Quality by Design and Single-Use Air Sampling Approaches FAQ
This FAQ paper is a follow up to the webinar, “Quality by Design and Single-Use Air Sampling Approaches”. Many thoughtful questions were asked about the future of viable air monitoring. Questions submitted during and after the webinar are answered in the paper.
Topics in this paper include:
- cRABs and Isolators
- Continuous Monitoring
- Slit Impaction Technology
- Settle Plate Usage
- HEPA Filtration
- Sample Flow Rates and Volume
- Specialized Monitoring Applications
- Compressed Gas Sampling
- Air Sampler Usage and Care
- CFU and Single Use
- Regulation and Guidelines
- Validation
Some questions covered in this paper are
- In a Grade B area, is continuous monitoring for viable microbial active air sampling required?
- If more colonies are present (such as in a Class D cleanroom environment), how is a finalized air sampling result achieved when colonies overlap each other as incubation time increases?
- Is settle plate monitoring recommended during aseptic processing of sterile products where the filling process lasts more than 15 hours?
- Why are flowrates of 25 LPM used rather than lower rates?
- What are the results of studies evaluating the impact of laminar flow in the room on the new method recovery rates? If there are higher air exchange rates in the room is there a decrease in viable recovery efficiency?
- Where and how should an air sampling unit be stored?
- In a single use impaction head, are there media containing a neutralizing agent that allows impact-free use of disinfection agents such as hydrogen peroxide after exposure (i.e. fogging)?
- ….and more!
