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 <<