5.2.4 The material used in the construction of equipment should be compatible with products and the cleaning and sanitizing agents.设备自身的材料不能和产品，清洗消毒试剂起反应
5.3 Installation 安装
5.3.1 The design and the installation of equipment should ease its drainage in order to facilitate cleaning and sanitization.
设备的设计和安装要方便排水从而易于清洗消毒。
5.3.2 Equipment should be placed so that movement of materials, mobile equipment and personnel do not pose a risk to quality
设备应放在不影响原料的转移，设备和人员移动的地方从而不会对产品质量产生风险。
5.3.3 Reasonable access under, inside and around equipment should be provided for maintenance and cleaning.
在设备的下面，里面和周围要有合理的空间以方便清洗消毒。
5.3.4 Major equipment should be readily identifiable.
主要设备能容易的被识别出来。
5.4 Calibration 校准
5.4.1 Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly.
与生产、产品质量控制重要的实验和生产的测量设备，应被定期校准
5.4.2 If results of calibration are out-of-acceptance criteria, measuring instruments should be appropriately identified and removed from service
.如果校准结果超出标准，那么这个测量设备要被标识，并不能使用。
5.4.3 An out-of calibration condition should be investigated to determine if there is any impact to the quality of the product and appropriate steps taken based on this investigation.
需要分析超出校准的原因，以确定是否对产品质量造成影响，并且需要采取消除其影响的相应的措施。
5.5 Cleaning and sanitization 清洗消毒
5.5.1 All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme.
所有设备需适合清洗消毒
5.5.2 Cleaning and sanitizing agents should be specified and effective.
清洗消毒试剂要有说明并且是有效的
5.5.3 Where equipment is assigned to continuous production or production of successive batches of the same product, equipment should be cleaned and, if necessary, sanitized at appropriate intervals.
如果设备被安排持续生产或同种产品的连续生产，应对其进行清洁，必要时在适宜的间隔进行消毒。
5.6 Maintenance 维护保养
5.6.1 Equipment should be regularly maintained.
设备应定期保养
5.6.2 Maintenance operations should not affect the quality of the product.
保养项目不能影响产品质量
5.6.3 Defective equipment should be identified accordingly, excluded from use and isolated if possible
故障的设备应被标识并且不能再使用，如果可能进行隔离。
5.7 Consumables 设备耗材
Consumables used for equipment should not affect the quality of the product.
用于设备的耗材不能影响产品质量
5.8 Authorizations 使用授权
Equipment or automated systems used in production and control should be accessed and used by authorized personnel. 设
备或用在生产和控制的自动化系统应通过授权的人员访问和使用
5.9 Back-up systems 系统备份
Adequate alternative arrangements should be available for systems which need to be operated in the event of a failure or breakdown.当操作系统失败和故障时，适当的替代安排应可获得。