公司是否需要验证在清洁前，脏的设备可以放置的最长时间。

Question 7: Is it necessary for companiesto validate a maximum time allowed for a piece of equipment to be dirty beforecleaning?

Advice: Companies should have SOPs inplace, which require cleaning to be performed immediately after production has stopped.This scenario should be validated.

However, if for some reason immediatecleaning is not always possible, companies should consider the effect of timeon the material deposited on the equipment. It may be possible to ‘Group’ or‘Bracket’ products, and validate a worst case scenario.

问题8：公司是否需要验证在清洁前，脏的设备可以放置的最长时间。

建议7：公司应制订SOP，其中说明生产结束后应立即对设备进行清洁，这种情况是需要验证的。但是如果因为某些原因，使得设法总是立即清洁，公司应考虑放置时间对设备中残留物料的影响。可以考虑对于“一组”或“一类”产品，验证其最差情形。

Question 8: Is it necessary for companiesto validate a maximum time allowed for a piece of equipment to be left clean beforere-use?

Advice: Companies should have SOPs in placeto ensure that pieces of equipment are adequately protected from anycontamination after cleaning has taken place i.e. ensure that the equipment isadequately covered, closed from dust etc.

If the company feels that there is any riskof contamination during ‘idle time’ after cleaning, validation should beconsidered.

问题8：公司是否需要验证在清洁后，已清洁的设备再使用前可以放置的最长时间？

建议：公司应制订SOP，保证清洁后的设备受到充分的保护，不受到污染，例如保证设备被遮盖、关闭防止灰尘进入等。

如果公司觉得在清洁后的“闲置时间”内还是被污染的风险，则需要考虑验证。