Im being continually fustrate by my companies lack of interpretation of the ISPE baseline guide.
We have an existing HVAC system that in a couple of months will support a new Blister Line. There are no specific requirements for the HVAC system apart from the norm which are not product critical, 21oC +/-2, 40-60Rh, Air Changes, Class 100,00. Ive been trying to get the powers that be to buy in to my new concept. We do not need to Qualify the system as it is indirect. The requirements indicated in the URS will all be tested during a commissioning document i will write. Filters will be checked after installation for DOP testing and put onto a PM schedule. Magnahelics are above the doors to ensure the correct pressures are being met so continuous monitoring will be performed. Particulate testing will be performed for 5 days as will Temp and Hum. They can't see the woods for the trees and its frustrating.
I actually think we need to get the ISPE baseline guide updated. One of the questions it asks is "does the system preserve product status". Well if its a nitrogen system blanketing a product in a reactor then yes as if the N2 system failed then the product would be affected. But if its a HVAC system that does not effect the product if it failed, then should we be validating it in the first place. I know im right but its a new concept that people are struggling to come to terms with.
Does anyone think that my argument should stand up!?!