Pt01- Introduction to HVAC Systems

8/13/2019 Pt01- Introduction to HVAC Systems

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HVAC Systems and the Pharmaceutical Manufacturing Environment Radisson SAS Hotel, Amsterdam 2008

Validation in Partnership Limited Part 01 Introduction to HVAC Systems - Page 2

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HVAC?HVAC?

HVAC is an acronym for:

Heating Ventilation and Air

Conditioning

The name of a building-related system

HVAC is an acronym for:

Heating Ventilation and Air

Conditioning

The name of a bui lding-related system


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What Does It Do?What Does It Do?

HVAC systems provide forced ventilation offacilities with conditioned air

Conditioning may involveHeating*

Cooling*

Humidification

Dehumidification

Filtration

Fumigation

* Basic functions of HVAC

HVAC systems provide forced ventilation offacilities with conditioned air

Conditioning may involveHeating*

Cooling*

Humidification

Dehumidification

Filtration

Fumigation

* Basic functions of HVAC


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General UsesGeneral Uses

Protection of productCGMP (Pharmaceutical)

Micro-electronics

Comfort of personnel

Protection of personnel fromhazardous material (Safety)

Protection of patients (hospitals)

Protection of building fabric (mouldinfestation)

Enables use of different buildingarchitecture.

Protection of productCGMP (Pharmaceutical)

Micro-electronics

Comfort of personnel

Protection of personnel f romhazardous material (Safety)

Protection of patients (hospitals)

Protection of building fabric (mouldinfestation)

Enables use of different buildingarchitecture.


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History [1]History [1]

1902 - First air conditioning machinedeveloped in a Brooklyn (USA)

Willis Haviland Carrier

Controlled local temperature andhumidity - 4 colour printing

1906 - Term 'air conditioning firstused

Patent for humidifying system

1911 - Basic Rational PsychrometricFormulae disclosed (Willis Haviland

Carrier).

1902 - First air conditioning machinedeveloped in a Brooklyn (USA)

Willis Haviland Carrier

Controlled local temperature andhumidity - 4 colour printing

1906 - Term 'air conditioning firstused

Patent for humidifying system

1911 - Basic Rational PsychrometricFormulae disclosed (Willis Haviland

Carrier).

In 1902, only one year after Willis Haviland Carrier graduated from Cornell University with a Masters inEngineering, the first air (temperature and humidity) conditioning was in operation, making one Brooklyn printingplant owner very happy. Fluctuations in heat and humidity in his plant had caused the dimensions of the printing

paper to keep altering slightly, enough to ensure a misalignment of the coloured inks. The new air conditioningmachine created a stable environment and aligned four-colour printing became possible. All thanks to the newemployee at the Buffalo Forge Company, who started on a salary of only $10.00 per week.

The 'Apparatus for Treating Air' (U.S. Pat# 808897) granted in 1906, was the first of several patents awarded toWillis Haviland Carrier. The recognized 'father of air conditioning' is Carrier, but the term 'air conditioning' actuallyoriginated with textile engineer, Stuart H. Cramer. Cramer used the phrase 'air conditioning' in a 1906 patentclaim filed for a device that added water vapour to the air in textile plants - to condition the yarn.


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History [2]History [2]

Automobile Air -condit ioning

One final frontier for air-condit ioning

Weight and size of early units - prohibitive

Immense social status - as with the first carphones!!!

Drivers in US (1950s) - driving around w ith carwindows closed to fool their neighbours!!!!

First car refrigeration unit - 1939 Packard

Cadillac followed suit in 1941 with 300 air-conditioned cars

Harrison Radiator Division, General Motors

First efficient, affordable unit - made in mass

production Continued to be a rare option for many years

It wasn't un til the late 70s and 80s that air-conditioned cars became a craze.

Automobi le Air -condit ioning

One final frontier for air-conditioning

Weight and size of early units - prohibitive

Immense social status - as with the first carphones!!!

Drivers in US (1950s) - driving around with carwindows closed to fool their neighbours!!!!

First car refrigeration unit - 1939 Packard

Cadillac followed suit in 1941 with 300 air-conditioned cars

Harrison Radiator Division, General Motors

First efficient, affordable unit - made in mass

production Continued to be a rare option for many years

It wasn't unt il t he late 70s and 80s that air-conditioned cars became a craze.

First car with an actual refrigeration system was the 1939 Packard. It consisted of a large evaporator, calledthe 'cooling coil,' which took up the entire boot space. The only control was a blower switch. Packard, in fact,ran its advertising as, "Forget the heat this summer in the only air-conditioned car in the world.

Cadillac followed suit in 1941 with 300 air-conditioned cars. All of these early air-conditioning systems had onebig drawback: there was no compressor clutch, so the pump was on when the engine was running. To shut thesystem off, one had to stop, get out, open the hood, and remove the belt. It wasn't until after WWII thatCadillac advertised a new, high-tech feature: the air-conditioning controls. The controls were located on therear package shelf, which meant that the driver had to climb into the back seat to shut the system off. Yet itwas still better than reaching under the bonnet.

The Harrison Radiator Division of General Motors may be credited with developing the first efficient, affordableunit that could be made in mass production. It was available as an option on all 1954 Pontiacs with V8s. Itfeatured a two-cylinder reciprocating compressor, and an all-brazed condenser. It also used a magnetic clutch,so when it was not in use, no power was needed to drive the compressor, which improved performance andfuel economy.

However, air conditioning continued to be a rare option for many years. It wasn't until the late 70s and 80s thatair-conditioned cars became a craze. Systems were getting better and people realized that they didn't reallyhave to sweat it out because their air-conditioning units did not run well. It's estimated that now over 80% ofthe cars and light trucks in operation in the United States have air conditioning.


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Examples of Grades Used [1]Examples of Grades Used [1]

Secondary Packing - All Term General Pharmaceutical Environment

often used

No regulatory prescribed classification

Ventilated and temperature controlled withsome level of dust fi ltration on supply

Non-sterile solid dose (tablets /capsules) manufacture and primary

packaging


Could be General PharmaceuticalEnvironment

Many manufacturers using controlledenvironments approximating to Grade D or

ISO 8 at rest .

Secondary Packing - All Term General Pharmaceutical Environment

often used


Ventilated and temperature controlled withsome level of dust f iltration on supply

Non-sterile sol id dose (tablets /capsules) manufacture and primary

packaging


Could be General PharmaceuticalEnvironment

Many manufacturers using controlledenvironments approximating to Grade D or

ISO 8 at rest .


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Non-Sterile ExampleNon-Sterile Example

Zone 1: Approx imates to Grade C

at rest

Zone 2: Approx imates to Grade D

at rest

Zone 3: Approximates to general pharm.

Environment

Zone 4: Unclassified

Zone 1: Approx imates to Grade C

at rest

Zone 2: Approx imates to Grade D

at rest

Zone 3: Approximates to general pharm.

Environment

Zone 4: Unclassified

Process

Room 1

Process

Room 2

Material Out Air

Lock

MaterialsEntry

Changing

Room

Process

Room

Access

Air -Lock


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Sterile ExampleSterile Example

Grade A Grade B Grade C

Grade D General Pharm.

Grade A Grade B Grade C

Grade D General Pharm.

Cooling RoomCooling Room

Asep tic

Processing

Room

Changing RoomChanging Room

Air lockAir lock

Aut ocl aveAut ocl ave

Aut ocl ave

loading Room

Autoclave

loading Room

Component

preparation

Component

preparation

Packing Hall

Critical Area

Critical Area

Solution Preparation AreaSolution Preparation Area

Final Washing /

Sterilising Tunnel

Final Washing /

Sterilising Tunnel


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Procedures and

Responsibilities

Procedures and

Responsibilities

It is Everyones responsibility formanufacturing in accordance with CGMP

Not just QA / QC

It is Everyones responsibility formanufacturing in accordance with CGMP

Not just QA / QC


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End of PresentationEnd of Presentation

Any further questions?Any further questions?


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Pt01- Introduction to HVAC Systems

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