sop for Area Validation
To lay down a procedure to organize HVAC area validation activities & to conduct area validation of HVAC system
This Standard Operating Procedure is applicable for area validation to follow at formulation
2.1 Tablet & Capsule Area.
2.2 Liquid & Lozenges.
2.3 Micro area.
2.4 DPI area
3.1 Officer / Executive Engineering shall be responsible for the execution of this procedure.
3.2 Engineering Manager shall be responsible for the implementation of this SOP.
3.3 Head QA/ designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
No : Number
NA : Not Applicable
QA : Quality assurance
Sr. No. : Serial number
OC : Out of calibration
SEP : Standard Engineering Procedure
HEPA : High efficiency particulate air
FPM : Feet per minute
5.1 The engineering department shall identify the agencies/personnel who is capable of carry out HVAC validation services.
5.2 Screen the agencies for capability and qualifications.
5.3 Validation of HVAC system should be carried out through approved external agencies. The Vendor should bring all required validation master Instruments at site for validating HVAC system. The master instrument includes following.
5.3.1 Laser Particle Counter
5.3.3 Aerosol Generator
5.3.4 Sling Psychrometer.
5.3.5 Aerosol Photometer.
5.4 The vendor shall be selected based on technical qualification, experience, infrastructure facility, confidence level. Verification of traceability of master instruments.
5.5 The vendor shall be audited & evaluated for adherence of HVAC validation requirements, traceability, suitability of validation methods, & documentation practice.
5.6 There shall be written Agreement between vendor & company.
5.7 The vendor shall provide written validation procedure to various types of Instruments. This procedure shall be reviewed & approved by engineering manager.
5.8 The scope of HVAC validation activities is as follow
5.8.1 Verification of air changes of all process area, Quality & warehouse.
5.8.2 Integrity testing of HEPA filter.
5.8.3 Particle count report of all process area under static condition.
5.8.4 Recovery studies.
5.9 The engineering person shall witness validation activity.
5.10 The frequency & acceptance criteria of HVAC validation is as per Master Validation Plan/Protocol.
5.11 Integrity test of HEPA filter shall be carried out by Introducing an aerosol challenge upstream of filter and scanning immediately down stream of filter & support frame. It is carried out by using aerosol generator. This procedure detects any leakage in the HEPA filter media, frame & gasket seal.
5.12 Particle count in the designated area is carried out by using particle counter. The test is carried out under static condition. Before conducting particle count study, ensure that all components of clean room system which contribute its operation (air handling units, filtration system, walls, ceiling, and floor) are completed & functioning in accordance with the clean room requirements. The number of test points and their location should be chosen to satisfy statistical requirement of the area.
5.13 The report of the particle count should cover following points
5.13.1 Particle size Range.
5.13.2 The volume of air sampled.
5.13.3 The particle count
5.13.5 The sampling point locations
5.13.6 The particle data shall be indicated in the form of No. of particle per cubic feet or cubic meter.
5.14 During validation if area do not meet acceptance criteria, revalidation to be carried out. If area fails in revalidation,
complete investigation to be carried out the performance of blower, motor, cooling coils, ducts micro-vee filter shall be checked.
If required, HEPA filter shall be replaced. Replacement of HEPA filter record shall be maintained.
Failure instrument destruction record shall be maintained as per format No In case of failure of acceptance
criteria in area validation, evaluation of the impact of (OC) out of calibration measurement on product shall be evaluated.
In such cases all products which are manufactured in that area from last date of area validation shall be evaluated.
The report failure of area shall be made by engineering manager to production manager for Initiating product evaluation.
The production and quality department shall be responsible for review of product manufactured in that area where “area validation failed.”
5.15 Entry of validation to be made in area validation register as per format No Validation shall be maintained.
5.16 Engineering & Quality Assurance department is authorized to accept or reject validation contract in case of any deviation.
5.17 The area validation activity to be performed by outside approved agencies. After performing validation the approved contract agencies should submit certificate. The validation certificate should cover( Not limited to ) following points
5.17.1 Name of the Area & Room identifications
5.17.2 AHU System No
5.17.3 Filter area
5.17.4 Minimum 05 air Velocity reading in FPM.
5.17.5 Percentage of DOP / PAO Penetration.
5.17.6 Master instrument specification used for calibration.
5.17.7 Traceability certificate details.
5.17.8 Specification of master Instrument like Aerosol Photometer, Anemometer etc. With its calibration traceability & calibration due date.
5.17.9 Test standard code of ISO.
5.17.10 Particle count report, indicating meeting acceptance criteria as per ISO-14644-1.
5.18 The HVAC area validation certificate issued by contractor shall be reviewed and approved by Engineering Manager.
5.19 The periodic review shall be carried out during self inspection following points shall be considered in the periodic review.
5.19.1 HVAC Area validation system.
5.19.2 Planning for validation in case of addition of new facility.
5.19.3 Validation procedures.
5.19.4 HVAC validation frequency.
5.19.6 Environmental condition during validations.
5.19.7 Training needs.
5.20 The report of particle count, HEPA filter Integrity, verification of air changes, air flow pattern & recovery study summary report based on outside contractor certificate shall be recorded by executive- engineer as per format.
5.21 The report of temperature, relative humidity & differential pressure shall be recorded at beginning of the shift & after every four hours by production Executive of respective area as per format no. .
6.0 Forms and Records
6.1 Temperature & Relative Humidity Log Record – Annexure-1
6.2 Differential pressure Log Record – Annexure-2
6.3 Verification of air changes Log Record – Annexure-3
6.4 Destruction Record Log Record – Annexure-4
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Engineering department