。
” 在工厂中制定一套害虫控制清除体系要从多方面进行考虑，其中有（但不局限于）厂房和地面、结构布局、工厂机械、设备和器具、内务管理、废物处理、杀虫剂的使用和其他控制措施等。
应提出一份控制害虫的审查或检查表，以助于最初评估中可能遇到的害虫问题。
虽然HACCP法规中没有要求，但这种详细记录时很有用的。
害虫控制检查内容通常包括：（1）是否已清除地面杂草、草丛、灌木丛、垃圾等，以减少害虫接近和进入工厂的保护物；（2）地面是否有吸引害虫的脏水；（3）是否有足够的“捕虫器”，是否进行了良好的保护和维护；（4）有没有家养或达的野生动物存在的痕迹（包括但不限于狗、猫）；（5）门窗是否关闭且密封并能阻止害虫或污染物的入侵；（6）窗户有没有维护良好防止害虫进入的帘子；（7）是否存在超过约0.6cm的可使啮齿类动物和昆虫进入的洞口；（8）排水道是否清洁干净，且没有吸引啮齿类动物和其他害虫的杂物；（9）有没有充足的干净空间以限制啮齿类动物的活动（从墙到设备之间至少为约15cm）；（10）排水道的盖子是否保养良好并正确安装；（11）机器、设备和工器具是否正确进行清洗和消毒处理而消除了那些可能吸引害虫的食品或固态物；（12）生产线旁是否有适当的空间以便于进行清洁工作；（13）是否存在能存积食品或其他杂物的、可作为害虫引诱物和藏身地的卫生死角；（14）黑光灯是否有合适的光强度来吸引飞虫；（15）黑光灯安装是否合适；（16）黑光灯捕捉器装置是否定期清洁；（17）垃圾、废物、杂物等害虫藏身之处是否已清除；（18）工人橱柜室和休息室是否经过清洗和消毒，不会吸引啮齿类动物和其他害虫；（19）是否有啮齿类动物、昆虫、鸟类的迹象，如粪便、毛发、羽毛、啮齿痕迹、啮齿类动物沿墙活动的油迹、尿/氨味；（20）已经观察到了的害虫居留处的标记是否已清扫干净，以便于观察害虫新的活动迹象；（21）味禁止害虫入侵，是否正确收集、贮藏和处理废物，以防其吸引啮齿类动物和害虫；（22）垃圾桶、盆、箱等是否经过正确清洗、消毒，以防其吸引啮齿类动物和害虫。
28防虫鼠控制程序
5.4.6预防纠正措施
5.4.6.1如果发现合约公司的消杀效果不好时，要求消杀公司重新消杀;
5.4.6.2如果清洁工没有对已杀死的虫子及残骸清理干凈，需要再次清理；
5.4.7纠正之后，PCO人员需要再次检查，至到合格为止。
5.5杀虫鼠药物要求
5.5.1杀虫鼠药物之采购及贮存；
5.3.7.3储存区内包装袋/箱子有无啃咬或鼠类活动痕迹,任何区域有无排泄物；
5.3.7.4在诱饵区或周边有无腐烂的鼠类或其它动物(蛙、壁虎等)；
5.3.7.5检查是否有捕获到老鼠，对巡查的情况进行记录。
5.3.8预防纠正措施
5.3.8.1巡查中发现捕鼠器中若捕到老鼠，需及时通知行政部进行处理，先杀死再填埋。并对捕鼠器及周围用100℃开水清洗消毒，并重新换上功能测试合格之备用捕鼠器；
5.5.1.1本公司不采购和保存任何杀虫鼠药物，由消杀公司采购和保存；
5.5.1.2合同公司完成消杀后将剩下的杀虫鼠药物带离我们厂区，本厂不储存任何杀虫鼠药物；
5.5.2杀虫鼠药的使用
5.5.2.1施药位置及使用方法需根据消杀公司的规划进行施药，但是为了为防止污染产品，所有车间及仓库时不可以使用虫鼠药，也就是说虫鼠药只能在厂房周边使用；
5.3.5.2车间内围每隔9米应放置一个捕鼠器；
5.3.5.3厂区周围每隔15米放置一个捕鼠器；
5.3.5.4须在所有通往外部区域的出口两边3米之内各放置一个捕鼠器；
5.3.5.5捕鼠器应保证安全，确保其得到有效防护；
5.3.5.6捕鼠器设置位置必须适当，应使捕鼠器与墙平行，也最接近墙体，且捕鼠器开口朝外侧；
5.5.2.2杀虫药使用的时间分为:定期施药（每月两次）；
质量管理体系的英语翻译
质量管理体系的英语翻译质量管理体系的英语翻译项目Section审核人AuditorName一月Jan二月Feb三月Mar四月Apr五月May 六月Jun七月Jul八月Aug九月Sep十月Oct十一月Nov十二月Dec1.质量策略QualityPolicy2.质量管理体系QualityManagementSystem3.组织机构OrganisationalStructure4.N/AN/A5.规划/产品流程Layout/ProductFlow6.配置Equipment7.内部工作/卫生Housekeeping/Hygiene8.维护Maintenance9.害虫控制PestControl10.废弃物/废弃物处理Waste/WasteDisposal11.员工设施StaffFacilities12.地点Location13.交通Transport14.个人卫生PersonalHygiene15.健康问卷MedicalScreening16.工作服ProtectiveClothing17.培训Training18.操作控制ControlofOperations19.过程控制ProcessControl20.物理和化学产品污染风险Physical&ChemicalProductContaminationRisks21.不一致产品控制ControlofNon-ConformingProduct22.产品发放ProductRelease23.可追溯性Traceability24.设备和过程确认EquipmentandProcessValidation25.技术支持TechnicalSupport26.过程分析ProcessAnalysis27.架子寿命测试Shelf-LifeTesting28.HACCP体系HACCPSystem29.说明Specifications30.原料购入Purchasing31.常规文件要求GeneralDocumentationRequirements32.记录保存RecordKeeping33.投诉处理ComplaintHandling34.内部审核InternalAudit35.意外事故和召回产品的管理ManagementofIncidentsandProductRecall36.纠偏措施CorrectiveAction【质量管理体系的英语翻译】。
植物园专业英语词汇合集
植物园专业英语词汇合集Introduction这份文档旨在为植物园相关工作提供一份专业英语词汇合集。
这些词汇将涵盖植物园的各个方面，包括植物分类、园艺技术、管理和研究等。
这些词汇对于与植物园相关的职业人士、研究人员和爱好者来说都非常重要。
Plant Classification（植物分类）- Botany（植物学）Botany（植物学）- Taxonomy（分类学）Taxonomy（分类学）- Genus（属）Genus（属）- Species（种）Species（种）- Family（科）Family（科）- Order（目）Order（目）- Class（纲）Class（纲）- Division（门）Division（门）- Kingdom（界）Kingdom（界）- Phylum（门）Phylum（门）Horticulture Techniques（园艺技术）- Propagation（繁殖）Propagation（繁殖）- Pruning（修剪）Pruning（修剪）- Transplanting（移栽）Transplanting（移栽）- Fertilization（施肥）Fertilization（施肥）- Irrigation（灌溉）Irrigation（灌溉）- Pest control（害虫控制）Pest control（害虫控制）- Plant nutrition（植物营养）Plant nutrition（植物营养）- Grafting（嫁接）Grafting（嫁接）- Mulching（覆盖）Mulching（覆盖）- Pollination（授粉）Pollination（授粉）Garden Design（园林设计）- Landscape architecture（景观设计）Landscape architecture （景观设计）- Plant selection（植物选择）Plant selection（植物选择）- Garden layout（园林布局）Garden layout（园林布局）- Pathway design（路径设计）Pathway design（路径设计）- Water feature（水景设计）Water feature（水景设计）- Garden structures（园林结构）Garden structures（园林结构）Garden Management（园林管理）- Plant maintenance（植物保养）Plant maintenance（植物保养）- Pest management（害虫管理）Pest management（害虫管理）- Weed control（杂草控制）Weed control（杂草控制）- Plant disease control（植物病害控制）Plant disease control（植物病害控制）- Budgeting（预算管理）Budgeting（预算管理）- Staff coordination（员工协调）Staff coordination（员工协调）- Visitor services（游客服务）Visitor services（游客服务）Scientific Research（科学研究）- Botanical research（植物研究）Botanical research（植物研究）- Ecology（生态学）Ecology（生态学）- Conservation biology（保护生物学）Conservation biology（保护生物学）- Plant genetics（植物遗传学）Plant genetics（植物遗传学）- Ethnobotany（民族植物学）Ethnobotany（民族植物学）- Biodiversity（生物多样性）Biodiversity（生物多样性）- Plant physiology（植物生理学）Plant physiology（植物生理学）- Plant taxonomy（植物分类学）Plant taxonomy（植物分类学）- Plant ecology（植物生态学）Plant ecology（植物生态学）Conclusion希望这份植物园专业英语词汇合集能够对您在植物园相关的工作和学习中有所帮助。
虫鼠害控制流程
虫鼠害控制流程The pest control process begins with a thorough inspection of the premises to identify potential infestation areas and the types of pests present. This is crucial as it helps in devising an effective control strategy tailored to the specific situation.虫害控制流程首先从对场所的全面检查开始，以确定潜在的虫害区域和现有的虫害种类。
这一步至关重要，因为它有助于我们针对具体情况制定有效的控制策略。
Following the inspection, a comprehensive treatment plan is formulated, encompassing both chemical and non-chemical methods. Chemical treatments involve the use of pesticides and insecticides, which are applied in strategic locations to eliminate pests effectively. Non-chemical methods, such as baiting, trapping, and exclusion techniques, are also employed to complement the chemical approach and ensure a sustained pest-free environment.检查完毕后，我们将制定一套全面的处理计划，包括化学方法和非化学方法。
化学处理涉及使用杀虫剂和农药，将它们应用于关键位置以有效消除虫害。
虫害控制知识
虫害控制知识一．虫害控制的目的预防和消除有害生物，控制产生食品安全危害的污染源。
二．基本术语虫害：是指所有对食品安全有危害的生物，如:各种啮齿类动物、昆虫、鸟类、家养宠物。
虫害控制：（pest control operation简称PCO）即虫害控制操作，指预防和消除有害生物.三．有害生物的危害1．传播疾病：虫害最大危害是传播疾病给人类2．污染食物：虫害会给食品带来致病性微生物的污染（苍蝇和蟑螂可传播沙门氏菌、葡萄球菌、志贺氏菌、链球菌等；啮齿类动物是沙门氏菌和寄生虫的来源;鸟类是多种病源菌寄主，如沙门氏菌和李斯特菌)；并在食品上留下令人厌恶的东西,如:粪便、毛发、尸体等等。
3．财物损失：虫害会直接消耗、破坏食品；会破坏设施和设备甚至咬坏电线令电流短路造成火灾.四．虫害控制的三个阶段1．除去虫害的藏匿地及食物。
2．将区间内的虫害驱逐出去.3．消除那些进入区间内的虫害。
五．制订预防措施和消杀计划并实施（可委托专业消杀公司来做）1．检查整个区域内是否有吸引虫害的地方（重点是厕所、下水道、垃圾区、厨房、库房等。
频率：每月一次，可在消杀作业进行时检查，见《消杀记录表》。
2．统计针对不同虫害进行防治的地点.3．制订预防措施和消杀计划；。
4．按计划定期(通常为1个月)进行检查和消杀;。
5．需由专人负责对消杀工作的追踪和反馈；.六．虫害的预防返（一）虫害控制措施1．虫害存在的原因：(1)设备不正确存放，靠墙堆放,妨碍了地面清扫和垃圾清除;（2)食物贮存不当，食品残渣处理不当，有食物碎屑存在，可能成为虫害的吸引物和藏匿处;（3）垃圾区不清洁：垃圾箱的门未关或垃圾外溢,积存的垃圾废物可成为虫害的吸引物和它们的藏匿处；（4)外环境、建筑物附近的草丛、灌木丛、杂草可成为虫害的吸引物和它们的藏匿处;；(5）捕捉虫害的工具数量不足，或保养、维修不好；;（6)外环境、建设物附近的草丛、灌木丛、杂草可成为虫害的吸引物和它们的藏匿处;；2．虫害预防措施:(1）定期检查周边环境，移走或整理闲置的设备、机器、材料等以杜绝或减少对虫害的吸引，清除聚集的垃圾和废料.垃圾箱、垃圾房密闭，垃圾无溢出。
PESTCTRLDL虫害防治
This Document is licensed toMr. Zhengxian Ke, Damon KeShijiazhuang, HebeiID number: 323997Pest Control Handbook Downloaded on: 2/16/11 11:28 PMEdition 2 (English Translation)This Document is licensed toMr. Zhengxian Ke, Damon Ke Shijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMPage 2 ISPE Japan Affiliate:Pest Control Handbook© Copyright ISPE 2010Disclaimer:All the contents of this Pest Control Handbook prepared by the ISPE Pest Control Handbook Working Group, including the revised editions, do not constitute legal obligations such as GMP guidelines. The contents are made up of general information on pest control activities, designed to strengthen initiatives for protecting pharmaceutical products from contamination by insects and rodents.Limitation of LiabilityIn no event shall ISPE or any of its affiliates, or the officers, directors, employees, members, or agents of each of them, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of or in connection with the use of this information. © Copyright ISPE 2010. All rights reserved.No part of this document may be reproduced or copied in any form or by any means – graphic, electronic, ormechanical, including photocopying, taping, or information storage and retrieval systems – without written permission of ISPE.All trademarks used are acknowledged.ISPE Japan Affiliate:Pest Control HandbookEdition 2 (English Translation)Edited by Pest Control Handbook Working Group, Factory Issues SubcommitteeManufacturing Management Community of Practice (COP), ISPE Japan AffiliateISPE Japan Affiliate OfficeIshijima Bldg.7F, 1-11-10 Yushima Bunkyo-ku, Tokyo 113-0034, JapanTel: +81-(0)3-3818-6737, Fax: +81-(0)3-3818-0575 www.ispe.gr.jpThis Document is licensed toMr. Zhengxian Ke, Damon Ke Shijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMISPE Japan Affiliate: Page 3Pest Control Handbook© Copyright ISPE 2010AcknowledgmentsThe ISPE Pest Control Handbook was edited by the Factory Auxiliary Issues Subcommittee in the Manufacturing Management Community of Practice (COP) of the ISPE Japan Affiliate.This Pest Control Handbook was edited by gathering together the knowledge and experience gained from theoutcomes achieved by each of the working group members who have conducted pest control works at their facilities. First Edition: 1 August 2010Second Edition: 1 October 2010Edited by:Working Group of Pest Control Handbook, Factory Issues Subcommittee, Manufacturing Management COP , ISPE Japan AffiliateEditors (Japanese alphabetical order):Fumio Adachi (Novartis Pharma K. K.) Akihiro Okabe (Bayer Yakuhin, Ltd.)Masaki Kato (Taisho Pharmaceutical Co., Ltd.) Kiyoshi Kashimura (GlaxoSmithKline K. K.) Yutaka Kobayashi (Nippon Shinyaku Co., Ltd.) Makoto Takao (MSD K. K.)Toshiyuki Takahashi (Mitsubishi Tanabe Pharma Factory Ltd.) Makoto Takeda (Nippon Shinyaku Co., Ltd.) Katsuhiko Hashido (Taiyo Yakuhin Co., Ltd.) Taka-aki Maeda (Bushu Pharmaceuticals, Ltd.) Tadahiko Masuda (MSD Co., Ltd.) Goichi Yokoyama (Sanofi-Aventis K. K.)It is the sincere wish of the ISPE Japan Affiliate and all involved in the compilation of this handbook that it will be read by many people in pharmaceutical companies and the pharmaceutical industry. We hope that by doing so they can improve their knowledge and awareness on pest control management.In addition, in compiling this handbook, we offer our gratitude to the people who gave us citations and references, as well as all the people in related companies who are making efforts in pest control on a daily basis with the editors.We the member of Working Group or the authors are grateful for Mr. T. Tani (C&S Co. Ltd.) of his supportive advices for compilation of this Handbook. We also appreciate Jiho Inc. that allowed us to quote valuable articles edited in their journal Pharm Tech Japan .This Document is licensed toMr. Zhengxian Ke, Damon Ke Shijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMPage 4 ISPE Japan Affiliate:Pest Control Handbook© Copyright ISPE 2010Table of Contents1Introduction (5)1.1Scope (5)2 Key Concepts (6)2.1 The Objectives of Pest Control ....................................................................................................................6 2.2 PDCA Cycles in Pest Control .. (6)2.3Definitions (7)3 Pest Control Governance Organization (8)3.1 Governance Organization and Control Manager (8)3.2Supplier Services (8)4 Monitoring (10)4.1 Basic Policy for Monitoring.........................................................................................................................10 4.2 Insect Monitoring Process..........................................................................................................................10 4.3 Types of Insect Monitoring .........................................................................................................................12 4.4 Methods of Periodic Insect Monitoring .......................................................................................................13 4.5 Methods for Managing Insect Monitoring Results (Evaluation and Analysis/Policies on Indicators) .........15 4.6 Methods for Evaluating Insect Monitoring Results .....................................................................................17 4.7 Making the Most of Insect Monitoring Results, and Measures to be Taken when Control Criteria are Exceeded .............................................................................................................................................18 4.8 Types of Rodent Monitoring .......................................................................................................................20 4.9 Methods for Managing Rodent Monitoring Results (21)4.10Measures for Rodents (Corrective Action (CA)) (21)5 Pest Control (22)5.1 Basic Policy for Pest Control......................................................................................................................22 5.2 Environmental Pest Control .......................................................................................................................22 5.3 Physical Pest Control (25)5.4Chemical Pest Control (29)6 Inspections (Self-Inspections and Self-Audits) (31)6.1 Basic Policy ................................................................................................................................................31 6.2 Self-Inspections (Physical Aspects) ...........................................................................................................31 6.3 Self-Audits (Procedural Aspects) (32)6.4Recording Inspection Results (Records of Self-Inspections and Audits) (32)7 Training (33)7.1 Objectives of Training ................................................................................................................................33 7.2 Training Types.. (33)7.3Ad-Hoc Training (34)8 Citations and References (35)9 Glossary (36)This Document is licensed toMr. Zhengxian Ke, Damon Ke Shijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMISPE Japan Affiliate: Page 5Pest Control Handbook© Copyright ISPE 20101 IntroductionThe ISPE Pest Control Handbook considers fundamental concepts and policies for the control and management of pests (“pest control”) in pharmaceutical manufacturing sites.This Handbook is intended to assist organizations in satisfying Good Manufacturing Practice (GMP) regulatory expectations, which relate to the basic management of pharmaceutical manufacturing and associated quality management standards.This Handbook does not stipulate regulations on control criteria for pest control. In cases where alternative methods are deemed appropriate based on rational evidence those methods may be employed.1.1ScopeThis Handbook applies to pest control in pharmaceutical manufacturing sites.1.1.1Target Areas (Buildings and Facilities)1. Areas where raw materials and products are received, dispatched from, and stored2. Areas where raw materials and products are inspected, weighed, processed, and packaged3. Areas where specimens are stored and tested4. Areas where personnel change clothes and take breaks5. Outdoor areas adjacent to buildings or places where pharmaceuticals are handled (the periphery of buildings andgreen zones adjacent to the periphery)6. Areas where waste, etc., is temporarily stored such as machine rooms, water supply facilities, canteens, andperipheral areas1.1.2Intended AudienceThis Handbook is recommended for: 1. Pest control officers and advisors2. Personnel involved in processes ranging from receiving raw materials through to shipping products3. Personnel involved in the management of buildings and facilitiesThis Handbook may also be used during introductory training on pest control for personnel involved in: • production of pharmaceuticals • facility management•personnel that plan to begin such workThis Document is licensed toMr. Zhengxian Ke, Damon Ke Shijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMPage 6 ISPE Japan Affiliate:Pest Control Handbook© Copyright ISPE 20102 Key Concepts2.1The Objectives of Pest ControlPest Control should prevent the contamination of pharmaceutical products by insects and rodents. It should provideevidence to ensure the proper management of production facilities by understanding the status of habitat, breeding, and entry of insects and rodents into pharmaceutical manufacturing sites.Investigating the habitat and breeding of insects can be a useful means of: • confirming outbreaks of mold and the existence of dusts in hygiene-controlled areas•evaluating the suitability of hygiene management (cleaning procedures, procedures for receiving and dispatching goods, locker room procedures, etc.)Pest Control should verify whether the pest control function in buildings and facilities at pharmaceutical manufacturing sites is being appropriately maintained.2.2PDCA Cycles in Pest ControlThe PDCA cycle is an activity of four continuous steps: 1. Plan 2. Do 3. Check 4. ActionThese steps are performed in a sequential manner. 1. PlanMake operational plans based on past performance, future predictions, etc.:• Establishment and revision of pest control standards and procedural guidelines•Formulation of an operational plan for pest control across a set period of time (periodic monitoring, pesticide spraying, autonomous inspections, autonomous auditing, training, and operational conferences, etc.).2. DoConduct operations according to the plan:•Understand the demographics of insects and rodents through Insect Fauna monitoring and periodic monitoring•Conduct planned pesticide spraying, self-inspection, self-audit and training, management conferences, etc.This Document is licensed toMr. Zhengxian Ke, Damon KeShijiazhuang, Hebei ID number: 323997Downloaded on: 2/16/11 11:28 PMISPE Japan Affiliate: Page 7Pest Control Handbook© Copyright ISPE 20103. CheckVerify whether operations are in accordance with the plans:• Analysis of the numbers and types of pests captured•Evaluation of risks relating to buildings and facilities and pest control procedures4. ActionIdentify operations that are not in accordance with the plan, and manage them:•Devising and implementing measures based on the results of evaluations, and assessing the managementof progress and its outcomes•Conducting and training (organized and systematic pest control activities become more practical through deepening of personnel’s understanding of pests)•Pest control achieves the above objectives through suitable application of the PDCA cycle and through its systematic and sustainable management.2.3DefinitionsDefinitions of terms used in this Handbook may be found in the Glossary (Section 9).This Document is licensed toMr. Zhengxian Ke, Damon Ke Shijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMPage 8 ISPE Japan Affiliate:Pest Control Handbook© Copyright ISPE 20103 Pest Control Governance Organization3.1Governance Organization and Control ManagerPest control is normally given high priority in GMP . The governance organization should be established as a sub-component of the existing GMP organization or as an independent governance organization, taking into account theresources of the manufacturing site (e.g., personnel, facilities and machines, technologies, and know-how).Personnel responsible for managing pest control operations should: • have an understanding of the buildings and facilities, and of insects and rodents •be assigned from each department of the pharmaceutical manufacturing siteExamples of work done by, and driven by, the governance organization and managers include: 1. Preparation and review of documents relating to control criteria and procedural guidelines 2. Design, execution, and ongoing management of action plans 3. Periodic monitoring, identification, and trend analysis4. Corrective action and verification of improvement when unusual outbreaks occur5. Preventive action6. Inspections (self-inspections)7. Operational conferences and activity reports 8. Training 9. Records keeping10. Cooperation with pest control contractors3.2Supplier ServicesPharmaceutical organizations should investigate local companies that may have a detailed knowledge of local concerns to determine who can provide the required services.If a contract is entered into it should contain text to cover potential concerns to quality (i.e., a quality section in the agreement) so that any changes in the procedures or materials used are pre-approved, staff training requirements are defined and understood from the supplier and pharmaceutical organization perspectives, so the training requirements are defined and can be managed should personnel change.This Document is licensed toMr. Zhengxian Ke, Damon KeShijiazhuang, Hebei ID number: 323997Downloaded on: 2/16/11 11:28 PMISPE Japan Affiliate: Page 9Pest Control Handbook© Copyright ISPE 2010Example Supplier Activities • Insect Fauna studies• Periodic monitoring (setting and collecting traps)• Verification and counting of insects captured • Insect identification • Insect control measures• Execution of practical pest control work • Diagnostic of building structures •Personnel trainingThis Document is licensed toMr. Zhengxian Ke, Damon KeShijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PMPage 10 ISPE Japan Affiliate:Pest Control Handbook© Copyright ISPE 20104 Monitoring 4.1Basic Policy for MonitoringMonitoring is more than just a study of the habitat, breeding, and entry of insects and rodents. It can also be used in assessment of physical aspects (pest control structures and other hardware) and procedural aspects (cleaning methods and other software) of pharmaceutical manufacturing sites.Insect monitoring means periodically investigating the types of insects that inhabit, breed in, and enter pharmaceutical manufacturing sites, as well as their distribution, and the number captured. The results from the study should become reference materials for lowering the risk of products being contaminated by biologically-derived foreign substances, and maintaining a high-quality production environment.Rat monitoring requires conducting periodic investigations to make sure that rodents have not entered or are not living inside pharmaceutical manufacturing sites. Where symptoms that rodents have entered or are living in a site are identified, monitoring allows response measures to be taken quickly.4.2Insect Monitoring ProcessInsect monitoring involves: • Insect Fauna monitoring • periodic monitoring • ad-hoc monitoring •and follow-up studiesThe time taken to conduct each study and the sequence of activities is shown in Figure 4.1.Insect Fauna monitoring is conducted where a pharmaceutical manufacturing site is built or extended, or where insect studies are initiated. In addition to trapping studies across the whole pharmaceutical manufacturing site using traps, both physical (hardware) and procedural (software) aspects of the site should be investigated.Following Insect Fauna monitoring, the conditions should be checked by periodic monitoring. If deviations from Control Criteria or out-of-trend events arise, a follow-up study should be conducted. In cases where a temporaryzone break occurs in a hygiene-controlled area due to construction works or equipment brought in, ad-hoc monitoring should be conducted.Periodic monitoring and ad-hoc monitoring are both trapping studies that use traps. Periodic studies on the physical (hardware) and procedural (software) aspects in pharmaceutical manufacturing sites are addressed in Section 6 Inspections.Details of each type of study are addressed in Section 4.3 Types of Insect Monitoring.This Document is licensed to Pest Control HandbookMr. Zhengxian Ke, Damon KeFigure 4.1: Insect MonitoringShijiazhuang, HebeiID number: 323997Downloaded on: 2/16/11 11:28 PM © Copyright ISPE 2010Mr. Zhengxian Ke, Damon KeShijiazhuang, Hebei ID number: 323997Downloaded on: 2/16/11 11:28 PM© Copyright ISPE 20104.3Types of Insect Monitoring4.3.1Insect Fauna MonitoringIn Insect Fauna monitoring, comprehensive studies should be conducted by several study methods, using as manysampling points as possible across the entire pharmaceutical manufacturing site in order to understand the insectdemographics. In addition, studies on hardware and software aspects of the site should be included to identify locations which need pest control and periodic monitoring for the purpose of establishing and maintaining hygiene environment.Study methods for Insect Fauna monitoring involve combining studies such as: • trapping studies of crawling and flying insects • studies of insects living in dirt•insect studies using insect-attracting agentsThe terms of “hardware aspects” refers to the internal condition of areas in pharmaceutical manufacturing sites that are usually closed, such as pits, wastewater tanks, electricity distribution switchboards, and control boards, thesealing condition of areas where ceilings or walls are penetrated, such as ventilation duct apertures and electric light frames, and the sealing condition of gaps formed in machinery and facilities, as well as structural defaults (broken caulking, cracks, incomplete seals on wastewater outlets, etc.)The term of “software aspects” refers to cleaning methods, management methods for closed areas; methods for bringing in materials from outside, etc.In order to understand year-round insect demographics, Insect Fauna monitoring should initially be conducted several times a year, taking seasonal changes into consideration. Afterwards, they should be conducted continually as many times as is necessary.The establishment of and suitability assessment of monitoring programs (sampling points, control criteria) should be conducted based on the results of Insect Fauna monitoring. Generally the period of study is 1 week (7 days) or 1 month.4.3.2Periodic MonitoringPeriodic monitoring is monitoring planned and implemented for the purpose of continuous monitoring of insect demographics based on a one-year time frame, with specified methods, sampling points, frequency, etc. Sampling points should be determined taking into consideration, e.g.: • points with high-catches in the Insect Fauna monitoring • places where problems have occurred in the past•places where the risk of entry of foreign substances is highOther objectives of periodic monitoring include promptly identifying issues such as mold formation and gaps instructures in cases where specified environmental indicator species have been captured, and verifying the presence of species that have not appeared in past results.In order to maintain data consistency, sampling points should not be changed without due consideration.This Document is licensed toMr. Zhengxian Ke, Damon KeShijiazhuang, Hebei ID number: 323997Downloaded on: 2/16/11 11:28 PMPest Control Handbook© Copyright ISPE 20104.3.3Ad-Hoc MonitoringIn cases where a hygiene-controlled area faces a temporary zone break due to construction or an incoming oroutgoing piece of equipment, the need for ad-hoc monitoring should be determined with consideration of the scale ofthe zone break and pest control risks.In cases where a need is identified to conduct ad-hoc monitoring, its planning phase should take into account theecology and behavioral patterns of species that enter from outside following the zone break and species able to hide behind floors, walls, and ceilings. Sampling points for ad-hoc monitoring should be determined independently from periodic monitoring, and ad-hoc monitoring should be conducted for the duration of the zone break, or for one week (7 days) after the zone break.4.3.4Follow-Up StudiesIn cases where periodic monitoring identifies a deviation from the Control Criteria, or a deviation from a trend, the breeding source or entry path should be identified after gaining an understanding of the ecology and behavioral patterns of the target insects.One method of follow-up study is to increase the number of sampling points close to the location where the deviation was observed, and continue the monitoring for one week. Other methods include monitoring by tape, zoning studies, search for mold growing, fiberscope observations, etc. These studies can be used collectively to meet the objectives.Follow-up studies should help to strengthen the monitoring system and simultaneously narrow down the problem locations and conduct measures to counter the habitation, breeding, and entry of insects.4.4Methods of Periodic Insect MonitoringThis section discuses some simple methods of periodic insect monitoring.4.4.1 Traps Used in Insect Monitoring4.4.1.1 Adhesive TrapsA non-attractive adhesive trap set on the floor that mainly captures crawling insects. Because it is non-attractive, it easily shows crawling insect demographics. These traps are made of paper or plastic. Plastic traps are expensive but have the advantage of being tough, unlikely to generate foreign substances, and are available in sterilized form.Sampling points (locations where traps are set) should be determined after considering the characteristics of thepharmaceutical manufacturing site, hygiene levels at the sampling points, structures and items in production, etc. The number of sampling points should be sufficient to allow monitoring of habitat, breeding, and entry. All sampling points should be included in the Procedural Guidelines.4.4.1.2 Light TrapsLight traps use an insect attracting light to attract mostly positive-photo tactic flying insects. They are captured by an adhesive sheet inside the trap.Because they are attractive traps, consideration should be given before placing them in a room with high hygiene levels. In addition, it may be difficult to understand insect demographics or make a precise evaluation based on Control Criteria.Mr. Zhengxian Ke, Damon KeShijiazhuang, Hebei ID number: 323997Downloaded on: 2/16/11 11:28 PM© Copyright ISPE 2010Sampling points should be set up in locations where the risk of entry by flying insects is high, and other locations where it is deemed necessary (rooms containing the wastewater outlet, etc.). All sampling points should be included in the Procedural Guidelines.4.4.2Frequency of Periodic MonitoringIn order to gain an understanding of year-round insect demographics, monitoring should be planned in advance and conducted at least twice a year in the peak insect activity periods of May-to-June, and September-to-October, or alternatively a sufficient number of times so that insect demographics can be monitored.The period of study (duration in which traps are in place) is generally one week (7 days) or one month, but it is considered best to check the catch as necessary.4.4.3 Procedures for Periodic Monitoring4.4.3.1 Monitoring Crawling Insects Using Adhesive Traps 1. MaterialsAdhesive traps, oil-based markers, plastic bags 2. Method for setting trapsa. Write on each trap the Sampling Point No., date set, and planned collection date. (Where this has not beendone, write on the trap with an oil-based marker.) b. Open up the trap, remove the seal from the adhesive section, and assemble the top covering. c. Set a trap in each sampling point.d. Once all traps have been set, confirm that a trap is set for each sampling point. 3. Considerations for setting traps, and while traps are in place.a. If traps are to be set near walls, place them so that they make contact with the wall.b. In cases where rooms containing traps are to be cleaned, temporarily move the traps to locations wherethey will not become wet, and after the water has dried, return them to their original positions.c. If an adhesive trap becomes crushed or wet while it is in place, replace it after marking the original andreplacement traps with the date of replacement using an oil-based marker. The number of insects captured should be the sum of the pre- and post-replacement traps. 4. Collection Methoda. On the collection date, collect all traps in plastic bags.b. Once all traps have been collected, confirm that no trap is left uncollected.4.4.3.2 Monitoring Flying Insects Using Light Traps 1. MaterialsLight trap (with insect attracting light), adhesive sheets, plastic bagsThis Document is licensed toMr. Zhengxian Ke, Damon KeShijiazhuang, Hebei ID number: 323997Downloaded on: 2/16/11 11:28 PMPest Control Handbook© Copyright ISPE 20102. Method for setting trapsa.Set up a light trap in each sampling point and install an adhesive sheet. If a permanently-installed light trapis being used, check that the interior is clean and replace the adhesive sheet.b. Turn on the light (it should remain turned on all day throughout the study period).c. Once all traps have been set (including adhesive sheets), confirm that a trap is set for each sampling point.3. Considerations for setting traps, and while traps are in placea. In order to avoid attracting flying insects from outside, set up traps inside doors or shutters, in a positionwhere the light cannot be seen from outside. b. Insect attracting lights should be replaced periodically to maintain their efficacy.c. Do not set traps in locations where there is a risk of insects being drawn into products, etc. 4. Collection Methoda. Turn off the light.b. Protecting the adhesive side of the adhesive sheet, remove it from the main body and place it in a plasticbag, etc. c. Once all adhesive sheets have been collected, confirm that no trap is left uncollected.d. If a permanently-installed light trap was used, confirm that it is clean on the inside, apply a new adhesivesheet, and turn the light back on.4.5Methods for Managing Insect Monitoring Results (Evaluation and Analysis/Policies on Indicators)The information collected from monitoring covers the number and species of insects captured.The insect count information can be used as an indicator of demographics within each controlled area, and the information on species can be used as an indicator for estimation of the cause of the outbreak or for countermeasures (see Citations and References 4).When evaluating and managing monitoring results it is important to specify Control Criteria against which theinsect count information can be evaluated. Control Criteria are not fixed, but rather they change in response to the management level of the pharmaceutical manufacturing site, and should be used as indicators for the purpose of raising the future monitoring levels and management levels.4.5.1Control Criteria for Adhesive TrapsControl Criteria should be set for each controlled area and each key environmental indicator species. Monitoring results should be evaluated against these benchmarks. Policies concerning monitoring levels include:。
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诺兰特移动通信配件（北京）有限公司害虫防治管理制度
Nolato Mobile Communication Polymers (Beijing) Co Ltd pest control management.
1、目的：为使诺兰特移动通信配件（北京）有限公司医疗用品生产环境保持洁净，避免因为害虫孳生，造成产品携带细菌，引起产品品质问题。
1. Purpose: Protect manufacturing environment for medical product, control pest breed.
2、范围：诺兰特移动通信配件（北京）有限公司医疗产品生产车间以及原料、半成品和成品储存地点。
2. Scope: Nolato Mobile Communication Polymers (Beijing) Co Ltd medical production room and store area of raw materials, raw products and finished products.
3、名词定义：
害虫：指代一切携带细菌和病毒的昆虫和小生物。
如：老鼠、苍蝇、蚊子、蚂蚁等等。
3. Definition:
Pest: All hexapod, animal and rodent. Such as mouse, fly, mosquito and ants.
4、相关单位职责：
4. Responsibility:
4.1EHS工程师
制定诺兰特移动通信配件（北京）有限公司的害虫防治管理制度
4.1 EHS engineer
Establish pest control management for Nolato (BJ).
4.2保洁主管
负责组织实施害虫防治与灭杀计划的具体实行，如投药、清理死亡害虫等。
4.2 Cleaner
Implement pest control procedure, such as clean death pest.
4.3医疗产品生产部门
生产场所的监查。
当发现有害虫出现的情况时，及时与保洁部门联络采取措施。
4.3 Medical production dept.
Inspect work place. When find pest in workplace, contact cleaner to take action of pest control.
5、主题内容：
5. Subject
5.1害虫防治手段的选择原则：
5.1 Principal of Pest Control
5.1.1当同样的手段都能达到要求的情况下，以物理防治方式、低毒灭杀方式优先。
其
优先权如下所示：
5.1.1 When all methods can meet requirement of pest control, the priority as below:
物理方式〉低毒药品〉高毒药品
Physics > Low poison > High poison
A. 物理方法包括：紫外线灯、蚊虫引诱器、捕鼠器、蟑螂粘纸等
5.2灭虫器具的管理
5.2 Pest killing apparatus management
5.2.1所有灭虫器具的摆放点都必须有明显的标识，避免其他人员误触或移动。
5.2.1 All place where have pest killing apparatus should have obvious mark.
5.2.2建立并执行灭虫器具管理制度。
5.2.2 Establish and implement pest control procedure.
A. 制定完整的害虫防治实施方案，并附有灭虫器具布点图。
所有使用的灭虫药剂必
须有表单备查并有完备的物质安全数据表（MSDS）。
A. Establish pest control plan, and prepare map to sign where all the killing apparatus are
placed in the building. All insecticides and pesticides should be register on the list and have the MSDS.
B. 害虫防治应贯穿医疗产品生产的整个过程。
其控制场所至少应包括：原物料的储
存、产品的生产、成品的和半成品的储存等。
B. Pest control procedure shall protect raw materials, intermediates, production equipment
and the final product against pests and microbiological contamination.
C. 灭虫器具的投放点必须考虑对生产的影响，避免与产品产生交叉污染。
C. The place where put the killing apparatus must be deliberated, avoid products pollution.
D. 建立定期点检表。
定期对灭虫器具进行检查。
保证发现死亡害虫及时清理；损坏
和缺少的器具及时维修和补充。
D. Establish routine checklist and check killing apparatus. Make sure clean death pest,
repair and maintain killing apparatus in time.
E. 当使用灭虫药品时，操作人员必须配戴适当的防护器具。
E. When need use pesticide to control pest, operator must wear suitable PPEs.
5.2.3 记录保存。
所有点检记录保存6年备查。
5.2.3 Record. All record must be stored at lease 6 year.。