| Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities | 翻译部分编号
| 页数 |
| 1.0 INTRODUCTION 1 | 1 | 16 |
| 2.0 GLOSSARY OF TERMS 2 |
| 3.0 SANITIZER, DISINFECTANT, AND SPORICIDE CLAIMS AND CLASSIFICATIONS 5 |
| 4.0 REGULATORY EXPECTATIONS 6 |
| 5.0 QUALIFICATION OF NEW SUPPLIERS AND AGENTS 8 |
| 6.0 IN-USE EXPIRATION DATING 15 |
| 7.0 CONTROL OF THE ENVIRONMENT 16 | 2 | 8 |
| 8.0 IN-SITU FIELD STUDIES 22 |
| 9.0 CLEANING AND DISINFECTION 24 | 3 | 11 |
| 10.0 FREQUENCY FOR CLEANING AND DISINFECTION 35 | 4 | 10 |
| 11.0RESISTANCE AND ROTATION 38 |
| 12.0 RETURN FROM A SHUTDOWN 39 |
| 13.0 HOLD TIMES FOR CLEANED AREAS, NON-PRODUCT-CONTACT EQUIPMENT, AND UTENSILS 40 |
| 14.0TRAINING 41 |
| 15.0 CONDUCTING INVESTIGATIONS RELATED TO CLEANING AND DISINFECTION 45 | 5 | 10 |
| 16.0 CONCLUSION 47 |
| 17.0 APPENDIX I: HISTORY OF DISINFECTION 48 |
| 18.0 APPENDIX II: REGISTRATION OF SANITIZERS, DISINFECTANTS AND SPORICIDES 51 |
| 19.0 APPENDIX III: OVERVIEW OF THE U.S. ENVIRONMENTAL PROTECTION AGENCY 52 |
| 20.0 APPENDIX IV: OVERVIEW OF THE EU BIOCIDAL REGULATIONS 53 |
| 21.0 APPENDIX V: EPA-RELATED SAFETY LABELING INFORMATION 54 | 6 | 11 |
| 22.0 APPENDIX VI: AOAC PROTOCOL TESTING FOR DISINFECTANT REGISTRATION 57 |
| 23.0 APPENDIX VII: EN TESTS FOR DISINFECTION EFFICACY 60 |
| 24.0 APPENDIX VIII: LARGE-SCALE GASSING OR FOGGING OF CLEAN ROOMS 62 |
| 25.0 REFERENCES 65 |
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| 26.0 SUGGESTED READING 66 |
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