Environmental Monitoring in contamination control strategy
How to use the results of Environmental Monitoring for a good definition and compliance with the Contamination Control Strategy (CCS). We would now like to give you a brief summary of what you should take into account.
Sources of contamination
We start by reviewing some of the possible origins of contamination sources:
- Problems in the design of facilities, equipment or services
- Insufficient or ineffective monitoring and control
- Insufficient calibration, maintenance or qualification plans.
- Insufficient tools for controlling starting materials (sampling, specifications, management).
- Inadequate personnel management (ineffective personnel qualification systems, insufficient personnel monitoring, insufficient continuous training, etc.).
- Poor process design (material and personnel flows, insufficient monitoring tools, non-representative aseptic process simulation…).
- Insufficient cleaning and disinfection systems (insufficient cleaning validation, frequency, rotation of disinfectants, etc.).
- Inefficient sterilisation processes (inadequate sterilisation systems, insufficient sterilisation validation, loss of control of the outsourced process, contamination of materials after sterilisation, etc.).
- Insufficient management of quality events (recurrence of deviations, poor root cause analysis, inadequate OOS or OOT management, poor or insufficient trend assessment, insufficient management of corrective actions…).
At this point we remind you of the importance of having a good Environmental Monitoring strategy, as it will be the key to detect possible changes in trends in time. All of this will save time and provide valuable information to make good decisions that will improve the day-to-day work of technicians.
How to implement the Environmental Monitoring strategy?
After looking at the sources of contamination, we will now review the steps necessary to carry out an Environmental Monitoring strategy:
- Define adequately the sampling points. We will conduct a risk analysis to define the type, sampling frequency, location and coding
- Define sampling plans. That is, routine control plans, batch-related plans, at-rest control plans, control plans after cleaning and/or disinfection, aseptic filling plans and, finally, define sampling patterns for incidents during manufacture.
- Set alert and action limits. These limits should allow to react to changes in results trends.
Fixing will be done according to the type of sampling and room classification. These limits should be reviewable according to the review frequency we set in the strategy.
EU Annex 1, 2020 revision
9.8 Appropriate alert levels and action limits should be set for the results of viable and non-viable particle monitoring. Alert levels should be established based on results of cleanroom qualification tests or trend data and should be subject to periodic review.
The CCS document, as a living document, should reference the internal procedures available detailing how microbiological contamination investigations are to be carried out. A form for activities must be available for each investigation according to the associated risk of contamination versus the quality of the finished product. Investigations need to follow a systematic and comprehensive approach.
In addition, we must have an agile system for transferring information on changes in trends of micro-organisms, breaches of alert levels or changes in results.
Managing the results can be a time-consuming and research-intensive process, interpretations can differ between departments and good communication becomes paramount.
Therefore, we must have an automatic alarm system for example, in case of consecutive rising or falling values, presence of yeasts, presence of spore-forming organisms or presence of specific micro-organisms. And an automatic system of notifications to specific users can make a big difference.
As we can see in this graph by way of example, having this alarm system activated would have allowed us to react just at the moment in which the presence of molds was detected and we would have saved subsequent detections by taking action as soon as we receive alerts on trend change.
If you want to know more about how to use the results of environmental monitoring for a good definition and compliance with the contamination control strategy, we will be happy to assist you; you can also ask us about our proposal and the full presentation of the workshop we held in Madrid and Barcelona last March.