10-20-2017 06:18 AM
Sampling on the dirty side of the line of demarcation does have it's place, but not as part of routine sampling. Since we need to consider taking routine samples in locations that could have an effect on the state of control and ultimately on the CSP, sampling in the dirty side of the LOD doesn't provide us with that data. We should expect some level of growth and a mold colony or two. However, when there are excursions, more investigative sampling needs to be performed since we need to determine the source and eliminate it. This is where sampling on the dirty side of the LOD may be required in order to gather more information as to where the other contamination may have entered. The world of EM reaches far beyond the information provided in 797, which is essentially the tip of the iceberg. The best practice for designing an EM sampling plan is to do a risk assessment of your process. This is a huge undertaking, but will enable the pharmacy to know the best locations for them to take samples to determine their state control and the only true way to demonstrate that state of control is through more frequent sampling.