ISPE良好规范指南--供暖、通风和空调 ISPE Heating, Ventilation, and Air Conditioning (HVAC)

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This Document is licensed to

Mr. Gerardo Gutierrez, Sr.

Mexico, DF,

ID number: 299643

Downloaded on: 10/5/11 2:26 PM

This Document is licensed to

Mr. Gerardo Gutierrez, Sr.

Mexico, DF,

ID number: 299643

Downloaded on: 10/5/11 2:26 PM

Your drug goes from

benchtop to blockbuster.

Faster.

Your regulatory approval

and proﬁ ts arrive sooner.

Better.

Your products and services

set industry standards.

Smarter.

At Southland, we know that speed to market is crucial, but not at the expense of quality or

compliance. When you partner with us, we’ll Design • Build • Maintain mechanical systems

that are both cutting edge and in keeping with regulations, making it easier to meet cGMP/

GLP requirements, validate your systems and pass quality and regulatory audits.

Life Science Authorities in R&D Labs, Biocontainment and cGMP Manufacturing Facilities.

Trust Your Life Sciences

Mechanical Systems to Southland.

HVAC

Process Piping

Plumbing

Fire Protection

Controls & Automation

Energy Analysis

Planning & Development

Project Management

Maintenance

Repair & Retroﬁ t

www.southlandind.com

LifeSciences@southlandind.com

East Coast: 703.834.5570

West Coast: 949.440.5000

This Document is licensed to

Mr. Gerardo Gutierrez, Sr.

Mexico, DF,

ID number: 299643

Downloaded on: 10/5/11 2:26 PM

Table of Contents

Preface ......................................................................................................................................... 4

Acknowledgements .................................................................................................................... 5

1 Introduction ......................................................................................................................... 7

1.1 Background ..................................................................................................................................................7

1.2 Purpose ........................................................................................................................................................7

1.3 Scope ...........................................................................................................................................................7

  1.4 Benets ........................................................................................................................................................8

 1.5 Objectives ....................................................................................................................................................9

 1.6 KeyConcepts...............................................................................................................................................9

  1.7 Structure ....................................................................................................................................................17

2 Design Process ................................................................................................................. 19

  2.1 Introduction ................................................................................................................................................19

  2.2 DevelopingUserRequirements .................................................................................................................23

  2.3 HVACSystemRiskAssessment ................................................................................................................35

  2.4 ProgrammingforDetailDesign ..................................................................................................................40

3 Design Considerations ..................................................................................................... 45

  3.1 Introduction ................................................................................................................................................45

  3.2 GeneralDesignConsiderations .................................................................................................................45

  3.3 AirFlowDiagramsbyFacilityType ............................................................................................................50

  3.4 ActivePharmaceuticalIngredients(APIs)–(WetEnd) .............................................................................50

  3.5 ActivePharmaceuticalIngredients(APIs)–(DryEnd) ..............................................................................51

  3.6 Biologics .....................................................................................................................................................52

  3.7 OralSolidDosage(Non-PotentCompounds) ............................................................................................54

  3.8 OralSolidDosage(PotentCompounds)....................................................................................................57

  3.9 AsepticProcessingFacility ........................................................................................................................60

Heating,

Ventilation, and

Air Conditioning (HVAC)

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标签： #ISPE

摘要：

本指南为制药与生物技术行业提供基于ISPE良好规范框架的供暖、通风和空调（HVAC）系统设计与验证核心参考，涵盖HVAC系统在受控环境中的关键作用，包括温湿度控制、空气洁净度管理、压差维护及能源优化策略。内容适用于洁净室、隔离区及无菌生产设施，强调风险合规与运行可靠性，帮助工程师与质量人员满足cGMP及国际监管要求，同时提升系统能效与维护效率。

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ISPE良好规范指南--供暖、通风和空调 ISPE Heating, Ventilation, and Air Conditioning (HVAC)

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