can any one help with what does the guidelines say about the distribution of the compressed air to the sterile area where the compressed air will come in contact with the product.
I would like to know which are the guideleines, what are the requirements
What will be the MOC of the storage tank.
What will be the MOC for the distribution lines.
Hello,
As per my knowledge, All the storage tank and the lines coming the contact with process air (compressed air coming in contact with product) should be SS 316 or SS316L.
Though I am not sure the risk of not using the MOC.
Will be excited to know what other people has to say… ?
Hi,
You are true logically if you evaluate it makes sense to have SS316/SS316L.
As it will not add the particles to the compressed air by itself. Secondly point is economic and load on the filters, it will increase the load on filters too which leads to changing of filters more frequent due to additional particle generation from the storage tank.
Compressed Air or Compressed gasses as per product specification will be classified high risk components as they come into contact with the product.
There are guidelines for each and individual gas which comes in contact with product in sterile area. Common guideline is low water vapour, No oil particles and free from Viable bacteria. To make these free from bacteria and sterile , these gasses must be passed through a validated filter (pvdf or PTFE) before it comes in to product contact.
The pipes must withstand pressures up to 65-75 psig in the distribution set up.
These pipes must have materials of SS304 or SS316L confirming standards of ASTM-270.
The pipes must be joined by Orbital welding , interiors should be electropolished.The tubes walls should have thickness of 0.28 -0.65inches depending up on applications.
If you are using these gasses for high purity applications in laboratories copper pipes can be used confirming to ASTM B-88 standards.
Tanks can be made from SS304 or SS316L.