HVAC system is very important part of a pharmaceutical company. So that we must know the basic term or procedure of a Pharmaceutical HVAC system. We are tying to give a brief description about HVAC system in our Slide. Hope all of u like it. Thank u..
Complete hvac ppt by kk 354647.pptx 1234KRISHAN KUMAR
This document provides an overview of heating, ventilation, and air conditioning (HVAC) systems. It discusses the history and development of HVAC, including early innovations in refrigeration. The core components and functions of HVAC systems are described, such as furnaces, ducts, air conditioners, and heat pumps. Various types of HVAC installations and systems are covered, like central air, zoned heating, and radiant heat. Recent developments in HVAC technology and applications are also summarized along with the advantages and disadvantages of HVAC.
This document provides an overview of Boreas' 5th generation composite steel modular air handling unit. It discusses the advantages of Boreas' units for investors, end users, design offices, and installers. Key features include the use of composite materials, selection and psychrometric calculation software, and Magnelis sheet metal. The document also outlines the unit's quality certifications and provides detailed specifications and dimensions. It describes the unit's modular structure and various components like fans, coils, filters, mixing sections, heat recovery systems, and automation.
The document discusses HVAC (heating, ventilation, and air conditioning) systems. It describes common components of HVAC systems like thermostats, furnaces, air filters, heat exchangers, evaporator coils, condensing units, ductwork, and vents. It explains how these components work together to heat, cool, filter, and circulate air to maintain appropriate temperature and humidity levels. The document also discusses air handling units, which condition and circulate air, and their key components like filters, fans, and sensors. Finally, it briefly mentions the importance of HVAC system commissioning to ensure proper installation, documentation, training, and ongoing performance monitoring.
An AC system is not only cools the room, that system do many things to make our life comfortable. It removes dust and dirt and fill with fresh air
Air condition system makes our life very comfortable.
We can protect hot or cold weather by air conditioning system
The document discusses heating, ventilation, and air conditioning (HVAC) systems and indoor air quality. It describes how HVAC systems work and the components involved, including the refrigeration cycle, air handling units, ducting, and different system types like window units, split units, and central air conditioning. It also discusses factors that affect indoor air quality like temperature, humidity, airflow, and maintenance of HVAC equipment. Poor indoor air quality can cause health issues and impact productivity.
Final Presentation Mehedei ID-13207016.pptxmehede1
This document provides an overview of Mohammad Mehedi Hasan's final presentation on the operation and maintenance of a fire tube steam boiler at Shine Textiles Ltd. The presentation covers the company overview, components and workings of a fire tube boiler, boiler draught types, boiler mountings and accessories, and the operation and maintenance processes. The objectives are to study the boiler components, understand the operation process, and learn about maintenance. Limitations included a lack of sufficient records and unavailability of machine catalogues due to a fire accident.
The document discusses validation and qualification protocols for a fluidized bed dryer (FBD). It describes the construction and working of the FBD, including fluidization principles. Validation includes design, installation, operational, and performance qualification steps to ensure the FBD operates as intended. Qualification tests are conducted to demonstrate that the FBD can consistently dry materials as specified and produce products meeting quality standards.
HVAC system is very important part of a pharmaceutical company. So that we must know the basic term or procedure of a Pharmaceutical HVAC system. We are tying to give a brief description about HVAC system in our Slide. Hope all of u like it. Thank u..
Complete hvac ppt by kk 354647.pptx 1234KRISHAN KUMAR
This document provides an overview of heating, ventilation, and air conditioning (HVAC) systems. It discusses the history and development of HVAC, including early innovations in refrigeration. The core components and functions of HVAC systems are described, such as furnaces, ducts, air conditioners, and heat pumps. Various types of HVAC installations and systems are covered, like central air, zoned heating, and radiant heat. Recent developments in HVAC technology and applications are also summarized along with the advantages and disadvantages of HVAC.
This document provides an overview of Boreas' 5th generation composite steel modular air handling unit. It discusses the advantages of Boreas' units for investors, end users, design offices, and installers. Key features include the use of composite materials, selection and psychrometric calculation software, and Magnelis sheet metal. The document also outlines the unit's quality certifications and provides detailed specifications and dimensions. It describes the unit's modular structure and various components like fans, coils, filters, mixing sections, heat recovery systems, and automation.
The document discusses HVAC (heating, ventilation, and air conditioning) systems. It describes common components of HVAC systems like thermostats, furnaces, air filters, heat exchangers, evaporator coils, condensing units, ductwork, and vents. It explains how these components work together to heat, cool, filter, and circulate air to maintain appropriate temperature and humidity levels. The document also discusses air handling units, which condition and circulate air, and their key components like filters, fans, and sensors. Finally, it briefly mentions the importance of HVAC system commissioning to ensure proper installation, documentation, training, and ongoing performance monitoring.
An AC system is not only cools the room, that system do many things to make our life comfortable. It removes dust and dirt and fill with fresh air
Air condition system makes our life very comfortable.
We can protect hot or cold weather by air conditioning system
The document discusses heating, ventilation, and air conditioning (HVAC) systems and indoor air quality. It describes how HVAC systems work and the components involved, including the refrigeration cycle, air handling units, ducting, and different system types like window units, split units, and central air conditioning. It also discusses factors that affect indoor air quality like temperature, humidity, airflow, and maintenance of HVAC equipment. Poor indoor air quality can cause health issues and impact productivity.
Final Presentation Mehedei ID-13207016.pptxmehede1
This document provides an overview of Mohammad Mehedi Hasan's final presentation on the operation and maintenance of a fire tube steam boiler at Shine Textiles Ltd. The presentation covers the company overview, components and workings of a fire tube boiler, boiler draught types, boiler mountings and accessories, and the operation and maintenance processes. The objectives are to study the boiler components, understand the operation process, and learn about maintenance. Limitations included a lack of sufficient records and unavailability of machine catalogues due to a fire accident.
The document discusses validation and qualification protocols for a fluidized bed dryer (FBD). It describes the construction and working of the FBD, including fluidization principles. Validation includes design, installation, operational, and performance qualification steps to ensure the FBD operates as intended. Qualification tests are conducted to demonstrate that the FBD can consistently dry materials as specified and produce products meeting quality standards.
An air handling unit (AHU) regulates and circulates air as part of an HVAC system. It contains components like filters, heating/cooling coils, fans, and controls. Filters remove dust from the air stream. Coils heat or cool the air. Fans circulate the air through the AHU and into ducts. Controls regulate factors like temperature, humidity, and air quality. Vibration isolators prevent noise and vibrations from transmitting through the ductwork. AHUs are constructed with metal frames and panels to house these components.
The audit examines the HVAC system and building by analyzing energy consumption, reviewing equipment and controls, assessing ventilation and lighting, and identifying safety issues. Key components include the furnace, evaporator coil, condensing unit, and ductwork. Control systems, demand charges, and additional equipment are also evaluated. Heat loss/gain calculations and ventilation balances are performed to determine efficiencies and recommend improvements. Routine testing procedures and action limits for utility systems are reviewed to ensure product safety.
The audit examines the HVAC system and building by analyzing energy consumption, reviewing equipment and controls, assessing ventilation and lighting, identifying safety issues, and calculating heat loss/gain. Key components like the furnace, evaporator coil, ductwork, and vents are inspected. The goal is to improve efficiency and indoor air quality by evaluating utility usage, potential upgrades, and routine testing procedures for compressed gases and utilities in contact with products.
The document summarizes validation of an HVAC system for a pharmaceutical facility. It discusses the importance of HVAC systems in cleanrooms and outlines some key validation parameters to test, including:
1. Airflow pattern, velocity, and changes per hour to ensure proper airflow.
2. Filter leak testing and particulate counting to check filter performance and air quality.
3. Pressure differential, temperature, humidity, and sound level testing to validate environmental controls.
Validation of the HVAC system is necessary to demonstrate that it can consistently supply air meeting quality standards to maintain aseptic manufacturing conditions.
HVAC presentation for masters in architecturegamertagore1999
The document provides an overview of HVAC (Heating, Ventilation and Air Conditioning) systems. It discusses what HVAC is, the components that make up an HVAC system like air conditioners, furnaces, ductwork and thermostats. It also covers the functions of HVAC systems to control temperature, humidity and air movement. The document outlines some industry standards and codes for HVAC design and installation like IS 659 and NBC. It discusses factors like desirable room temperature, ventilation requirements and inside design conditions for cooling and heating.
An air handling unit (AHU) controls temperature, humidity, air movement, and cleanliness in a building. It consists of a fan and equipment to circulate, clean, heat, cool, humidify, or dehumidify air. There are two main types - draw-through units where the fan pulls air through components like filters and cooling coils, and blow-through units where the fan pushes air through components. Key components include the housing, fan, cooling coil, filters, and mixing box where outside and return air are blended. The AHU works by filtering, cooling, and distributing return air or a mixture of return and outside air throughout a building via ductwork.
The document provides an overview of heating, ventilation and air conditioning (HVAC) systems. It begins with definitions of HVAC and its components. It then discusses the history of HVAC, with Willis Carrier inventing modern air conditioning in 1902. Applications of HVAC include shopping malls, hotels, hospitals and pharmaceutical industries. The document also covers clean rooms, airlocks, HVAC qualification processes including design, installation, operation and performance qualification tests.
Heating, ventilation, and air conditioning (HVAC) systems are used to control temperature, humidity, and air quality in enclosed spaces. The goal is to provide thermal comfort and indoor air quality. HVAC systems have several key components, including a furnace or heating unit, air filters, a heat exchanger, refrigerant lines, a condensing unit, an evaporator coil, ductwork, and vents. Together, these components use the refrigeration cycle of compression, condensation, expansion, and evaporation to transfer heat between indoor and outdoor air and maintain comfortable indoor conditions. There are various types of HVAC systems that provide heating and cooling through different methods like central heating/cooling, portable units, and
Validation of HVAC pharma geeta TUBE (Utility Systems)Saikat Bagchi
Validation Of HVAC, Heating, Ventilation, Air Conditioning; Utility Systems, Validation Parameters, Air Handling Unit, Work Flow Animation Diagram, Validation Process Tests & Parameters.
This document discusses the validation of HVAC systems used in the pharmaceutical industry. It begins with introductions to clean rooms, why they are necessary, and how contamination is controlled. It then discusses the components and purpose of HVAC systems, qualification steps including design, installation, and operation qualification, and regulatory requirements. The validation process ensures HVAC systems are designed and functioning properly to maintain environmental controls critical for product quality.
This document discusses laboratory design, safety, and management. It covers designing laboratory equipment such as heating devices, air conditioning systems, ventilation, and laboratory fume hoods. Specific heating devices covered include ovens, hot plates, heating mantles, oil/salt/sand baths, hot air baths, tube furnaces, and heat guns. The document also discusses constant volume and variable air volume air conditioning systems and considerations for ventilation and laboratory fume hood design.
- An air handling unit (AHU) conditions and circulates air within a building by taking in fresh air, cleaning it using filters, and heating or cooling it using coils. It then distributes the conditioned air through ductwork.
- Key components of an AHU include dampers, filters, heating/cooling coils, fans, and sensors to control temperature and humidity. Proper ventilation is provided through an intake of outside air.
- AHUs are used in HVAC systems to regulate indoor air quality and thermal comfort by filtering, heating, cooling, humidifying and circulating air throughout a building via a network of supply and return air ducts.
The document discusses validation of a hot air oven. It defines equipment validation and introduces the types and principles of dry heat sterilizers. The validation process for a hot air oven includes design qualification, installation qualification, operational qualification, and performance qualification. Key tests involve heat penetration studies, heat distribution studies, and biochallenge/pyrochallenge studies to develop a sterilization cycle. Routine monitoring after validation ensures the oven remains in a state of control. All validation documentation must be thorough and stored for regulatory review.
This document discusses ventilation and HVAC systems. It defines ventilation and explains why it is important for human respiration, diluting odors, removing combustion products, and providing a comfortable thermal environment. It describes natural and artificial ventilation systems. For artificial systems, it covers exhaust, plenum, exhaust-plenum, evaporative cooling, air conditioning, and different types of HVAC equipment. It emphasizes the functional requirements of an effective ventilation system.
The document discusses good operating practices and safety precautions for maintaining heat exchangers. It describes the tools and equipment needed, which are divided into working tools and safety equipment. Important safety practices include ensuring systems are shut down and isolated, draining heat exchangers before opening, and following confined space procedures. Preventative maintenance and troubleshooting responsibilities are also outlined.
Energy Conservation Energy ConservationEnergy ConservationAkshVashist1
This document discusses refrigeration, air conditioning, and heating systems. It describes vapor compression refrigeration (VCR) systems which use a compressor, condenser, expansion valve, and evaporator to circulate refrigerant and absorb/reject heat. It also describes vapor absorption refrigeration (VAR) systems which use a generator, absorber, pump, and non-return path instead of a compressor. Key differences between VCR and VAR are also outlined. The document further discusses heat pumps, factors affecting performance of refrigeration and air conditioning systems, diesel generator sets, and opportunities for improving energy efficiency in buildings, HVAC systems, fans, and blowers.
This document provides guidance on boiler maintenance activities. It discusses the importance of maintenance for ensuring safe and reliable boiler operation. It outlines the objectives of a boiler maintenance program and types of maintenance. The document describes general maintenance checks and inspection activities. It provides guidelines for specific maintenance activities for different boiler components, such as the furnace, superheaters, drums, headers, and fans. It also discusses operating checks that are related to maintenance. The overall summary is:
A boiler maintenance program involves regular inspection, testing, and repair of boiler components to ensure safe and efficient operation. The program includes procedures, scheduling, record keeping, training, and improvement planning. Maintenance activities involve inspection and cleaning of various parts, including the furn
This document discusses the validation of various sterilization processes including steam, dry heat, ethylene oxide, and radiation sterilization. It provides details on qualification and calibration of equipment used, selection and calibration of biological indicators, and heat distribution and penetration studies. The key steps in validating dry heat, ethylene oxide, and radiation sterilization cycles are also summarized.
An air handling unit (AHU) regulates and circulates air as part of an HVAC system. It contains components like filters, heating/cooling coils, fans, and controls. Filters remove dust from the air stream. Coils heat or cool the air. Fans circulate the air through the AHU and into ducts. Controls regulate factors like temperature, humidity, and air quality. Vibration isolators prevent noise and vibrations from transmitting through the ductwork. AHUs are constructed with metal frames and panels to house these components.
The audit examines the HVAC system and building by analyzing energy consumption, reviewing equipment and controls, assessing ventilation and lighting, and identifying safety issues. Key components include the furnace, evaporator coil, condensing unit, and ductwork. Control systems, demand charges, and additional equipment are also evaluated. Heat loss/gain calculations and ventilation balances are performed to determine efficiencies and recommend improvements. Routine testing procedures and action limits for utility systems are reviewed to ensure product safety.
The audit examines the HVAC system and building by analyzing energy consumption, reviewing equipment and controls, assessing ventilation and lighting, identifying safety issues, and calculating heat loss/gain. Key components like the furnace, evaporator coil, ductwork, and vents are inspected. The goal is to improve efficiency and indoor air quality by evaluating utility usage, potential upgrades, and routine testing procedures for compressed gases and utilities in contact with products.
The document summarizes validation of an HVAC system for a pharmaceutical facility. It discusses the importance of HVAC systems in cleanrooms and outlines some key validation parameters to test, including:
1. Airflow pattern, velocity, and changes per hour to ensure proper airflow.
2. Filter leak testing and particulate counting to check filter performance and air quality.
3. Pressure differential, temperature, humidity, and sound level testing to validate environmental controls.
Validation of the HVAC system is necessary to demonstrate that it can consistently supply air meeting quality standards to maintain aseptic manufacturing conditions.
HVAC presentation for masters in architecturegamertagore1999
The document provides an overview of HVAC (Heating, Ventilation and Air Conditioning) systems. It discusses what HVAC is, the components that make up an HVAC system like air conditioners, furnaces, ductwork and thermostats. It also covers the functions of HVAC systems to control temperature, humidity and air movement. The document outlines some industry standards and codes for HVAC design and installation like IS 659 and NBC. It discusses factors like desirable room temperature, ventilation requirements and inside design conditions for cooling and heating.
An air handling unit (AHU) controls temperature, humidity, air movement, and cleanliness in a building. It consists of a fan and equipment to circulate, clean, heat, cool, humidify, or dehumidify air. There are two main types - draw-through units where the fan pulls air through components like filters and cooling coils, and blow-through units where the fan pushes air through components. Key components include the housing, fan, cooling coil, filters, and mixing box where outside and return air are blended. The AHU works by filtering, cooling, and distributing return air or a mixture of return and outside air throughout a building via ductwork.
The document provides an overview of heating, ventilation and air conditioning (HVAC) systems. It begins with definitions of HVAC and its components. It then discusses the history of HVAC, with Willis Carrier inventing modern air conditioning in 1902. Applications of HVAC include shopping malls, hotels, hospitals and pharmaceutical industries. The document also covers clean rooms, airlocks, HVAC qualification processes including design, installation, operation and performance qualification tests.
Heating, ventilation, and air conditioning (HVAC) systems are used to control temperature, humidity, and air quality in enclosed spaces. The goal is to provide thermal comfort and indoor air quality. HVAC systems have several key components, including a furnace or heating unit, air filters, a heat exchanger, refrigerant lines, a condensing unit, an evaporator coil, ductwork, and vents. Together, these components use the refrigeration cycle of compression, condensation, expansion, and evaporation to transfer heat between indoor and outdoor air and maintain comfortable indoor conditions. There are various types of HVAC systems that provide heating and cooling through different methods like central heating/cooling, portable units, and
Validation of HVAC pharma geeta TUBE (Utility Systems)Saikat Bagchi
Validation Of HVAC, Heating, Ventilation, Air Conditioning; Utility Systems, Validation Parameters, Air Handling Unit, Work Flow Animation Diagram, Validation Process Tests & Parameters.
This document discusses the validation of HVAC systems used in the pharmaceutical industry. It begins with introductions to clean rooms, why they are necessary, and how contamination is controlled. It then discusses the components and purpose of HVAC systems, qualification steps including design, installation, and operation qualification, and regulatory requirements. The validation process ensures HVAC systems are designed and functioning properly to maintain environmental controls critical for product quality.
This document discusses laboratory design, safety, and management. It covers designing laboratory equipment such as heating devices, air conditioning systems, ventilation, and laboratory fume hoods. Specific heating devices covered include ovens, hot plates, heating mantles, oil/salt/sand baths, hot air baths, tube furnaces, and heat guns. The document also discusses constant volume and variable air volume air conditioning systems and considerations for ventilation and laboratory fume hood design.
- An air handling unit (AHU) conditions and circulates air within a building by taking in fresh air, cleaning it using filters, and heating or cooling it using coils. It then distributes the conditioned air through ductwork.
- Key components of an AHU include dampers, filters, heating/cooling coils, fans, and sensors to control temperature and humidity. Proper ventilation is provided through an intake of outside air.
- AHUs are used in HVAC systems to regulate indoor air quality and thermal comfort by filtering, heating, cooling, humidifying and circulating air throughout a building via a network of supply and return air ducts.
The document discusses validation of a hot air oven. It defines equipment validation and introduces the types and principles of dry heat sterilizers. The validation process for a hot air oven includes design qualification, installation qualification, operational qualification, and performance qualification. Key tests involve heat penetration studies, heat distribution studies, and biochallenge/pyrochallenge studies to develop a sterilization cycle. Routine monitoring after validation ensures the oven remains in a state of control. All validation documentation must be thorough and stored for regulatory review.
This document discusses ventilation and HVAC systems. It defines ventilation and explains why it is important for human respiration, diluting odors, removing combustion products, and providing a comfortable thermal environment. It describes natural and artificial ventilation systems. For artificial systems, it covers exhaust, plenum, exhaust-plenum, evaporative cooling, air conditioning, and different types of HVAC equipment. It emphasizes the functional requirements of an effective ventilation system.
The document discusses good operating practices and safety precautions for maintaining heat exchangers. It describes the tools and equipment needed, which are divided into working tools and safety equipment. Important safety practices include ensuring systems are shut down and isolated, draining heat exchangers before opening, and following confined space procedures. Preventative maintenance and troubleshooting responsibilities are also outlined.
Energy Conservation Energy ConservationEnergy ConservationAkshVashist1
This document discusses refrigeration, air conditioning, and heating systems. It describes vapor compression refrigeration (VCR) systems which use a compressor, condenser, expansion valve, and evaporator to circulate refrigerant and absorb/reject heat. It also describes vapor absorption refrigeration (VAR) systems which use a generator, absorber, pump, and non-return path instead of a compressor. Key differences between VCR and VAR are also outlined. The document further discusses heat pumps, factors affecting performance of refrigeration and air conditioning systems, diesel generator sets, and opportunities for improving energy efficiency in buildings, HVAC systems, fans, and blowers.
This document provides guidance on boiler maintenance activities. It discusses the importance of maintenance for ensuring safe and reliable boiler operation. It outlines the objectives of a boiler maintenance program and types of maintenance. The document describes general maintenance checks and inspection activities. It provides guidelines for specific maintenance activities for different boiler components, such as the furnace, superheaters, drums, headers, and fans. It also discusses operating checks that are related to maintenance. The overall summary is:
A boiler maintenance program involves regular inspection, testing, and repair of boiler components to ensure safe and efficient operation. The program includes procedures, scheduling, record keeping, training, and improvement planning. Maintenance activities involve inspection and cleaning of various parts, including the furn
This document discusses the validation of various sterilization processes including steam, dry heat, ethylene oxide, and radiation sterilization. It provides details on qualification and calibration of equipment used, selection and calibration of biological indicators, and heat distribution and penetration studies. The key steps in validating dry heat, ethylene oxide, and radiation sterilization cycles are also summarized.
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HVAC System | Audit of HVAC System | Audit and regulatory Comploance.pptx
1. Mahatma Gandhi Vidyamandir’s
Pharmacy college
Panchavati ,Nashik
Pharmaceutical Quality Assurance
Department
Sub : Audits and Regulatory Compliance
Prepared By Guided by
Mr. Kunal Anil Suryawanshi Mrs. P.D. Chaudhari Mam
Roll No:45
Presentation on
HVAC System
2. VISION:
To be a Centre of professional excellence by contributing honestly to the pharmacist
moulding process.
MISSION:
Impart high quality education to graduates
Contribute to all spheres of professional activities
Uphold human values and ethics
Nature them into globally competent professional
3. CONTENT
Introduction
Importance of HVAC
Clean Rooms
Parts of HVAC
Inspection of HVAC system
WHO-GMP auditing on HVAC
WHO guidelines on HVAC
6. COMPONENTS
6
1. Thermostat: Fixed on easily accessible wall, it may be either programmed in
advance or set manually to keep the home at a desired temperature.
2. Furnace: The furnace is the key component of your HVAC system. It's also the
largest, requiring substantial space typically in the cellar, your finished basement, a
special closet designed for that purpose. Its function is to heat a supply of air
which is to be distributed to various rooms of your home via the HVAC. This
heating process is accomplished using one of four possible heat sources -
combustion (burning natural gas, oil, coal, or propane), electric resistance, heat
pump, or solar energy collected on site.
7. 7
3. Heat exchanger: The heat exchanger is found inside your furnace unit's
housing. This component switches on when the furnace is activated by
thermostat to produce warmer temperatures in winter. The heat exchanger pulls
in cool air, heats it, and circulates the resulting heated air via your ducts and out
through the vents.
4. Evaporator coil: The evaporator coil has an opposite role to the heat
exchanger, it acts to cool the air when your thermostat is set to lower
temperatures in summer. Located in a metal enclosure on the furnace's exterior,
to the top or side, side, the t evaporator coil works similarly to an automobile
radiator to produce cool air, which is then circulated through the ductwork.
Components
8. COMPONENTS
8
5. Condensing unit. The condensing unit is connected to the evaporator coil. This
unit is installed by HVAC contractors on the outside of your home and filled with
refrigerant gas. When the refrigerant has been cooled to a liquid by heat exchange
with the exterior air, the condensing unit pumps the liquid to the evaporator coil to
evaporated into a gas once more.
6. Refrigerant lines. The refrigerant lines carry a refrigerant substance to the
condensing unit vaporized in the form of a gas, and return it to the evaporator coil
in liquid form. These "lines" are actually narrow tubes manufactured from a
durable heat- and cold-resistant metal such as copper or aluminum.
9. COMPONENTS
9
7. Ductwork. Ductwork refers to the system of ducts that transports, air warmed
various areas of your home. Ducts are commonly or cooled by the system to the
made of lightweight aluminum. However, they may also be manufactured from
steel, flexible plastic, polyurethane, fiberglass, or fabric.
8. Vents. The vents are the rectangular outlets which transfer the heated or cooled air
from the duct system into the individual rooms of your home. Made of high and
low-temperature safe metal, the vents are located on or near the ceiling and are
usually fronted with angled slats ("vents").
10. CLEANROOM
10
• Clean room in pharmaceutical industry are enclosed area that provides
controlled environmental conditions for various critical processes in a different
industrial environment.
• Their primary purpose is to provide a particle and contamination free
environment for manufacturing processes to prevent contamination.
• Clean rooms in Pharmaceutical industry provide suitable environmental
conditions for manufacturing sterile products, such as injectables, which have a
high degree of purity requirement. If the desired controlled area characteristics
are not provided, the product becomes hazardous and cannot be used for human
consumption.
12. CHECKLIST FOR AIR CONDITIONER
• Inspect the outdoor condensing unit
• Inspect the condenser coil
• Inspect the evaporator coil
• Inspect the blower assembly
• Check blower speed
12
• Inspect lines for visible refrigerant leaks
• Check the condensate drain pan for damage
• Check air registers and ducts for cleanliness
• Check for refrigerant leaks
• Ensure that superheat and subcooling are
correct
• Inspect the drain line
• Check for loose electrical connections
13. CHECKLIST FOR HEAT PUMP INSPECTION
• Verify thermostat sensors are working properly
• Check the exterior for snow or ice buildup (winter/spring)
• Check for dirt on outdoor coils
• Ensure the pump is elevated from the ground and away from leaky gutters
• Check for and repair air duct leakage
• Take note of any necessary heat pump repair work
• Inspect the condenser coil
• Inspect the evaporator coil
• Check the bearings and blower motor
13
14. CHECKLIST FOR GAS FURNACE INSPECTION
• Listen for excessive noise or vibration when furnace is running
• Check that the blower fan is properly connected
• Inspect the blower assembly for proper functioning
• Check the air filter for dirt accumulation
• Inspect the heat exchanger for corrosion, cracks, or damage in the ignitor, flame
sensor, and associated wiring
• Listen for clicking in the spark ignitor (if installed)
• Inspect wiring and control circuit
14
15. CHECKLIST FOR ELECTRIC FURNACE
INSPECTION
• Check that blower fan is clean, undamaged, and operating properly
• Measure blower motor amp draw
• Check air filters for dust and dirt
• Check that all humidifier components are positioned properly
• Check heat strips for corrosion, pitting, or burns
• Measure heat strip amp draw
• Verify the continuity of heat strips
• Check that sequencers are operating properl
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16. CHECKLIST FOR TANKLESS WATER HEATER
INSPECTION
• Clean out sediment, dust, and oil from the water filter
• Check for water leaks surrounding the system
• Remove and clean dirt traps
• Inspect and clean the burner
• Inspect and clean the spark rod and flame sensor
• Inspect and clean the combustion chamber
• Check the hot water temperature
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17. WHO-GMPAUDITING ON HVAC
• i) The HVAC system was provided with an alarm for Temp. and RH. Filters
cleaning was properly documented. Preventive maintenance schedule and check
lists were presented to inspectors.
• ii) Training records of the staff that was cleaning the HVAC pre-filters.
• iii) The SOP on preventive maintenance of motors showed that AHU motors were
serviced every 6 months.
• iv) The HVAC systems in each unit generally consist of many separate and
independent units.
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18. WHO GUIDELINES ON HVAC
• The HVAC system capacity should be sufficient to ensure that the required
performance is maintained during normal use.
• Materials for constructing the components of an HVAC system should not
become a source of contamination.
• Air-handling units (AHUs) should be provided with adequately designed
drains to remove any condensate that may form in them.
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19. REFERENCE
ISO 14644. Cleanrooms and associated controlled environments. Parts 1–15. Geneva:
International organization for Standardization; 2012–2018 (https://www.iso.org/obp/ui/#search,
accessed 14 March 2019).
WHO guidelines on quality risk management. In: WHO Expert Committee on Specifications for
Pharmaceutical Preparations, forty-seventh report. Geneva: World Health Organization; 2013:
Annex 2 (WHO Technical Report Series, No. 981; https://www.who.int/medicines/areas/quality_
safety/quality assurance/Annex2TRS-981.pdf, accessed 9 February 2019).
Good practice guide: heating, ventilation, and air conditioning (HVAC).North Bethesda (MD):
International Society for Pharmaceutical Engineering (ISPE); 2009.
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