Microbiological Hazards Assessment of Excipients

Microorganisms such as molds, viruses or bacteria are a threat in excipients that should not be underestimated. The process of determining the appropriate microbiological quality and determination of microbiological methods to examine the microbiological quality of excipients are important factors in the production of pharmaceutical products. For many pharmaceutical products, prior appropriate microbiological evaluation is necessary for customers. With new developments in the field of microbiology, there are many innovative techniques and methods for monitoring and eliminating microbiological hazards that allow new possible hazards to be effectively addressed. The usability of any pharmaceutical product must be repeatedly tested before it can be considered safe for sale, and attempts to circumvent these necessary initial testing requirements can lead to swift and severe legal and economic consequences. As a result, more and more pharmaceutical companies are choosing to work with specialized testing organizations to ensure that their final drug product meets regulatory standards.

Failure to assess the microbiological hazards can result in:

• lengthy regulatory delays
• Costly product recalls
• May cause harm to patients

BOC Sciences provides leading-edge excipient microbial hazard assessment services to reduce and control microbial contaminants in excipients by establishing microbial detection and analysis methods. With years of scientific and medical experience, our microbiologists provide the most relevant and appropriate testing methods to ensure that our standard microbiological tests ensure public safety.

Testing Procedure

At BOC Sciences, we provide reliable risk assessment services for microbiological quality of your excipient, which is properly performed by BOC Sciences' qualified technical staffs.

Microbial Limit Testing (MLT)

MLT is critical to the drug product development lifecycle because it provides a good early indication of manufacturing, formulation, and packaging issues before a drug product reaches the market. We offer MLT services to determine if excipients meet established microbiological quality specifications.

• Qualitative testing for microorganisms: Identification of whether a microorganism is a known pathogen or opportunistic pathogen
• Quantitative testing for microorganisms: It is important to know the number of microorganisms present in the excipient, especially when considering the infectious dose and virulence of the organism. Non-pathogenic microorganisms may not pose a health risk, but their presence may affect the stability and efficacy of the product
• Assessment of whether the excipient supports microbial growth: Evaluation of pH, water activity
• Whether the excipient has adequate antimicrobial preservation
• Evaluation of microorganisms in excipients for product interference with active ingredients, test methods, product stability, or container containment systems
• Consideration of the intended recipient of the product and whether the product will be used for neonates, infants, the elderly, or the immunocompromised

Figure 1. Assessment for Product Risk to be added to the severity. (Gilles, N.; et al. 2017）

Testing for Total Bioburden and the Presence of Specified Microorganisms

We perform microbiological testing of excipients using culture media that pass growth promotion tests:

• Identification of microorganisms
• Characteristic morphology of specific microorganisms
• Calculation of the rate of microbial failure

Determination of Microbiological Contamination

Microbial contamination may lead to product spoilage, which may pose a potential health hazard to patients and lead to outbreaks of infection that may cause other complications. In addition, microbial-derived substances (e.g., endotoxins) secreted in the product may be harmful to the health of patients.

• Bacteria and fungi
• Endotoxins
• Mycoplasma