ResourceDrug Discovery & Development
Choosing the right PCD configuration for reliable sterility assurance
17 Oct 2025Achieving the required Sterility Assurance Level (SAL) is vital for product safety and compliance. This paper guides manufacturers in selecting the right Process Challenge Device (PCD) configuration to ensure effective EO sterilization and efficient cycle validation.
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Process Challenge Devices® (PCD®)
Mesa LabsProcess Challenge Devices (PCD®) certified to ISO 13485 quality systems for medical devices. These external PCDs (ePCD) ensure success of terminal sterilization cycles of medical devices, and can be used for both validation and routine monitoring of EO sterilization cycles.
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Autoclaves and SterilizersAutoclaves and sterilizers are commonly used to sterilize laboratory equipment, instruments and growth media using constant pressure and temperature. When choosing an autoclave or sterilizer consider medical or laboratory application, size, loading and sterilization method. Sterilization methods include flame (Bunsen burners), heat (steam or dry), chemical and UV.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Process DevelopmentProcess development aims to optimize the performance of manufacturing systems. This involves the assessment of quality and efficiency of both processes and products. This is particularly important in the scale-up of chemical processes.