SECCO Scaffold Safe Working Practices English
减小食品加工设备的化学危害
减小食品加工设备的化学危害作者：暂无来源：《食品安全导刊》 2012年第4期NSF美国国家卫生基金会食品供应链的风险管理已成为食品和饮料公司首要挑战。
许多全球领先的零售和餐饮企业已要求他们的供应商通过独立的第三方检查或通过全球食品安全倡议（GFSI）的认证，以保证这些供应商遵守国际食品安全标准。
当GFSI用来评估供应商企业是否满足食品行业的安全要求时，它也促进了整个零售行业环境的信息交流。
以GFSI为基准的食品安全标准包括安全质量食品（SQF），英国零售业联盟（BRC），GlobalGAP，食品安全体系认证（FSSC）和国际食品标准（IFS）等等。
随着国际食品安全标准的出现，食品行业也出现了一些新标准，协助企减小食品加工设备的化学危害□ NSF美国国家卫生基金会业对风险进行识别，分析和管理。
如ISO22000标准（食品安全管理系统）对食品产业链上的机构设立了相应的要求，以证明它们识别及控制潜在危害的能力。
而HACCP（危害分析和关键控制点）刚是用来保障食品生产过程的清洁卫生，更是受到全球食品制造商、食品安全机构，包括WHO（世界卫生组织）和FAO（联合国粮农组织）及多国政府部门公认的科学的食品安全体系。
像ISO22000，HACCP和其他的标准，其首要目标就是确保食品供应链的食品制造包装与配销流程受到充分的管理与监督，除了食品之外，更需重视食品接触的设备机器以及相关化学品，以全面性保障消费者的食品安全权益。
曾经有这样的案例发生:有家食品包装设备商收到一些客户的投诉，说在存储产品的塑料衬垫上闻到油味。
调研后发现在包装线的设备有一个裂缝，设备润滑油从这里渗出到包装部件上面，导致产品包装上残留油味。
这家设备商没有采取适当的管理措施，来保证润滑油不会带来任何危害，因此他们只能通知他们的客户将全数产品召回，事件调查、产品召回以及后续销售业绩无法再提升，损失就达数万美元。
这个事件说明了维持严格的质量体系的必要性，应针对食品与相关设备全面进行审核，以达到对生产环境及消费者的保护作用。
c反应蛋白免疫层析试剂产品技术要求
英文回答：C—reactive protein （CRP） immunolysis reagent products, as an important tool for clinical diagnosis, must meet national standards and relevant policies. Its technical requirements should be strictly enforced to ensure that products have high sensitivity and specificity and are capable of accurately detecting CRP content in samples. Stability is an important safeguard of product quality and every step in the production process must be strictly controlled to ensure that the product retains good reagent performance over time, independent of environmental factors. The ease of use of the product is also an important technical requirement that needs to be simple to operate while meeting different models of instrument use. We will strictly enforce national policies and regulations to ensure that the quality and usefulness of products meet standard requirements and serve people ' s health priorities.C反应蛋白（CRP）免疫层析试剂产品作为临床诊断的重要工具，必须符合国家标准和相关政策。
制药工艺验证实施手册缩略语
术语/缩略语英文全拼中文AHU Air Handing Unit 空调机组AOAC Association of Official AnalyticalChemists美国公职化学家协会AMV Analytical Method Validation 分析方法验证API Active Pharmaceutical Ingredient 药物活性成分ASME American Society of MechanicalEngineers美国机械工程学会ASME BPE American Society of MechanicalEngineers Bioprocessing Equipment美国机械工程/生物工程设备学会ASTM American Society for Testing andMaterials美国材料与试验协会BD Bowie-Dick 布维-狄克BI Biological indicator 生物指示剂BMS Building Management System 楼宇控制系统CAPA Corrective and Preventative Action 纠正和预防措施CCA Component Criticality Assessment 部件关键性评估CCP Critical Control Point 关键控制点CD Cycle Development 程序开发CEHT Clean equipment hold time 干净设备保留时间CFR Code For Federal Regulations 美国联邦法规CFU Colony Forming Unit 菌落形成单位cGMP Current Good Manufacturing Practice 现行药品生产质量管理规范CHO Chinese Hamster Ovary 中国仓鼠卵巢细胞CIP Clean In Place 在线清洗ChP Chinese Pharmacopeia 中国药典C p/C pk Process Capability Index 工序能力指数CPP Critical Process Parameter 关键工艺参数CQA Critical Quality Attribute 关键质量属性CSV Computer System Validation 计算机系统验证CVP Cleaning Validation Plan 清洁验证计划DCS Distributed Control System 分布式控制系统DDS Detailed Design Specification 详细设计说明DEHT Dirty equipment hold time 脏设备保留时间DNA Deoxyribonucleic acid 脱氧核糖核酸DOE Design of Experiment 实验设计DOP Dioctyl Phthalate（Or Equivalent，I.E.,Dispersed Oil Particulate）邻苯二甲酸二辛脂（或等同品，例如分散油颗粒）DQ Design Qualification 设计确认DS Design Specification 设计说明ED 50 50% Effective Dose 半数有效量EDI Electrodeionization Deionization (USFilter)电级法去离子（美国滤材）EHS Environment Health Safety 环境健康安全ELISA Enzyme-Linked Immuno Sorbent Assay 酶联免疫吸附测定EMA European Medicines Agenc 欧洲药品管理局EMS Environmental Monitoring System 环境监测系统EP European Pharmacopoeia 欧洲药典EPA Environmental Protection Agency 美国环境保护署ERP Enterprise Resource Planning 企业资源计划ETOP Engineering turnover packages 工程交付包EU European Union 欧盟FAT Factory Acceptance Testing 工厂验收测试FDA Food and Drug Administration 美国食品与药品监督管理局FDS Functional Design Specification 功能设计说明FMEA Failure Modes And Effects Analysis 失效模式和影响分析FS Function Specification 功能说明FTA Fault Tree Analysis 故障树分析FQCP Field Quality Control Plan 现场质量控制计划GAMP Good Automated ManufacturingPractice良好自动化生产实践GDP Good Document Practice 良好文件管理规范GEP Good Engineering Practice 良好工程管理规范GLP Good Laboratory Practice 良好实验室管理规范GMP Good Manufacturing Practice 良好药品生产管理规范GxP Good x Practice 药品质量管理规范HACCP Hazard Analysis and Critical ControlPoints危害分析和关键控制点HAZOP Hazard and Operability Analysis 危险与可操作性分析HDS Hardware Design Specification 硬件设计说明HEPA High Efficiency Particulate Air 高效空气过滤器HBV Hepatitis B Virus 乙型肝炎病毒HIV Human Immunodeficiency Virus 人类免疫缺陷病毒HMI Human Machine Interface 人机界面HPLC High Performance Liquid Chromatography高效液相色谱HVAC Heating, Ventilation, And AirConditioning采暖通风和空调系统I/O Input and Output 输入/输出IC 50 The Half maximal inhibitory concentration半抑制浓度ICH International Conference onHarmonization of TechnicalRequirements for Registration ofPharmaceuticals for Human Use人用药品注册技术要求国际协调会IEC International Electro technicalCommission国际电工委员会IQ Installation Qualification 安装确认ISO International Standards Organization 国际标准化组织ISPE The International Society forPharmaceutical Engineering国际制药工程协会IUPAC International Union of Pure and AppliedChemistry国际理论（化学）与应用化学联合会LIMS Laboratory Information ManagementSystem实验室信息管理系统LOD Limits of Detection 检测限度LOQ Limit of Quantizatity 含量限度MB/L Methyleneblue 亚甲蓝光敏法MCB Master Cell Bank 主细胞库MES Manufacturing Execution System 生产执行系统MTDD minimum treatment daily dosage 最低日治疗剂量OOS Out of Specification 检验结果偏差OQ Operational Qualification 运行确认OSD Oral Solid Dosage 口服固体制剂P&ID Piping and Instrumentation Diagrams 管道和仪表图PAO Poly-Alpha-Olefin 聚Α-烯烃PAT Process Analytical Technology 过程分析技术PBS phosphate buffer 磷酸缓冲液PCB Primary Cell Bank 原始细胞库PCR Polymerase Chain Reaction 聚合酶链反应PDA Parenteral Drug Association 美国注射剂协会PDI Pre-delivery Inspection 发货前检查PEP Project Execution Plan 项目执行计划PFD Process Flow Diagrams 工艺流程图PHA Preliminary Hazard Analysis 初步危害分析PIC/S Pharmaceutical Inspiration ConventionAnd Pharmaceutical InspectionCo-Operation Scheme国际药品检查协会组织PLC Programmable Logic Controller 可编程逻辑控制器PM Project Managemnet 项目管理PP Polypropylene 聚丙烯PPE Personal Protective Equipment 人员保护装备PPQ Process Performance Qualification 工艺性能确认PQ Performance Qualification 性能确认PS Pure Steam 纯蒸汽PTFE Polytetrafluoroethylene 聚四氟乙烯PV Process Validation 工艺验证PVC Polyvinyl Chloride 聚氯乙烯PVP Process Validation Plan 工艺验证计划PW Purified Water 纯化水QA Quality Assurance 质量保证QbD Quality by Design 质量源于设计QC Quality Control 质量控制QMS Quality Management System 质量管理体系QPP Quality and Project Plan 质量及项目计划QRM Quality Risk Management 质量风险管理RA Risk Assessment 风险分析RABS Restricted Access Barrier System 限制进出隔离系统RH Relative Humidity 相对湿度RNA Ribonucleic Acid 核糖核酸RO Reverse Osmosis 反渗透RPN Risk Priority Number 风险优先性RSD Relative Standard Deviation 相对标准偏差RTM Requirements Traceability Matrix 需求追溯性矩阵RTP Rapid Transfer Port 快速运转接口SAL Sterility Assurance Level 灭菌保证水平SAT Site Acceptance Testing 现场验收测试SCADA Supervisory Control And DataAcquisition检测控制和数据收集SCR Source Code Review 源代码审核SDA-PAGE Sodium DodecylSulfate-polyacrylamide gel十二烷基硫酸钠-聚丙烯酰胺凝胶SDI Silt Density Index 淤泥指数SDS Software Design Specification 软件设计说明SFDA State Food and Drug Administration 国家食品药品监督管理局SIA System Impact Assessment 系统影响性评估SIP Sterilize In Place 在线灭菌SME Subject Matter Expert 主题专家SMS Software Module Specifications 软件模块说明SMT Software Module Test 软件模块测试SOP Standard Operating Procedure 标准操作规程SV Sindbis Virus 辛德毕斯病毒TM Traceability Matrix 可追溯矩阵TOC Total Organic Carbon 总有机碳TR Technical Report 技术报告UAF Unidirectional Airflow 单向气流UCL Upper confidence limit 置信上限UPS Uninterruptable Power Supply 不间断电源URB User Requirements Brief 用户需求简介URS User Requirements Specification 用户需求说明USP United States Pharmacopoeia 美国药典UV Ultraviolet Light 紫外灯VHP Vaporized Hydrogen Peroxide 汽化过氧化氢灭菌技术VMP Validation Master Plan 验证主计划/验证总计划VP Validation Plan 验证计划VSR Validation Summary Report 验证总结报告VSV Vesicular Stomatitis Virus 水疱性口炎病毒WCB Working Cell Bank 工作细胞库WFI Water for Injection 注射用水WHO World Health Organization 世界卫生组织WIP Wetting In Place 在线加湿。
制药和食品行业过程安全基础epsc
制药和食品行业过程安全基础epsc 下载提示：该文档是本店铺精心编制而成的，希望大家下载后，能够帮助大家解决实际问题。
文档下载后可定制修改，请根据实际需要进行调整和使用，谢谢!本店铺为大家提供各种类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，想了解不同资料格式和写法，敬请关注!Download tips: This document is carefully compiled by this editor. I hope that after you download it, it can help you solve practical problems. The document can be customized and modified after downloading, please adjust and use it according to actual needs, thank you! In addition, this shop provides you with various types of practical materials, such as educational essays, diary appreciation, sentence excerpts, ancient poems, classic articles, topic composition, work summary, word parsing, copy excerpts, other materials and so on, want to know different data formats and writing methods, please pay attention!制药和食品行业过程安全基础 (EPSC)引言制药和食品行业在生产过程中必须严格遵守安全规范，以确保产品质量和消费者健康。
Scaffold Safety
Additionally, key scaffold components such as suspension rope and connecting hardware must be able to support six times the maximum intended load. OSHA has published scaffold design specifications as part of their 1926.450 scaffold safety regulations. The intent of these specifications is to aid in their fabrication. They can also be used to assure that purchased or rented scaffolds meet OSHA requirements. The American National Standards Institute (ANSI) has also published design specifications for aerial lifts and other mobile elevating scaffolds.
Scaffold Safety September 2012
Page 2ຫໍສະໝຸດ E EV VE ER RE ES ST T L LO OS SS S C CO ON NT TR RO OL L A AL LE ER RT T
Inspection: A competent person, an individual that has the skills to identify scaffold safety hazards and has the authority
美国FDA药品质量控制实验室检查指南年
(1)不得进行两次复检和凭据三次化验的平均值对产物进行发放；
(2)不能用。outlinertest做化学查验；
(3)不能用重复取样的步伐假定取样或制备历程误差；
(4)当确认可以复检时(见另外的标准)，可以取同一样品中的差别药片做复检。
C．正式视察
超出厂实验室范畴的正式视察，必须依照一个提纲进行，并要特别注意整改步伐。
不切合规格标准结果可以分成三类：
一——实验室误差；
——一非生产工艺性误差大概称为操纵者误差；
———和生产工艺有关的误差大概称为生产工艺误差；
A．实验室误差
实验室误差产生于下列情况：化验员未能正确地按阐发要领操纵；使用不正确的标准和(或)简单地算错了数据。实验室误差必须通过一项视察来确定，以便判定不切合规格标准的原因。—旦不切合规格标准结果的性质被确定了，就可以把它归入上述三类中的一类。由于视察的目的不一样，查询可能很不相同。
我们希望实验室查验数据能直接记在记录本上，制止使用纸片或活页纸。这些知识性要领可以增强数据的准确性和完整性。
审查和评价实验室用于进行产物不合格视察的标准操纵步伐，对单一和多个不切合规格标准结果的视察应遵循差别的步伐。对单一不切合规格标准结果，视察应包罗下列步调，并且这些视察应当在该样品被复检之前进行：
法庭认为对不切合规格标准结果进行的复检只有在此种情况下才是适合的，即对不合格的视察正在进行且该视察部分地决定厂复检是否符合。当视察发明不切合规格标准结果确由化验员误差所致或对化验员事情的复查是“无结论性的(inconclusive)”情况下，复检是符合的。而对付众所周知，没有争议的与生产历程有关或无关的错误，复检是不符合的。
药物申请的阐发部分通常只包罗化验结果和用来得到这些结果的要领，并不要求卖力人提交所有的化验数据，因为这样做会使提交的资料体积太大，并可导致提供过多不须要的资料。卖力人可能有意无意地选择并陈诉那些能显示药物宁静有效并能得到批准的数据，而不陈诉那些证明该产物不能满足预先制定的规格标准的数据。查抄组必须确定这样做是否存在有效的、科学的解释。
secc复合体名词解释(一)
- SECC 复合体- 概念解释SECC（Surface Enclosure Coating Compound）复合体是一种用于表面处理的特殊涂层材料，主要用于金属制品的防腐蚀和美观处理。
这种涂层由锌、铁和铬等元素构成，能够有效地提高金属制品的耐腐蚀性能，并且具有较好的装饰性。
- 主要应用领域1. 建筑业SECC复合体广泛应用于建筑业中，如钢结构、建筑外墙等金属构件的表面处理，能够有效地延长构件的使用寿命，并且保持其外观的美观性。
例如，建筑中的金属屋顶、墙面和窗框等部件的表面经过SECC复合体处理后，能够在恶劣的环境条件下依然保持良好的外观和功能。
2. 家电行业家电产品中的金属外壳、零部件等通常也需要进行防腐蚀处理，SECC复合体涂层能够满足家电产品的质量和美观要求。
例如，冰箱、洗衣机、空调等家电产品的金属外壳经过SECC复合体处理后，不仅能够抵抗腐蚀，还能够提升产品的整体质感。
3. 汽车制造业SECC复合体涂层也被广泛应用于汽车零部件的表面处理，如车身、车门等金属构件，能够提升汽车的耐腐蚀性和外观质量。
例如，汽车表面的防锈处理、车身板件的涂装等环节都可以采用SECC复合体涂层技术，提高汽车零部件的使用寿命。
- 技术特点SECC复合体涂层的技术特点主要包括以下几个方面：1. 耐腐蚀性能强：SECC复合体涂层能够在潮湿、盐雾等恶劣环境下保持金属制品的表面完好，具有较好的防腐蚀能力。
2. 装饰性好：SECC复合体涂层不仅具有保护功能，还能够使金属制品表面具有亮丽的外观，满足不同领域的装饰要求。
3. 环保性高：SECC复合体涂层材料中不含有害物质，符合环保要求，对人体和环境无害。
4. 施工方便：SECC复合体涂层的施工工艺相对简单，能够适应不同形状和尺寸的金属构件的表面处理需求。
- 发展趋势随着工业技术的不断进步和市场需求的不断增长，SECC复合体涂层技术在未来的发展中将呈现以下几个趋势：1. 高性能化：未来SECC复合体涂层将不断提升耐腐蚀性能、装饰性能和环保性能，以满足更高要求的使用环境和产品需求。
HACCP、GMP、SSOP之间的关系
2011.12.28
1. 什么是HACCP？
HACC P
r
• 英文全称：
Hazard Analysis and Critical Control Point
• 中文全称： 危害分析和关键控制点 HACCP 危害分析和关键控制点，是 用来控制食品安全危害的一种技术， 是一种重要的管理体系。
HACCP的特点
• 通过对整个食品链（原料的种植/饲 养、收获、加工流通和消费者消费 过程）实际存在的或潜在的危害进 行评价，找到CCP点进行控制，并 采取预防和纠正措施在危害发生前 就使其得到有效控制，从而最大限 度地减少对人体有危害的食源性病 患发生的概率
• 建立在GMP、SSOP基础之上的安全 卫生预防体系,有较强的针对性。
2. 什么是S SOP ？
S SOP
• SSOP—
• Sanitation Standard Operation Procedures
卫生标准操作程序
是食品企业为了满足食品安全的要 求，在卫生环境和加工过程等方面 所需要实施的具体程序，是实施 HACCP的前提条件
SSOP内容
1)水和冰的安全性 2)食品接触表面的清洁和卫生 3)防止交叉污染 4)洗手, 手的消毒和卫生间设施的维
点制定
1.GMP与HACCP关系
GMP和HACCP在食品企业卫生管理中所起的作用是 相辅相成的。通过HACCP系统，我们可以找出GMP 要求中的关键项目，通过运行HACCP系统，可以控 制这些关键项目达到标准要求。掌握 HACCP的原理 和方法还可以使监督人员、企业管理人员具备敏锐 的判断力和危害评估能力，有助于GMP的制定和实 施。GMP是食品企业必须达到的生产条件和行为规 范，企业只有在实施GMP规定的基础之上，才可使 HACCP系统有效运行。控制CCP并不是孤立的，单 抓这一点就万事大吉了。一个缺乏基本卫生和生产 条件的企业是无法开展HACCP工作的，试想一个企 业如果连完整的厂房、能正常运行的生产设备、合 适的质量管理人员都没有，还有建立HACCP系统 的 必要和可能吗?所以说，GMP和HACCP对一个想确保 产品卫生质量的企业来讲是缺一不可的。
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Scaffold Training
Example of a Protection Fan
Scaffold Training
Example
Of a Tower Scaffold
Scaffold Training
Example of a
Cantilevered Scaffold
Example of an Independent Tied Scaffold
Recognize scaffolding that meets SECCO as well as internationally standards
Scaffold Training
• Recognize safe and acceptable scaffolding • Be familiar with the approval, inspection and tagging procedure
Scaffold Training
Definitions
Scaffold Inspector:
A person who has been trained to a level of competency and has been designated to inspect scaffolds to identify deficiencies with scaffolds such as; • Missing components
Bay
Scaffold Training
• Responsible scaffold management
Course Objectives continued…
Scaffold Training
• Basic scaffold components and definitions •The scaffold request and approval process • Scaffold inspection and tagging procedure
Scaffold Training
“Ledgers”
Are tubes that tie the standards together
Ledgers
Basic Scaffold Components
Scaffold Training
“Transoms “ Are horizontal tubes that tie standards together at right angles to the ledgers that support the scaffold boards. To be installed at maximum distance of 1.4 metres apart.
Scaffold Training
Terms for „People‟ associated with Scaffolds
• At the completion of this course you will be considered a „competent person‟.
• You will be qualified to identify hazards with scaffolds, associated work areas and activities.
Terms
Scaffold Training
Scaffold Request Form:
A formal document that is submitted to the safety department prior to building any scaffold on the site. Why? To ensure that any requested scaffold has been properly evaluated and recorded in the scaffold register
Responsible Scaffold Management
Scaffold Erector Responsibilities:
• Shall ensure compliance with current site scaffold design, erection and dismantling practices and procedures • To ensure areas below elevated scaffolds are adequately barricaded to safeguard people walking below. •To maintain good housekeeping of scaffolding and formwork materials at all times
Scaffold Training
Box Tie
Scaffold Training
Example of a Wide Base Support Structure (BUTTRESS)
An Example of a Spur Braced Scaffold
Scaffold Training
Terms
Course Objectives
Scaffold Training
During this training course you will learn the following:
• Types of scaffolds to be used
• Internationally accepted terms
• Material Blocking Access & Walkways
• Obstructions Causing Injuries
• Missing Toeboards & Handrails
Types of Scaffolds
Scaffold Training
Types of scaffolds that will be commonly built and used on the SECCO construction site include the following:
Transoms
Basic Scaffold Components
Scaffold Training
• The transoms that support the
work platform must always be placed on top of the ledgers
• If you don‟t put the transom(s) on top of the ledgers,if one clamp(s) fail, this can cause the work platform to fall,and could kill the workers.
SCAFFOLD SAFE WORK PRACTICES
SECCO IPMT Training Department
Caojing Construction Site
Objectives for this Training Course
At the completion of this training course you will be able to:
Course Objectives continued…
Practical Application Exercise:
Following the classroom instruction portion of this training course you will work in small teams and inspect scaffolds on site
Scaffold Training
Responsible Scaffold Management
Professional Engineer Responsibilities:
Scaffold Training
• A registered Professional Engineer is required to design and approve, prior to it‟s erection, any scaffold to be built over fifty (50) meters in height • The professional engineer will determine such things as load requirements, double uprights and/or additional bracing and will provide the SECCO Scaffolding Coordinator with a detailed drawing.
Proper Ladder Placement
1:4
4 Meters
4 Meters in height
=
1
Basic Scaffold Components
Scaffold Training
“Bay “
Is the horizontal distance between standards
Hazards with Scaffolding
• Poor initial design • Inadequate Lift Height
Scaffold Training
• Inadequate bracing
• Overloading • Deteriorated or faulty fittings or materials • Unauthorized alteration • Impact from passing vehicles