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清洁验证英文术语有哪些？

In the pharmaceutical industry, ensuring the cleanliness of manufacturing facilities is of paramount importance. This process is known as "clean validation," and it involves various English terms and phrases that professionals use to describe different aspects of this crucial process. This article aims to provide a comprehensive list of English terms related to clean validation, along with explanations and examples.

1. Clean Validation (CV) Clean validation is a systematic approach to assess and document the effectiveness of cleaning procedures in a manufacturing environment. It ensures that the manufacturing process produces a quality product by eliminating contamination risks.

2. Cleaning Validation Protocol A cleaning validation protocol is a document that outlines the objectives, scope, methods, and acceptance criteria for a cleaning validation study. It serves as a roadmap for conducting the study and provides a framework for data analysis and reporting.

3. Cleaning Operations Cleaning operations refer to the specific activities performed to remove contaminants from surfaces, equipment, and the manufacturing environment. These operations can include manual cleaning, automated cleaning, and the use of cleaning agents.

4. Cleaning Agent Cleaning agents are substances used to remove contaminants from surfaces. They can be categorized into different types, such as detergents, solvents, and sanitizers.

5. Cleaning Procedure A cleaning procedure is a step-by-step guide that outlines the cleaning operations to be performed. It includes the cleaning agent, method, duration, and equipment used.

6. Cleaning Validation Study A cleaning validation study is a series of experiments conducted to demonstrate the effectiveness of cleaning procedures. It involves collecting data on cleaning parameters, such as time, temperature, and concentration, and analyzing the results to determine if the cleaning process is effective.

7. Cleaning Verification Cleaning verification is a process that confirms that the cleaning procedures have been performed correctly and that the equipment is clean. It can be performed manually or using automated methods, such as ATP bioluminescence testing.

8. Cleaning Qualification Cleaning qualification is a process that demonstrates the effectiveness of cleaning procedures for a specific piece of equipment or system. It involves conducting a cleaning validation study and documenting the results.

9. Cleaning Validation Report A cleaning validation report is a document that summarizes the results of a cleaning validation study. It includes data on cleaning parameters, test results, and conclusions.

10. Critical Cleaning Critical cleaning refers to the cleaning of equipment or surfaces that have a direct impact on product quality. These areas are subject to more stringent cleaning requirements to ensure that no contaminants can affect the product.

11. Non-Critical Cleaning Non-critical cleaning refers to the cleaning of equipment or surfaces that do not have a direct impact on product quality. While these areas still require cleaning, the requirements are less stringent compared to critical cleaning.

12. Cleaning Verification Protocol A cleaning verification protocol is a document that outlines the objectives, scope, methods, and acceptance criteria for a cleaning verification study. It serves as a guide for conducting the study and ensures that the cleaning process is effective.

13. Cleaning Process Validation Cleaning process validation is a process that demonstrates the effectiveness of cleaning procedures for a specific process. It involves conducting a cleaning validation study and documenting the results.

14. Cleaning Equipment Cleaning equipment refers to the tools and devices used to perform cleaning operations. This can include brushes, wipes, sprayers, and automated cleaning systems.

15. Cleaning Room A cleaning room is a controlled environment where cleaning operations are performed. These rooms are designed to minimize the introduction of contaminants and ensure that cleaning is effective.

16. Cleaning Validation Master Plan A cleaning validation master plan is a document that outlines the overall strategy for conducting cleaning validation studies. It includes the scope, objectives, and timelines for each study.

17. Cleaning Verification Master Plan A cleaning verification master plan is a document that outlines the overall strategy for conducting cleaning verification studies. It includes the scope, objectives, and timelines for each study.

18. Cleaning Validation Study Design Cleaning validation study design refers to the process of planning and conducting a cleaning validation study. This includes selecting the appropriate methods, data collection, and analysis techniques.

19. Cleaning Verification Study Design Cleaning verification study design refers to the process of planning and conducting a cleaning verification study. This includes selecting the appropriate methods, data collection, and analysis techniques.

20. Cleaning Validation Expert A cleaning validation expert is a professional with specialized knowledge and experience in clean validation. They can provide guidance on designing, conducting, and interpreting cleaning validation studies.

By understanding these English terms and their applications in clean validation, professionals in the pharmaceutical industry can ensure that their manufacturing processes are safe, effective, and compliant with regulatory requirements. This comprehensive list serves as a valuable resource for anyone involved in clean validation, from engineers and technicians to quality assurance personnel.