Sterility Testing

Ensuring that pharmaceutical products are free from microbial contamination is essential for maintaining product safety and efficacy. At Apta Labs Pvt Ltd, we offer comprehensive sterility testing services to verify the absence of microorganisms in your pharmaceutical products, ensuring they meet stringent safety and quality standards.

Our Sterility Testing Services Include:

Testing Methods: Utilizing validated and reliable methodologies to detect microbial contamination, including the membrane filtration method and the direct inoculation method.

Microbial Detection: Assessing samples for the presence of a wide range of microorganisms, including bacteria, yeast, and molds, to ensure product sterility.

Regulatory Compliance: Adhering to international guidelines and standards such as USP <71>, EP 2.6.1, and JP etc ensuring that your products meet all necessary regulatory requirements.

Applications:

Pharmaceutical Products:
Testing injectable drugs and topical products for microbial contamination.
Biological Products:
Ensuring the sterility of biological products and vaccines.
Medical Devices:
Verifying the sterility of medical devices and packaging materials.
Regulatory Submissions:
Providing detailed sterility testing reports and documentation to support regulatory filings and product approvals.

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Apta Labs Pvt Ltd is a premier contract research and testing laboratory providing a comprehensive range of services to the pharmaceutical, biopharmaceutical, and packaging industries.