AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING

AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING
A presentation By Pharm R.A.BINITIE Assistant Director Drug Evaluation and Research Directorate NAFDAC In the following slides, we will study alternatives in air handling systems Turbulent or uni-directional airflows Filter position Air re-circulation vs fresh air Return air systems (positions) Overpressure requirements 17-Feb-18

OUTLINE INTRODUCTION OBJECTIVES REGULATORY IMPERATIVE APPLICATIONS HVAC SYSTEM PRODUCT PROTECTION CONCLUSION REFERENCES 17-Feb-18

INTRODUCTION (I) Air handling system plays a major role in the quality of pharmaceutical product manufacturing( all types). It is the technology of indoor and manufacturing space environmental control and or comfort It regarded as one of the most important utility in drug product manufacturing (a critical system) The manufacturing environment or space is very critical to product quality and is premised / dependent on the air handling system which controls the level of containment ( pressurization)and cleanliness( room classification) 17-Feb-18

INTRODUCTION (II) The uncontrolled environment can lead to product degradation, loss of product, and economic issue-profit , product contamination/cross contamination The manufacturing environment is critical for products and considers these factors(GMP environment) :light , temp, humidity, air movement, microbial contamination, particulate contamination, Air handling system to satisfy GMP/regulatory requirements must be suitably designed, installed, qualified/Validated, monitored and maintained by professionals ( GEP) 17-Feb-18

OBJECTIVES To understand the need for air handling system in the pharmaceutical industry The technical requirements for air handling system Different types of air handling system Qualification and validation of HVAC system Monitoring and maintenance 17-Feb-18

WHY AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING Needed to condition and provide the ideal GMP environment or air space cleanliness needed for the various pharmaceutical processes and controls in manufacturing . A critical factor of Quality Assurance for pharmaceutical products( Clean areas/space for manufacturing) Issue of personnel comfort, satisfaction and safety As a means of containment control ( airborne particulate)and prevent Contamination and cross contamination Avoid product rejection Contamination only mentioned in the presentation 17-Feb-18

REGULATORY IMPERATIVES NAFDAC cGMP Regulatory Guidelines for Pharmaceutical Products 2106 – entrenches/prescribes Air handling system in manufacturing; viz Sections 3.20 : Production areas Section 3.22 : Dust Controls Section 3.25 : Storage of equipment air requirement Section 3.26 : Air Supply to manufacturing space and laboratory operations. Section: laboratory design(for microbiology section) Section 3.28: storage area for materials Section : HVAC system section 4.3a-d: Qualification & Validation ( equipment and utilities) etc Other sections not included on this slide 17-Feb-18

APPLICATIONS OF AIR HANDLING SYSTEM An ideal cGMP environment for manufacturing (HVAC system) should provide: Product protection: protect from contamination , cross contamination, prevent contamination by operatives, correct conditions of humidity and temperature. Personnel protection: prevent contact with dust, prevent contact with fumes, good comfort condition Environment protection: No dust discharge, no fumes discharge, no effluent discharge Preservation of materials and equipment Handling, holding and storage Maintenance of animals and equipment The GMP environment is only possible with an Air Handling System 17-Feb-18

WHAT IS AIR HANDLING SYSTEM Air handling system is regard as HVAC and refers to Systems which are mechanical arrangements that treats outside air to produce cleaned (from dust and microbes) conditioned air ( temperature and humidity) which is circulated or re-circulated for use in controlled and critical areas within the pharmaceutical manufacturing space OR Can be simply said to be a utility system used to provide air ventilation, heating, cooling and air conditioning services to a building or a pharmaceutical space for drug manufacturing The Acronym HVAC means: H= Heating, V= Ventilation; A= Air; C= Conditioning 17-Feb-18

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HVAC SYSTEM HVAC system comprises of Air Handling Unit ( AHU) connected to a ductwork ventilation system that distributes the conditioned air through the building and returns it to the air handler(AHU). Air Handling Unit (AHU) is a device used to condition and circluate air as a part of HVAC. It is usually a large metal box containing a blower, heating or cooling elements, filter racks or chambers, sound attenuators and dampers 17-Feb-18

INSIDE AN AIR HANDLING UNIT 17-Feb-18

SCHEMATIC OF AIR HANDLING UNIT (AHU) AHU SECTION 17-Feb-18

AIR HANDLING SYSTEM/HVAC COMPONENTS Ducting ( for delivery of controlled air) Fan component Vibration isolator (flex joint) Heating and /or coiling coil Filter compartment ( houses pre and post filters) HEPA Filter Mixed (re-circulated + outside ) air duct Louvers ( Weather) Damper ( fixed adjustment of volume of air) Dehumidifiers Flow rate controller Humidity, Temperature, Pressure sensors, alarms and audit log system Dust extractors 17-Feb-18

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TYPICAL INSTALLATION OF AHU UNIT (VISUAL) 17-Feb-18

HVAC MAIN SUBSYSTEMS + Production Room Exhaust air treatment Central air handling unit Terminal air treatment at production room level Fresh air treatment (make-up air) 17-Feb-18

Filter Silencer Terminal filter Weather louvre Control damper Fan Flow rate controller Humidifier Heating coil Cooling coil with droplet separator Production Room OVERVIEW OF HVAC COMPONENTS + Prefilter 17-Feb-18

Air-handling unit Filter Pressure Gauges AHU with fan Variable Speed Controller Control damper for airflow Humid room air Air heater Regeneration air Adsorber wheel 17-Feb-18

CHARACTERISTICS OF AIR HANDLING SYSTEM/HVAC Turbulent air flow ( air flow pattern) Unidirectional airflow ( air flow pattern) Filter position ( Terminal Position, air recirculation system) Fresh air (100%)/Once through / external air Air re-circulation Return air systems (positions low wall air return) Overpressure requirements Local extraction system( deduster, canister) 17-Feb-18

FUNCTIONS OF AIR HANDLING SYSTEM (HVAC) Control airborne particulate , dust and micro-organisms through air filtration using HEPA filters Maintains room pressures ( in areas that must remain cleaner that surrounding areas (+ve) Reduces contamination by air flow from cleaner areas toward adjoining space through doors, , ceiling openings ( reduces chances of contamination) Maintains space moisture RH(by cooling to due point temperature and using desiccant dehumidifiers) Maintains space temperature ( can affect product directly or indirectly) All to minimise and prevent contamination and cross contamination 17-Feb-18

WHAT CAN AIR HANDLING SYSTEM NOT DO Cannot clean up contaminated surfaces, room or equipment Do not compensate for workers who do not follow procedures 17-Feb-18

QUALITIES AND ATTRIBUTES OF A GOOD HVAC SYSTEM Suitably designed, installed, Qualified / validated and maintained (GEP) to meet GMP requirements for the intended purpose Reliable and economical to run Supported by appropriate documentation (lay outs, SOPs, reports of commissioning, qualification and validation, monitoring and maintenance records etc 17-Feb-18

CLEAN AIR SUPPLY CONCEPTS There are two basic concepts of clean air delivery for pharmaceutical production: Full Fresh air or Make up air Recirculation or Return air All to provide the need conditioned clean air for intended clean room required for manufacturing areas. What is clean area/ room/space? A closed room supplied with filtered ( purified air ) in which the particulate and microbial contamination load is below specified level. And is used in such a way to minimise introduction, generation and retention of contaminants 17-Feb-18

CLEAN AREA/ROOM CONSIDERATIONS All pharmaceutical facilities belong to one/ certain or other class of clean rooms Facility classification are based on clean air supply that matches the requirement for manufacturing process/product Clean rooms classification differs for sterile and non sterile and can be classified as such: Non sterile operations/controlled or non aseptic Sterile operation/critical areas/aseptic applications Examples of clean room requirements for some product lines: eg tablets class D (10,000) topical and oral liquids belong to class C(10,000) sterile preparations/injectable – class A or B(100) 17-Feb-18

CLEAN AREA CLASSIFICATION CONSIDERATIONS Clean Room Classification defined in the state of “as built”, “at rest ,” or “in-operation” Clean rooms are also Categorized by way of which supply air is distributed : Generally two air configuration: Unidirectional -UDAF (Laminar) LAF or RLAF) . This achieved by Vertical down displacement of room air or by horizontal laminar flow) – defined air velocity Or Non –Unidirectional air flow EU classification is based on alphabet system A,B,C,D; FDA numerical eg class 100; 1000; 10,000; and 100,000 17-Feb-18

CLEAN ROON CLASIFICATION CONSIDERATIONS WHO & EC,EU, PIC/S, TGA: classes A,B, C, D USFDA : critical and Controlled ISE: level1,2,or 3 INSERT PICTURE OR SLIDE of classification?????? 17-Feb-18

as built at rest in operation AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING DEFINITIONS OF ROOM CONDITION 17-Feb-18

AIR FILTRATION AND CONTROL OF CONTAMINANTS External Air contaminants are removed by filtration Internal contaminants are controlled by dilution and flushing or by displacement air flow Airborne particulates and level of filtration are considered critical in Air Handling system The filtered air entering a production room can be derivable from 100% fresh air/external air or a proportion re-circulated ( Mixed with external/fresh air) New technologies: barrier technology/isolator technology 17-Feb-18

Types of Air encountered in HVAC system: fresh air, supply air, recirculated and exhaust air + Production Room Exhaust air Return air (recirculated) Fresh air (make-up air) Supply air Air types 17-Feb-18

FRESH AIR ( 100%)/ONCE THROUGH SYSTEM (1) Applicable to factory dealing with toxic products Low risk of cross contamination Provides The exhaust air filtration depends on the degree of contaminants and local environmental regulations Offers abundant oxygen rich fresh air for dilution of contaminants Air leakage between the supply and exhaust air should be prevented, supply air pressure should be higher that the exhaust air pressure Exhaust fan may be located remote from the AHU making ducting simpler 17-Feb-18

FRESH AIR ( 100%)/ONCE THROUGH SYSTEM (2) Usually more expensive to run ( heating and cooling demand) High filter loading resulting in frequent filters replacement Additional requirement for air treatment(scrubber, dust collectors) Applicable in laboratory hood, API plant handling highly inflammable materials, oral solid dosage plant( OSD) where potent /product/materials are exposed. 17-Feb-18

VENTILATION WITH 100% FRESH AIR (no air re-circulation) W Washer (optional) Central Air Handling Unit Exhaust Unit 17-Feb-18

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RECIRCULATION SYSTEM (1) A proportion or % of re-circulated air mixed with fresh air/external air Requires installation of HEPA filters in the supply air stream to remove contaminants which may be placed terminally or in AHU ( H13 HEPA filter recommended) Single product facility may not require HEPA Not suitable for fumes or dust from highly toxic processes 17-Feb-18

RECIRCULATION SYSTEM (2) Proportioning of fresh (external air) to re-circulated air can be fixed or variable air volumes( temperature and no of operatives, ) Less air filter loading –lower maintenance cost ( variable air flow) Energy saving/cost Complex design and high level of automation Chances of cross contamination from system failures Applicable for OSD manufacturing , sterile operations, Final bulk APIs 17-Feb-18

VENTILATION WITH RECIRCULATED AIR + MAKE UP AIR Central Air Handling Unit Return air Exhaust Unit 17-Feb-18

AIR FLOW PATTERN (1) The air flow pattern is used to control the internal contaminant by dilution or displacement flow May be unidirectional or turbulent flow Turbulent can cause particulate settled on the ground to be re-entrained in the air. Vertical down flow is the preferred ( displacement flow) 17-Feb-18

AIR FLOW PATTERN (2) Usually class 100 (must have unidirectional ( laminar) with 100% HEPA Coverage on the ceiling or wall and return on opposite side Class 1000 and above are generally non unidirectional with supply air outlet at the ceiling and return at the floor level Return grill – positioned low down , not near a door opening into an adjacent lower pressure room ( to prevent reverse air leakage to the high pressure room during door opening Return risers should be fitted with manually operated dampers 17-Feb-18

AIR FLOW PATTERN Uni-directional / laminar displacement of dirty air Turbulent dilution of dirty air 0,30 m/s 17-Feb-18

AIR HANDLING SYSTEM IN PHARMACEUTICALMANUFACTURING
AIR FLOW PATTERN (II) Prefilter AHU Main filter 1 2 3 Low level exhausts Ceiling exhausts 17-Feb-18

AIR FLOW PATTERN (III) Workbench (vertical) Cabin/ booth Ceiling 17-Feb-18

POSITIONING OF FILTERS The required cleanliness or purity of air can be achieved with effective cleaning of the external air or recirculated air through correctly designed and installed filters to meet the specifications or requirements for intended activity or manufacturing operation. Filter location can be in the AHU, terminal …………….???? filters are of various types , specifications and classes TYPES OF AIR FLTERS Ultra Low Particulate Air filter( ULPA) High Efficiency particulate air filter( HEPA) Packed towers Membrane filter cartridges Hydrophobic filters 17-Feb-18

SPECIFICATIONS FOR FILTERS Simple MERV (1-16), pre filters (10, 20, 50µ efficiency 80-90% , secondary filters(5µ: efficiency up to 99%), HEPA filters (0.3µ: efficiency upto 99.99 CLASSES OF FILTERS Coarse (Dp < 10µ , G1-G4, Fine ( 1.0µ <Dp <10µ : F5 –F9); HEPA( H10-H14) &ULPA(U15-U16) both of Dp < 1.0µ) Filter efficiency testing should be linked to the standard test methods ( different test methods could give different results for same filter) 17-Feb-18

FILTERS 17-Feb-18

HEPA FILTER 17-Feb-18

POSITIONING OR LOCATION OF FILTER IN AHU (1) TERMINAL ( AHU OR ROOM SUPPLY VENT

POSITIONING OF HEPA FILTERS (2) AHU mounted final filter Filter in terminal position Production Room HEPA Filter + 17-Feb-18

POSITIONING OF FILTERS (3) Prefilter AHU Main filter 1 2 3 Ceiling exhausts 17-Feb-18

AHU Prefilter Final filter 2 1 POSITIONING OF FILTERS (4) 17-Feb-18

VALIDATION AND HVAC SYSTEM An HVAC system is viewed as a process using outside air as a raw material and producing conditioned air. The conditioned air comes in contact with the product and hence has a direct impact on the quality of the product Such system being a part of the facility in which manufacturing occurs must be qualified and validated. 17-Feb-18

QAULIFICATION/ VALIDATION ISSUES A good design is essential, but it has to be complemented by: Qualification of air handling systems (USR, DQ, IQ, OQ,). Process validation ( process performance qualification PPQ- encompassing the facility, utility and equipment Operation &Continuous process Verification ( establish environmental monitoring program, data collection trend analysis, define action and alert limits). Maintenance and periodic re-qualification Adequate documentation USR & DQ concept should be based on data from process(target critical environmental parameters), Quality (regulatory & quality principles-impact on product), Operation and maintenance 17-Feb-18

WHAT TO QUALIFY/VALIDATE The mechanical system( the installations and operations; and the controls The air distribution system (installation, adequacy, safety issues, air flow pattern, filter integrity test) The condition prevailing in the rooms( temperature and humidity, air changes, air velocity, relative pressurization – differential pressure across filter F6. F9, H13, classification if applicable) Particulate and microbial validation Alarms and audit log features Time scheduling of AHU ???????? 17-Feb-18

Qualification (OQ, PQ) (1)
AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING Qualification (OQ, PQ) (1) Test Differential pressure on filters Turbulent / mixed airflow Description Uni-directional airflow / LAF Room differential pressure Airflow velocity / uniformity Airflow volume / rate Parallelism Air flow pattern ( Smoke test) 2 N/A 2, 3 Optional 3 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) IQ tests are not mentioned on this slide 17-Feb-18

Turbulent / mixed airflow Uni-directional airflow / LAF
AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING Qualification (OQ, PQ) (2) Test Turbulent / mixed airflow Description Uni-directional airflow / LAF Recovery time Room classification (airborne particle) Temperature, humidity N/A 2 2,3 1 := As built (ideally used to perform IQ) 2 = At rest (ideally used to perform OQ) 3 = Operational (ideally used to perform PQ) 17-Feb-18

WHAT TO MONITOR Temperature Humidity Pressure (pressure differential) Particulate Microbial or Biological load 17-Feb-18

WHERE TO MONITOR All production areas ( including corridors and airlock) Storage areas for product, intermediates and raw materials( especially if affected by environmental conditions, in critical areas near the doors, ceiling) Clean rooms an laminar flow hoods Critical surfaces Environmentally controlled rooms and chambers Freezers, refrigerators, incubators 17-Feb-18

CRITERIA Set criteria from product requirements( temp sensitivity, microbial contents for sterile areas, regulatory, compendia standards, literature and industry experience etc HOW TO MONITOR Various specified instruments, equipment and materials for monitoring are in use – eg pressure Magnehelic gauges (method should be specific) ALERT AND ACTION LIMITS Define alert and action limits –use of historical data to calculate the standard deviation and apply 3standard deviations around the mean as action limit and 2 standard deviation as alert limit 17-Feb-18

EXPECTATIONS Data trends towards deviations Repeat occurrences ( problematic issue) Data pattern Any changes / differences from what you have been observing in the past 17-Feb-18

POSSIBLE PROBLEMS THAT CAN OCCUR Problem with controller : blockage Control damper: Poorly adjusted , bad pressure differential system Humidifier : Bad water/steam quality poor drainage Cooling battery : No elimination of condensed water/poor drainage Filters: Incorrect retention rate/damage/badly installed Duct:- Inappropriate material internal insulator leakage 17-Feb-18

DEFINING ALERT AND ACTION LIMITS Definition of alert / action limits as a function of cleanliness zone. Identification and marking of sampling points Definition of transport, storage, and incubation conditions 17-Feb-18

AIRHANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING
CLEAN ROOM MONITORING (1) Clean rooms should be monitored for microorganisms and particles air Sampling point 17-Feb-18

CLEAN ROOM MONITORING (2) There should be routine monitoring program as part quality assurance Additional monitoring and triggers Shutdown Replacement of filter elements Maintenance of air handling systems Exceeding of established limits) 17-Feb-18

CLEAN ROOM OPERATIONS/ ACTIVITIES All operations within a pharmaceutical facility should be correlated to well defined clean room classes and can be included in a hygiene concept etc. X Filling for aseptic process Filling for terminal sterilization Depyrogenisation of containers Preparation of solutions for aseptic filling Preparation of solution for terminal sterilization Washing of containers D C B A Cleanroom Class 17-Feb-18

CLEAN ROOM MAINTENANCE PROGRAM (1) 17-Feb-18

CLEAN ROOM MAINTENANCE PROGRAM (2) 17-Feb-18

HVAC PARAMETER MONITORING AND FREQUENCY Serial No PARAMETER FREQUENCY 1 HEPA Filter Integrity ( DOP testing) Annual / Yearly ( 12 monthly) 2 Air Change rate Every 6 months( biennially) 3 Air pressure differential Daily 4 Microbial load ( settle plate & Swabs) 5 Temperature 6 Humidity ( Relative Humidity) 17-Feb-18

DOCUMENTATION REQUIREMENT FOR AIR HANDLING SYSTEM Description of installation and functions Specification of the requirements ( Engineering and MOC) Operating procedures (SOP) Instructions for performance control (switch on and off) Maintenance instructions and Maintenance records Training of personnel (program and records) O& M manual (operation and maintenance manual) Test and balance ( TAB) reports/ Commissioning Engineering drawings ( mechanical drawings, architectural drawings Log records for monitoring and data 17-Feb-18

CONECRNS FOR PRODUCT PROTECTION IN MANUFACTURING (1): Include contamination/cross contamination of products that could result from: Non reliable and poorly designed air handling s/ dust extraction system Poor operation and no maintenance Inadequate procedures for equipment and personnel Improperly cleaned equipment 17-Feb-18

CONECRNS FOR PRODUCT PROTECTION IN MANUFACTURING (2) Product protection can be archived through controls: filtration of particulates from incoming air to remove external contaminants and Air dilution and displacement to control internal contaminants/ local extraction (point of use) Local air supply or extraction eg isolators and barrier systems Maintaining sufficient air supply velocity and volume to flush unwanted dust from work areas. Air lock system used to limit or minimise migration of contaminants Airlock system can be cascade, bubble or sink type Pressurizing helps to prevent cross contamination between areas, ingress of materials from outside, separate areas of different cleanliness 17-Feb-18

SOME DESIGN FEATURES OF AIR HADNDLING SYSTEM Airlocks Pressurization Supply air diffuser Gauges, alarm and warning system 17-Feb-18

AIRLOCK SYSTEM (1) Small room with controlled air flow acting as barrier between spaces, minimises volume of contaminated air that is introduced into the cleaner area when door is opened Air lock should open and close fast( minimise time of contamination No simultaneous opening of booth doors High air change rate and smaller airlock ensure faster recovery time Three types : cascade, sink and bubble airlock. Airlock should open to the higher pressure side Cascade : High pressure on one side of the airlock and low pressure on the other side. They are very common. Outward for sterile operations and inward d for toxic or hazardous materials Pressure differential range from 10-15pa and is measured across the airlock and not the single doors Used in dispensary layout must be designed to be adequate for purpose 17-Feb-18

AIRLOCK SYSTEM (2) Sink Low pressure inside the air lock and high pressure on both outer sides Usually designed 5-8pa below the smaller of the two classes pressure Designed for dirty operation like gowning, decontamination/exit Used when there are requirements for both area and classification and product containment Bubble High pressure inside and low pressure on both outer sides Used for clean operations like gowning and Material entry airlock Used when there are requirements for both area and product containment 17-Feb-18

THREE TYPES OF AIRLOCK IN USE IN PHARMACEUTICAL INDUSTRY 17-Feb-18

PRESSURIZATION Pressure gradient maintained between adjacent rooms Net airflow from aseptic to the non aseptic areas Air flow from high pressure to low pressure zone Pressure between two room is pressured differential measured Air locks are used when there is requirement for pressure demarcations. Alarms for pressure drops and failures required 17-Feb-18

DIFFUSERS Used to create air supply pattern in the room Types include induction diffusers, perforated plate diffuser, swirl diffusers Caution should be preclude non usage of high induction diffusers in clean areas because of induction of air, instead non induction type should be used so as to maximise flushing effects 17-Feb-18

Swirl Type air diffusors with terminal filters 1 2 3 4 Filter Tightening frame Registered outlet Screw fixation for register 17-Feb-18

HIGH INDUCTION DIFFUSOR AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING Low induction swirl diffusor (preferred) High induction office type diffusor (avoid) 17-Feb-18

REGULATION OF ROOM PRESSURE – pressure differentials concept Room pressure gauges Room pressure indication panel Room pressure indication panel could also be electronic type 17-Feb-18

AIR HANDLING SYSTEM AND PHARMACEUTICAL MANUFACTURING
INSPECTING THE AIR HANDLING PLANT Verification of design documentation, including description of installation and functions specification of the requirements Operating procedures Maintenance instructions Maintenance records Training logs Environmental records Discussion on actions if OOS values Walking around the plant 17-Feb-18

HOW MANY HVAC SHOULD BE USED HVAC are of simple or small unit ( Modular) or Large Single Unit ( Central Unit) The use of multiple small units ( modular) improves reliability ( impossible for all units to fail) Air balancing is easier with multiple small units They require smaller distribution ductwork and is easier to route through ceiling void It is easier to make modification to parts and upgrade as compared to large single units ( Central unit) Allows for easier separation of areas within multi-products concurrent manufacturing facility or plant 17-Feb-18

CONCLUSION Air Handling System plays a critical role in the wheel of factors contributing to product quality in pharmaceutical manufacturing by providing the specific set of room space conditions needed to make quality product. It must be properly designed, installed , validated by professionals, , monitored and maintained as a part of continuous validation/revalidation of the citical system. 17-Feb-18

REFERNCES NAFDAC GMP Guidelines for Pharmaceutical products 2016 HVAC Design for Pharmaceutical Products, A. Bhatia WHO Technical Report Series No.937, 2006, Annex 2 GMP and Quality Assurance of TB products, Kuala Lumpur, by Majia Hietava HVAC ; Gamal Amer, Premier Compliance services limited HVAC Basics; Vishal Katyar 17-Feb-18

THANK YOU THANK YOU 17-Feb-18

CASE STUDY 1 A multiproduct OSD pharmaceutical company with a central HVAC system of recirulated air has just commenced operation in Nigeria and one of the product being manufactured in the facility is misoprostol. It was noticed that air supply to production was by induction system and during a production section water was observed to be dripping from the false ceiling void along the HVAC duct . What do think are a stake in this situation?- Outline 17-Feb-18

CASE STUDY 2 Outline the interventions you would take for a multiproduct manufacturing plant that has been having issues of down time with their air Handling System, which resulted in microbial load exceeding limits and eventual adoption of AHU scheduling( shutdown at weekends). 17-Feb-18

AIR HANDLING SYSTEM IN PHARMACEUTICAL MANUFACTURING

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