Bioburden Testing

Bioburden refers to the total number of viable microorganisms present on a surface or within a substance, such as on medical device or in pharmaceutical products. Accordingly, bioburden testing is performed to evaluate the level of microbial contamination on a medical device or pharmaceutical product. This testing is very important as it can accurately measure the level and type of sterilization agent required in the sterilization process of pharmaceutical products and help ensure that the correct sterilization process is followed. Additionally, bioburden testing is required by regulatory bodies because it is an essential step in the overall quality control and assurance process for medical devices and pharmaceutical products. At Alfa Chemistry, we provide professional and comprehensive bioburden testing service to meet the specific needs of our clients. Our experienced team of microbiologists follows strict protocols to accurately determine the bioburden of a product.

Our bioburden testing can detect the below types of microorganisms and contaminants:

Alfa Chemistry's bioburden testing methods include but not limited to:

• Membrane Filtration Method: This method involves filtering a sample of the product through a membrane filter, which traps microorganisms. The filter is then placed on a culture medium to allow the microorganisms to grow, and colonies are counted to determine the bioburden.
• Plate Count Method: This method involves spreading a sample of the product on a nutrient agar plate and incubating it to allow microbial growth. After incubation, colonies are counted to determine the bioburden.
• Most Probable Number (MPN) Method: This method is used for products with low bioburden levels. It involves diluting the sample and inoculating multiple tubes with the diluted sample. The tubes are then incubated, and the presence of microbial growth in the tubes is used to calculate the MPN per unit volume of the sample.

The typically process at Alfa Chemistry involves the following steps:

Sample Collection: A sample is collected from the product or material to be tested using a sterile swab or other sampling method.

Sample Preparation: The sample is prepared for testing by diluting it in a suitable growth medium to encourage the growth of any microorganisms that may be present.

Incubation: The prepared sample is incubated at the appropriate temperature for a specified period of time to allow any microorganisms present to grow.

Enumeration: After incubation, the number of colony-forming units (CFUs) of microorganisms present in the sample is counted using techniques such as spread plate or pour plate methods.

Identification: During this process, microorganisms are identified as needed.

Analysis and Reporting: The results of the bioburden testing are analyzed and reported.

Applicable standards include:

Alfa Chemistry's advantages: