HVAC - The Ultimate Guide to HVAC and Its Components

Supplementary Training Modules on Good Manufacturing Practice Heating, Ventilation and Air- Conditioning (HVAC) Part 3: HVAC systems and components

HVAC Objectives In the following slides, we will study the components of air- handling systems in order to: 1. Become familiar with the components 2. Know their functions 3. Become aware of possible problems

HVAC Main subsystems Exhaust air treatment Fresh air treatment + Terminal air treatment (make-up air) at production room level Production Room Central air handling unit

Components Components in HVAC may include, depending on need: • Filters • Fans • no fan failure; including supply air fans, return air fans, exhaust air fan, dust extract system fans • Driers • Drying of air with chemical driers, e.g. rotating desiccant wheel • Frost coils for preheating air

General • Pharmaceutical products should be manufactured in areas of appropriate cleanliness • Prevent contamination and cross-contamination • Design of HVAC dependent on various factors e.g. • Outside air quality • Recirculation of air (or not) • Products and range of products • Risk assessment to determine clean room conditions.

General • Two basic concepts of air delivery –a re-circulation system, and –a full fresh air system (100% outside air supply). • Recirculation – determine the amount of fresh air based on criteria: –to compensate for leakage and loss –to comply with national building regulations; and –for odour control.

General • Validated automated monitoring systems (e.g. Building management systems (BMS), building automation system (BAS) or system control and data acquisition (SCADA) system) - capable of indicating any out-of- specification condition without delay e.g. by means of an alarm – Also helps with preventive maintenance and trend logging – Critical alarms easily identifiable, visible and/or audible • Fan interlock failure matrix • Fan failures can cause a system imbalance, resulting in a pressure cascade malfunction with a resultant airflow reversal.

Air distribution • Positioning of supply and extract grilles to provide effective room flushing. • Low-level return or exhaust air grilles preferred. • If not possible, a higher air change rate may be needed to achieve a specified clean area condition, e.g. where ceiling return air grilles are used. • There may be alternative locations for return air 7.2.1 – 7.2.2





HVAC Air types Fresh air Supply + Exhaust (make-up air) air air Production Room Return air (recirculated)

Recirculation systems • Increased risk of contamination and cross-contamination. • Need HEPA filters (EN1822 classification of H13) • HEPA filters may not be required: – a single product facility and there is evidence that cross-contamination would not be possible. – No dust generated e.g. secondary packing • HEPA filters installed in the air-handling unit or terminally placed – If terminally mounted - not with flexible ducting • If highly toxic processes – never recirculate

HVAC Ventilation with recirculated air + make-up air Exhaust Unit Central Air-Handling Unit Return air

Full fresh-air systems • 100% fresh air normally used in a facility dealing with toxic products or solvents, where recirculation of air with contaminants should be avoided • Degree of filtration of the exhaust air depends on the exhaust air contaminants and local environmental regulations • HEPA filters in the exhaust system normally when handling hazardous materials



HVAC Ventilation with 100% fresh air (no air recirculation) Exhaust Unit Washer (optional) W Central Air-Handling Unit Production Rooms

Energy-recovery wheels • Risk assessment to determine cross-contamination risks • Should not become a source of possible contamination • Alternatives include crossover plate heat exchangers and water-coil heat exchangers • Prevent air leakage between the supply air and exhaust air – exhaust air system operates at a lower pressure than the supply system.





Components Components in HVAC may include, depending on need: • frost coils to preheat the air • reheaters for humidity control, moisture eliminators • automatic air volume control devices • sound attenuators • snow eliminators, dust eliminators, • fresh air precooling coils

HVAC Overview components Exhaust Air Grille Silencer Flow rate controller Fan Filter Weather louvre Control damper Humidifier Prefilter + Heater Terminal filter Cooling coil Secondary Filter Production Room Recirculated air with droplet separator Heating coil

HVAC Components (1) • Weather louvre • To prevent insects, leaves, dirt and rain from • Silencer entering • Flow rate controller • Control damper • To reduce noise caused by air circulation • Automated adjustment of volume of air (night and day, pressure control) • Fixed adjustment of volume of air

HVAC Components (2) • To heat the air to the proper temperature • To cool the air to the required • Heating unit • Cooling unit/ temperature or to remove moisture from dehumidifier the air • To bring the air to the proper humidity, if • Humidifier • Filters too low • Ducts • To eliminate particles of predetermined dimensions and/or microorganisms • To transport the air

HVAC Air-handling unit Adsorber wheel Dry air Humid room air AHU with fan Variable Regeneration air Humid room air Speed Controller Air heater De-humidification Filter Pressure Gauges

HVAC

HVAC HEPA or tertiary filter Primary panel filter Secondary filter

HVAC 1 2 3 4 1 Filter 2 Tightening frame 3 Register outlet 4 Screw fixation for register

HVAC Problems with components • Flow rate controller • Blocked • Control damper • Poorly adjusted, bad pressure differential • Humidifier system • Bad water/steam quality/ • Cooling battery poor drainage • Filters • No elimination of condensed water/ poor • Ducts drainage • Incorrect retention rate/damaged/badly installed • Inappropriate material/internal insulator leaking

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