HVAC | Slide 1 of 27 2013 Heating, Ventilation and Air- Conditioning (HVAC) Part 4: Commissioning, qualification and maintenance Supplementary Training

HVAC | Slide 1 of 27 2013

Heating, Ventilation and Air-

Conditioning (HVAC)

Part 4:

Commissioning, qualification and

maintenance

Supplementary Training Modules on Good Manufacturing Practice

Section 8

WHO Technical Report Series, No. 961, 2011. Annex 5


HVACHVAC

Objectives

To understand key issues in

commissioning,

qualification and

maintenance of HVAC systems

8.


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 in commissioning, qualification and maintenance

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HVACHVAC

Commissioning

Commissioning (is integrated in qualification) and includes:

Setting up, balancing, adjustment and testing of entire HVAC system

It helps to ensure it meets URS and capacity

Acceptable tolerances for parameters set before commissioning

Precursor to qualification8.1.1, 8.1.4, 8.1.6


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Commissioning (2)

Records and data include:

Installation records – documented evidence of measured capacities of the system

Acceptance criteria set for system parameters

Training of personnel (e.g. operation and maintenance)– O&M manuals, schematic drawings, protocols, reports

8.1.2, 8.1.3, 8.1.5


HVACHVAC

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.

Risk-based approach for HVAC qualification

See also full guidelines on "Validation" in WHO TRS No 937, 2005, Annex 4.

8.2.1


HVACHVAC

Qualification

Described in a Validation Master Plan (VMP)

Reflects the nature and extent, test procedures, 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


HVACHVAC

Qualification

Direct impact components and critical parameters should be included

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

Acceptance criteria and limits defined in design stage

Design conditions, normal operating ranges, operating ranges, alert and action limits

8.2.6 - 8.2.11


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Design conditions and normal operating ranges set to achievable limits

OOL results recorded and investigated

8.2.10 – 8.2.12

A C TIO N LIM IT

A LERT LIM ITA LERT LIM IT

A C TIO N LIM IT

O perating Range - Validated Acceptance Criteria

Norm al O perating Range

Design Condition


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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


HVACHVAC

Qualification

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)

8.2.13


HVACHVAC

Qualification

Typical parameters to be included in qualification (based on risk assessment) (2):

Room air flow patterns

Room clean-up rate

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

HEPA filter penetration tests

Containment system velocity

Warning/alarm systems 8.2.13.


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Conduct of the tests:

Time intervals and procedure to be defined by the manufacturer - based on risk assessment (influenced by the type of facility and level of protection)

See also ISO 14644 for procedures

Requalification, and change control

Documents: system airflow schematics, room pressure cascade drawings, zone concept drawings, air-handling system allocation drawings, particle count mapping drawings

8.2.14 – 8.2.18


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Qualification

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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Schedule of tests to demonstrate continuing compliance

*Test procedure as per ISO 14644 8. Table 3

Test ParameterObjectiveConsiderationsTest procedure* and key aspects

Particle count testVerifies cleanlinessNumber of readings and positions

Particle counter. Readings and positions

Air pressure difference

Absence of cross-contamination

Continuous. Defined limits

Measure pressure difference

Airflow volumeVerify air change rates

See ISO 14644Measure supply and return air, calculate air change rate

Airflow velocityVerify unidirectional airflow and or containment condition

Velocity and containment

Velocity measurement


HVACHVAC

Recommended optional strategic tests

*Test procedure as per ISO 14644 8. Table 3

Test ParameterObjectiveConsiderationsTest procedure* and key aspects

Filter leakageVerify filter integrityFor HEPA filtersFilter media and filter seal integrity

Containment leakageVerify absence of cross-contamination

Containment, smoke and air pressure

Airflow direction and pressure differential

Recovery (time)Verify clean-up timeCertain classesTime taken maximum 20 minutes

Airflow visualizationVerify required airflow patterns

Clean to dirty area, uniformly. Video

Airflow direction, documented evidence


Cleanroom monitoring program (1)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

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Cleanroom monitoring programme (2)Particles and Microbiological contaminants

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

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See also ISO 14644


Cleanrooms should be monitored for microorganisms and particles

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S e rv i c e R o o m

W a re h o u se

A/ L

ock 1

Air L

ock 2

A i r S h o w e r

S a m p l i n gR o o o m S e rv i c e C o rr i d o r

(contains Vacuum & RO water supply)

W e i g h i n g T a b l e t 1 T a b l e t 2 L i q u i d s M i x S o f t g e l C a p su l eP a c ki n g

Em ergencyExit

C l e a n C o rr i d o r

E q u i p m e n t W a sh

A i r L o c k 3

S t e ri l e e y e d ro p sd i sp e n si n g

& a c e p t i c f i l l i n g

2 S t a g ep e rso n n e l

e n t ry f o re y e d ro p s

M a l eC h a n g e 2


F e m a l eC h a n g e 1


P a c ke dG o o d s

Q u a ra n t i n e

A i r L o c k 4

P ri m a ry & S e c o n d a ryP a c ki n g

Example of a sampling points


Qualification – examples of aspects to consider in qualification (OQ, PQ)

Qualification – examples of aspects to consider in qualification (OQ, PQ)

Test

Differential pressure on filters

Turbulent / mixed airflow

Description 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)

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HVACHVAC

Maintenance

Procedure, programme and records for planned, preventative maintenance

– e.g. cleaning of filters, calibration of devices

Keep O&M manuals, drawings etc.

Appropriate training for personnel

Change of HEPA filters by suitably trained persons

Impact of maintenance on:– Product quality and Qualification

8.3.1 – 8.3.6


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Premises may influence HVAC design / performance. Therefore consider:

Adequate airlocks, change rooms, passages

Required pressure cascades

Detailed diagrams available with pressure cascades, air flow directions and flow routes for personnel and materials should be prepared and maintained;

Change room classification9


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

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Appropriate design of AHUs and HVAC system

Correct components, and MOC

Ensuring appropriate cleanliness of air, environmental conditions

(e.g. temperature and RH), and area classification to prevent

contamination and cross-contamination

Qualification data to support claims

Regular calibration, maintenance and cleaning

Take home message. What is essential?

HVAC


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

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Group Session

S e rv i c e R o o m

W a re h o u se

A/ Lo

ck 1

Air L

ock 2

A i r S h o w e r

S a m p l i n gR o o o m S e rv i c e C o rr i d o r

(contains V acuum & RO water supply)

W e i g h i n g T a b l e t 1 T a b l e t 2 L i q u i d s M i x S o f t g e l C a p su l eP a c ki n g

Em ergencyExit

C l e a n C o rr i d o r


A i r L o c k 3


& a c e p t i c f i l l i n g

2 S t a g ep e rso n n e l

e n t ry f o re y e d ro p s





P a c ke dG o o d s

Q u a ra n t i n e

A i r L o c k 4

P ri m a ry & S e c o n d a ryP a c ki n g

HVAC


Group Session – modified layout

S e c o n d a ryP a c ki n g

30P a

0P a

20P a 30P a

0P a0P a

10P a

10P a 10P a

20P a20P a

40P a

50P a

60P a

50P a

40P a

15P a

15P a

P ri m a ryP a c ki n g

C h a n g e

M A L 3

A i r L o c k

30P a

P o stS t a g i n g

30P a

30P a

0P a

15P a15P a

20P a

20P a

30P a

20P a

0P a

10P a

S e rv i c e R o o mA i r L o c k 4

P a c ke dG o o d s

Q u a ra n t i n e





P A L


& a sc e p t i c f i l l i n g

M A L 4


C l e a n C o rr i d o rEm ergency

Exit

S o f t g e l C a p su l eP a c ki n gL i q u i d s M i xT a b l e t 2T a b l e t 1

W e i g hB o o t h

(contains V acuum & RO water supply)S e rv i c e C o rr i d o r

S a m p l i n gR o o o m

A i r S h o w e r

MAL

2

MAL

1

W a re h o u se

MAL = Material Air Lock

PAL = Personnel Air Lock

HVAC