Bioburden is a term used to describe the microbial numbers, or germs, present on a surface that has not been sterilized. Bioburden can be found on all surfaces, but medical instruments, pharmaceuticals, and other instruments are controlled and rely on bioburden testing in order to save lives. The bioburden test is used to Indicate problems in the production process which can lead to inadequate sterilization. Bioburden testing is done on many pharmaceutical and health care products for quality management. In actuality, many medical products, as well as new drug products, require this testing in order to measure the complete quantity of micro-organisms before the item is used or ingested. Bioburden testing is used in situations such as:
- Validation of sterilization process
- Routine monitoring for control of manufacturing processes
- Tracking of raw materials, components, and packaging
- Assessment of the efficacy of cleaning procedures
- An overall environmental monitoring program
Once bioburden testing is Complete and has been validated, the right method of removal will be carried out. Removal methods include techniques with and without elution, as well as incubation and enumeration, and are ascertained through the validation procedure.
- Ultrasonication
- Shaking
- Vortex mixing
- Flushing
- Blending
- Removal techniques by Non-elution include:
- Contact putting
- Agar overlay
- Most probable number MPN
- Incubation and enumeration Techniques include:
- Total aerobic count
- Spore-forming colony count
- Total yeast and mold count
The bioburden testing helps provide A precise basis for calculating effective sterilization and give the number of viable microorganisms on a medical device, or raw material. Bioburden is an important part of quality control and in deciding the bioburden of a certain device. Validation needed A number of the aforementioned methods are easier to Validate for regular use than others. The Endosome-PTSTM, by way of instance, uses the very same reagents as the compendial techniques. There are a few aspects e.g., the archived standard curve that require validation work, but much less than when using a compendial system like ATP detection. Moreover, if the methods are utilized for in-process management or trouble shooting, validation work can be decreased. In Conclusion, each method must be seriously evaluated by the user to view If it matches his needs and what degree of validation work is involved. These methods are extremely attractive and can help reduce workload but the investment has to be calculated beforehand.