Controlling is necessary

In the pharmaceutical industry, utilities are used for several applications, including drug production. An example is WFI, which is added to medication. Or PW, for cleaning cleanrooms. Pure steam is used to sterilise equipment, vials, etc. 

This also means that patients are might be exposed to utilities. Sampling and controlling these utilities are necessary to minimalize and avoid the presence of contaminants. 

Cleanroom testing on critical parameters

A cleanroom is a very clean and controlled drug production environment. In function of the activities that take place in the room, it has to meet a certain cleanliness level. For this purpose, several tests were developed to test the critical parameters. Some examples:

  • Microbial sampling
  • Temperature measurements
  • Air flow rate measurements
  • Pressure differences between rooms
  • Pressure differences over filters
  • Relative air humidity
  • Filter integrity testing

Utilities en cleanroom sampling – Advipro @ your service

  • Writing of User Requirements Specifications (URS) and Risk Assessments (RA)
  • Set up sampling plans
  • Writing protocols
  • Performing sampling/testing
  • Reporting results and providing advice for optimal testing
MoVE test equipment

Advipro, expert in utilities & cleanroom sampling