YOGESH SHELKE. A SEM ON HVAC SYSTEM VALIDATION

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A SEMINAR ON ‘VALIDATION OF HVAC SYSTEM’:

A SEMINAR ON ‘VALIDATION OF HVAC SYSTEM’ GUIDED BY- DR. DEOKAR .G.S (HOD- DEPT. OF QUALITY ASSURANCE) PREPARED BY- SHELKE YOGESH SHANTARAM MET’s INSTITUTE OF PHARMACY BHUJBAL KNOWLEDGE CITY. 1

CONTENTS :

CONTENTS Introduction Types of clean room Components of HVAC system HVAC Qualification Validation parameter 2

INTRODUCTION:

INTRODUCTION HVAC- Heating Ventilation and Air Conditioning. The need and reason for pharmaceutical air handling systems. The technical requirements for air handling systems. Different types of air handling systems. Qualification and Validation requirements. 3

WHAT IS CLEAN ROOM? :

WHAT IS CLEAN ROOM? A room in which the concentration of airborne particle is controlled and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room and in which other relevant parameters. e.g.. Temperature, humidity and pressure, are controlled as necessary. 4

WHY CLEAN ROOM NECESSARY? :

WHY CLEAN ROOM NECESSARY? It controls 3 types of contamination transfer Air borne contamination Direct contamination by personnel, equipment etc. Contamination from fluids like cleaning fluids, solutions etc. As airborne particulate are reduced, chances of particles entry in the process reduced. Protects product, personnel & environment. 5

TYPES OF CLEAN ROOMS :

TYPES OF CLEAN ROOMS Horizontal Clean Room – Horizontal Laminar flow (HEPA filters in a wall force clean air from one side of the room to other.) Vertical Clean Room – Vertical Laminar flow (HEPA filters on the ceiling push clean air down to the floor.) 6

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The manufacturing environment is critical for product quality. Environment consists of, Light Temperature Humidity Air movement Microbial contamination Particulate contamination Uncontrolled environment can lead to product degradation product contamination loss of product and profit 7

HVAC consists of following parts :

HVAC consists of following parts Air conditioner AHUs Dehumidifier / Heater Filters (Pre & HEPA) Dust Extractors Ducting (For delivery of controlled air) Supply Fans Smoke Detector Dampers Humidity / Temperature / Pressure sensors Bag Filters Heating / Cooling Coils 8

HVAC SPECIFICATIONS:

HVAC SPECIFICATIONS 9 Temperature 18-23 o C Relative humidity 45% ± 5% Dry powder- 30% ± 5% Moisture sensitive drug- 5% ± 5% Air velocity 80- 120 ft/min Air f low Laminar airflow Pressure gradient 15 Pascal Particulate count (Critical area) NMT 100 particles of 0.5 µm/ft 3 Air system failure alarm (ASFA)

US FDA:

US FDA 21 CFR part 211 (Requirement for building & Facilities) Under 211.42 (c) Operation shall be performed within the specifically defined areas and such other controls, necessary to prevent contamination or mix ups. Temperature and Humidity controlled. An air supply filtered through HEPA filter under positive pressure. A system of monitoring environmental conditions. Under 211.46 (C) Air filtration system, including pre-filters and particulate matter air filtration shall be used when appropriate on air supplies to production areas. 10

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11 HVAC Area - 1 Area - 2 Area - 3 Area - 4 Impure Air I M P U R E A I R Impure Air Pure Air 90% 10% Return Air Exhaust

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12 AIR FLOW PATTERNS Prefilter AHU Main filter Uni-directional Turbulent Turbulent 1 2 3

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13 HVAC QUALIFICATION QULIFICATION VALIDATION

USER REQUIREMENT SPECIFICATION:

USER REQUIREMENT SPECIFICATION Room dimensions Machine horse power and lighting load Temperature R.H Pressure gradient Class of air Air changes per hour 14

DESIGN QUALIFICATION:

DESIGN QUALIFICATION First step in the qualification of new HVAC systems. It documents the design of the system and will include : Functional Specification. Technical / Performance specification for equipment. Detailed Air Flow Schematics. Detailed layout drawing of the system. 15

DESIGN QUALIFICATION:

DESIGN QUALIFICATION Technical Data: General Make and model no. Noise level Overall dimension in mm. Weight in kg. 16

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Casing Outer skin Inner skin Material of frame structure Insulation materials and thickness Fan Type and make Fan speed in RPM Fan BHP Recommended Motor Operating voltage and frequency 17

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Chilled water and Hot water coils Make Air quantity through coil Face area sq.feet Selected water velocity across coil ( meters /sec) Material of cooling coil Tube diameter 18

INSTALLATION QUALIFICATION :

INSTALLATION QUALIFICATION The goal of IQ is to verify and document the quality, installation and integrity of the HVAC system. Execution of IQ protocols provides assurance that a HVAC system is installed in accordance with the qualified design. IQ should highlight discrepancies between design layouts detailed in the DQ and what has been constructed (‘As-built” status). 19

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Verification of materials of construction . DQ to be complete and signed off before IQ begins. IQ protocols approved prior to implementation. 20

I.Q PROTOCOL:

I.Q PROTOCOL Equipment Name: Equipment make : Proposed location : Contents: Approval page System description S.O.Ps Calibration Review Installation Checklist Inspection checklist Materials of construction Supporting Utilities Manufacturer’s Certifications Deficiency and Corrective Action Report Final Report Appendix Reference Documents 21

OPERATIONAL QUALIFICATION:

OPERATIONAL QUALIFICATION Ability to provide air of sufficient quality and quantity to ensure achievement of specified clean room conditions. Ability to maintain temperature, relative humidity and pressure set points. IQ reports must be completed and signed off. OQ protocols to be written and approved prior to completion. ‘as built’.. ‘at rest’.. ‘operational’ 22

PERFORMANCE QUALIFICATION:

PERFORMANCE QUALIFICATION The purpose of PQ is to verify and document that an HVAC system provides acceptable operational control under ‘ full operational ‘ conditions. PQ verifies that over time, the critical parameters, as defined in the DQ are being achieved. PQ is used to demonstrate consistent achievement of critical parameters over time. ( under manufacturing conditions). 23

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It consists of the following parameters : HEPA filter leak test. Temperature control test. Humidity control test. Test for air flow patterns. Pressure control test. Particle count test. Airborne microbial sampling . Air flow velocity test. 24

HEPA filter leak test:

HEPA filter leak test Purpose : To ensure against filter damage (installation/ operation ). Method : Introduction of DOP aerosol (0.3um) upstream of the filter through a test port and search for leaks downstream with an aerosol photometer . Acceptance criteria : An unacceptable leak is defined as 0.01% of the reference calibration curves . 25

Temperature control test:

Temperature control test Purpose : To demonstrate the ability to control temperature at 72F+- 10% all year round. Equipment :Calibrated dry-bulb thermometer, thermocouple and recorder. Method: Air conitioning systems and all the lights to be in Continuous operation atleast 24 hrs prior to test. Measure and record temperatures at 15 min intervals for 2 hrs . Repeat the test for at rest and dynamic conditions. Acceptance criteria: It should be capable of maintaining a dry bulb temperture of 72F+- 10% . 26

Humidity control test:

Humidity control test Purpose : To demonstrate the capability to control humidity at the specified level for each room . Equipment : Calibrated dry-bulb and wet bulb thermometer, recorder Method: Measure and record humidities at rest and dynamic conditions. Operate the system atleast 6 hr prior to test. Record the wet/dry bulb temperatures at the beginning and at the end. Acceptance criteria: RH should be within tolerance limits. 27 Humidity control test

Air flow pattern test:

Air flow pattern test Purpose : To demonstrate minimum turbulence and determine air flow pattern. Equipment :White visible or yellow smoke generator,anemometer ,35mm camera Method : Generate white smoke . Film the smoke as it travels . If the air returns (back flows ) due to turbulence , system cannot be accepted . Acceptance criteria : turbulance should not be Observed . 28

Pressure control test:

Pressure control test Purpose : To demonstrate the capability of the system to control pressure level within the specified levels . Equipment : Pressure gauge. Method : All HVAC and laminar flow units to be in continuous operation during the tests. All doors in sterile facility must be closed . Pressure readings are taken with high and low -pressure tubings at selected locations. Acceptance criteria : Pressure differentials should be above 0.02 at the primary environments . 29

Particle count test:

Particle count test Purpose : To establish that within clean room, a Count of less than 100 particles per cubic foot, 0.5um is maintained . Equipment : Light scattering particle counter . Method : Using particle analyzer , count particles greater than or equal to 0.5 microns at heights of 40 inches in the center of each grid . Acceptance criteria : The particulate count shall not exceed 100 particles of 0.5 micron per cubic foot of air. 30

AIR BORNE MICROBIAL SAMPLING:

AIR BORNE MICROBIAL SAMPLING Purpose : To determine airborne microbial contamination level. Equipment : Andersons air sampler (1 cubic foot/min). Method : Sampling time 20 min.s at every location. Plates are then placed in an incubator, maintained inverted to prevent condensation drop for a period of 18-24 hrs at 35 o C. After incubation the number of colonies on each plate is Counted using a standard bacterial colony counter. 31

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Acceptance criteria : The total number of colonies from sample plates in the same location divided by the time in minutes assuming , a sample of cubic foot per minute will give the number of viable particles per cubic foot of air sampled . This number should not exceed 0.1 assuming the accepted microbiological theory that each colony represents a single particle . In case of no. of colonies per cubic meter of air, limit established is 3.5 colonies in class 100. 32

AIR FLOW VELOCITY TEST :

AIR FLOW VELOCITY TEST Purpose : To demonstrate that air system is balanced and capable of delivering sufficient air volumes . Equipment: Hot wire anemometer . Method : Measurements taken at 15 mins interval . Record the pressure readings (in inches ) . Acceptance criteria : Average measured clean air velocity shall be higher than 90 foot per minute and not exceeding 150 fpm at 6 inches downstream from the filter face. 33

REFERENCES:

REFERENCES Frederick J. carleton , James P. Agalloco , ‘Validation of pharmaceutical processes ’, sterile Products , second edition , published by Marcel Dekker, Inc. New york 2006, page no:- 225-257. Robert A. Nash, Alfred H. Wachter , ‘Pharmaceutical process validation’ , An international third edition , 2008, Published by Marcel Dekker, Inc. New york , Inc. Page no:- 427-441. Potdar M.A, Pharmaceutical Quality Assurance, second edition , nirali prakashan , pg .no.529-545. http://www.gmpua.com http://www.tulipgroup.com/Common_New/HS_magazine_PDF/Hygiene_sciences%206.pdf. 34

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THANK YOU… 35

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