Pharma HVAC

HVAC For Pharmaceutical Facilities

Basic System Components

slide 1

What is "HVAC"

Heating,
Ventilating &
Air Conditioning

Pronounced "H-V-A-C" or "H-vack"

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Pharma HVAC

Air CONDITIONING

Conditioning =
Remove contaminants
Cool
Heat
Dehumidify
Humidify

slide 3

What can HVAC do?

T = maintain space temperature

RH = space moisture (Relative Humidity)
Humidify
Dehumidify
C = airborne particles
DP = room pressure ("delta P")
Product/process segregation (Separate facilities if cephalosporin/penicillin/certain
other actives)
Supply fresh (makeup) air for health (U.S. 10-20 CFM - per occupant)

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Pharma HVAC

What HVAC Can't Do

HVAC can not clean up the surfaces of a

contaminated room
HVAC can not compensate for workers
who do not follow procedures
HVAC cannot work miracles

slide 5

Basic HVAC Systems

Once - through air

Air is conditioned, enters the space, and is discarded

Recirculated air
Air is conditioned, enters the space, and a portion is re-
conditioned. Some may be discarded

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Pharma HVAC

Once-thru Air Schematic

Outdoor Air Handler Unit Supply air

air (AHU)

Exhaust Infiltration
Room
(Extract)

Exfiltration

slide 7

Once-thru HVAC
What are the advantages of this system?
FRESH AIR… lots of it
CAN HANDLE HAZARDOUS MATERIALS, although will need to clean up air leaving
the space
Exhaust duct is usually easy to route as high velocity = smaller diameter
DISADVANTAGES?
EXPENSIVE TO OPERATE, especially when cooling and heating.
Filter loading very high = frequent replacement
Potential need for dust collection/scrubbers/cleanouts
APPLICATIONS?
Labs with hoods, potential hazards (high operating costs)
BPC (API) plants handling flammable materials
OSD plants where potent products/materials exposed
Where high potential of product cross-contamination - segregation
Some bio API facilities with exposed potent materials
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Pharma HVAC

Recirculated (Return) Air Schematic

Makeup Air Handler Unit Supply air

(Fresh) (AHU)
air Possible extract

Room
Return air
Exfiltration
Infiltration

slide 9

Recirculated HVAC
WHAT ADVANTAGES HERE?
Usually less air filter loading = lower filter maintenance and energy cost
Opportunity for better air filtration
Less challenge to HVAC = better control of parameters (T, RH, etc)
Less throw-away air = lower cooling/heating cost
DISADVANTAGES?
Return air ductwork routing to Air handler may complicate above ceiling
Chance of cross contamination = Requires adequate supply air filtration (and
sometimes return air filtration)
APPLICATIONS?
Classified spaces such as Sterile manufacture (few airborne materials, very
clean return air)
Finished OSD manufacture where product is not airborne with other products
in the facility
Final bulk APIs, usually with dedicated air handler for each room
Wherever a process is proven closed
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Pharma HVAC

Segregation

Some product manufacture must be segregated from

other areas
SEPARATE Pen/Ceph facilities
Potent materials
Can do with DEDICATED once-thru or recirculated
systems
Be CAREFUL

slide 11

Extract System Schematic

Stack
(follow 1.3x
rule of thumb
if "foul air"…
see ASHRAE)

Exfiltration
Infiltration
Fan Air cleaner duct leakage
duct leakage

Ductwork

"Space" with airborne contaminants

Space may be a room, a glovebox or an exhaust hood

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Pharma HVAC

Exhaust May
Contaminate Supply Air

WIND
X

Building

H
Air inlets
X > 0.3 H

slide 13

Spot Extract for

slide 14

Powders and Flammables

Commonly found in BPC and OSD plants
Capture system is first line of defense.
Airborne concentrations are usually driven by worker
exposure levels, not flammability/explosive levels.

Personal Protection High duct velocity for powder conveying

Equipment (PPE)
may be required Slot velocity may exceed
7.5 m/s = NOISE

V = Capture velocity at point of release,

at least 0.5 to 1 m/s

Open processing of flammable

Required CMH = 7.5 LVX liquids or low-toxicity powders
L = length of slot, meter LOTS more info in the Industria
V = minimum capture velocity, m/s Ventilation Manual, ACGIH.
X = distance to capture point, m
(modified from Industrial Ventilation Manual 20th Edition)
If material is more than mildly hazardous to people,
CMH=cubic meters per hour close the process or use CONTAINMENT technology
Pharma HVAC

LEL or TLV ?
Typical materials found in a pharmaceutical manufacturing facility

Material LEL TLV-TWA

PERCENT ppm mg/cu.M
LEL = lower
Acetone 2.55 750 1780 explosive limit

TLV = threshold
A.C.N. 3.05 40 70 limit value

ETOH 3.28 1900 1900 TWA = time

weighted average
Formaldehyde 7 1-carcinogen? 1.5

Airborne concentrations harm people at levels much

lower than lower explosive levels.

slide 15

Fume Hood Tests

Containment of a tracer gas SF6
(ASHRAE 110 test)
Face velocity uniformity
Fully open sash
Partially open sash
Nearly closed sash
Response time for VAV hood (to return
to desired velocity)

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Pharma HVAC

System Components
AMD (air moving device) usually a "fan" or "blower"
Coils for heating and cooling
Filters for cleaning air (possibly air washers as well)
Humidifier (steam or water)
Air handler casing
Desiccant dehumidifier for lower RH <35%
Ductwork to distribute air
Exhaust system to remove contaminated air*
Controls
* with dust collectors, scrubbers, filters

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Air movers
Commonly called the "Fan" or"Blower"
Drive and bearings are source of particles.
HEPA filters must be downstream.

Drawing symbol
for centrifugal fan
For every inch of static pressure
the fan must overcome, estimate Centrifugal Fan
0.2 hp per 1000 CFM, add
0.2F degrees of heat to the air, and add
X decibels of noise. (see fan catalog) Motor in
Pressure drop comes from: airstream
• Ductwork & dampers
• Filters and their dirt
• Coils
• Grilles
• Silencers
• Dehumidifiers slide 18
Pharma HVAC

Vaneaxial Fans

Motor in airstream

Courtesy Buffalo
slide 19

Fan Noise
Many HVAC designers undersize AHU and fan in order to save first cost.

DON'T DO THIS! (Life Cycle cost usually not OK)

Increases energy and maintenance costs, increases noise generated.

LOW RPM
HIGH RPM = high tip speed, bearing speed
Backward
Inclined (BI)
or Airfoil (AF)
Forward
Curve (FC)
AIR
AIR

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Pharma HVAC

Heating And Cooling Coils

Heat with steam, hot water or glycol, electricity

Cool with chilled water or glycol, refrigerant ("freon",
R123, R134a)
May be in AHU or in the ductwork

Q
Q
Heating Cooling
Condensate removal

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Coils Work Together

Cool to remove moisture,
but air is too cold for the room (10-12 C)

Supply air to room

(usually 12 to 29C)

Fan "Reheat" to achieve desired

supply air temperature

This "Constant Volume Reheat" scheme is

common in pharmaceutical HVAC where air
supply volumes can not be reduced (sterile, BPC).

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Pharma HVAC

Humidifier
Humidification needed when cooling coil
is NOT condensing (winter or desert)
cool reheat

Fan H2O
into hot air in
H2O (summer)
duct
Humidifier may be steam injection *,
DI water spray, DI water evaporator tray, or Ultrasonic

* steam should be free of volatile additives for product exposure areas.

Clean steam may be used, or steam from a small boiler may be used.
Feed water should be EPAdrinking water quality. slide 23

Humidification and
Dehumidification
Humidification
Steam injection
Falling film
Spinning disc
Evaporating pan
Dehumidification
Cooling batteries [Capable of down to ~40% room RH]
Slowly rotating wheel coated with a hygroscopic, sorbent
material. Wheel is then heated to drive off the moisture
[Used below ~40% RH]
What can go wrong??
Water accumulation in AHUs = corrosion & micro
problems
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Pharma HVAC

Typical Desiccant Dehumidifier

Desiccant Wheel
rotates ~7rev/hr Heat in

120C+
Exhaust Reactivation
49C (outdoor) air

Process air 49C

(21C) 12-20C
cooling
These are very easy to screw up. Check schematic design with
an experienced HVAC designer or dehumidifier manufacturer.
Ask how many ways you can break it, then train your people.

slide 25

Air Handlers And Ductwork

"Hard" materials for product contact air

Aluminum, galvanized steel, some plastics (special applications)
Liners/silencers can retain contaminants
Reasonably tight, industry practice
Keep leakage low, not 0% leakage (welded) unless it's a threat (as in
toxic material exhaust). Keep duct pressures low (< 50mm w.g.).
Usually test to a SMACNA class A seal.
Duct sealant compatible with product

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Pharma HVAC

FLEXIBLE DUCT IS OK, BUT

Be sure the inside is SMOOTH

Fiberglas lining is great for noise abatement, but it can shed or
harbor bacteria
Be sure it is not kinked
Major restriction of airflow
Be sure it is tightly fastened to filter or diffuser
What happens if it comes loose?

slide 27

Consider Duct SIZE

Cheaper first cost to use smaller duct
Architect loves you (space constraints)
Energy cost will be higher (Pressure drop is
proportional to Velocity2)
Noise is proportional to pressure drop
Duct half the area has twice velocity
Noise increases 4 times (6 dB)
Energy lost in duct increases 4 times

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Pharma HVAC

Air Diffusers And Registers

Air supply grilles, registers, or
diffusers may be needed to enhance
room air mixing. May also be needed Supply air
to protect terminal HEPA filters
from damage.

Room air is educted into patterns that can

deposit room contents onto the diffuser plates.
Return Duct May be a cleaning problem, or an "image" problem.

Room air leaves samples of its contents on

return air grilles. Should be removable for cleaning.

slide 29

Return Air Grilles

Easy to clean, especially in aseptic cleanrooms

(where it is sanitized)
Prevent entry of "bigger" foreign materials
Prevent accidental removal of cleaning cloths, bunny suits,
hats, people
Not meant to be dust collector, keep face velocities
low

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Pharma HVAC

Air Handlers (AHU)

Pre-filter cool reheat
Blow-thru
Pre-filter
cool reheat

Draw-thru
High reheat
cool efficiency filter

Moist air

reheat

Multi-zone
slide 31

Drains and Pans

Small detail, but easy to goof up
Trap height must prevent air flow Cooling coil drain pans can
and facilitate drainage at grow bacteria. A diligent bio-
Cooling highest internal pressure burden control program is
coil with (or vacuum) in the air handler. is needed where pharma
Problems arise if AHU is set products are exposed to room
condensing too close to floor. environments.

Steam coil condensate traps

Condensate Height of trap need a few feet of head above
pan B greater than them and a short dirt leg below.
internal pressure Can be a problem if coil is too low.
A
in AHU Do not count on pressure of steam
in coil to lift condensate after the
A if positive
trap.
B if negative
Open to drain
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Pharma HVAC

Drains and Pans