Biopharmaceutical products can be divided into sterile and non-sterile in microbiological term. Non-sterile therapeutic products must satisfy the appropriate microbiological purity criteria which are included in pharmacopoeial monographs. Microbiological test of nonsterile products is essential and required to ensure that the biological product is therapeutically effective and safe for the patients. [1]
Creative Proteomics offers various pharmaceutical microbiology test services:
- Microbial limits test
- Antimicrobial/Preservative efficacy test (AET/PET)
- Bioburden test
- Endotoxin test
- Water test
Microbial Limits Test
The microbial limit test is used to perform the qualitative and quantitative estimation of viable microorganisms represent in test articles. This method is usually performed for the total viable count of bacteria and fungi. Microbial limits test is suitable for both the pharmaceutical products without sterilization and raw materials used in the production of other products.
Antimicrobial Efficacy Test
Antimicrobial or preservatives are added to biological products to protect them from microorganism contamination during normal use or storage. Antimicrobial efficacy test or preservatives efficacy test is important to demonstrate the agents are effective in the final package to inhibit the growth of microorganisms. In addition, it is necessary to evaluate the safety analysis of agents for human use. Products which have inherent antimicrobial properties must also be analyzed for this test.
Bioburden Test
Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized.[2] Bioburden test is performed to ensure that the biopharmaceutical products comply with the associated standards. The aim of this test is to measure the total number of viable microorganisms of the test articles prior to final sterilization. It is usually performed before manufactured in order to implement the sterilization procedure into the assembly process.
Endotoxin Test
Endotoxins are compounds found in the outer cell membrane of certain gram-negative bacteria with a heat-stable characteristic. The Limulus Amoebocyte Lysate (LAL) assay for endotoxin test was commercially introduced in the 1970s and is used to ensure injectable therapeutics safe for human use. The mechanism of LAL test is that LAL enzymes in blood cells may bind and inactivate bacteria endotoxin.
Water Test
During the manufacturing process of the biological products, water is the essential and required solvent. It's extremely important to ensure that microorganisms are not introduced to the products by water. Water test of microbiological analysis is a method to estimate the numbers of bacteria present in water. This result represents water quality.
Creative Proteomics provides a wide range of analytical services for microbiological test. Scientists from Creative Proteomics are experienced and they can help you with specific requirements.
[1] Microbiological quality of non-sterile pharmaceutical products. Ratajczak M, Saudi Pharm J., 2015, 23(3).
[2] Mosby's Dental Dictionary (2nd edition), Mosby, 2008.
