REVALIDATION OF AIR HANDLING UNIT IN FLUID BED PROCESSOR / DRIER / EQUIPMENT AND AUTOMATIC COATING EQUIPMENT

• OBJECTIVE:

To lay down a procedure for to perform periodic Revalidation of Air Handling Unit in Fluid Bed Processor /Drier / Equipment and Automatic Coating Equipment.

• SCOPE:

This SOP is applicable for to perform periodic Revalidation of Air Handling Unit in Fluid Bed Processor /Drier / Equipment and Automatic Coating Equipment {Company Name} {Company Location}.

• RESPONSIBILITY:

• Technical Assistant – Engineering to perform periodic Re-validation activities.
  • Executive – Engineering to monitor the periodic Re-validation activities for compliance of SOP.
  • Executive – Validation – Quality Assurance to monitor and review the periodic Re-validation activities.
  • Head Engineering/Designee – To review the periodic Re-validation activities.
  • Head Production/Designee – To review the periodic Re-validation activities.
  • Head Quality Assurance/Designee – To review and approve the periodic Re-validation activities.

• ACCOUNTABILITY:

Engineering Head

Head Quality Assurance

• PROCEDURE:

• Revalidation of Air Handling Unit in Fluid Bed Processor/Drier/ Equipment and Automatic Coating Equipment
  • This SOP covers Periodic Revalidation activities for Air Handling Unit in Fluid Bed Processor / Drier/Equipment and Automatic Coating Equipment.
  • In case of any Modification in the Air handling unit for Fluid Bed Processor / Drier/Equipment and Automatic Coating Equipment which have an impact on validated system, a new protocol shall be prepared and executed.
  • The following test parameters shall be performed during periodic revalidation as per the defined frequencies.

• HEPA Filter Integrity test.
  • Air Velocity Measurement
  • Non-viable Particle Count test

• The test parameters along with acceptance criteria and frequencies is mentioned below.

• Grace period for frequencies of Revalidation tests.

The Revalidation tests shall be performed as per the below frequencies and grace period.

S. No	Validation Frequency	Grace Period
1.	12 Months	± 15 days
2	24 Months	±30 days

• However, in case of in case of any Modification in the Air handling unit for Fluid Bed Processor / Drier/Equipment and Automatic Coating Equipment which have an impact on validated system, a new protocol shall be prepared and executed immediately ,ones after modification activity is completed.
  • AIR VELOCITY MEASUREMENT
    • Ensure that the blowers of the respective equipment are switched “ON” prior to the start of  the air velocity test.Measure the air velocity at 5 locations of the supply air filter/ Grill (Four Corners and centre) with the Anemometer and record.Calculate the average velocity of the air coming from Supply Grill.
    • Calculate the airflow by multiplying the average velocity with the effective filter area.

• Air flow (F) =          Average Velocity x Face Area of the Air supply Grill / Filter

=         Ft / Min. X Ft ²

=         Ft ³ / Min. or CFM

• Calculate the airflow for all the Supply Grill and record the results in Annexure-I.
  • Repeat the above procedure for Return air grill wherever applicable and record the observation in Annexure-I.

Acceptance criteria: Air Velocity shall be +/- 5% of the rated air velocity.

• HEPA Filter integrity test:
• Duly calibrated Aerosol photometer shall be used for filter integrity test and Operation of Aerosol photometer as per SOP.HEPA Filter integrity test shall be done only at rest condition.
• DOP (Di Octyle Phthalate) / PAO (poly alpha olophine) shall be used as challenging agent for filter integrity test.
• Place the Aerosol generator at the supply of the air handling unit.Generate the aerosol (challenging agent) with a concentration between 20-80 µg per litre at upstream of the filter on the equipment. Using Aerosol Photometer, measure the upstream concentration of Aerosol and set to 100% base line.

• Scan the downstream side of the entire filter face and frame at maximum distance of 5 cm from the filter face with an appropriate Aerosol photometer probe at a scan rate of at least 3 cm / second (Rectangular probe).
• The maximum scan area should not exceed 15 Cm² /Second. Record the downstream concentration in % in Annexure-III.
• Scanning shall be covered entire filter face, perimeter of each filter, the seal between the filter frame & the grid structure including the joints and frame.
• If leak is observed while scanning, equal / greater than the acceptance limit, the location of the leak shall be identified by the positioning of the probe that sustains the maximum reading on the photometer.
• Upstream aerosol concentration shall be checked repeatedly at reasonable time intervals during scanning to confirm the stability of the challenge aerosol concentration.Record the results in Annexure-II.
• In case the integrity test is not within the acceptable limit, replace the HEPA filter and record the same in Annexure-III.

Acceptance criteria:

• Any leakage shall not be greater than 0.01% of the upstream challenge aerosol concentration.

•  Non –Viable Air Borne Particle Count Test

• Duly calibrated Air borne particulate counter shall be used and operations of air borne particle counter as per SOP.
• Ensure that the AHU is working for 1 hour before performing the test the equipment(s) are cleaned before performing this test.
• Calculate the number of locations using square root of the area in square meter.
• Divide the measuring plan in to equal grid cells based on number of sampling locations calculated.
• Perform the test adjusting the sampling time not less than one minute and flow rate shall be 1 ± 0.1CFM.
• Minimum sample volume 1CFM.Perform the test with minimum 3 cycles at each location repeat the above procedure at all the other locations as per the sampling location layout.
• Record the average particle count of the 0.5µ and 5.0µ in Annexure-IV.
• In case the non-viable airborne particle count test is not within the acceptable limit, clean the area and perform the test again.
• Calculate the mean average particle count for all the locations. Calculate as per below formula.

Formula :

Formula for calculating the number of sampling point locations.

N= Minimum number of sampling locations (rounded up to a whole number) A= Area of the clean room or clean zone in square meters.

Formula for calculate the particle count UCL.

Upper Confidence limit (UCL)

UCL = M + (UCL Factor X SEM)

UCL factor for 95% upper confidence limit for different number of locations is indicated in the following table.

• REFERENCES:

  Not Applicable

• ANNEXURES: 

ANNEXURE No.	TITLE OF ANNEXURE
Annexure-I	Air velocity measurement
Annexure-II	Integrity Testing of HEPA Filters
Annexure-III	HEPA Filter Replacement Record
Annexure-IV	Airborne Non-Viable Particle Matter Count Test
Annexure-V	Validation Summary Report
Annexure-VI	Equipment AHU’s Revalidation Schedule

ENCLOSURES: SOP Training Record.

• DISTRIBUTION:

• Controlled Copy No. 01                     Head Quality Assurance
• Controlled Copy No. 02                 Head-Engineering
• Master Copy                           Quality Assurance Department

• ABBREVIATIONS:

AHU           :       Air handling unit.

m                :       Micron.

ISO            :       International organization for standardization.

SEM          :       Standard Error Mean.

SD             :       Standard Deviation.

UCL          :        Upper confident limit.

CM/S        :        Cubic Meter per Second.

m³             :        Cubic meter.

HEPA        :        High Efficiency Particulate Air.

m²             :         square meter.

m               :         millimeter.

°C              :         degree Celsius.

NMT         :         Not more than

NLT          :         Net less than

SOP         :         Standard Operating Procedure

• REVISION HISTORY:

                                                             CHANGE HISTORY LOG

Revision No.	Details of Changes	Reason for Change	Effective Date
00	New SOP	Not Applicable	To be written manual

ANNEXURE-I
AIR VELOCITY MEASUREMENT

ANNEXURE-II
INTEGRITY TESTING OF HEPA FILTERS

ANNEXURE-III
HEPA FILTER REPLACEMENT RECORD

ANNEXURE-IV
AIRBORNE NON-VIABLE PARTICLE MATTER COUNT TEST

ANNEXURE-V
REVALIDATION SUMMARY REPORT