How to perform Real World Evidence Air Monitoring

1. Establish Containment Targets

Target Containment Level ("TCL")

Level of containment provided by containment equipment/system:

  • Based on OEL
  • Driven by in-house, toxicology, Quality Agreement or engineering specifications

2. Determine the Means to Simulate the Operation

  • In-use process train” incorporating all critical steps in the process
  • Multiple operators is preferred
  • Perform multiple runs
  • Containment must be performed in a test facility with low relative background contamination relative to the desired levels of detection <10% of target containment level
  • All room, materials, and equipment must be cleaned prior to testing
  • Environmental conditions:
    • Temperature range: 20 ºC +/- 5 ºC
    • Relative Humidity ("RH"): 50 % +/- 10 %
    • Positive room pressure: + 10 Pa (minimum) relative to the adjacent space
    • Air change rate: 3-5/hour

Only necessary, authorized personnel are permitted in the test facility.

Gowning and PPE must be used to minimize contamination.

Personnel must be trained

3. Selection of Surrogate Material

  • Physical properties (flow characteristics, particle size, dustiness)
  • Safety – Health and physical hazard * Quality Issues (API vs. non-API)
  • Cost
  • Ease of procurement
  • LOD (The smallest amount of a material that the laboratory can detect using an analytical method)
  • Flowability (bulk powder movement), Compactability and adhesion (tableting), Solubility (emulsion vs. solution)

4. Selection of Sampling Methods

Air Sampling

The type of filter needed to collect air samples for a given contaminant is dictated by the laboratory’s sampling and analytical method:

  • Polytetrafluoroethylene (PTFE)
  • Glass Fiber Filter (GFF)
  • Quartz Fiber Filter (QFF)
  • Polyvinyl Chloride (PVC)
  • Mixed Cellulose Ester (MCE)

Minimum Air Volume (MAV)

>> MAV Formula equation <<


You can check Tox by Design methodology for Air Monitoring on your manufacturing line, signed by an European Registered Toxicologist expert here.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Tox by Design is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using this email link to receive a quotation for Air Monitoring on your manufacturing line.