A Real-World Approach to Evaluating Cleanroom Garments

Sherwin-Williams will showcase its advanced coating systems, which are designed to ensure safety, sterility, and efficiency in pharmaceutical manufacturing environments.

Compliance and competitiveness are key factors in aseptic processing, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

As biopharma anticipates the “Facility of the Future,” a definition of what closed processing is, and quantification of its value, can be helpful information.

Aseptic fill/finish of biopharmaceuticals requires an understanding of the structure and limitations of each molecule.

In this article, the authors explored the elimination of a water rinse and blow down following the caustic wash step, examining potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing this change.