ISPE發(fā)布的《ISPE良好規(guī)范指南：HVAC和工藝設(shè)備空氣過濾器》，該指南旨在成為制藥行業(yè)過濾器的選擇，應(yīng)用，標(biāo)準(zhǔn)，測試以及操作和維護(hù)提供寶貴參考。本指南為ISPE良好實(shí)踐指南：暖通空調(diào)（HVAC）系統(tǒng)指南的補(bǔ)充，提供有關(guān)HVAC和工藝設(shè)備應(yīng)用中空氣過濾器的詳細(xì)信息。本指南介紹了與當(dāng)前指南相關(guān)的技術(shù)及其應(yīng)用。本指南還說明了在制造過程和安裝后進(jìn)行的過濾器測試的原理和目標(biāo)，并包括一種用于評估生命周期成本對過濾器選擇的影響的建議方法。
目錄如下：
1 Introduction
介紹
1.1 Background
背景
1.2 Purpose
目的
1.3 Structure of the Guide
指南結(jié)構(gòu)
2 Fundamental Concepts in Air Filtration
空氣過濾器的基本概念
2.1 Filtration Theory
過濾理論
2.2 Filtration Efciency
過濾效率
2.3 Air Filtration Characteristics
空氣過濾特性
3 Filter Standards
過濾器標(biāo)準(zhǔn)
3.1 GMP Regulatory Requirements
GMP監(jiān)管要求
3.2 Relevant Organizations
相關(guān)組織
3.3 Filter Classifcations/Grades/Performance Criteria
過濾器分類/級別/性能標(biāo)準(zhǔn)
4 Filter and Filter Housing Design and Construction
過濾器和過濾器外殼的設(shè)計(jì)與構(gòu)造
4.1 Filtration Media Structures and Media Manufacturing
過濾介質(zhì)構(gòu)造和介質(zhì)制造
4.2 Filter and Filter Housing Construction
過濾器和過濾器外殼構(gòu)造
4.3 HEPA Filters
HEPA過濾器
4.4 Containment/Biosafety
隔離/生物安全
5 Process Equipment Air Filters
工藝設(shè)備空氣過濾器
5.1 Tablet Processing Equipment
片劑生產(chǎn)設(shè)備
5.2 Depyrogenation Tunnels/Ovens
去熱原隧道/烘箱
5.3 Unidirectional Air?ow Applications
單向流應(yīng)用
5.4 Washing Machines
清洗設(shè)備
6 Filter Testing (HVAC Related Only)
過濾器測試（僅HVAC相關(guān)）
6.1 Introduction
介紹
6.2 Relevant Test Standards and Recommended Practices
相關(guān)測試標(biāo)準(zhǔn)和建議的做法
6.3 Factory Tests
工廠測試
6.4 In Situ/Field Testing of HEPA Filters: Filter Integrity Leak Testing
HEPA過濾器的在位/現(xiàn)場測試：過濾器完整性泄漏測試
6.5 Background on Leaks and Sizing
有關(guān)泄漏的背景
6.6 Challenge Aerosols
挑戰(zhàn)用氣溶膠
6.7 Equipment Used for Filter Integrity Leak Testing
用于過濾器完整性泄漏測試的設(shè)備
6.8 Acceptance Criteria
接受標(biāo)準(zhǔn)
6.9 Bleed Through or Excessive Widespread Non-Site Specifc Penetration
滲濾或過度擴(kuò)散的非現(xiàn)場特定穿透
6.10 Filter Repairs
過濾器修補(bǔ)
6.11 Additional In Situ Filter Measurements
附加原位過濾器的測試
7 Verifcation (Commissioning and Qualifcation)
確認(rèn)（調(diào)試與確認(rèn)）
7.1 Introduction
介紹
7.2 Design, Specifcation, Verifcation, and Acceptance Process
設(shè)計(jì)、規(guī)范、確認(rèn)和接受標(biāo)準(zhǔn)
8 Operations and Maintenance
運(yùn)行和維護(hù)
8.1 Filter Storage
過濾器儲存
8.2 Filter Inventory
過濾器庫存
8.3 Filter Bank
過濾器庫房
8.4 Filter Life
過濾器生命周期
8.5 Filter Repair Techniques
過濾器修補(bǔ)技術(shù)
8.6 Filter Replacement
過濾器更換
8.7 Filter Failure Modes
過濾器失效模式
8.8 Filter Serviceability
過濾器適用性
8.9 Specifying and Ordering HEPA/ULPA Filters
指定和調(diào)整HEPA/ULPA過濾器
8.10 HEPA/ULPA Filter Installation
HEPA/ULPA過濾器安裝
9 Training
培訓(xùn)
9.1 Vendor/Contractor Training and Qualifcation versus In-House Training and Qualifcation
供應(yīng)商/承包商的培訓(xùn)和確認(rèn)以及內(nèi)部培訓(xùn)和確認(rèn)
9.2 Responsibility
責(zé)任
9.3 Training Program, Policies, and Procedures
培訓(xùn)計(jì)劃、政策和程序
9.4 Accreditation/Certifcation
資質(zhì)認(rèn)定
9.5 Education and Training
教育與培訓(xùn)
10 Lifecycle Costs
生命周期成本
10.1 Introduction
介紹
10.2 Annual Filter Energy Cost Factors
每年過濾器能耗系數(shù)
10.3 Additional Factors Impacting Total Cost of Ownership
影響總擁有成本的其他因素
10.4 Total Cost of Ownership (TCO)
總擁有成本
11 Appendix 1 – Regulatory and Other Guidance
附錄1 法規(guī)和其他指南
11.1 Introduction
介紹
11.2 US GMPs
美國GMP
11.3 EU GMPs
歐盟GMP
11.4 Japan GMPs
日本GMP
11.5 Canada GMPs
加拿大GMP
11.6 Mexico GMPs
墨西哥GMP
11.7 China GMPs
中國GMP
11.8 Brazil GMPs
巴西GMP
11.9 Other Guidance
其他指南
12 Appendix 2 – Example Forms
附錄2 表格舉例
12.1 Example Form to Document the Installation of the Correct Filter
用于記錄正確過濾器安裝的示例表格
12.2 Example Form to Document Leak Testing of a HEPA Filter (Imperial Units)
用于記錄 HEPA 過濾器泄漏測試（英制單位）的示例表格
12.3 Example Form to Document Leak Testing of a HEPA Filter (Metric Units)
用于記錄 HEPA 過濾器泄漏測試（公制單位）的示例表格
13 Appendix 3 – References
附錄3 參考文獻(xiàn)
14 Appendix 4 – Glossary
附錄4 術(shù)語
14.1 Acronyms and Abbreviations
縮略語和縮寫
14.2 Defnitions
定義
