Microbiological safety is especially important for the pharmaceutical industry. In the pharmaceutical industry, whether it is sterile drugs or non-sterile drug production industries, it involves microbiological testing and quality control of drug products. Creative BioMart Microbe provides customers with a number of microbiological testing services applicable to the pharmaceutical industry, such as sterility testing, endotoxin testing and microbial enumeration testing. Our experienced experts and professional detection systems can provide support to customers.
- Sterility Testing
We have established systems suitable for sterile testing, including world-class sterile isolators, vaporized hydrogen peroxide (VHP) systems, clean rooms that meet the requirements of sterile testing, and membrane filtration systems. We also have a team of technicians with many years of experience in sterility testing, and we have formulated standard operating procedures for sterility testing in accordance with USP <71> to prevent false positive results.
- Microorganism Identification & Typing
The process of drug quality control may involve the identification of microorganisms isolated during environmental monitoring or product testing. We provide microbial identification and typing services for customers in the pharmaceutical industry, and the services are applicable to bacteria, yeasts and molds.
- Mycoplasma Testing
Mycoplasma contamination affects the growth and metabolism of eukaryotic cells, as well as the production of biological products such as vaccines. In the pharmaceutical and vaccine manufacturing industries, strict mycoplasma detection procedures need to be implemented to realize timely detection of mycoplasma contamination. We have formulated standard operating procedures for mycoplasma detection and implemented them strictly.
- Microbial Enumeration Testing
Microbial enumeration test is a test item recommended by the FDA for drugs, cosmetics and personal care products. It can be used to test whether the presence of microorganisms in non-sterile pharmaceutical products is within acceptable limits. We provide customers with microbial enumeration testing services according to standard operating procedures.
- Endotoxin Testing
Endotoxin is released when the cell wall of Gram-negative bacteria is ruptured. Endotoxin belongs to exogenous pyrogen, which will affect drug safety. We provide endotoxin testing services for customers, including gel clot method, kinetic turbidimetric method and kinetic chromogenic method.
- Specified Organisms Testing
We provide specified organisms testing services, including Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella species, Clostridia species, Candida albicans testing, to evaluate whether there are harmful microorganisms that may endanger the health of patients in drugs.
- Minimum Inhibitory Concentration (MIC) Evaluations & Minimum Bactericidal Concentration (MBC) Evaluations
MIC refers to the lowest concentration of antibacterial agents that can inhibit the growth of microorganisms, and MBC refers to the lowest concentration of antibacterial agents that can kill bacteria under certain conditions. We provide MIC evaluation and MBC evaluation services to help customers evaluate antimicrobial drugs.
- Burkholderia Cepacia Complex (BCC) Testing Service
BCC is a complex composed of Gram-negative aerobic bacteria. They are opportunistic pathogens that are resistant to many antibiotics and are prone to infect people with weakened immune functions. BCC can maintain vigor under harsh conditions, and drug production systems, especially water systems, are easily contaminated by these microorganisms. We provide customers in the pharmaceutical industry with BCC testing services performed in accordance with standard operating procedures.
