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1、4 建筑及其建筑物布局4.1 一般要求建筑物的设计、建造和保持应与将要加工操作的特性、与这些操作有关的食品安全危害和来自厂区环境的潜在污 染源相适宜。Establishments shall be designed, constructed and maintained in a manner fit for the nature and purpose of the food packaging manufacturing operations to be carried out, the food safety hazards associated with those operation
2、s and the potential sources of contamination.建筑物应是对包装无危害的持久建筑。Buildings shall be of durable construction that presents no food safety hazard to the food packaging.注:例如屋顶需可自行排雨并无渗漏。NOTE For example, roofs should be self-draining and not leak.定期评审针对食品包装防护污染物的有效性。The effectiveness of measures taken to
3、protect against contamination of the food packaging shall be periodically reviewed.4.2 环境应考虑当地环境可能带来的潜在污染。Consideration shall be given to potential sources of contamination from the local environment.注:当地环境应包括对内部和外部区域的考虑。NOTE “Local environment” includes both internal andexternal areas.4.3 工厂选址应清晰识别
4、场地的边界。The boundaries of establishments shall be clearly identified.场地应保持良好状况以防止对包装的污染。All areas within the boundaries of establishments shall be kept in a condition that will protect against contamination.5 工作场所布局5.1 总要求内部布局应设计、建造和维护以有助于良好卫生和制造操作。Internal layouts shall be designed, constructed and m
5、aintained to facilitate good hygiene and manufacturing practices.原料、包装和人员的流动,以及设备的布局应在布局设计上确保避免交叉污染以及不可预料的混合材料或产品。 The movement patterns of materials, products and people and the layout of equipment shall be designed to protect against contamination sources and unintended mixing of materials or prod
6、ucts.定期评审针对食品包装防护污染物的有效性。The effectiveness of measures taken to protect against contamination of the food packaging shall be periodically reviewed.5.2 内部设计、布局和交通建筑物应提供充足的空间,并确保原料、中间产品、成品包装和人员通过生产过程的逻辑流程图。Buildings shall provide sufficient space to allow a logical flow of materials, products and peop
7、le through the production process.用于原料、中间产品和成品包装传递的通道设计时应尽量降低外来异物和虫害的进入。Openings intended for transfer of materials and products (e.g. transport hoses, conveyors) shall be designed to prevent entry of foreign matter and pests.5.3 内部结构和配置墙和地面应便于清洗或清洁,以应对和包装有关的食品安全危害。墙和地面应耐清洁。Walls and floors shall be
8、 washable or cleanable, as appropriate for the food safety hazards associated with the food packaging production.在食品安全可能会被影响的区域避免积水。Standing water shall be prevented in areas where food safety may be impacted.排水设施应装防虫设施,并覆盖。Drains shall be trapped and covered.天花板和头顶装置的设计应尽量减小灰尘和冷凝物的积累并易于检查和清洁。Ceilin
9、gs and overhead fixtures shall be designed to prevent build-up of dirt and condensation and shall be accessible for inspection and cleaning.对于悬空装置以及不可行或不实用的构造的常规清洗区域,其设备应覆盖。In areas where routine cleaning of overhead fixtures and structures is not feasible or practical, equipment shall be covered.在生
10、产和储存区域如有对外开的门、窗、顶部通风或风扇,应处于关闭状态或应装纱窗(如:防虫纱窗,风幕)。 External opening doors, windows, roof vents and fans in production and storage areas shall be closed or screened (e.g. insect screens, air curtains).注:对外开放口应尽量避免。如不可避免,保持关闭是最好的选择。NOTE External openings should be avoided wherever possible. Where this i
11、s not possible, keeping these openings closed is the preferred option.5.4 设备设备的设计和摆放应有助于良好卫生操作和监视。Equipment shall be designed and located to facilitate good hygiene and manufacturing practices and monitoring.设备的放置应便于操作、清洁和维护。Equipment shall be located to permit access for operation, cleaning and mai
12、ntenance.5.5 临时/移动设施临时结构的设计、放置和建造应避免虫害滋生和潜在包装污染。Temporary structures shall be designed, located and constructed to prevent pest harbourage and contamination.5.6 储存用于储存原料、中间产品、化学品和最终食品包装的设施应防灰尘、冷凝物、排水设施、废物和其他污染物的污 染。Facilities used to store raw materials, intermediate materials, chemicals or finished
13、 food packaging shall provide protection from dust, condensation, drains, waste and other sources of contamination.室内储存区域应干燥并通风良好。有规定时,应有温度和湿度的监控。Internal storage areas shall be dry and well ventilated. Monitoring and control of temperature and humidity shall be applied where necessary.储存区域设计或安排应使原料
14、、半成品和成品包装隔离。Storage areas shall be designed or arranged to allow segregation of raw materials, intermediate materials, chemicals and finished food packaging.如原材料,中间材料,化学物品或食物成品包装储存在室外,应制定适当措施管理污染危害。If raw materials, intermediate materials, chemicals or finished food packaging are stored outside, mea
15、sures shall be in place to manage contamination hazards.适于食品接触的原料、中间产品、化学品和最终成品包装应与其他的非食品接触物品隔离。Raw materials, intermediate materials, chemicals and finished food packaging that are suitable for food contact shall be segregated from hose that are not.所有包装、中间产品和原料在储存时应离地,且与墙间应有足够具体以确保检查和虫害控制活动的实施。All
16、 raw materials, intermediate materials, chemicals and finished food packaging shall be stored off the floor and with sufficient distance from the walls to allow inspection.储存区域的设计应便于维护和清洁,防止污染和降低腐烂。Storage areas shall be designed to allow maintenance and cleaning and to prevent contamination and det
17、erioration. 化学品和其他有害物质应该适于使用,适当的标识,安全储存在封闭的容器内,根据供应商的说明书使用。 Chemicals and other hazardous substances shall be suitably labelled, secured in closed containers and used in accordance with manufacturers instructions.6 公共设施-空气、水和能源6.1 总要求加工和储存区域周边设施及其通路设施的设计应尽量降低包装污染的风险。The provision and distribution ro
18、utes for utilities to and around production and storage areas shall be designed to prevent contamination.定期评审针对食品包装防护潜在污染物的有效性。The effectiveness of measures taken to protect against potential contamination of the food packaging shall be periodically reviewed.6.2 水供给饮用水的供给应充分满足生产加工的需要。用于接触包装的水(包括冰或蒸汽
19、),应满足包装特定质量和和包装 有关的食品安全要求。The supply of potable water or water suitably treated to prevent contamination shall be sufficient to meet the needs of the food packaging production process.用于清洁或与包装接触风险的水应满足包装特定质量和和包装有关的食品安全要求。The food packaging manufacturing organization shall establish requirements for
20、water (including ice or steam) used for direct food packaging contact or cleaning and shall monitor accordingly.非饮用水应有单独的供应系统并加以标识,不与饮用水连接;同时,防止回流到饮用水系统。Non-potable water shall have a separate supply system, labelled, not connected to the potable water system and prevented from refluxing into the po
21、table water system.6.3 空气质量和通风食品包装制造组织应制定与包装直接接触的空气的要求并相应的加以监控。The food packaging manufacturing organization shall establish requirements for air used for direct food packaging contact and shall monitor accordingly.应提供适宜和充分的通风(自然或机械)以去除多余或不需要的蒸汽、灰尘和气味。Suitable and sufficient ventilation (natural or
22、mechanical) shall be provided to remove excess or unwanted steam, dust and odours.对适用的包装类型,车间供给空气的质量应加以控制以降低气源性微生物污染的风险。Room air supply quality shall be controlled to prevent airborne microbiological contamination.注:当没有恰当的控制时,诸如纸板类包装能够潜在支持微生物的繁殖。NOTE Food packaging such as paper and board could pote
23、ntially support microbiological growth if appropriate controls are not in place.通风系统设计和建造时,应确保空气不是从污染区域流向清洁区。通风系统应便于清洁、滤网的更换和维护。 Ventilation systems shall be designed and constructed such that air does not flow from contaminated areas to clean areas.应定期检查外部空气进入口的物理完整性。Ventilation systems shall be ac
24、cessible for cleaning, filter changing and maintenance.6.4 压缩空气和其他气体压缩空气、和其他使用在制造中的气体系统安装和维护应防止污染。Compressed air and other gas systems used in food packaging manufacturing shall be constructed and maintained so as to prevent contamination.气体直接或意外与包装接触(包括运输、吹气或干燥物料、中间材料、食物成品包装或设备),应有适当的标准 以避免包装材料的污染。
25、The food packaging manufacturing organization shall establish requirements for gases used for direct food packaging contact (including those used for transporting, blowing or drying raw materials, intermediate materials, finished food packaging or equipment) and shall monitor accordingly.当对包装有潜在污染风险
26、时,用于压缩机的油应是食品级。Oil used for compressors shall be food grade wherever there is a potential for contamination.应对过滤、相对湿度和微生物的要求进行评估,控制和监控措施应根据评估而制定。Requirements for filtration, humidity and microbiology shall be assessed. Control and monitoring measures shall be applied as determined by the assessment.
27、注:空气过滤应尽量靠近使用地点。NOTE Filtration of the air should be as close to the point of use as is practicable6.5 照明照明(自然或人工)应使人员便于卫生操作。The lighting provided (natural or artificial) shall allow correct operation of the food packaging production process.注:照明强度需与操作特性相适宜。NOTE The intensity of the lighting should
28、be appropriate to the nature of the operation.当有食品安全风险时,照明装置应防护以确保原料、中间产品、包装货设备在照明破碎时无污染。Where there is a food safety hazard (e.g. manufacture of containers such as jars, cans, bottles or trays), light fixtures shall be protected to prevent contamination of raw materials, intermediate materials, che
29、micals, finished food packaging and equipment in the case of breakages.7 废弃物管理7.1 总要求应建立系统以确保废弃物得到识别、收集、清除和处理,并在此过程中不污染包装、生产或储存区域。Systems shall be in place to identify, collect, remove and dispose of waste in a manner that prevents contamination.定期评审针对食品包装防护污染物的有效性。The effectiveness of measures take
30、n to protect against contamination of the food packaging shall be periodically reviewed.7.2 废弃物容器废弃物和有害物质容器应 Containers for waste shall be:a) 容易识别其用途;a) clearly identified for their intended purpose;b) 位于规定的地方;b) located in a designated area;c) 用易于清洗和消毒的不渗透材料制成;c) constructed of impervious material
31、that can be readily cleaned;d)不使用时,应封闭,若有危害应上锁 d) closed when not in immediate use, and locked if hazardous.7.3 废弃物管理和清理应对废弃物隔离、储存和清理制定规定。Provision shall be made for the segregation, storage and removal of waste.废弃物不应在生产或储存区域堆积。Waste shall not be allowed to accumulate in production or storage areas.
32、食品包料制定作废时,应使其变形或损毁以确保商标不能重复使用。Food packaging designated as waste shall be disfigured or destroyed so that trademarks or food ingredient information cannot be reused. Removal and destruction shall be carried out by pproved disposal contractors.销毁和清理应由批准的处理分包方实施。组织应保留处理的记录。The food packaging manufactu
33、ring organization shall retain records of destruction.7.4 排水排水的设计、建造和选址应避免污染。Drains shall be designed, located and constructed to prevent contamination.8 设备适宜性、清洁和维护8.1 总要求设备应设计防止污染。Equipment shall be designed to prevent contamination.定期评审针对食品包装防护污染物的有效性。The effectiveness of measures taken to protec
34、t against contamination of the food packaging shall be periodically reviewed.8.2 卫生设计所有的接触最终包装的设备零部件应设计和安装便于情节和维护。设备应能满足所规定的卫生设计原则,包括: All parts of equipment coming into contact with food packaging shall be designed and constructed to facilitate cleaning and maintenance. Equipment shall meet establi
35、shed principles of hygienic design, including:a) 光滑、易接近、易清洁表面;a) smooth, accessible, cleanable food packaging contact surfaces;b) 自动排水(针对湿加工)b) self-draining (for wet processes);c) 使用的材料要与预期包装、润滑剂和清洁或冲洗剂相匹配;c) use of construction materials compatible with the intended food packaging, lubricants and
36、cleaning or flushing agents.管线和管路应易清洁、可排水并无死角,且不应有冷凝水或泄漏影响包装污染。Piping and ductwork shall be cleanable and drainable and shall not cause condensation or leakage that could contaminate food packaging.阀门连接和控制应自动防故障以防治污染。Valve connections and controls shall have fail-safes to prevent contamination.当可能对包
37、装的食品安全造成影响时,含有毒性金属的设备零部件不允许使用。Equipment components containing metals of known toxicity (e.g. mercury) shall not be allowed where they could compromise the food safety of the food packaging.8.3 食品包装接触表面包装接触面的建造应考虑使用适用的预期原料以避免污染。Food packaging contact surfaces shall be constructed from materials suita
38、ble for the intended use, to prevent contamination.8.4 检测和监控在线检测设施应加以控制,尽可能减少包装污染的风险。Inline and online test facilities shall be controlled to prevent food packaging contamination.用于放射过程的设备应满足相关包装的规范。Equipment used for irradiation processes shall meet the provisions given in relevant food packaging s
39、pecifications.应监视并记录生产过程中用于控制食品安全的设备的有效性。The effectiveness of equipment used for control of food safety criteria in the production process shall be monitored and documented8.5 预防和纠正措施应有预防性维护方案。A preventive maintenance programme shall be in place.预防性维护方案应包括用于监视和(或)控制食品安全危害的所有仪器。The preventive mainten
40、ance programme shall include all equipment used to monitor and control food safety hazards.注:如上仪器包括筛网和过滤器(包括空气过滤器)、磁铁、金属探测器和 X 光探测器。NOTE Examples of such equipment include screens and filters (including air filters), magnets, metal detectors and X-ray detectors.纠正性维护的实施应确保临近生产线的生产或设备没有污染的风险。Correcti
41、ve maintenance shall be carried out in such a way as to prevent contamination of raw materials, intermediate materials or finished food packaging on adjacent equipment.影响包装食品安全的维护要求应优先考虑。Maintenance requests that impact the food safety of the food packaging shall be given priority.临时性安装不应对包装的食品安全带来风
42、险。永久性维修所导致的更换要求应包括在维护计划中。Temporary fixes shall not compromise the food safety of the food packaging. A request for replacement by a permanent repair shall be included in the maintenance schedule.维护后设备返回生产的放行程序应包括:清扫和使用前检查。The procedure for releasing maintained equipment back into production shall in
43、clude clean-up and pre-use inspection.9 采购材料和服务的管理9.1 总要求影响食品安全的材料和服务采购应加以控制以确保所使用的供应商有能力满足特定的要求。进货材料和服务满足 特定采购要求的程度应予以验证。Purchasing of materials, services and subcontracted activities that may impact food safety of food packaging shall be controlled such that the suppliers used have the capability
44、to meet the specified requirements.注:服务包括(但不限于)第三方存储和分包方返工 NOTE Services may include (but are not limited to) third-party storage and rework by subcontractors.定期评审针对食品包装防护污染物的有效性。The effectiveness of measures taken to protect against contamination of the food packaging shall be periodically reviewed
45、.9.2 供应商的选择和管理选择、批准和监视供应商应有规定的过程。包括:There shall be a defined process for the selection, approval and monitoring of suppliers, including:a) 评价供应商满足质量和食品安全要求的能力;a) assessment of the suppliers ability to meet food safety requirements;b) 描述如何进行供应商评审。所使用的方法应通过危害评估加以证明,包括对最终包装潜在的风险。评估应由有 能力的人员进行;b) descri
46、ption of how suppliers are assessed. The method used shall be justified by hazard assessment, including the potential food safety hazard to the food packaging;c) 安全检查员进行评估 c) assessment by competent persons;注:描述如何进行供应商评估的例子包括:NOTE Examples of a description of how suppliers are assessed include:a) 在接
47、收用于生产的原料前审核供应现场;a) audit of the supplying site prior to accepting materials for production;b) 适宜的第三方认证。b) appropriate third-party certification.c) 监视供应商满足持续批准状态的绩效。C) monitoring the performance of the supplier to verify continued approval status.注:监视可包括符合原料或产品规范,满足分析证书要求,满足审核结果。NOTE Monitoring may i
48、nclude conformance to specifications, meeting CoA requirements and satisfactory audit outcomes.9.3 进货原料适用时,在装前、运输和卸货中应检查负载交货车辆以验证原料的质量和安全在运输过程中的保持 情况(如, 密封完整性)。Loads on delivery vehicles shall be checked prior to, and during, unloading to verify that food safety and safety of raw materials has been
49、maintained during transit (e.g. seals are intact).当使用防拆封的封条时,应有验证过程以确定满足相关的客户或法规要求。Where tamper-evident seals are used, a verification process shall be in place to verify conformance to relevant customer or regulatory requirements.应在接收或使用前检验、测试原料,或通过出厂检验证书验证满足特定要求的程度。验证的方法应 形成文件。 Raw materials shall be inspected, tested or covered by CoA/CoC to verify conformance to specified requirements prior to acceptance or use. The method of verification shall be documented.当进货原料来自于可循环来源时,接收前应采取措施验证满足食品安全和可追溯性
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