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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
 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
CONTENT
 Introduction
 Importance of HVAC
 Clean Rooms
 Parts of HVAC
 Inspection of HVAC system
 WHO-GMP auditing on HVAC
 WHO guidelines on HVAC
INTRODUCTION
HVAC stands for
4
Heating
Ventilation
Air
Conditioning
 These system is responsible for precise control of temperature, Humidity, Air quality and
pressure in various area of pharmaceutical facilities including production area, laboratories
and storage areas.
INTRODUCTION
5
Fresh Air
Treated
Air
Pre Filter
Blower
Cooling Coil
Semi HEPA Filter
Fine Filter
Exhaust Air
Moisture Eliminator
Heating Coil
HEPA Filter
Clean Room
Pre Filter
Returned Air
 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
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
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.
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").
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.
11
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
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
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
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
15
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
16
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.
17
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.
18
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.
19
THANK YOU
20

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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
  • 4. INTRODUCTION HVAC stands for 4 Heating Ventilation Air Conditioning  These system is responsible for precise control of temperature, Humidity, Air quality and pressure in various area of pharmaceutical facilities including production area, laboratories and storage areas.
  • 5. INTRODUCTION 5 Fresh Air Treated Air Pre Filter Blower Cooling Coil Semi HEPA Filter Fine Filter Exhaust Air Moisture Eliminator Heating Coil HEPA Filter Clean Room Pre Filter Returned Air
  • 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.
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  • 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 15
  • 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 16
  • 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. 17
  • 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. 18
  • 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. 19