In accordance with GMP Annex 1, critical parameters affecting the operation of steam sterilizers and washing machines in sterile manufacturing include design, validation, and ongoing monitoring. Key factors include:
1. Equipment Design and Qualification: Equipment must be designed to prevent contamination, ensuring that steam sterilizers and washing machines are properly installed, qualified, and validated to maintain sterile conditions. The sterilization process should use pure steam of suitable quality, free from contaminants, and validated for parameters like non-condensable gases and dryness value.
2. Monitoring and Control: Regular monitoring of critical quality attributes and parameters, such as temperature and pressure, is essential to ensure consistent performance. Equipment must undergo periodic requalification, including tests for steam quality and sterilization efficacy.
3. Contamination Control: Implementing a robust Contamination Control Strategy (CCS) is crucial, focusing on minimizing microbial, particulate, and endotoxin risks. Cleaning and maintenance procedures must be rigorously followed to maintain the sterility of equipment surfaces and internal components.
These critical parameters ensure compliance with GMP standards, minimizing contamination risks in the manufacturing of sterile medicinal products

1. Understand the Critical Parameters Affecting Steam Sterilizers and Washing Machines:
o Identify the key factors influencing the operation of steam sterilizers and washing machines in sterile manufacturing as per GMP Annex 1.
2. Comprehend the Importance of Equipment Design and Qualification:
o Learn how equipment design, proper installation, qualification, and validation help prevent contamination and maintain sterile conditions.
o Recognize the importance of using pure steam of suitable quality and validating critical parameters such as non-condensable gases and dryness value.
3. Grasp the Role of Monitoring and Control in Maintaining Sterility:
o Understand the necessity of regular monitoring of critical quality attributes, including temperature and pressure, to ensure consistent equipment performance.
o Acknowledge the need for periodic requalification of equipment, including testing for steam quality and sterilization efficacy.

steam sterilizer, washing machine, GMP, Annex1