USP <788> Testing

In the pharmaceutical industry, particularly biopharmaceuticals, it is of paramount importance to maintain accurate measurements of the presence of particulate matter in drugs that are administered to patients. By remaining aware of the presence of these particles, pharmaceutical manufacturers can maintain a greater degree of control over the safety and quality of the drugs that they produce.

Particulate matter in parenteral drugs is of particular concern. Parenteral drugs are those that are administered in ways other than orally – most commonly, parenteral drugs are administered via injection. USP <788> testing adheres to US pharmacopeia standards for testing methods and particulate identification in injectable pharmaceuticals, enabling a consistent, reliable, repeatable method for determining the quality and safety of these types of materials.

BA Sciences features the advanced equipment, innovative processes, and deep experience necessary to carry out accurate and reliable USP <788> examination and testing. We offer a full range of pharmaceutical testing and validation processes designed to help manufacturers and labs ensure the quality and safety of their products and samples.

Without reliable testing and validation, products may pose direct safety risks to their end users. The effectiveness of products may also be at risk if contaminants or particulate matter are present, creating scenarios where prescriptions and usage recommendations no longer work as intended. In any case of contamination or unexpected presence of particulate matter, the safety of the pharmaceutical product is at risk, and thus should not be distributed to end users. USP Chapter <788> standards help to prevent these scenarios.

USP <788> Requirements and Testing

With USP <788>, particulate matter in injections can be accurately detected, and a determination can be made about the suitability of the product or sample for further distribution. There are two accepted methods for USP <788> testing:

  • Light obscuration testing: This is generally the first type of testing carried out under USP <788>, unless it is unable to be applied for any reason. In light obscuration testing, a sensor is used to determine the concentration of particles that would not otherwise be visible to the naked eye. Sensors are carefully calibrated to detect particulate matter of various sizes, with the standard validation measure being 15 μm. Note that while this type of testing detects nonvisible particulate matter concentration, injectable pharmaceuticals should never contain visible particles.
  • Microscopic particle count testing: This type of testing occurs if a sample appears not to pass light obscuration testing or is not suitable for light obscuration testing. In this type of testing, it is possible to make a more accurate determination as to the nature and type of particulate present in the sample, via color and shape. Microscopic testing also enables root cause testing, analysis, and identification of different material types.

Why Choose BA Sciences?

Backed by over 30 years of experience, BA Sciences helps pharmaceutical and life science companies ensure the quality and safety of their products through the highest quality analytical testing services. Our project managers work with each client to determine the right goals and strategies to pursue, and we provide the advanced technology, results-focused processes, and specialty services to achieve them. Our cGMP-compliant, FDA/DEA-registered, ISO/IEC-17025:2005-certified laboratory is ready to help you make your testing and manufacturing operations the best they can be. To learn more, contact us today.

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