At CD Formulation, we are dedicated to providing outstanding sterility testing for nucleic acid drugs. Utilizing cutting-edge technologies and equipment, our services detect even the smallest contaminants in complex samples, ensuring purity is upheld during every phase of drug development.

Why Conduct Sterility Testing for Nucleic Acid Drugs?

Sterility testing for nucleic acid drugs is a crucial step in ensuring safety and quality. Although nucleic acid drugs do not inherently support microbial growth, any potential microbial contamination poses a risk to patient safety. Therefore, we conduct rigorous sterility testing by detecting microbial growth in specific media to ensure product purity and efficacy. Additionally, we combine technology with good manufacturing practices to achieve high-standard environmental control. These stringent measures adhere to international standards, ensuring our nucleic acid drugs are safe and reliable when put to use.

Fig.1 The advantages of sterility testing for nucleic acid drugs. (CD Formulation)

Explore Our Sterility Testing Services for Nucleic Acid Drugs

Direct Inoculation Testing

By directly inoculating samples into an efficient culture medium, potential microorganisms can rapidly grow and be effectively detected. Our professional technical team rigorously supervises the entire testing process to ensure the accuracy and verifiability of each result. If any turbidity arise during testing, we promptly conduct an in-depth analysis to confirm that the occurrence is not linked to inherent sample properties. Our service aims to provide unparalleled sterility verification for your product, ensuring it meets the strictest quality standards at both development and production stages.

Membrane Filtration Testing

Through membrane filtration, we can precisely capture and concentrate microorganisms in samples, allowing them to grow to an observable state on specific media. For samples that may contain inhibitory components, our carefully designed rinsing process effectively removes interfering factors, ensuring that microorganisms retained on the filter can fully grow and be accurately detected. Our service not only enhances the precision of the test but also strengthens the safety and reliability of the product, providing robust sterility assurance for your research and production activities.

Our Solutions for Sterility Testing of Nucleic Acid Drugs

Microbial Inhibition Property Evaluation

We conduct specialized antibacterial and antifungal tests alongside sterility testing to ensure that the sample does not inhibit microbial growth. This B/F testing validates the accuracy of sterility results, ensuring no antimicrobial characteristics influence microbial testing in the sample.

VHP Penetration Testing

Utilizing vaporized hydrogen peroxide (VHP) purification technology, we perform penetration testing in isolated environments. This test effectively evaluates the permeability of VHP to sample containers, ensuring it does not affect the accuracy of analytical results and guaranteeing the reliability of nucleic acid drug testing.

Rapid Sterility Analysis

For nucleic acid products, our rapid sterility testing surpasses traditional culture methods, offering innovative services. Unlike the lengthy pharmacopeial sterility tests, rapid sterility testing can be completed in a shorter time frame, enhancing efficiency and ensuring the microbiological safety of products throughout the production cycle.

Workflow of Sterility Testing of Nucleic Acid Drugs

Fig.2 Flow chart of sterility testing for nucleic acid drugs. (CD Formulation)

• Sample Preparation

Samples are collected and processed within a sterile environment using strictly calibrated instruments to maintain conditions as close as possible to those during production.

• Preliminary Testing

An initial sterility test is conducted on nucleic acid samples to ensure they are free from common microbial contaminants.

• Detailed Analysis

Samples undergo a detailed microbial examination using media and microscopic inspection methods, and all observations are recorded to detect even low concentrations of contaminants.

• Quality Evaluation

Upon confirmation that analysis results are safe and compliant, a detailed quality report is generated, including the testing process, results, and any professional evaluations of anomalies.

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Our Advantages of Sterility Testing of Nucleic Acid Drugs

• Optimized operational processes significantly reduce testing cycles, guaranteeing quick and reliable results, thus facilitating accelerated development progress.
• Through an advanced data management system, we ensure secure storage and efficient analysis of testing data, guaranteeing traceability and integrity of each experimental result.
• Strict quality control is implemented at each stage of the testing process to ensure the accuracy and consistency of each analysis result, providing clients with the maximum level of trust and assurance.
• We employ advanced testing instruments and technologies to ensure the high precision of nucleic acid drug analysis, effectively identifying trace contaminants and safeguarding product safety.

Publication Data

For any inquiries or specific requirements about our nucleic acid drug sterility testing services, please contact us. Our experienced professionals are on standby to offer expert guidance and support, aiding you in reaching your research and development targets.