Testing for Microbiological Impurities in Excipients

There are many safety issues that can be associated with microbiological contamination of pharmaceutical products and their components. The presence of microbiological impurities in some common excipients such as starch and lactose powder include Geobacillus spp., Aspergillus spp. and Staphylococcus aureus. Microbial impurities in pharmaceutical excipients used in the manufacture of drug and over-the-counter products may significantly affect the outcome of individual processing steps and the microbial characteristics of the final drug product. Therefore, pharmaceutical manufacturer should develop microbiological specifications for their products in order to ensure patient safety throughout the manufacturing process. Strict measurements for microbial contamination control are widely used for many pharmaceutical formulations, and microbial impurities testing of excipients is an important part of impurity detection and quality control associated with pharmaceutical excipients. BOC Sciences' pharmaceutical microbiology laboratory provides testing services for microbial impurities in excipients by performing complete sterility testing, detection, isolation and identification of microorganisms (bacteria, yeasts and molds). The purpose of our microbiological impurity testing services is to ensure that your final drug product is safe from microbial contamination.

Sources of Microbiological Impurities

• If an excipient is manufactured using viral agents or there is a risk of contamination with viral agents, microbial impurities may present in the excipient.
• The water used in the manufacturing process may also be a potential source of microbial contamination in the finished excipient.
• Airborne microorganisms may also contaminate the excipient. For example, The excipients exposed to air during the packaging process may also receive microbial contamination and produce impurities.

Figure 1. Sources of Microbial Contamination. (Suvarna, K.; et al. 2011）

Microbiological Testing Services

BOC Sciences is a leader in microbiological impurity testing services for quality control, providing a full range of services to the bio/pharmaceutical industry. We offer microbial impurity identification, measurement and characterization services for different excipients:

• Microbial limits testing
• Microbial contaminant identification
• Mycoplasma testing
• Bacterial endotoxin detection
• Microbial characterization studies
• Non-viable particle testing
• Specialized microbial impurity analysis method development and validation

BOC Sciences’ Advantages

• Our team of microbiologists can help determine your needs and expectations to meet regulatory requirements
• We offer routine QC testing for microbial impurities and extensive services of method development and validation under USP. The validation program includes execution of analytical work and subsequent data processing. All data are displayed in a detailed study report
• By using Quality by Design (QbD) strategy, BOC Sciences helps you design and control of microbial impurities throughout the manufacturing process, from raw materials to finished products throughout the product lifecycle
• Our scientific testing methods are supported by our technical knowledge and expertise in microbiology
• With extensive experience in the method validation, our team of microbiologists can ensure the quality and integrity of all test results
• Thanks to our experts' thorough knowledge of qualified methods for drug microbiology testing, our current Good Laboratory Practices (GLP) compliance program helps make the testing process more cost-effective
• BOC Sciences’ facilities meet the stringent cleanliness and engineering requirements of microbiological testing programs for a wide range of microbial impurity assessments