Clean room shut down and re-validation or re-qualification?

[Ben124]

Hi all,

we are considering to invest in to clean room, due to the potential new business. ISO 8 would be enough, for our types of products (injection molding plastic parts).
- So the question is, can clean room be shutted down for month or two (several time per year), If we would not have enough orders to to keep clean room working 24/7? I guess, to have clean room on, only to keep clean room conditions is not cost effectively.
-As well, do we need to do re-validation before every strat up of clean room the same way as validation was done upon initial start up of clean room, including IQ, OQ, PQ? Or only qualificaiton of parameters is enough (Particulate Counts, Pressure Differential, Air Velocity, Temperature, Humidity, Leak Test?

Thank you in advance.

 

[indubioush]

It depends on which CER requirements will be affected by the shutdown. Different clean rooms are constructed differently. You shouldn't have to redo IQ if the equipment will remain as is. Review requirements, create a shut down and start up procedure based on the affected items. If you operate according to plan, and then later find out certain things are not affected, you update your procedure to do less. Ensure your CER is operating as required prior to manufacturing product.
Are you sure it is cheaper to shut it down and start it up vs keeping the HEPA filters going and forgoing monitoring for a while?

 

[Ben124]

Thank you for your answer indubioush. Not sure if is cheaper, that is what I want to find out . I've heard that energy consumption of HVAC system could very high. Would like to compare cons and pros.

 

[indubioush]

I think the big factor will be if you will be doing the cleaning and monitoring yourself or if you will have supplier perform these for you.

 

[Ben124]

So, I guess, it would be much easier for us, if we would have our own monitoring and cleaning, in case of several shut downs per year, than pay third party to do it for us?

 

[indubioush]

It is cheaper to do it yourself. However, there will be startup costs for equipment, and you will have to ensure you have a person who is appropriately trained, especially with microbiology practices.

 

[AgnieszkaSz]

From my experience - if you decide to perform the required monitoring, it would be good if you do recovery test at qualification stage. This will tell you how long your HVAC system must work till particle count drops to required level. Then you set up safety margin for HVAC operating to full extent, then add time from recovery test and then operator must take particle count measurements; if they are OK, work can commence. We operate this way - but our cleanrooms are down for no longer than 7 days in a row. No problems so far (6 years in operation).