4.10 Cleaning and sanitization 清洗消毒
4.10.1 Premises used for activities described in these guidelines should be maintained in a clean condition.
规范中描述的厂房应该保持干净状态
4.10.2 Cleaning and, if necessary, sanitization should be carried out to achieve the objective of protecting each product.
清洗,必要时要消毒以达到保护每个产品的目标
4.10.3Cleaning and, if necessary, sanitizing agents to be used should be specified and effective.清洗试剂必要时消毒试剂要有说明并是有效的
4.10.4There should be cleaning and, if necessary, sanitization programmes corresponding to specific needs of each area.
清洗消毒项目要符合各自区域的具体情况
4.11 Maintenance 维护
Premises used in activities described in these guidelines should be maintained in a good state of repair.规范中描述的厂房应保持在一个良好的维护状态
4.12 Consumables 耗材
Consumables used for premises should not affect the quality of the product.用于厂房维护的的耗材不能影响产品质量
4.13 Pest control 虫害控制
4.13.1 Premises should be designed, constructed and maintained so as to restrict access to insects, birds, rodents, pests and other vermin.
厂房设计建造和和维护要能阻止昆虫,鸟儿,啮齿动物,虫害和其他害虫的进入。
4.13.2 There should be a pest control programme appropriate for the premises.
应有适合厂房建筑的虫害控制计划
4.13.3 Measures should be taken to control the exterior of the premises to prevent attracting or harbouring pests.
厂房外部区域要采取措施以避免吸引害虫。
5 Equipment 设备
5.1 Principle 原则
Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If automated systems are introduced into activities described in these guidelines, they should take into account the application of the given relevant principles.
设备应满足预期的目的,便于被清洗,必要时可以消毒和维护。本条例适合本规范里所有的设备,如果自动化系统被引进在这个规范所提到的活动中,那么就要考虑相关条款的适用性。
5.2 Equipment design 设备的设计
5.2.1 Production equipment should be designed to prevent contamination of the product.
选择、设计的生产设备类型需确保不会对产品产生污染。
5.2.2 Bulk product containers should be protected from air contaminants, such as dust and moisture.
散装产品的储存容器应防止空气污染物,如灰尘和水汽。
5.2.3 Transfer hoses and accessories that are not in use should be cleaned and, if necessary sanitized,kept dry and protected from dust, splash or other contamination.