Steve Gonzales, CEO of Technical Safety Services12.02.22
Sterilization is one of the most important factors in medical device manufacturing. Contamination in the medical industry can be extremely harmful and sometimes fatal for patients relying on these devices.
Learn more about bioburden and the importance of bioburden testing for medical device manufacturing below.
Bioburden testing is an especially useful metric because it measures the actual levels of contaminants in a sample at the time of final sterilization. Other contaminants may be present at other times throughout the manufacturing and sampling process but may be neutralized through manufacturing processes, prior sterilization processes or the passage of time.
It is important to carry out a thorough test validation process to ensure the accuracy and reliability of the test. This entails an examination of the testing medium to ensure that it will allow microbes to grow and that it will not kill or destroy any potential contaminants (presenting a false negative or artificially low result).
Although bioburden testing is typically associated with the final sterilization process — and is most useful at that stage of production — it can be carried out at any point in the medical research or manufacturing cycle.
Safety and thorough adherence to standards are critical components of the medical manufacturing and testing field. With this knowledge, you are prepared to apply bioburden testing effectively.
Steve Gonzales is CEO of Technical Safety Services, which provides testing, certification and calibration of equipment and controlled environment crucial to the success of the biopharma, medical device, academic research and food production industries.
Learn more about bioburden and the importance of bioburden testing for medical device manufacturing below.
Understanding Bioburden
Bioburden is a measure of the contaminants and toxins present in a sample immediately prior to the final sterilization process. A sample presented for bioburden testing may be a device, component, solution, substrate or other material present in the pharmaceutical manufacturing process.Bioburden testing is an especially useful metric because it measures the actual levels of contaminants in a sample at the time of final sterilization. Other contaminants may be present at other times throughout the manufacturing and sampling process but may be neutralized through manufacturing processes, prior sterilization processes or the passage of time.
Why Is Bioburden Testing Important?
Bioburden testing is important for several reasons. These include:- The bioburden test serves as an accurate measure of the level and type of sterilization needed. As discussed above, different contaminant levels may be present at different times in the processing and production process. Bioburden is the most reliable measure of the contaminants that must be accounted for just prior to final sterilization before a product or component is delivered to the end user.
- Bioburden testing helps ensure that the correct sterilization procedures are followed. By determining the types and levels of contaminants present, this testing process is a primary indicator of the sterilization process needed. This is of critical importance in the medical industry because the presence of contaminants or toxins can pose severe short- and long-term health risks to end users who often include sick patients.
How Is Bioburden Testing Carried Out?
Bioburden testing is centered around a sample, which is extracted from the material that needs to be examined for contaminant levels. This may be a swab from a medical device or a portion of a solution. Using this sample, the tester can determine an overall rate of microbe presence and can then determine the proper sterilization process to be used.It is important to carry out a thorough test validation process to ensure the accuracy and reliability of the test. This entails an examination of the testing medium to ensure that it will allow microbes to grow and that it will not kill or destroy any potential contaminants (presenting a false negative or artificially low result).
Although bioburden testing is typically associated with the final sterilization process — and is most useful at that stage of production — it can be carried out at any point in the medical research or manufacturing cycle.
What Does Bioburden Testing Detect?
Bioburden testing is most frequently used to detect the presence of the below types of microorganisms and contaminants:- Aerobic bacteria
- Anaerobic bacteria
- Mold
- Spores
- Fungi
How Are Bioburden Testing Results Applied?
Once a properly validated, accurate bioburden test has been carried out, the results can be used in several ways. These include:- Ensuring that previous sterilization and production processes have been carried out accurately. In pharmaceutical production, processes must be followed carefully, and levels of contaminants are typically benchmarked based on previous processes and expected results. If bioburden testing results indicate a statistically significant difference from what is expected, it may indicate prior issues in the production and sterilization process.
- Determination of proper sterilization process and intensity. With an accurate bioburden test result in hand, lab personnel can be confident that they are conducting the proper final sterilization process — at the necessary level of intensity or time duration. While standards are stringent for minimum sterilization levels, a bioburden reading can help to reduce the margin of error and ensure that medical products are suitable for safe use even if higher levels of bioburden are present.
Safety and thorough adherence to standards are critical components of the medical manufacturing and testing field. With this knowledge, you are prepared to apply bioburden testing effectively.
Steve Gonzales is CEO of Technical Safety Services, which provides testing, certification and calibration of equipment and controlled environment crucial to the success of the biopharma, medical device, academic research and food production industries.