Hvac Part1a

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HVAC | Slide 1 of 26 May 2006

Heating, Ventilation and Air-Conditioning (HVAC)

Part 1 (a):Introduction and overview

Supplementary Training Modules onGood Manufacturing Practice

WHO Technical Report Series,No. 937, 2006. Annex 2


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HVAC

Objectives

To understand:

The need for HVAC systems (Part 1a)

The role of HVAC in protection:

Product

Personnel Environment

The role of HVAC in dust control (Part 1b)

HVAC system design and its components (Part 2)

Commissioning, qualification and maintenance (Part 3)

1, 2


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HVAC

Introduction and Scope

HVAC systems can have an impact on product quality

It can provide comfortable conditions for operators

The impact on premises and prevention of contamination and

cross-contamination to be considered at the design stage

Temperature, relative humidity control where appropriate

Supplement to basic GMP text 1, 2


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Factors contributing toquality products

Starting materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing materials

HVAC


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The manufacturing environment is critical for product

quality. Factors to be considered include:1. Light

2. Temperature

3. Relative humidity

4. Air movement

5. Microbial contamination

6. Particulate contamination

Uncontrolled environment can lead to product degradation

product contamination (including cross-contamination)

loss of product and profit

HVAC


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What is contamination?

It is "the undesired introduction of impurities (chemical/ microbial/

foreign matter into or on to starting material or intermediate

during sampling, production, packaging or repackaging".

Impurities could include products or substances other than the

product manufactured, foreign products, particulate matter, micro-

organisms, endotoxins (degraded microorganisms), etc.

HVAC

Glossary


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What is Cross-contamination?"Contamination of a starting material, intermediate product, orfinished product with another starting material or productduring production".

Cross-contamination can result from, e.g.

1. Poorly designed, operated or maintained air-handling systemsand dust extraction systems

2. Inadequate procedures for, and movement of personnel,materials and equipment

3. Insufficiently cleaned equipment

HVAC

Glossary,4.1.11


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Contamination

Contaminantfrom

Environment

Operators

Contaminantfrom

Equipment

CrossContamination

Product

fromEnvironment

Operators

Product

fromEquipment

Cross-Contamination

HVAC


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Cross-contamination can be minimized by, e.g.

1. Personnel procedures

2.Adequate premises

3. Use of closed production systems

4.Adequate, validated cleaning procedures

5.Appropriate levels of protection of product

6. Correct air pressure cascade

HVAC


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The guideline further focuses on three concepts ofthe system:

Product protection

Contamination

Cross-contamination

Environmental conditions

Personnel protection

Prevent contact

Comfort conditions

Environment protection 2


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HVAC

Protection: Product and personnel

Areas where materials and products are exposed, should beclassified as "clean areas"

Achievement of clean area classification depends on factors suchas:

Building finishes and structure Air filtration Air change rate Room pressure Temperature Relative humidity

Material and personnel flow

Outside environment Occupancy and type of product

4.1.1 - 4.1.3


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HVAC

Air filtration and air change rate should ensure attainment of

classification

Air change rate is dependent on factors, e.g.

Level of protection required

Quality and filtration of supply air

Particulates generated

Room configuration

Containment effect

Room heat load

Room pressure

Air change rate normally varies between 6 20 air changes

per hour

4.1.4 - 4.1.6


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HVAC

The classification should beachieved in the state as

specified (1):

"As built"

Bare room, without equipment or

personnel

4.1.7 - 4.1.8


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specified (2):

"At rest"

Equipment may be operating, but

no operators present

4.1.9


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specified (3):

"In operation" Normal production process with

equipment and personnel,

Clean up time validated

normally in the order of 20minutes

4.1.10


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Control of contaminants

External contaminants removed through effective filtration

Internal contaminants controlled through dilution and flushing,

or displacement airflow

Airborne particulates and level of filtration considered critical

4.1.12 - 4.1.15


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Therapeutic risks

ManufacturingEnvironment

requirements

Clean

roomClassA

/B

CleanroomClas

sC

Cleanrm.ClassD

Others

HVAC


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Level of protection and air cleanliness determinedaccording to:

Product to be manufactured

Process to be used

Product susceptibility to degradation

4.1.16


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Parameters influencing Levels of Protection

Number of particles in the air, number of microorganisms in theair or on surfaces

Number of air changes for each room

Air velocity and airflow pattern

Filters (type, position)

Air pressure differentials between rooms

Temperature, relative humidity

HVAC


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Tools to help achieve the desired Level ofProtection

Air HandlingSystem

Production Room

With

Defined

Requirements

SupplyAir

OutletAir

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Tools to help achieve the desired Level of Protection (2)

Air-handling system can be the main tool for reaching requiredparameters

May not be sufficient as such

Need for additional measures such as appropriate gowning (type of clothing, proper changing

rooms)

validated sanitation

adequate transfer procedures for materials and personnel

HVAC


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Cleanroom Classdefined by

Critical Parameters

Air HandlingSystem

Additional Measures

Tools to help achieve the desired Level of Protection (2)

HVAC


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Examples of Levels of Protection

Types of Clean room classes

WHO, EC, PIC/S: A, B, C, D

US FDA: Critical and controlled

ISPE: Level 1, 2 or 3

ISO: Class 5, 6, 7 or 8

HVAC


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Particles / m3

0.5mUS 209D

non-metric

US 209E1992

metric

EC cGMPAnnex I

1997

GermanyVDI 2083

1990

UKBS 5295

1989

JapanJIS B 9920

1989

ISO 14644-1

1

3,5 0 2 2

10 M 1

35 1 M 1.5 1 3 3

100 M 2

353 10 M 2.5 2 4 4

1.000 M 3

3.530 100 M 3.5 A, BA= unidirectional

B= turbulent

3 E or F 5 5

10.000 M 4

35.300 1.000 M 4.5 4 G or H 6 6

100.000 M 5

353.000 10.000 M 5.5 C 5 J 7 7

1.000.000 M 6

3.530.000 100.000 M 6.5 D 6 K 8 8

10.000.000 M 7

Comparing International Cleanroom Classifications

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Examples of levels of protection 4.1.16

Example of areaConditionLevel

Area with normal housekeeping, e.g.

warehouse

GeneralLevel 1

Area where steps are taken to protect

exposed material/product, e.g. dispensing

ProtectedLevel 2

Area with defined, controlled, monitored

environmental conditions to preventcontamination and degradation

ControlledLevel 3


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All operationswithin a pharmaceutical facilility should becorrelated to well-defined clean room classes, and can beincluded in a hygiene concept.

Example:

etc.

XFilling for aseptic process

XFilling for terminal sterilisation

XDepyrogenisation of containers

XXXPreparation of solutions for aseptic filling

XPreparation of solution for terminal sterilisation

XWashing of containers

DCBACleanroom Class

HVAC

Hvac Part1a

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