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11.1.2 equipment Grouping
Grouping of equipment is an efective method for encompassing equipment from a limited popula-tion of systems undergoing cleaning validation without redundant testing. The grouping strategy is based on designating equipment as “identical” or “similar,” based on design and cleanability. Once equipment has been placed within a designation, the designation defnes the cleaning validation requirements. If it involves identical equipment, a protocol with a minimum of three validation runs involving any
combination of three equipment items in the group is performed. Provided an adequaterationale is given for determining the equipment items are identical, there is no need to perform validation runs on every item in the group. For similar equipment, the representative equipment is the worst case or may involve bracketing of equipment. For example, for storage tanks of the same size but of diferent complexity, such as the number of bafes, the more complex equipment is chosen as the worst case. For similar equipment of diferent sizes, the largest and smallest (representing the extremes) may be chosen for the formal validation runs (unless one size can be determined as the worst case). Confirmatoryvalidation runs (perhaps only one run) are an option for other equipment (not a worst case) within the group.
11.1.2设备分组
要想让有个有限的群体系统包含设备而避免冗长的检测最终完成清洁验证，设备分组是一个高效的手段。分组策略是基于指定设备“相同”或”相似，“基于“设计”和“洁净力”。一旦设备定义为一个组系那么也就意味着清洁验证方面的要求也是一样。如果它涉及相同的设备，至少三个验证运行的方案应当含涉及的任何组合三个设备被执行。提供了一个确定设备项目是相同的充分的理由，则不需要执行验证条目中的每个运行。对于类似的设备，代表设备是最坏的情况下或也可能涉及设备托架。例如：对于储罐的大小相同，但是却有不同的复杂程度，比如过滤器的数量，更复杂的设备选为最坏的对象。对大小不同的类似设备，最大的和最小的（代表极端）可被选为正式验证运行（除非一个大小可以确定为最坏的情况下）。组内的验证运行(可能只有一个运行)对其他设备而言是一个选择(不是一个坏的情况下)。
11.1.3 Introduction ofa New Product or New equipment Into a Group
The introduction of a new product into an already validated group is then assessed using the same evaluation process to initially determine the worst-case product. It is recommended that when each new product is tested, a suitable control, such as the previous worst-case product, is included. Relative product cleanability is then used to determine validation requirements for that product on equipment used for other products in that group. The relative cleanability of the product in relation to the preceding worst-case product will dictate the validation requirements. Based on a risk assessment, introduction of an easier-to-clean product may just require laboratory and/or scale-up studies to confrm ease of cleaning or may require a confirmatory validation protocol. Introduction of a more difcult-to-clean product will require validation of that new worst-case product.
Based on risk considerations, introduction of new identical equipmentmay just involve determination that it is equivalent or may require an additional confrmatory validation protocol. Introduction of new similar equipment requires an evaluation if that new equipment represents a new worst case or a new extreme. If not anew worst case or new extreme, a confrmatory validation protocol using only a visually clean criterion can be used. If the new equipment is a new worst case or extreme, the validation requirements for the previous worst case or extreme should be repeatedfor the new worst case or extreme equipment.
11.1.3新产品或新设备引入一组
新产品的引入到一个已经验证的组内，然后使用相同的评估程序评估最初确定最坏的产品。建议每个新产品测试时，进行一个合适的控制，比如包括以前的最坏情形下的产品。相关产品的清洁性用于确定验证要求，产品组的设备用于其他产品。最坏情况下产品的相对清洁性决定产品的验证要求。风险评估的基础上，引入一种较易清洁产品可能只需要实验室和/或扩大研究去确认易于清洗或可能需要的验证方案。引入一个较难清洗的产品将会要求验证一个新的最坏情形下的产品。
基于风险的考虑，引入一个新的相同单元的设备可能涉及一个相同的假设或可能新增一个必要的验证程序。引入一个新的类似的设备如果新设备代表着一个最差条件或一个新的极端情况，则要求进行评估；如果不是，则验证中只需用一个显而易见的清洁确认。如若新设备是一个新的最坏情形或极端情况，则这个新的最坏情形或极端情况将取代先前的来完成验证要求。
11.1.4 Conclusion
The use of product and equipment grouping may be usedto streamline cleaning validation programs whileensuring sufcient data to support the validation of procedures, processes and equipment associated with cleaning. The grouping program for a given facility or company should be in a well-defined validation program/validation master plan.
11.1.4 结论
产品和设备的分组化的运用将使有数据可以支持验证程序的清洁验证项目变得简单化，过程与设备通过清洁关联起来。对于一个现有厂房或企业应当很好的在验证项目或验证主计划中完成分组项目的定义。
文章来源：允咨生物GMP学苑
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