خرید ایبوک ISPE Heating, Ventilation, and Air Conditioning (HVAC) 2rd Edition
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در صورتی که نیاز به پی دی اف هر کتابی از انتشارات International Society for Pharmaceutical Engineering (ISPE) دارید با گیگاپیپر مکاتبه کنید.
خرید کتاب ISPE Good Practice Guide: Heating, Ventilation, Air Conditioning (Second Edition) – 2024 – PDF
ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Second Edition
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering , 09/01/2024 by ISPE
Published: 2024
ISBN : 9781946964793
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Price : 25$
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https://ispe.org/publications/guidance-documents/good-practice-guide-heating-ventilation-air-conditioning-second-editionدانلود رایگان کتاب Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) 2TH
Heating, Ventilation, and Air Conditioning (HVAC) design and operation play a crucial role in ensuring pharmaceutical facilities’ ability to safeguard product quality, operator and facility safety, occupant comfort, and environmental integrity.
Designing HVAC systems for the pharmaceutical industry involves unique considerations. These environments demand exceptionally clean and safe environments to protect both personnel and products. As a result, HVAC systems in pharmaceutical settings require higher levels of reliability, robustness, design scrutiny, and operational assurance compared to less stringent applications. Given that HVAC systems can consume a significant portion of the energy used by a facility, their design necessitates a blend of Good Engineering Practice (GEP) and Good Manufacturing Practice (GMP).
دانلود ایبوک راهنمای عمل خوب ISPE: گرمایش، تهویه، و تهویه مطبوع (ویرایش دوم)
طراحی و بهره برداری گرمایش، تهویه و تهویه مطبوع (HVAC) نقش مهمی در تضمین توانایی تجهیزات دارویی برای محافظت از کیفیت محصول، ایمنی اپراتور و تأسیسات، راحتی سرنشینان و یکپارچگی محیطی ایفا می کند.
طراحی سیستم های HVAC برای صنعت داروسازی شامل ملاحظات منحصر به فردی است. این محیط ها نیازمند محیط های فوق العاده تمیز و ایمن برای محافظت از پرسنل و محصولات هستند. در نتیجه، سیستمهای HVAC در تنظیمات دارویی به سطوح بالاتری از قابلیت اطمینان، استحکام، بررسی دقیق طراحی و اطمینان عملیاتی در مقایسه با برنامههای کاربردی کمتر نیاز دارند. با توجه به اینکه سیستمهای تهویه مطبوع میتوانند بخش قابل توجهی از انرژی مورد استفاده یک تأسیسات را مصرف کنند، طراحی آنها به ترکیبی از عملکرد مهندسی خوب (GEP) و عملکرد خوب تولید (GMP) نیاز دارد.
فهرست مطالب Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition) دومین نسخه 2024
Table of Contents
1
Introduction ……………………………………………………………………………………………………… 9
1.1
Background ………………………………………………………………………………………………………………………………..9
1.2
Purpose and Objectives ……………………………………………………………………………………………………………….9
1.3
Scope ………………………………………………………………………………………………………………………………………..9
1.4
Benefits ……………………………………………………………………………………………………………………………………10
1.5
Summary of Revisions ………………………………………………………………………………………………………………. 11
1.6
Key Concepts and Terms …………………………………………………………………………………………………………… 11
2 Purpose of HVAC in Pharmaceutical Facilities (Basic Concepts) ………………………19
2.1
Regulations ………………………………………………………………………………………………………………………………19
2.2
Product Quality …………………………………………………………………………………………………………………………19
2.3
Cleanroom Classification – ISO 14644 versus GMP Regulation ………………………………………………………21
2.4
Environmental Classification and Monitoring: Occupancy States ……………………………………………………..24
2.5
Contamination Control ……………………………………………………………………………………………………………….30
2.6
Airlocks ……………………………………………………………………………………………………………………………………32
3 Specification and Design Qualification Process ………………………………………………. 39
3.1
Introduction ………………………………………………………………………………………………………………………………39
3.2
Quality by Design (QbD) …………………………………………………………………………………………………………….40
3.3
Concept Design ………………………………………………………………………………………………………………………..42
3.4
User Requirements Specification…………………………………………………………………………………………………42
3.5
Identification of HVAC CPPs and SPPs ………………………………………………………………………………………..44
3.6
Basis of Design …………………………………………………………………………………………………………………………48
3.7
Detailed Design…………………………………………………………………………………………………………………………48
3.8
Design Review and Risk Assessment…………………………………………………………………………………………..52
4 System Design Configuration and Components ………………………………………………. 59
4.1
Equipment Specification …………………………………………………………………………………………………………….59
4.2
Fans ………………………………………………………………………………………………………………………………………..62
4.3
Motors and Drives ……………………………………………………………………………………………………………………..67
4.4
Airflow Control Devices ………………………………………………………………………………………………………………68
4.5
Control Valves …………………………………………………………………………………………………………………………..73
4.6
Coils ………………………………………………………………………………………………………………………………………..76
4.7
Additional Equipment …………………………………………………………………………………………………………………79
4.8
Sound Attenuators …………………………………………………………………………………………………………………….83
4.9
Air Filters ………………………………………………………………………………………………………………………………….85
4.10
HVAC System Configuration ……………………………………………………………………………………………………….94
4.11
Pressure Control Strategies ………………………………………………………………………………………………………101
4.12
AFDs and AFIDs ……………………………………………………………………………………………………………………..104
5 Energy and Environment…………………………………………………………………………………107
5.1
Introduction …………………………………………………………………………………………………………………………….107
5.2
Energy Demand Reduction ……………………………………………………………………………………………………….107
5.3
Waste Energy Recovery …………………………………………………………………………………………………………..109
5.4
Energy-Efficient Design …………………………………………………………………………………………………………… 113
5.5
Measure/Verify/Optimize ………………………………………………………………………………………………………….. 114
5.6
Refrigerants …………………………………………………………………………………………………………………………… 115
5.7
Water Use Reduction ………………………………………………………………………………………………………………. 115
5.8
Lifecycle Cost Considerations…………………………………………………………………………………………………… 116
5.9
Building Rating Systems ………………………………………………………………………………………………………….. 116
5.10
Sustainable Design for HVAC Systems ……………………………………………………………………………………… 119
Page 6
ISPE Good Practice Guide:
Heating, Ventilation, and Air Conditioning
6 Design Considerations …………………………………………………………………………………….123
6.1
Introduction …………………………………………………………………………………………………………………………….123
6.2
General Design Considerations …………………………………………………………………………………………………124
6.3
AHU and Control Considerations ……………………………………………………………………………………………….127
6.4
Airflow Diagrams by Facility Type ………………………………………………………………………………………………131
6.5
Process Equipment Integration ………………………………………………………………………………………………….156
7 Controls/BMS/EMS ………………………………………………………………………………………….161
7.1
Introduction …………………………………………………………………………………………………………………………….161
8 Commissioning and Qualification (C&Q) …………………………………………………………179
8.1
Equipment Installation and Startup …………………………………………………………………………………………….179
8.2
Commissioning and Qualification Planning………………………………………………………………………………….187
8.3
Commissioning and Qualification of HVAC Systems …………………………………………………………………….193
9 Lifecycle Documents – Documentation Requirements …………………………………..207
9.1
Introduction …………………………………………………………………………………………………………………………….207
9.2
Engineering Document Life Cycle………………………………………………………………………………………………207
10 Equipment Operation and Maintenance …………………………………………………………..211
10.1
Introduction ……………………………………………………………………………………………………………………………. 211
10.2
Air Handling Units …………………………………………………………………………………………………………………… 211
10.3
Fans ………………………………………………………………………………………………………………………………………212
10.4
Heating and Cooling Coils ………………………………………………………………………………………………………..213
10.5
Steam Humidifiers ……………………………………………………………………………………………………………………214
10.6
Desiccant Dehumidifier …………………………………………………………………………………………………………….214
10.7
Air Filtration [60] ………………………………………………………………………………………………………………………215
10.8
Ductwork ………………………………………………………………………………………………………………………………..216
10.9
Dampers and Louvers………………………………………………………………………………………………………………217
10.10 Diffusers and Registers …………………………………………………………………………………………………………….217
10.11 Ultraviolet Lights ……………………………………………………………………………………………………………………..217
10.12 Fume Exhaust/Extraction Systems …………………………………………………………………………………………….217
10.13 Building ………………………………………………………………………………………………………………………………….217
10.14 Air Balancing …………………………………………………………………………………………………………………………..217
10.15 Spare Parts …………………………………………………………………………………………………………………………….218
11 Appendix 1 – Psychrometrics…………………………………………………………………………..219
11.1
Introduction …………………………………………………………………………………………………………………………….219
11.2
Dry-Bulb Temperature ………………………………………………………………………………………………………………221
11.3
Wet-Bulb Temperature ……………………………………………………………………………………………………………..221
11.4
Dew Point Temperature ……………………………………………………………………………………………………………222
11.5
Relative Humidity (Percentage of Saturation) ………………………………………………………………………………223
11.6
Barometric or Total Pressure …………………………………………………………………………………………………….223
11.7
Specific Enthalpy …………………………………………………………………………………………………………………….224
11.8
Specific Volume ………………………………………………………………………………………………………………………224
11.9
Humidity Ratio or Specific Humidity ……………………………………………………………………………………………225
11.10 Vapor Pressure ……………………………………………………………………………………………………………………….226
11.11 Eight Fundamental Vectors ……………………………………………………………………………………………………….227
11.12 System Mapping ……………………………………………………………………………………………………………………..228
ISPE Good Practice Guide:
Page 7
Heating, Ventilation, and Air Conditioning
12 Appendix 2 – System Risk Assessment ………………………………………………………….. 229
12.1
Suggested Approach for the Classification of HVAC/Facility Monitoring Instruments …………………………229
12.2
SRA for an HVAC System – with the System Boundary including the
HVAC System and Final HEPA Filter ………………………………………………………………………………………….230
12.3
SRA for a Room – with the System Boundary including the Room and Final HEPA Filter …………………. 232
13 Appendix 3 – Design Review and Design Qualification Examples …………………. 235
13.1
Design Review Process ……………………………………………………………………………………………………………235
14 Appendix 4 – Sample Test and Balance Report ………………………………………………241
15 Appendix 5 – Continuous Dilution Modeling for Air Change Rates in
Non-Unidirectional Cleanrooms ……………………………………………………………………. 247
15.1
Introduction …………………………………………………………………………………………………………………………….247
15.2
Assumptions …………………………………………………………………………………………………………………………..247
15.3
Example Input Data …………………………………………………………………………………………………………………248
15.4
Solution ………………………………………………………………………………………………………………………………….249
15.5
Conclusion ……………………………………………………………………………………………………………………………..251
15.6
Discussion ………………………………………………………………………………………………………………………………251
16 Appendix 6 – References ………………………………………………………………………………. 253
17 Appendix 7 – Glossary …………………………………………………………………………………… 259
17.1
Acronyms and Abbreviations …………………………………………………………………………………………………….259
17.2
Definitions ………………………………………………………………………………………………………………………………263
