Содержание
- 2. Objectives To understand: The need and reason for pharmaceutical air handling systems The technical requirements for
- 3. Factors that contribute to quality products: Starting materials and packaging materials Validated processes Personnel Procedures Equipment
- 4. Factors contributing to quality products
- 5. The manufacturing environment is critical for product quality Light Temperature Humidity Air movement Microbial contamination Particulate
- 6. What are contaminants ? Contaminants are Products or substances other than product manufactured Foreign products Particulate
- 7. Cross-Contamination (1) What is Cross-Contamination ? Definition of Cross-Contamination: Contamination of a starting material, intermediate product,
- 8. Cross-Contamination (2) From where does Cross-Contamination originate? Poorly designed air handling systems and dust extraction systems
- 9. Cross-Contamination ( 3 )
- 10. Cross-Contamination (4) Cross-contamination can be minimized by: Personnel procedures Adequate premises Use of closed production systems
- 11. Level of Protection Concept Defines environmental requirements Helps prevent contamination and cross-contamination Allows production under optimal
- 12. Therapeutic risks Manufacturing Environment requirements Cleanroom Class A / B Cleanroom Class C Cleanrm. Class D
- 13. Levels of Protection Parameters to be defined: Air cleanliness requirements (filters type and position, air changes,
- 14. Levels of Protection Types of Cleanroom Classes International WHO A, B, C, D National
- 15. Levels of Protection All operations within a pharmaceutical facilility must be correlated to well-defined cleanroom classes,
- 16. Levels of Protection Based on the cleanroom class requirements, various Levels of Protection have to be
- 17. Parameters influencing Levels of Protection (1) Annex 1, 17.4
- 18. Parameters influencing Levels of Protection (2) Number of particles in the air Number of micro-organisms in
- 19. Cleanroom Class defined by Critical Parameters Air Handling System Additional Measures Parameters influencing Levels of Protection
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