Pharmaceutical Microbiology Testing

As a special commodity, drugs should not only ensure the effectiveness of their treatment, but also ensure the safety of their use. On the one hand, the safety of drug use refers to whether its chemical composition and content are safe, on the other hand, it refers to whether the drug is contaminated by microorganisms. There are many kinds of microorganisms and complex nutritional components, which may decompose the effective components of drugs after contamination, resulting in the reduction or loss of curative effect. At the same time, toxic metabolites of microorganisms and some pathogenic microorganisms can also cause adverse reactions or secondary infection to patients, and even endanger the lives of patients. Drug-induced diseases caused by microbial contamination of drugs have been reported from time to time. The detection of microbial limit is one of the important measures to ensure its quality and drug safety. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency, etc. We can perform microbiology testing according to USP <60>, <61> and <62>. Welcome to contact our experts for consultation.

Why conduct microbiological testing

• Determine whether the drug is contaminated or its degree of contamination, and control the quality of the drug
• Ensure the effectiveness and safety of medication
• Can be used as one of the basis for measuring the sanitation level of the whole process of drug production

Sources of microbial contamination

All aspects of drug production may cause microbial contamination, including but not limited to:

• Raw materials
• Excipients
• Water
• Air
• Workshop equipment.
• Packaging material
• Operator

Our testing services include but are not limited to

• Microbial limits testing
• Sterility testing, USP <71>
• Endotoxin analysis, USP <85>
• Preservative efficacy testing
• Environmental monitoring
• Disinfectant testing
• Water testing
• Total bacterial counts
• Total fungal counts
• Method development and validation

Instruments and data

Note: this service is for Research Use Only and Not intended for clinical use.

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