Can anyone help with information on Nitrogen testing, within a pharma manufacturing facility, testing for oil/water/particulate & bioburden? Info required includes testing procedures, suitable testing equipment & any reference to appropriate ISO’s. Many thanks.
In a previous life, many years ago, I used to occasionally test the piped gas supplies (nitrogen and CO2) in manufacturing areas. The company manufactured non sterile oral products, so the bioburden requirements were not very strict.
I can only answer for bioburden testing, but the method I used was to pass the gas through 0.22 um membrane filters, which were held in autoclavable filter holders, for a set time. The time was calculated on measured flow rate to pass a sensible fraction of a cubic metre of gas (but balanced against too long an exposure time which would desiccate any bugs on the filter) . The filters were cultured by placing onto the surface of appropriate nutrient agar plates (TSA for the Total Viable Count and Sabauraud agar for the Total Fungal Count) and incubating at appropriate temperatures. I am sorry that I can’t remember the test limits off the top of my head, but they would have been comparable to the test limits used for air testing of manufacturing areas. I used a method set up by the parent company.
Equipment needed: suitable membrane filters, autoclavable membrane filter holders, autoclavable tubing and fittings to connect the filter holder to the gas takeoff point, flow meter to measure gas flow rate through the filter (I connected the flow meter to the outlet side of the filter holder). Oh … and a microbiology laboratory!
I would suggest that you contact filter companies such as Sartorius or Millipore, as they can advise you on the equipment you will need and appropriate methods to use.
You will also have to consider how you will validate the test method…