Air Handling System New

8/8/2019 Air Handling System New

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DRA 1

Heating, Ventilation and Air

Conditioning (HVAC)

Introduction and overview

Good Manufacturing Practice


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DRA 2

HVAC

ObjectivesTo understand: The need for HVAC systems The role of HVAC in protection:

Product Personnel Environment

The role of HVAC in dust control

HVAC system design and its components Commissioning, qualification and maintenance


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DRA 3

HVAC

Introduction and scopeHVAC systems can have an impact onproduct qualityIt can provide comfortable conditions for

operatorsThe impact on premises and prevention ofcontamination and cross-contamination tobe considered at the design stage

Temperature, relative humidity controlwhere appropriateSupplement to basic GMP text


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DRA 4

Factors contributing

to quality products

Starting materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing materials

HVAC


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DRA 5

The manufacturing environment is critical forproduct quality. Factors to be considered include:

1. Light

2. Temperature

3. Relative Humidity4. Air movement

5. Microbial contamination

6. Particulate contamination

qUncontrolled environment can lead to product degradation product contamination, (including cross-contamination)

loss of product and profit

HVAC


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DRA 6

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 re-

packaging".Impurities could include products or substances

other than the product manufactured, foreign

products, particulate matter, micro-organisms,

endotoxins (degraded micro-organisms) etc.

HVAC


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DRA 7

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

Cross-contamination can result due to e.g.:1. Poorly designed, operated or maintained air

handling systems and dust extractionsystems

2. Inadequate procedures for, and movement ofpersonnel, materials and equipment

3. Insufficiently cleaned equipment

HVAC


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DRA 8

Contamination

Contaminant

from

Environment

Operators

Contaminant

from

Equipment

Cross

Contamination

Product

from

Environment

Operators

Product

fromEquipment

Cross-Contamination

HVAC


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DRA 9

Cross-contamination can be minimized bye.g.:

1. Personnel procedures

2. Adequate premises

3. Use of closed production systems

4. Adequate, validated cleaningprocedures

5. Appropriate levels of protection ofproduct

6. Correct air pressure cascade

HVAC


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DRA 10

HVAC

The guideline further focuses on threeconcepts of the system:Product protection

ContaminationCross-contamination

Environmental conditionsPersonnel protection

Prevent contactComfort conditions

Environment protection


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DRA 11

HVAC

Protection: Product and personnelAreas where materials and products are exposed, should beclassified as "clean areas"

Achievement of clean area classification depends on factorssuch as:

Building finishes and structureAir filtration

Air change rate

Room pressure

Temperature

Relative humidity

Material and personnel flow

Outside environment

Occupancy and type of product


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DRA 12

HVAC

Air filtration and air change rate should ensure attainmentof classification

Air change rate is dependent on factors e.g.

Level of protection required

Quality and filtration of supply air

Particulates generatedRoom configuration

Containment effect

Room heat load

Room pressureAir change rate normally varies between 6 20 airchanges per hour.


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DRA 13

HVAC

The classification should be achieved in the

state as specified:

"As built" Bare room, without equipment or personnel in

operation.


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DRA 14

HVAC

The classification should be achieved in the state

as specified :

"At rest" Equipment may be operating, but no operators

present


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DRA 15

HVAC

The classification should be achieved in the

state as specified :

"In operation" Normal production process with equipment and

personnel,

Clean up time validated normally in the order of

20 minutes


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DRA 16

HVAC

Control of contaminantsExternal contaminants removed through

effective filtration

Internal contaminants controlled throughdilution and flushing, or displacement

airflow

Airborne particulates and level of filtrationconsidered critical


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DRA 17Therapeutic risks

ManufacturingEnvironment

requirements

CleanroomClass

A/B

CleanroomClassC

Cleanrm.C

lassD

O

thers

HVAC


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DRA 18

HVAC

Level of protection and air cleanlinessdetermined according to:

Product to be manufactured

Process to be usedProduct susceptibility to degradation


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DRA 19

Parameters influencing Levels ofProtection

qNumber of particles in the air, number ofmicro-organisms in the air or on surfaces

qNumber of air changes for each roomqAir velocity and air flow pattern

qFilters ( type, position )

qAir pressure differentials between roomsqTemperature, relative humidity

HVAC


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DRA 20

Tools to help achieve the desired Level of Protection

Air Handling

System

Production Room

With

Defined

Requirements

Supply

AirOutlet

Air

HVAC


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DRA 21

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, properchangingrooms)

validated sanitationadequate transfer procedures for materials and

personnel

HVAC


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DRA 22

Cleanroom Class

defined by

Critical Parameters

Air HandlingSystem

Additional Measures

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

HVAC


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DRA 23

Examples of Levels of ProtectionTypes 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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DRA 25

HVAC

Examples of levels of protectionLevel Condition Example of area

Level 1 General Area with normal housekeeping e.g.

warehouse

Level 2 Protected Area where steps are taken to protectexposed material/product e.g. dispensing

Level 3 Controlled Area with defined, controlled, monitoredenvironmental conditions to preventcontamination and degradation


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DRA 26

All operations within a pharmaceutical facililityshould be correlated to well-defined clean roomclasses, and can be included 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


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DRA 27

q Description of design, installation and functions

q Specifications, requirements

q

Manualsq Operating procedures

q Instructions for performance control, monitoring

and recordsq

Maintenance instructions and recordsq Training of personnel

q program and records

Documentation requirements to assist in

commissioning, qualification and maintenance

HVAC


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DRA 28

HVACSchedule of tests to demonstrate continuing compliance

Test Parameter Objective Maximum time interval Test procedure* and key aspects

Particle count test Verifies cleanliness 6 months or 12 monthsdepending on Class

Particle counter.Readings and positions

Air pressure difference Absence of cross-contamination

12 months Measure pressuredifference

Airflow volume Verify air change rates 12 months Measure supply andreturn air, calculate airchange rate

Airflow velocity Verify unidirectionalairflow and orcontainment condition

12 months Velocity measurement

*Test procedure as per ISO 14644


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DRA 29

HVAC

Recommended optional strategic testsTest Parameter Objective Maximum time

intervalTest procedure* andkey aspects

Filter leakage Verify filter integrity 12 months Filter media and filter seal integrity

Containment leakage Verify absence ofcross-contamination

12 months Airflow direction andpressure differential

Recovery (time) Verify clean-up time 12 months Time taken maximum15 minutes

Airflow visualization Verify required airflowpatterns

12 months Airflow direction,documented evidence

*Test procedure as per ISO 14644


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DRA 30

Air handling systems:

q Play a major role in the quality of pharmaceuticals

q Should be designed properly, by professionals

q Should be treated as a critical system

Conclusion

HVAC

Air Handling System New

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