FAQ - Pharmaceutical/Life Sciences Particle Counting

Lasair II Particle Counter

Question
We have a filling line which includes the following elements; vial in-feed turntable, filling, stopper handling and capping stations. I understand that the clean space is required to be certified and qualified however, from your experience and what you observe in industry, how many and what locations are monitored on a routine basis for the filling line application indicated above. For example, is it industry practice that monitoring continuously takes place at the vial in-feed, filling and stoppering zones?

Answer

There are several areas that constantly come up for review when realizing what processes to monitor.

Steriliser tunnel outfeed

This may also be where glassware is loaded on manual systems. This is of a concern as particulates may fall into exposed glassware prior to filling, so surety over the environment between end of depyrogenation and filling is important. Typically even if a conveyor moves the glass from the carousel to the point of fill it is the carousel where any residence time occurs and is the more important location for monitoring.

Point of fill (POF)

Possibly the most important area as far as audits are concerned, where product is exposed and interventions from personnel may occur. This is the whole 12" from POF that the FDA retain as the guiding measure of monitoring.

Stoppering

The point at which again process and product come together. If the distance between the POF and stoppering is relatively short then a single point located strategically between POF and stoppering will suffice, if the distance is approximately 1 m then a sample point at the stoppering point is required. There is much debate over the monitoring of the stopper bowl while the stoppers are being fed; the same rationale as the sterilizer tunnel is used as contaminated stoppers could impact the finished product, however the particulate cleanliness of stoppers is always a concern and monitoring of a clean shedding process is not required.

These are the key areas, along with a suitable point in the background that would cover the application in the paper and are the minimum that would be expected, although I have seen more they become problematic trying to correlate real issues with false positives. The goal would be to be able to quantify personnel interventions and from that ascertain the risk to finished product.

For more information, see Choosing the Most Suitable Non-viable Sample Point Locations