Our previous blog discussed monitoring for certification. Today we address monitoring for qualification. Learn more about the difference by downloading our paper Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom.
The qualification phase considers the risks to the quality of the finished product. Each activity must be considered and measured. With the example of the filling line, let us consider the accumulator table at the exit of the sterilizer tunnel. The risk is that glassware (vials/bottles) are exposed to the open environment and operator. Therefore, contamination can fall into clean vials/bottles prior to filling. Operator intervention and the shifting of glassware cause turbulent air movement on the table, impacting contamination risk to the exposed vials/bottles. Therefore, it is an area of contamination risk, and the following actions should be taken:
- Divide the area of risk into a 3 x 3 or a 4 x 4 grid. If the activity can occur at several levels, then each level (that is, working height, +150 mm from work height and +300 mm from work height) must be considered.
- Take a particle sample at the center of each of the grid squares and on each level.
- Samples are taken during ‘At Rest’ and ‘Operational’ states. It may be required to work around an activity or operator to gain suitable data. Slight movement of sample points within the grid square is acceptable. A location is invalid if found to impede normal activities.
- When all samples are taken this will provide a particle map of the pharmaceutical activity.
Each of the key functions within the cleanroom (filling point, stoppering, general background activities, etc) should be analyzed accordingly.
Tomorrow’s blog will discuss monitoring or the ongoing sampling of the cleanroom on a frequency relative to the degree of control required to prove management over risk to the finished product. Learn more now by downloading Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom.