Kaye Solutions for Washer Disinfectors
Cleaning and Disinfection Processes: An Overview of Methods and Standards
Cleaning and disinfection processes are essential in the medical, pharmaceutical, and biotech industries. These processes are particularly used for cleaning and thermal disinfection of medical devices, instruments, and glassware. Thorough cleaning and disinfection are critical preliminary steps for subsequent sterilization methods such as steam or dry heat sterilization.
Adhering to specific parameters such as temperature and exposure time is crucial to ensure effective cleaning and surface decontamination. These parameters must be precisely monitored and controlled to ensure that all microorganisms and contaminants are removed. Documented protocoling of these critical process parameters is also essential during IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification) of a new system and during the annual qualification and validation in a GxP environment. Whether it's a smaller lab-scale system or a large-scale pharmaceutical production facility, compliance with the standards applicable to this application is mandatory.
A typical example of this application is the pre-cleaning of glass vials before they are fed into a hot air tunnel. This pre-cleaning ensures that the vials are free from particles and other contaminants before being subjected to depyrogenation. Similarly, the qualification and validation of a stopper-washing machine in aseptic filling is a challenging task but crucial for maintaining sterile conditions.
As always in a GxP environment, adherence to standards and guidelines plays an important role in ensuring the effectiveness of cleaning and disinfection procedures. ISO 15883 (Washer-disinfectors) serves as an example of relevant standards defining requirements and testing procedures for these processes. Additional guidelines and regulations are also available for reference.
Kaye AVS and ValProbe-RT validation systems are ideal for the qualification and validation of cleaning and disinfection processes in a regulated GxP environment. Our innovative monitoring technologies ensure process safety and high operational efficiency, ultimately enhancing the quality and integrity of pharmaceutical products.
For more information about our products and solutions, please visit our website. We are happy to assist you with customized solutions for your specific requirements in the pharmaceutical and biotechnology sectors.