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