Hvac Part3

5/23/2018 Hvac Part3

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HVAC | Slide 1 of 28 May 2006

Heating, Ventilation and

Air-Conditioning (HVAC)

Part 3:

Commissioning, Qualification,

and maintenance

Supplementary Training Modules on

Good Manufacturing Practice


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HVAC

Objectives

To understand key issues in

commissioning,

qualification and

maintenanceof HVAC systems

8.


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Description of design, installation and functions

Specifications, requirements

Manuals Operating procedures

Instructions for performance control, monitoring and records

Maintenance instructions and records

Training of personnel

programme and records

Documentation requirements to assist incommissioning, qualification and maintenance

HVAC


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HVAC

Commissioning Precursor to qualification

Includes setting up, balancing, adjustment and testing of entire

HVAC system to ensure it meets requirements in URS and

capacity

Acceptable tolerances for parameters

Training of personnel

8.1.1, 8.1.4, 8.1.5


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HVAC

Commissioning (2)Records and data maintained include:

Installation records documented evidence of measure

capacities of the system

Data: Design and measurement for, e.g. airflow, system

pressures

O&M manuals, schematic drawings, protocols, reports

8.1.2, 8.1.3,8.1.6


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HVAC

Qualification Validation is an extensive exercise

Qualification of the HVAC system is one component in the

overall approach that covers premises, systems/utilities,

equipment, processes, etc.

See also full guidelines on "Validation" in WHO TRS No 937,

2005, Annex 4.

Risk-based approach for HVAC qualification

8.2.1


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HVAC

Qualification (2) Described in a Validation Master Plan (VMP)

VMP to include the nature and extent of tests, and

protocols

DQ, IQ, OQ, and PQ

Risk analysis to determine critical and non-critical

parameters, components, subsystems and controls

8.2.2 - 8.2.5


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HVAC

Qualification (3) Direct impact components and critical parameters should

be included

Non-critical systems and components are subjected toGood Engineering Practices (GEP)

Acceptance criteria and limits defined in design stage

Design conditions, normal operating ranges, operating

ranges, alert and action limits

8.2.5 - 8.2.11


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HVAC

Design

conditions

and normal

operating

ranges set to

achievable

limits

OOS results

recorded

8.2.128.2.15

ACTION LIMIT

ALERT LIMITALERT LIMIT

ACTION LIMIT

Operating Range - Validated Acceptance Criteria

Normal Operating Range

Design Condition


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HVAC

Qualification

examples of aspects to consider

DQ Design of the system, URS

(e.g. components, type of air treatment needed, materials

of construction)

IQ Verify installation

e.g. relevant components, ducting, filters, controls,

monitors, sensors, etc.

includes calibration where relevant


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HVAC

Qualification (4)

Typical parameters to be included in qualification (based

on risk assessment):

Temperature

Relative humidity

Supply, return and exhaust air quantities

Room air change rates

Room pressures (pressure differentials)

8.2.17


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HVAC

Qualification (5)Typical parameters to be included in qualification (based on

risk assessment) (2):

Room clean-up rate

Particulate matter, microbial matter (viable and non-viable)

HEPA filter penetration tests

Containment system velocity

Warning/alarm systems

8.2.17.


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HVAC

Qualification (6)Conduct of the tests:

Time intervals and procedure to be defined by the

manufacturer

Influenced by the type of facility and level of protection

See also ISO 14644 for methods of testing

Requalification, and change control8.2.188.2.20, 8.2.9


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HVAC

Qualification (7) Tests performed according to protocols and procedures

for the tests

Results recorded and presented in report (source data

kept)

Traceability, e.g. devices and standards used, calibration

records; and conditions specified


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HVAC

Schedule of tests to demonstrate continuing compliance

*Test procedure as per ISO 14644 8. Table 3

Test p rocedure*

and key aspects

Maximum t ime

interval

Object iveTest Parameter

Particle counter.

Readings and

positions

6 months or 12

months depending on

Class

Verifies cleanlinessParticle count test

Measure pressuredifference

12 monthsAbsence of cross-contamination

Air pressuredifference

Measure supply and

return air, calculate

air change rate

12 monthsVerify air change

rates

Airflow volume

Velocity

measurement

12 monthsVerify unidirectional

airflow and orcontainment condition

Airflow velocity


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HVAC

Recommended optional strategic tests

*Test procedure as per ISO 146448. Table 3

Test p rocedure*

and key aspects

Maximum t ime

interval

Object iveTest Parameter

Filter media and filter

seal integrity

12 monthsVerify filter integrityFilter leakage

Airflow direction and

pressure differential

12 monthsVerify absence of

cross-contamination

Containment leakage

Time taken maximum

15 minutes

12 monthsVerify clean-up timeRecovery (time)

Airflow direction,

documented evidence

12 monthsVerify required airflow

patterns

Airflow visualization


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Cleanroom monitoring program (1) Routine monitoring program as part of quality assurance

Additional monitoring and triggers, e.g.

1.Shutdown

2.Replacement of filter elements

3.Maintenance of air-handling systems

4. Exceeding of established limits

HVAC


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Cleanroom monitoring programme (2)Particles and Microbiological

contaminants

Number of points/locations for monitoring determined, specified,documented in procedure and or protocol

Sufficient time for exposure, and suitable sample size

Identification and marking of sampling points

Definition of transport, storage, and incubation conditions

Results to reflect the procedure/protocol followed Define alert and action limits as a function of cleanliness

zone/class

HVAC

See also ISO 14644


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air

Example of a sampling point

Cleanroom monitoring program (3)Cleanrooms should be monitored for microorganisms and

particles

HVAC


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Definition of Conditions

air

as built

air air

at rest in operation

HVAC


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Qualification

examples of aspects to consider inqualification (OQ, PQ)

Test

Differential pressure on filters

Turbulent / mixed

airflowDescription

Uni-directional

airflow / LAF

Room differential pressure

Airflow velocity / uniformity

Airflow volume / rate

Parallelism

Airflow pattern

2 2

N/A 2, 3

2, 3 Optional

2 2

2 N/A

2 3

1 := As built (ideally used to perform IQ)

2 = At rest (ideally used to perform OQ)

3 = Operational (ideally used to perform PQ)

HVAC


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Test Turbulent /mixed airflow

DescriptionUni-directionalairflow / LAF

Recovery time

Room classification (airborne

particle)

Temperature, humidity

N/A 2

2 2,3

N/A 2,3

1 := As built (ideally used to perform IQ)

2 = At rest (ideally used to perform OQ)

3 = Operational (ideally used to perform PQ)

HVAC

Qualification

examples of aspects to consider inqualification (OQ, PQ)


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HVAC

Maintenance Procedure, programme and records for planned, preventative

maintenance

e.g. cleaning of filters, calibration of devices

Appropriate training for personnel

Change of HEPA filters by suitably trained persons

Impact of maintenance on:

Product quality

Qualification8.3.18.3.5


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Verification of design documentation, including

description of installation and functions

specification of the requirements

Operating procedures Maintenance instructions

Maintenance records

Training logs

Environmental records

Discussion on actions if OOS values On site verification (walking around the site)

Inspecting the air-handling system

HVAC


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Air-handling systems:

Play a major role in the quality of pharmaceuticals

Should be designed properly, by professionals

Should be treated as a critical system

Conclusion

HVAC


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This series of explanations will now be followed by:

Group discussion, with a simple exercise Short test

Further proceedings

HVAC


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Group Session

Service Room

Warehouse

A/Lock1

AirLock2

Air Shower

Sampling

Rooom Service Corridor

(contains Vacuum & RO water supply)

Weighing Tablet 1 Tablet 2 Liquids Mix Softgel Capsule

Packing

Emergency

Exit

Clean Corridor

Equipment Wash

Air Lo ck 3

Sterile eyedrops

dispensing

& aceptic filling

2 Stage

personnel

entry for

eyedrops

Male

Change 2

Male

Change 1

Female

Change 1

Female

Change 2

Packed

Goods

Quarantine

Air Lo ck 4

Primary & Secondary

Packing

HVAC


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Group Sessionmodified layout

Secondary

Packing

30Pa

0Pa

20Pa 30Pa

0Pa0Pa

10Pa

10Pa 10Pa

20Pa20Pa

40Pa

50Pa

60Pa

50Pa

40Pa

15Pa

15Pa

Primary

Packing

Change

MAL 3

Air Lo ck

30Pa

Post

Staging

30Pa

30Pa

0Pa

15Pa15Pa

20Pa

20Pa

30Pa

20Pa

0Pa

10Pa

Service RoomAir Lock 4

Packed

Goods

Quarantine

Female

Change 2

Female

Change 1

Male

Change 1

Male

Change 2

PAL

Sterile eyedrops

dispensing

& asceptic filling

MAL 4

Equipment Wash

Clean Corridor

Emergency

Exit

Softgel Capsule

PackingLiquids MixTablet 2Tablet 1

Weigh

Booth

(contains Vacuum & RO water supply)

Service Corridor

Sampling

Rooom

Air Shower

MAL2

MAL1

Warehouse

MAL = Material Air Lock

PAL = Personnel Air Lock

HVAC

Documents

Hvac Part3