Environmental monitoring and the part it plays in sterility testing
By Andy Whittard
Continuous environmental monitoring (EM) gives constant insight into microbial levels throughout your facility. Contamination can happen from any one of multiple potential sources. If a sterility test shows a positive contamination result, your environmental monitoring data can help you narrow down the cause very quickly – but only if your EM processes are sound.
Your EM program and sterility testing ensures safety throughout production
Your EM program must focus on collecting data consistently and accurately if it is going to help you mitigate risks effectively. If contamination occurs, the data gleaned from the environmental monitoring program becomes critical in the subsequent investigation.
Your EM program must consist of a variety of different monitoring techniques and ideally be an ongoing, continuous exercise. Using a program such as this can significantly reduce the length of an investigation because you will be able to pinpoint precise areas with the highest risk and conduct your procedural tests in a very targeted way.
Your EM program should consist of monitoring techniques such as active air sampling, settle or exposure plates, surface contact plates or swabs, operator finger dabs. The EM data for both viable and non-viable monitoring results can prove invaluable in identifying the root cause of a contamination and reducing disruption to your production.
How your EM program can help prevent any future sterility test failures
A continuous EM program will give you far better insights into the hygiene of your facility, thereby informing future precautionary measures. The best defence, as they say, is offence. Taking a proactive stance towards maintaining the sterility of your entire facility is your best weapon against a future sterility test failure.
It is important that your EM program is monitoring and gathering data from both the test room facility and the testing environment, such as a uni-directional airflow isolator. Even if your sterility testing has so far proved negative, there are no guarantees that all future tests will go the same way.
A well designed EM program will reveal any shift in the trend of your microbial levels, allowing you to predict increased risks and inform your teams accordingly of areas where greater attention to sterility protocol is required.
The idea is to prevent any future sterility test failure before it can happen, to take away as much risk of contamination as possible. Your EM program can reveal a potential contamination problem before it can impact a sterility test. It can also make your facility even safer, by detecting early issues that a one-off sterility test might not necessarily detect.
Make sure your EM program covers all pharmaceutical manufacturing process areas
Your EM program must cover all areas and processes within your facility if the data it collects is to be most useful.
You need to make sure that if you do suffer a sterility test failure, you have data to prove that the rest of your facility is sterile and met all necessary safety standards at the time of the test failure.
Effective environmental monitoring is not solely about collecting air samples. You need to prove that your program includes the monitoring of filling areas, operator effectiveness and the behaviour of your team.
Make sure the assessment of your process and facility includes daily disinfection, deep decontamination procedures, staff training and equipment calibration records. Being able to provide these in the event of an investigation can have you up and running again much more quickly than if all areas and protocols need to be checked and tested from scratch.
Key areas for your environmental monitoring program to cover:
The testing environment
This environment could be a uni-directional airflow unit, such as an isolator within a classified cleanroom and it must be considered for monitoring and testing. The cleaning and maintenance records, physical test data and the sanitisation cycle must be included in this procedure.
To examine, monitor and test your manufacturing process, you need to remain vigilant of incoming raw materials, the consistency of your processes and the intermediate process bioburden. You must ascertain if the microbial trend shows an increase or decrease through this process. Also consider pre-sterilisation bioburden, endotoxin results and the filling room and fill lines, as well as operational procedures.
Sterility testing officer
Examine the performance history of the sterility testing officer. This will help you better understand whether there may be a possibility of a contamination occurring due to a lack of training or a lack of understanding of the particular product. You must know whether they have the necessary training to proficiently undertake the processes required by your specific facility, manufacturing process and product.
For a more in-depth look at sterility testing and how you can best avoid the risk of any test failures, download our free eBook.
NEW! Revised Environmental Monitoring Process and Validation Guide
How are you going to meet the challenge of the new EU GMP Annex 1?
Our revised and updated guide helps highlight decisions and actions to ensure you remain compliant.