دانلود کتاب ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water (Pharm Water) Storage and Distribution Systems, 2nd Edition (Second Edition) – 2024 – PDF

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خرید کتاب Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition

ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water (Pharm Water) Storage and Distribution Systems, 2nd Edition (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical
Engineering , 2024 by ISPE
Published: 2024
ISBN : 9781946964809
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Price : 25$
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دانلود رایگان کتاب Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
2024 – PDF
This updated Guide offers comprehensive guidance on designing and operating pharmaceutical water storage and distribution systems that utilize ozone for sanitization. It outlines key principles for implementing an effective sanitization approach.
Using ozone as the primary sanitizing agent in a pharmaceutical water distribution system offers a wide range of operating and cost advantages. Their significance varies depending upon the site and project. Like all sanitization methods, ozone technology imposes specific requirements on system design and operation.
As with any system design, it is the responsibility of the owner and the design team to evaluate ozone’s applicability and compatibility with processes and APIs. This Guide provides design guidance to assist in this evaluation and decision.
The key advantages of Ozone Sanitization discussed in this Second Edition include:
Improved Water Quality Reliability
Higher Productivity
Capital Equipment Savings
Safety
Pipe Insulation
Reduced Energy Costs
Reduced Carbon Footprint
Advantages over Chemical Sanitization
Reduced System Downtime
Ease of Frequent Use
Reduced Excursions and Related Cost
Reduced Water Consumption
Reduced Chemical Disposal Costs
This Second Edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems describes established design methodologies. Drawing from their experience, the expert team of authors share best practices to assist in expanding use of ozone sanitization based on knowledge of its principles and benefits.
دانلود ایبوک راهنمای عمل خوب ISPE: سیستمهای ذخیرهسازی و توزیع آب دارویی ضدعفونیسازی ازن (Pharm Water)، ویرایش دوم
این راهنمای به روز شده راهنمایی جامعی را در مورد طراحی و راه اندازی سیستم های ذخیره و توزیع آب دارویی که از ازن برای پاکسازی استفاده می کنند ارائه می دهد. این اصول کلیدی برای اجرای یک رویکرد ضدعفونی موثر را تشریح می کند.
استفاده از ازن به عنوان عامل ضدعفونی کننده اولیه در سیستم توزیع آب دارویی طیف وسیعی از مزایای عملیاتی و هزینه ای را ارائه می دهد. اهمیت آنها بسته به سایت و پروژه متفاوت است. مانند همه روشهای پاکسازی، فناوری ازن الزامات خاصی را بر طراحی و عملکرد سیستم تحمیل میکند.
مانند هر طراحی سیستمی، مسئولیت ارزیابی کاربرد و سازگاری ازن با فرآیندها و APIها بر عهده مالک و تیم طراحی است. این راهنما راهنمایی طراحی را برای کمک به این ارزیابی و تصمیم گیری ارائه می دهد.
مزایای کلیدی پاکسازی ازن که در این ویرایش دوم مورد بحث قرار گرفت عبارتند از:
قابلیت اطمینان کیفیت آب بهبود یافته است
بهره وری بالاتر
صرفه جویی در تجهیزات سرمایه ای
ایمنی
عایق لوله
کاهش هزینه های انرژی
کاهش ردپای کربن
مزایا نسبت به پاکسازی شیمیایی
کاهش زمان خرابی سیستم
سهولت استفاده مکرر
کاهش گشت و گذار و هزینه های مرتبط
کاهش مصرف آب
کاهش هزینه های دفع مواد شیمیایی
این ویرایش دوم راهنمای عمل خوب ISPE: پاکسازی ازن سیستمهای ذخیره و توزیع آب دارویی، روشهای طراحی ایجاد شده را توصیف میکند. تیم متخصص نویسندگان با تکیه بر تجربیات خود، بهترین شیوه ها را برای کمک به گسترش استفاده از پاکسازی ازن بر اساس دانش اصول و مزایای آن به اشتراک می گذارند.
فهرست مطالب Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems
Table of Contents
1
Introduction ……………………………………………………………………………………………………… 9
1.1
Background ………………………………………………………………………………………………………………………………..9
1.2
Purpose ……………………………………………………………………………………………………………………………………..9
1.3
Scope ………………………………………………………………………………………………………………………………………10
1.4
Rationale for the Second Edition …………………………………………………………………………………………………10
2 Use of Ozone in the Pharmaceutical Industry ……………………………………………………11
2.1
Introduction ……………………………………………………………………………………………………………………………… 11
2.2
Background ……………………………………………………………………………………………………………………………… 11
2.3
Overview of Ozone Use – Advantages and Disadvantages …………………………………………………………….12
3 Regulatory and Industry Guidance …………………………………………………………………… 15
3.1
Introduction ………………………………………………………………………………………………………………………………15
3.2
United States Pharmacopeia (USP) …………………………………………………………………………………………….15
3.3
United States Food and Drug Administration (FDA) ……………………………………………………………………….17
3.4
European Regulations ……………………………………………………………………………………………………………….18
3.5
World Health Organization (WHO) ……………………………………………………………………………………………….20
3.6
International Society for Pharmaceutical Engineering (ISPE)…………………………………………………………..20
4 Ozone Characteristics ……………………………………………………………………………………… 21
4.1
Introduction and Properties …………………………………………………………………………………………………………21
4.2
Ozone Generation and Introduction ……………………………………………………………………………………………..22
4.3
Ozone Reactivity ……………………………………………………………………………………………………………………….25
4.4
Ozone Destruction …………………………………………………………………………………………………………………….26
4.5
Ozone Detection and “Added Substances” Considerations……………………………………………………………..26
5 Effectiveness of Ozone for Microbial Control ………………………………………………….. 27
5.1
Introduction ………………………………………………………………………………………………………………………………27
5.2
Ozone Use in Pharmaceutical Water Systems ………………………………………………………………………………27
5.3
Mechanisms and Targets of Ozone Attack …………………………………………………………………………………….27
5.4
Factors Affecting Ozone Efficacy …………………………………………………………………………………………………28
5.5
Ozone Sanitization Strategies……………………………………………………………………………………………………..29
5.6
Ozonated System Microbial Sampling ………………………………………………………………………………………….32
5.7
Determining Ozone Sanitization Efficacy and Frequency ………………………………………………………………..33
5.8
Summary Elements of Optimal Microbiological Control Using Ozone ……………………………………………….35
6 Ozone Generation …………………………………………………………………………………………… 37
6.1
Introduction ………………………………………………………………………………………………………………………………37
6.2
General Considerations ……………………………………………………………………………………………………………..37
6.3
Electrolytic Ozone Generation …………………………………………………………………………………………………….37
6.4
Corona Discharge Ozone Generation…………………………………………………………………………………………..41
6.5
Ozone Generator Sizing …………………………………………………………………………………………………………….46
7 Ozone Sensors …………………………………………………………………………………………………49
7.1
Introduction ………………………………………………………………………………………………………………………………49
7.2
Polarographic Sensors……………………………………………………………………………………………………………….49
7.3
UV Photometers ………………………………………………………………………………………………………………………..50
7.4
Ozone Sensor Properties and Related Term Definitions …………………………………………………………………52
7.5
Calibration ………………………………………………………………………………………………………………………………..53
7.6
Sensor Verification …………………………………………………………………………………………………………………….57
7.7
Servicing ………………………………………………………………………………………………………………………………….57
For individual use only. © 2024 ISPE. All rights reserved.
Page 6
ISPE Good Practice Guide:
Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems
8 UV Light for Ozone Destruction ……………………………………………………………………… 59
8.1
Introduction ………………………………………………………………………………………………………………………………59
8.2
Electromagnetic Spectrum ………………………………………………………………………………………………………….60
8.3
Mercury Arc Lamps ……………………………………………………………………………………………………………………61
8.4
Conventional Low-Pressure Lamps ……………………………………………………………………………………………..61
8.5
Low-Pressure High Output (Amalgam) Lamps ………………………………………………………………………………62
8.6
Medium-Pressure HG Arc Lamps ………………………………………………………………………………………………..62
8.7
Ozone Absorbance of UV Light……………………………………………………………………………………………………63
8.8
UV Dose …………………………………………………………………………………………………………………………………..64
8.9
Sizing of UV System for Ozone Destruction ………………………………………………………………………………….65
8.10
UV Intensity Monitors …………………………………………………………………………………………………………………67
8.11
UV Lamp Aging …………………………………………………………………………………………………………………………67
8.12
Equipment Maintenance, Safety and Parts Replacement ……………………………………………………………….69
8.13
UV and Water Temperature ………………………………………………………………………………………………………..71
8.14
Frequency of Lamp On/Off (Cycling) and Power Fluctuations ………………………………………………………….71
8.15
Flow and Pressure Related Concerns ………………………………………………………………………………………….72
8.16
UV Selection Process ………………………………………………………………………………………………………………..72
9 System Design ………………………………………………………………………………………………… 73
9.1
Introduction ………………………………………………………………………………………………………………………………73
9.2
Ozone Introduction…………………………………………………………………………………………………………………….73
9.3
Vent Filter and Gas Blanketing Considerations ……………………………………………………………………………..79
9.4
Vent Gas Destruction …………………………………………………………………………………………………………………83
9.5
Water Temperature Control …………………………………………………………………………………………………………83
9.6
Ozone Sensor Location and Configuration ……………………………………………………………………………………84
9.7
UV Unit Location and Configuration……………………………………………………………………………………………..84
9.8
Materials of Construction ……………………………………………………………………………………………………………85
9.9
Feed Gas Purity and Control ………………………………………………………………………………………………………85
9.10
Safety ………………………………………………………………………………………………………………………………………85
9.11
Additional Design References……………………………………………………………………………………………………..87
9.12
Retrofitting Water Systems with Ozone Sanitization Capability ………………………………………………………..88
10 System Operation and Control ………………………………………………………………………… 93
10.1
Introduction ………………………………………………………………………………………………………………………………93
10.2
Ozone Dispensing Options …………………………………………………………………………………………………………93
10.3
Storage Tank Dissolved Ozone Levels …………………………………………………………………………………………94
10.4
UV Operation for Ozone Destruction ……………………………………………………………………………………………95
10.5
Dissolved Ozone Monitoring and Verification of Removal ……………………………………………………………….95
10.6
Distribution Loop Sanitization and Frequency ……………………………………………………………………………….96
10.7
System Shock Sanitization Capability…………………………………………………………………………………………..98
10.8
Conductivity Monitoring………………………………………………………………………………………………………………99
10.9
TOC Monitoring …………………………………………………………………………………………………………………………99
10.10 Point of Use Sampling and Maintenance for Microbiological Control ………………………………………………100
10.11 Safety …………………………………………………………………………………………………………………………………….100
10.12 Ozone Related Process Parameter Summary ……………………………………………………………………………..103
10.13 Rouge ……………………………………………………………………………………………………………………………………103
10.14 Deviations ………………………………………………………………………………………………………………………………104
For individual use only. © 2024 ISPE. All rights reserved.
ISPE Good Practice Guide:
Page 7
Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems
11 Commissioning and Qualification ……………………………………………………………………105
11.1
Introduction …………………………………………………………………………………………………………………………….105
11.2
Design Requirements ………………………………………………………………………………………………………………106
11.3
Commissioning and Qualification Verification ………………………………………………………………………………108
11.4
Installation Qualification/Verification …………………………………………………………………………………………..109
11.5
Operational Verification/Operational Qualification ………………………………………………………………………..109
11.6
Performance Qualification………………………………………………………………………………………………………… 110
12 Ozone and Heat Sanitization Comparison ……………………………………………………….113
12.1
Introduction ……………………………………………………………………………………………………………………………. 113
12.2
Importance of Considering All User Requirements ………………………………………………………………………. 114
12.3
Heat Versus Ozone Sanitization Considerations …………………………………………………………………………. 114
12.4
Comparison of Heat Versus Ozone Sanitization Configurations…………………………………………………….. 115
12.5
Lifecycle Cost Development …………………………………………………………………………………………………….. 116
13 Ozone and Chemical Sanitization Comparison ………………………………………………. 119
13.1
Introduction ……………………………………………………………………………………………………………………………. 119
13.2
Comparing Ozone to Other Sanitization Approaches …………………………………………………………………… 119
13.3
Justification for Considering Changes in Sanitization Approaches …………………………………………………. 119
13.4
Common Challenges of All Chemical Sanitants……………………………………………………………………………120
13.5
Comparison of Conventional Chemical and Ozone Sanitization Approaches …………………………………..120
14 Appendix 1 – Estimating a Lower LOD for Sensors Using
System Specific Data ………………………………………………………………………………………125
15 Appendix 2 – Ozone Off-Gassing During Flushing of Points of Use and
Impact on Worker Safety ………………………………………………………………………………..129
15.1
Worker Exposure Limits ……………………………………………………………………………………………………………130
16 Appendix 3 – Safety of Airborne Ozone Release During Outlet Flushing ……….133
17 Appendix 4 – References ………………………………………………………………………………..137
18 Appendix 5 – Glossary ……………………………………………………………………………………. 141
18.1
Acronyms and Abbreviations …………………………………………………………………………………………………….141
18.2
Definitions ………………………………………………………………………………………………………………………………143