HVAC Validation Protocol PPT
Protocol Approval
This is a specific protocol for Performance Qualification of
HVAC System for Pharmaceutical Filling Area.
This protocol has been approved by the following:
Final Approval
Final approval has been given by the following:
Name Signature Date
Approved By
(Plant Head)
Approved By
(Head – QA)
2.0 Overview
2.1 Objective:
To establish the methodology for the Performance
Qualification of, HVAC System of Pharmaceutical Filling Area.
2.2 Purpose
and Scope for HVAC Validation Protocol PPT
The purpose is to provide an outline for the Performance of
equipment for its intended use:
•Demonstrate that the HVAC system shall perform reproducibly
and consistently within its full dynamic range of operation according to
pre-laid specifications.
•The HVAC system shall be able to perform in worst cases.
•Assure that the HVAC system Performance shall be adequate
to support the process for which the system is intended.
•Ensure that the system shall be included in preventive
maintenance program.
The scope of this Qualification exercise is limited to the
Performance Qualification of Heating, Ventilation & Air-Conditioning (HVAC)
System, supplying controlled air to the Pharmaceutical Filling Area.
Responsibility
• Protocol
/ Report Preparation: Engineering
Executive, QA Executive and Service Engineer
• Approval
of Protocol / Report: QA Manager
• Execution
of Qualification Activity: Engineering Executive, Service Engineer
2.4Qualification Team:
•User Department Executive / Manager
•Project Executive / Manager
•Validation Manager
•Quality Assurance Manager
3.0 Training
Record
3.1 Purpose
The purpose of the training is to familiarize the trainees
with the Performance Qualification, Performance Qualification procedure,
Documentation Procedure and Overall Strategy of Performance Qualification.
3.2 Scope
This Training is applicable to the HVAC System for Pharmaceutical
Filling Area.
3.3 Topics
The following topics shall be covered during training:
• Performance
Qualification Procedure.
• Documentation
Practices for filling of report.
• Overall
strategy of Qualification process.
• General
precautions / guidelines to be followed during Qualification.
Note:
• Training
shall be given as per SOP Title: __________________________
___________________________________________________________
SOP No.:
____________________________________.
• Attach
training record with the report as Annexure - 01
Pre – Performance Qualification Requirements
Following instruments shall be required for the Performance
Qualification of HVAC System for Pharmaceutical Filling Area.
S. No. Equipment
Name Equipment Code / S. No. Calibration Certificate No. Calibration Due On
1. Thermometer
2. Hygrometer
3. Smoke
Generator
4. Anemometer
5. Particle
counter
6. Aerosol
Photometer
5.0 System /
Equipment Description -HVAC Validation Protocol PPT
5.1 System /
Equipment details
The Heating, Ventilation & Air-Conditioning (HVAC)
System, supplying controlled air to the critical area in Pharmaceutical Filling
Area.in the First floor of Production Block, consists of the following Fourteen
separate HVAC subsystems:
5.2 Generic
Design of all HVAC systems:
5.2.1 General HVAC
sub-system description –
There are two types of sub system in Pharmaceutical Filling Area.
5.2.1.1 HVAC with dehumidifier -
These subsystems supply dehumidified air to the Pharmaceutical
Filling Area.. Each of these units consists of Dehumidifier and double skin AHU
body. These heavy gauge CRCA steel and powder coated Dehumidifier units
consists of process and reactivation fans, motors, the silicon seals, Desiccant
Rotor, RH and Temp indicators, RH and Temp dual sensors, Microprocessor based
PLC, filters, Reactivation Heaters, Treated Fresh Air is supplied as fresh air
in the system.
The AHU consists of pre-filter section, chilled water coil,
Hot water coil, blower, and Fine filter section. Chilled water and hot water
shall be circulated in the coils to attain the required Temp. & RH
conditions. Automatic control valves are provided to control the required flow
of Chilled water and hot water. There are two systems catering to the Pharmaceutical
Filling Area..
Brief descriptions of the systems are as follows:
1. This subsystem
supplies air to the Filling Area. The process air and reaction air sections,
separately with individual process and reactivation fan and motor. Regeneration
is done with the help of electrical heaters. The fresh air coming from Treated
fresh air unit is supplied to the system. Process air is passed through 70 %
portion of the fluted rotor, it absorbs moisture from the process air and dry
air is send to the AHU. Heat applied to the remaining 30 % of the rotor surface
to reactivate the desiccant material. The hot air will take away the moisture
from rotor. The rotor is externally sealed and divided with the help of silicon
seals into 70% and 30% for process and reactivation zones respectively. The
rotor spins slowly between the seals and with the help of drive motor.
Dehumidifier has capacity of 2600 and 825 CFM and humidity of 25% ± 5% is
supplied to the process area. Around 10 % of fresh air is sucked in to the
areas to maintain the sufficient oxygen levels in the working area through
Treated Fresh Air unit and approximately 90% of the air is re-circulated,
through the return air risers. The system consists of a blower fans of 31524
CFM capacity. The air is then passed through cooling coils and hot water coils,
with chilled brine and hot water circulation, having 12.7 TR capacities, for
cooling. The air is then filtered through pre filters having an efficiency of
95% down to 5-micron filtration level of standard BSEN 779. The controlled air
is further filtered through Fine filters having an efficiency of 95% down to
3-micron filtration level of standard
BSEN 779. Automatic valves have been
provided in the chilled brine and hot water piping to control chilled brine and
hot water flow. This area is provided with 99.97% down to 0.3 -micron HEPA
filters located terminally in the areas.
5.2.2 Data Sheet
for all Systems
5.2.3 General System Description
The objective of the HVAC system is to control the
environment of areas as per the design specifications / URS supplied by NLL.
Following provisions have been accommodated in the design to accomplish the
job:
• For this
job Air Conditioned rooms are classified as Comfort zone and Class D.
• Air
Handling Units have been installed on the service floor; which provide air
conditioning to various specified areas.
• Airflow
Control Dampers are provided at each outlet to ensure air balancing and the
desired pressure gradient between (VCD) the rooms if required.
• Duct
fabrication is as per SMACNA/ISS standards.
• Fire
Dampers are provided in the Return air duct as safety measures for all AHU’s.
• Chilled
Water, generated at 7 deg C by the chillers in the Utility Room, is circulated
through MS heavy duty (Class C) pipes to various AHU ’s. Butterfly valves are
provided at in/out for isolation.
• Balancing
Valves, Strainers are provided to ensure adequate flow of chilled water through
cooling coils. The Two-way Motorized Valves control the chilled water flow
based on return air temperature sensor input, in order to maintain the desired
temperature in the process room.
• Strip
Heaters are provided with thermostats at 60 deg C and located at Service area
in order to maintain the desired Relative humidity in the process room.
• Drain
lines are provided in the AHU with U traps and adequate slope towards the main
water drain.
• Chilled
water piping is insulated with Expanded Polystyrene thin film.
• Dehumidifiers
have been installed on the service floor; which provide dehumidified air to
various specified AHU’s.
• Volume
control dampers are provided at each outlet of the process air, inlet of fresh
air and in between the tapping of the room return air from the return air duct
and the process air outlet joining point on the return air duct to ensure air
balancing.
• Canvas
with zip lock is provided at inlet and outlet ducts of the dehumidifier to
measure and adjust the airflow in to the dehumidifier.
• Duct
fabrication is as per SMACNA/ISS standards.
• Chilled
Water, generated at 6 deg C by the chillers in the Utility Room, is circulated
through MS heavy duty (Class C) pipes to various Dehumidifier’s.
• Steam is
circulated through MS heavy duty (Class C) pipes to various AHU ’s. Ball valves
are provided at in/out for isolation.
• Drain
lines are provided in the Dehumidifiers with U traps and adequate slope towards
the main water drain.
• Chilled
water piping is insulated with Expanded Polystyrene thin film and the Steam
piping is insulated with PUF insulation.
5.3 Safety
Features Description - HVAC Validation Protocol PPT
1. Fire
Dampers:
Fire Damper is provided in the return air duct of the HVAC
system, which when senses the smoke closes the Damper during fire, as per the
input signal from smoke sensor.
2. Temperature
High Alarm:
The reactivation temperature goes beyond the set point the
safety thermostat is cut off the heaters and gives indication to PLC to
activate the alarm.
3. Process /
Reactivation Motor Tripped:
The process / Reactivation motor burned or stopped the PLC
gives display of same and alarm is activated.
4. Rotor
Tripped:
The rotor is stopped the limit switch gives indication to
the PLC to indicate the fault and activate the alarm. The heaters are also put
off automatically.
5. Set RH
achieved:
The set humidity is achieved the RH transmitter gives
indication to PLC and Humidity controller to put off the heaters and activate
the PLC display.
6. High
Temperature Safety thermostat:
Whenever process value goes high above 5ºC then set value
the safety thermostat is trip and cut off the power supply to heater bank.
5.4 Testing
Procedures:
The following tests shall be done to evaluate the
Performance of HVAC system:
1. Air
velocity Test:
Measure the air velocity at five points (four at corners and
one at the middle) 6 inch below the surface of the filter / diffuser using
calibrated anemometer. Calculate average of the five reading of the filter.
2. CFM of
the Diffuser:
Calculate air quantity of filter in CFM with the help following
formula.
CFM = Average velocity of the air x Effective surface area
of the Diffuser
3. Air
changes Calculation:
Calculate air changes of the rooms in the area with help of
following formula:
Average
Velocity x Surface area of the filters x 60
Air changes per hour =
---------------------------------------------------------------
Volume of the room in cubic feet
4. HEPA
filter Integrity Test (DOP Test):
An aerosol spray created by passing compressed air through Di-Octyl
Phthalate smoke generator. Introduced the DOP smoke at return air grill or
upstream of HEPA filters by pressuring DOP smoke at 1.0kg/cm2. Scanned with a
probe of aerosol photometer at downstream of the HEPA filter (below 6 inches
from filter surface) slowly move the aerosol photometer at a speed of 10
inches/ min covering all the surface of filter.
5. Smoke Test:
Smoke test shall be performing to check air movement between
the rooms and airflow pattern in rooms. The air movement shall be done once in
a day for three consecutive days. Place the torch of TiCl4 in between two rooms
in door open condition. Observe the flow of TiCl4 smoke between the rooms.
Videotape / Photograph the smoke flow pattern. Smoke should flow from the
higher-pressure zone to low-pressure zone between the rooms when the door is
open.
6. Room
Differential Pressure monitoring:
Room Differential Pressure shall be monitored four times in
a shift visually on Magnehelic gauges for three consecutive days.
7. Temperature
and RH monitoring:
Temperature and RH shall be monitored four times in a shift
visually by thermometer and Hygrometer for three consecutive days.
8. Area
Stabilization and Destabilization study:
Run the AHU & measure the time required by the system to
get stabilize. Measure the temperature and RH of the area; take readings after
every 15 minutes. Repeat the process for three consecutive days. Maximum time
taken among three consecutive runs shall be considered as stabilization time.
Stop the AHU and measure the time required by system to get
destabilize. Measure the temperature & RH of the area; take readings after
every 15 minutes. Repeat the process for three consecutive days. Maximum time
taken among three consecutive runs shall be considered as stabilization time.
6.0 Performance
Qualification Procedure
The following procedure shall be used for the Performance
Qualification of the HVAC System for Pharmaceutical Filling Area. supplied by Contac
Airflow Limited.
6.1 Ensure
that OQ of system is completed and system is cleared for Performance
Qualification.
6.2 The air
velocity test and air changes calculation shall be done for each room. The
observations shall be recorded as per Exhibit –.
6.3 DOP test
shall be carried out for leakage of HEPA filters. The observations shall be
recorded
6.4 The air
movement pressure between rooms shall be checked. The observations shall be
recorded
6.5 The room
differential pressure between rooms shall be checked. The observations shall be
recorded. Data shall be attached
6.6 The
temperature and relative humidity of the rooms shall be checked. The
observations shall be recorded
6.7 The area
stabilization and destabilization study shall be done to evaluate time. The
observations shall be recorded.
6.8 The
preventive maintenance list of the maintenance department shall be updated. The
observations shall be recorded
6.9 Any
deviation observed during Performance Qualification shall be recorded in the
observed deviation, corrective action and justification report section.
6.10 Observed
deviation shall be reported to the department head and quality head.
6.11 If the
observed deviation does not have any major impact on the Qualification the
final conclusion shall be provided.
6.12 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 redone.
7.0 Acceptance
Criteria
Performance Qualification shall be considered acceptable
when requirements listed in section 6.0 of this protocol have been fulfilled
and are as per the design specifications of the system.
8.0 Qualification
Report
The Performance Qualification report shall consist of a
summary document, in narrative form,
which shall briefly describe the activity performed along with the observations
recorded in relevant exhibits.
This report shall also include the related documents and
attachments / annexure which were completed at the time of Qualification
activity.
9.0 Approval
of Qualification Report
The report shall be evaluated and proper references /
conclusions / recommendations shall be recorded by Quality Assurance.
The Installation Qualification report shall be evaluated and
finally approved by Quality Assurance.
10.0 Observed Deviation
11.0 List of
Exhibits / Annexure
11.1 List of
Exhibits
Exhibit No. Exhibit
Title No. of Pages
E01 Air Velocity
Test and Air Changes Calculation Data Sheet
E02 HEPA Filter
Integrity Testing
E03 Air
Movement Verification Data Sheet
E04 Room
Pressure Differential Monitoring Data Sheet
E05 Temperature
and Relative Humidity Monitoring Data Sheet
E06 Area Stabilization
& Destabilization Study Data Sheet
E07 Preventive
Maintenance List Up-dating Verification Checklist
01 Training
Record
02 Differential
Pressure
03 Temperature
& R.H
12.0 Reference
Documents (If Any)
12.1 Operations
and Maintenance Manual of Equipment
12.2 Test
Certificates of components
12.3 G A Drawing
12.4 Air flow
Schematic
12.5 AHU Data
sheet provided by Contec Airflow Limited.
12.6 Area layout
Thanks for publishing such great information. You are doing such a great job. This information is very helpful for everyone. Keep sharing about air duct cleaning palatine. Thanks.
ReplyDeleteHello simply needed to give you a speedy fair warning. The words in your substance appear to be running off the screen in Ie. I don't know whether this is a designing issue or something to do with internet browser similarity yet I figured I'd post to tell you. However, the style and configuration look perfect! Trust you sort the issue out soon. Much appreciated. how to share airbnb calendar with cleaner
ReplyDelete