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List of Protocols

1.0          PURPOSE

The purpose of Performance Qualification is to confirm through the provision of objective evidence, that the performance requirements for the Heating Ventilated and Air Conditioning System meet its intended use. 

2.0          SCOPE

The Performance Qualification Protocol cum report applicable to Heating Ventilated and Air Conditioning System which includes air handling unit, ventilation system and exhaust system catered to Manufacturing Section. 

3.0 SUMMARY OF TEST PERFORMANCE, ITS RATIONALE AND ACCEPTANCE CRITERIA

Sr. No.

Name/Title of Test

Rationale /Reference

for Test

Rationale /Reference for Acceptance Criteria

Frequency

1

Measurement of Air Flow Velocity      

To measure airflow velocity, uniformity and supply airflow rates in clean rooms.

In-house specification.

Once

2

Measurement of Number of Air Changes per Hour

[Air Exchange Rate]

The measurement of air exchange rate is carried out to ascertain the air volume supplied to the clean room per hour and to ensure sufficient quantity of fresh air enters in each room.

Minimum number of air sweeps in a clean room is based on the room design, to flush the prevailing air so as to minimize the ingress of air borne particle contamination.

Once

3

Filter System Leakage Test

To confirm that the filter system is properly installed and that leaks have not developed during installation/use.

According to the ISO – 14644 series guidelines on air cleanliness.

Once

4

Non – viable particle count monitoring

This is to provide the overall cleanliness and classification of the environment with respect to the concentration of nonviable particles.

Based on stringent air classification limits, the acceptance criteria for nonviable particle concentration have been fixed.

Consecutive

3 Days

5

Viable count (Microbial) monitoring

The purpose of this test is to provide overall cleanliness and classification of the environment with respect to the concentration of viable particles.

Based on stringent EU air classification, the acceptance criteria for viable particle concentration have been fixed.

Consecutive

3 Days

6

Air Flow Pattern

The purpose of this test is to demonstrate the flow of air from high pressure zone to lower pressure zone area or more clean zone to less clean zone in order to avoid thecontamination/cross contamination

According to the ISO – 14644 series guidelines on air cleanliness

Once

7

AHU Recovery study

The purpose of the test is to establish how long it takes for the cleanroom to recover from a challenge concentration to the Target Cleanliness Level. The ISO 14644-3

Recovery time for ISO 8 Class is not more than 15 minutes

Once

8

Relative Humidity

The purpose of this test is to verify moisture (expressed as relative humidity or dew point) levels are within the control limits over the time period.

Relative Humidity Should not more 55 %

Consecutive

3 Days

9

Temperature

The purpose of this test is to verify the air temperature levels are within the control limits over the time

period specified by the customer for the area being tested

Temperature not more 27 °C

Consecutive

3 Days

10

Differential Pressure

The purpose of the air pressure difference test is to verify the capability of the cleanroom air movement system to maintain the specified pressure differential between the clean room and its surroundings

WHO TRS 961, Annex 6,

WHO TRS1044- Annex 2

Consecutive

3 Days

11

Containment Study

This test is performed to determine if there is intrusion of unfiltered air into the clean room or clean

zone(s) from outside the clean room or clean zone enclosure(s) through joints, seams, doorways and

pressurized ceilings

According to the ISO – 14644 series guidelines on air cleanliness. Leakage should not more than 0.01 % of Challenge Concentration

Once

 

12

Segregation test

The purpose of this test is to assess the separation effectiveness achieved by a specific airflow,

challenging the lesser classified area with particles and determining the particle concentration in the

protected area at the other side of the segregation.

• Grade C, The Particle Concentration is reduced by a factor of 10.

• Grade B, The Particle concentration is reduced by a factor of 100.

Once

 

 

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Installation Qualification Protocol For Air Handling Unit| IQ Protocol for AHU

1.0 Overview

The Installation Qualification of Air Handling Unit is carrying out in order to provide the high degree of assurance that the equipment installed as per vendor recommendation and design specification.

1.1 Purpose

The purpose is to provide an outline for the Installation Qualification of equipment for static attributes to verify that:

  • The system meets the Design Specification / Qualifications.

  • Document the verification of all aspect of the equipment.

  • The Air Handling Unit installed as per manufacturers /in house specification.

  • No unauthorized or unrecorded modifications have taken place.

  • Assure that Air Handling Unit is adequate to support the process for which the system is intended.

​1.2 Background

The Air Handling Unit supplied by XXXXXXXXXXXXXXXX., Equipment I.D. XXXXXXXX installed at XXXXXXXXXXX. This protocol defines the methods and documentation that shall be use to evaluate the static attributes of Air Handling Unit in accordance with the design specifications and intended use.

3.0 Installation Qualification Procedure

The following procedure shall be used for Installation of Air Handling Unit:

  • Training shall be imparted to the concerned personal on Installation Qualification protocol.

  • Availability of calibration certificates of all the attached instruments shall be checked and recorded

  • Identification, location and Specification (Make, Model, Sr. No. Capacity etc.) of the equipment shall be verified.

  • Major component installation (Make, Model, Sr. No. etc) shall be verified.     

  • Verification of Supporting Utilities shall be done.

  • Verification of Material of Construction shall be verified.

  • Identification of Critical Instruments for Calibration shall be done.

  • Any deviation observed during qualification shall be recorded in the observed deviation, corrective action and justification report section.

  •  Observed deviation shall be reported to the department head and quality head.

  • If the observed deviation does not have any major impact on the qualification the final conclusion shall be provided.

  • If the observed deviation has major impact on the qualification, deviation shall be reported to the manufacturer for the corrective action and qualification activity shall be done.

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Installation Qualification Report For Air Handling Unit| IQ Report for AHU

1.0 Purpose

The purpose of this report is to provide the documented evidence that the Installation Qualification of equipment is adequate to support the process for which the system is intended and system meets the Design Specification / Qualifications.

2.0 Scope

This Installation Qualification report is limited to the Air Handling Unit supplied by XXXXXXXXXXXXXXX., Equipment I.D. XXXXXXXXXXXX installed in packing area at XXXXXXXXXXXXX.

3.0 Reference Document:

Installation Qualification report raw data sheet (Annexure-I)

4.0 Installation Qualification Test, Observation and Results:

All the observation recorded in the data sheet are summarized in this report in below mentioned sections.

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Operational Qualification Protocol For Air Handling Unit| OQ Protocol for AHU

1.0 Overview

The Operational Qualification of Air Handling Unit is carrying out in order to provide the high degree of assurance degree that the equipment operated as per functional specification.

2.0 Purpose

The purpose is to provide an outline for the Operation Qualification of equipment for dynamic attributes to verify that:

  • The system meets the Functional Specification / Qualifications.

  • Document the verification of all aspect of the equipment.

  • The Air Handling Unit operated as per manufacturers /in house specification.

  • No unauthorized or unrecorded modifications have taken place.

  • Assure that Air Handling Unit is adequate to support the process for which the system is intended.

3.0 Background

The Air Handling Unit supplied by XXXXXXXXXXXXXX., Equipment I.D. XXXXXXXXXX installed at XXXXXXXXXXXX. This protocol defines the methods and documentation that shall be use to evaluate the dynamic attributes of Air Handling Unit in accordance with the functional specifications and intended use.

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Operational Qualification Report For Air Handling Unit| OQ Report for AHU

1.0 Purpose

The purpose of this report is to provide the documented evidence that the Operational Qualification of equipment is adequate to support the process for which the system is intended and system meets the functional Specification / Qualifications.

2.0 Scope

This Operational Qualification report is limited to the Air Handling Unit supplied by XXXXXXXXXXXXXXXX. , Equipment I.D. XXXXXXXXXXX installed at XXXXXXXXXXXXX.

3.0 Reference Document:

Operational Qualification report raw data sheet (Annexure-I)

4.0 Operational Qualification Test, Observation and Results:

All the observation recorded in the data sheet is summarized in this report in below mentioned sections.

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Performance Qualification Protocol and Report for Air Handling Unit| PQ Protocol cum Report for AHU

1.0 Overview

The Performance Qualification of Air Handling Unit is carrying out in order to provide the high degree of assurance degree that the equipment performs as intended.

1.1 Purpose

The purpose of Performance Qualification is to confirm through the provision of objective evidence, that the performance attributes and to verify that:

  • The system meets the user requirement Specification.

  • Document the verification that equipment performs consistently and in the state of control.

  • Assure that Air Handling Unit is adequate to maintained the clean room requirement for which the system is intended.

2.0 Background

The Air Handling Unit supplied by XXXXXXXXXXX., Equipment I.D. XXXXXXXXXX installed at XXXXXXXXXXX. This protocol defines the methods and documentation that shall be use to evaluate the performance attributes of Air Handling Unit in accordance with the user requirement specifications and intended use.

3.0 SUMMARY OF TEST PERFORMANCE, ITS RATIONALE AND ACCEPTANCE CRITERIA

Sr. No.

Name/Title of Test

Rationale /Reference

for Test

Rationale /Reference for Acceptance Criteria

Frequency

1

Measurement of Air Flow Velocity      

To measure airflow velocity, uniformity and supply airflow rates in clean rooms.

In-house specification.

Once

2

Measurement of Number of Air Changes per Hour

[Air Exchange Rate]

The measurement of air exchange rate is carried out to ascertain the air volume supplied to the clean room per hour and to ensure sufficient quantity of fresh air enters in each room.

Minimum number of air sweeps in a clean room is based on the room design, to flush the prevailing air so as to minimize the ingress of air borne particle contamination.

Once

3

Filter System Leakage Test

To confirm that the filter system is properly installed and that leaks have not developed during installation/use.

According to the ISO – 14644 series guidelines on air cleanliness.

Once

4

Non – viable particle count monitoring

This is to provide the overall cleanliness and classification of the environment with respect to the concentration of nonviable particles.

Based on stringent air classification limits, the acceptance criteria for nonviable particle concentration have been fixed.

Consecutive

3 Days

5

Viable count (Microbial) monitoring

The purpose of this test is to provide overall cleanliness and classification of the environment with respect to the concentration of viable particles.

Based on stringent EU air classification, the acceptance criteria for viable particle concentration have been fixed.

Consecutive

3 Days

6

Air Flow Pattern

The purpose of this test is to demonstrate the flow of air from high pressure zone to lower pressure zone area or more clean zone to less clean zone in order to avoid the contamination/ cross contamination

According to the ISO – 14644 series guidelines on air cleanliness

Once

7

AHU Recovery study

The purpose of the test is to establish how long it takes for the cleanroom to recover from a challenge concentration to the Target Cleanliness Level. The ISO 14644-3

Recovery time for ISO 8 Class is not more than 15 minutes

Once

8

Relative Humidity

The purpose of this test is to verify moisture (expressed as relative humidity or dew point) levels are within the control limits over the time period.

Relative Humidity Should not more 55 %

Consecutive

3 Days

9

Temperature

The purpose of this test is to verify the air temperature levels are within the control limits over the time

period specified by the customer for the area being tested

Temperature not more 27 °C

Consecutive

3 Days

10

Differential Pressure

The purpose of the air pressure difference test is to verify the capability of the cleanroom air movement system to maintain the specified pressure differential between the cleanroom and its surroundings

WHO TRS 961, Annex 6,

WHO TRS1044- Annex 2

Consecutive

3 Days

 

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