Fluids and Solids Handling

Selecting
Agitator Seals for
Bioprocessing Applications
Issues such as sterility, isolation and
Gregory T. Benz
Benz Technology International, Inc.
contamination must be considered when
William Ho Liam Teng choosing seals for use in biotech and
John Crane Asia Pacific pharmaceutical processes. This overview
describes common types of seals and
offers guidance on selecting the
appropriate seal for various applications.

M
any process steps in the pharmaceutical and bio- • avoidance of contamination, which is similar to isola-
processing industries require mechanical agita- tion, but includes particle shedding from the seal and
tion. Some, such as fermentation, involve grow- material left over from previous processing
ing a culture of living organisms. Others, such as blending • static and dynamic sealing to maintain the vessel
of injectable drugs before packaging, must have no living pressure, whether operating or stationary
organisms present. Most process vessels must avoid both • personnel safety from physical hazards, such as sud-
chemical and biological contamination. den pressure venting.
Except where a magnetic-drive mixer is employed, the Agitator seal applications for pharmaceutical service
normal configuration of an agitator consists of a motor, gear are typically characterized by: strict leakage-prevention
drive, shaft and impeller (Figure 1). Where the shaft pene- requirements; high process purity — i.e., zero contamina-
trates the agitator mounting flange, some type of seal is nor- tion; hygiene, CIP and SIP requirements; exposure to haz-
mally employed. Various seal types, differing in functionality, ardous, corrosive or
cost, durability, reliability and maintainability, are available. volatile fluids
The pharmaceutical industry emphasizes zero batch (including chlo- Motor
contamination, process hygiene, and clean-in-place (CIP) rides); large shaft
and sterilize-in-place (SIP) requirements. High equipment size; low speed Gear Box
reliability is also needed to minimize production costs. (typically 30–350
Correct selection of agitator seals is vital to achieving rpm); high radial Packing or
Mechanical
these objectives. This article explains the many differences shaft run-out (up to Seal
and guides the user in selecting the most appropriate style 1.5 mm); and high
for specific bio-pharma applications. vibration velocity Shaft
(up to 20 mm/s on
The functions of seals large fermenters). Vessel
Agitator seals may perform several functions, including:
Figure 1. A typical
• containment of tank contents to protect plant personnel agitator assembly
or the surrounding community from biohazards, toxins, etc. consists of a motor, Impeller
• isolation of tank contents to protect against exposure gear drive, shaft and
to the outside environment impeller. Photo courtesy
of Chemineer, Inc.

44 www.aiche.org/cep January 2008 CEP

Shaft entry position
The position of the agitator mounting has a major influ-
ence on selection and design. Agitator mounting is classi-
fied as top, side or bottom entry.
Top entry is most common because it has several impor-
tant advantages. Viscosity and abrasiveness of the liquid
have no impact on the seal operation and performance,
since the seal is not wetted by the process liquid. Corrosion
may be lessened, since the agitator has contact only with
vapor. And any particles formed by mechanical seal wear
can be trapped so that none contaminate the product.
A bottom-entry seal is fully immersed in the process
fluid. In some cases, the seal can be lubricated by the
process fluid. However, if the process fluid contains abra-
sives, these particles will accumulate in the agitator seal
area, which will require an external flush with clean,
process-compatible liquid. Product dilution can also be an
issue. Bottom-entering agitators are uncommon in pharma-
ceutical and bioprocessing, although they are occasionally
used in small vessels, especially in fermenters that need
many nozzles on top, leaving insufficient room for the agi-
tator. Unlike top-entry agitators, bottom-entry units need
only a short shaft. However, it is impossible to totally pre-
vent contamination by seal wear particles.
Side-entry agitators are fully immersed in the process
liquid, and their seals operate similarly to a horizontal
pump’s mechanical seal. They are not normally used for
pharmaceutical and bioprocessing, and will not be dis-
cussed further here.
Common types of shaft seals
Although many kinds of seals are used in the chemical
process industries (CPI), this article covers only those com-
monly used in pharmaceutical and biotech applications.
Compression packing, or stuffing box (Figure 2).
This consists of a series of rings of packing material
arranged between the rotating shaft and a stationary tube
attached to the mounting flange. Its pressure rating
depends on how many rings are used; generally, pressure
is limited to 6 bar-g. There can be some shedding of pack-
ing into the process fluid. This type of seal can be lubri-
Gland
Packing
Stuffing Box

Figure 2. Compression packing. Photo courtesy of Chemineer, Inc.
KEY TERMINOLOGY
Aseptic. Lacking any undesirable living organisms.
Fermenters and bioreactors, for example, must have some
living organisms present, but they must also be aseptic.
Asepticity refers to the state of being aseptic.
Containment. Prevention of dangerous substances from
exiting the process unit.
Contamination. Any undesirable material that has entered
the process fluid, whether it comes from outside the process
unit or from within (such as from wearing parts or trapped
material from previous batches).
Isolation. The state of having a secure barrier between the
process unit and the outside environment that prevents con-
tamination from outside.
Sanitary. Easily cleaned; not prone to trapping material.
This adjective refers to the equipment, not the process, which
is described by the terms aseptic or sterile.
Sterile. Having no living organisms present. Sterility is the
state corresponding to this adjective. It is impossible to
achieve sterility in bioreactors.
cated or dry, and it can be sterilized by steam injection.
The packing acts mainly as a throttling device; it cannot
provide complete isolation or containment. However, it
can provide a sterile barrier if it is steamed.
Single mechanical seal (Figure 3). This consists of two
sealing faces, one stationary and one rotating with the
shaft. The faces are lapped nearly flat, allowing a leakage
rate that is several orders of magnitude lower than that of
packing. The initial cost is higher, but seal life is longer,
so reduced downtime normally pays for the investment.
Single mechanical seals provide sufficient containment
and isolation for non-critical applications. They should not
be used on sensitive or pathogenic cultures or on vessels
containing highly toxic reagents.
A single mechanical seal can be either wet-running or
contact dry-running. Wet seals require lubrication either
from the process fluid or from an external source. A contact
Drive Collar
Lip Seal
Bearing
Lip Seal
Grease
Connection Drain
Connection
Quench Out Retainer
Connection Spring
O-Ring Thrust Ring
Seal Face Quench In
(Primary Ring) Connection
Mating
Ring
O-Ring

Figure 3. Single mechanical seal.
CEP January 2008 www.aiche.org/cep 45
Fluids and Solids Handling

dry-running seal operates in the absence of lubrication; the
seal ring and mating ring are in direct rubbing contact. Due
to the absence of a lubricating fluid, a contact dry-running
seal is limited to low-temperature and low-speed operation.
A dry seal’s operating life is shorter than that of a wet seal
due to higher face wear. If no carbon particles can be toler-
ated in the process fluid, the wear particles from the carbon
face will have to be contained by a debris well. A dry-run-
ning seal offers the advantage of simplicity and eliminates
the need for an external fluid source.
Single fully split mechanical seal (Figure 4). The sin-
gle fully split mechanical seal works the same as a single
mechanical seal, but adds a longitudinal split line for ease
of maintenance, making it unnecessary to provide shaft
support, couplings and spacers, or to remove the agitator
to change seals. However, this design creates an additional
leak path, resulting in a lower pressure rating and higher
leakage rate compared with an equivalent non-split seal.
Dual pressurized (double) mechanical seal (Figure 5).
While other configurations of dual pressurized seals are
possible, the most common for agitators is the back-to-back
arrangement. This uses two single seals mounted in a pres-
sure-bearing chamber — an outboard seal that seals the
Flat Clamp Gland Retaining
Gasket Ring Assembly Ring
chamber contents from the outside environment, and an
inboard seal that seals the chamber contents from the tank.
In such an arrangement, a barrier liquid is introduced into
the sealing chamber for lubrication. This liquid completely
isolates the process fluid and vapors from the environment.
The mechanical seal chamber is pressurized above the tank
pressure, so any leakage is from the pressure chamber into
either the tank or the outside environment; when everything
is working properly, tank contents cannot leak out and out-
side contaminants cannot leak in. A lubricator is used to
pressurize the barrier fluid, and may be equipped with a
heat exchange jacket or coil for removing the heat generat-
ed by the mechanical seals (this is known as a thermo-
syphon arrangement). The barrier fluid must be compatible
with the process fluid and the mechanical seal materials, or
contamination may be a problem.
Some modern dual pressurized seals are designed with
reverse pressure capability on the inboard seal and mating
ring. Reverse pressure is caused either by the failure of bar-
rier fluid pressurization, or the tank pressure unexpectedly
surging higher than the barrier fluid pressure. Reverse pres-
sure capability of a seal will hold the seal parts at their cor-
rect location to prevent catastrophic failure, but the inboard
seal will still open and process fluid or vapor will flow from
the tank into the pressurized seal chamber if pressure
reverses. A dual pressurized seal should not operate continu-
ously with reverse pressure, as the fluid between the seal
faces becomes process fluid. The seal may prematurely fail
due to abrasives, clogging or vaporization of the process
fluid, or due to running dry on top-entry units.
This is the first seal type discussed so far that can pro-
vide complete containment and isolation. Its use is man-
dated for processes containing pathogens or toxins. Only
hermetically sealed devices, such as magnetic-drive or
immersed agitators, are safer for containment.
Drive Collar

Spring Spacer
Retainer Bearing
Lip Seals
O-Ring
Drain Connection
Finger
Spring Barrier Fluid
Outlet Connection Outboard Seal

Barrier Fluid
Inlet Connection
Inboard Seal
Mating Ring O-Ring Mating Seal Face
Adapter Ring (Primary Ring)

Figure 4. Single fully split mechanical seal.
Figure 5. Dual pressurized mechanical seal with a bearing.

46 www.aiche.org/cep January 2008 CEP

 Drive Collar F D
Lip Seal C
Bearing Locknut
E
Bearing
Outboard Non-Contact B
Gas-Lubricated Seal A
Barrier Gas Inlet G
Connection
Drain Face Lift: V I
VI
Connection 3–3.5 bar
Nitrogen H O
Normally above
Closed the maximum Barrier Gas
process
pressure
Inboard
Non-Contact
Gas-Lubricated Seal

Figure 6. Dual pressurized gas-lubricated seal with a bearing

(non-contacting). A = Coalescing Filter (5–10 µm)
B = Pressure Regulating Valve
C = Pressure Indicator
Gas-lubricated seal (non-contacting) (Figure 6). D = Low-Pressure Alarm Switch
E = Flowmeter, Low Range
Available in either single or dual pressurized configura-
F = Flowmeter, High Range
tions, these seals have the same functionality as single or G = High-Flow Alarm Switch
double wet seals. However, they are designed to run dry H = Gas Supply Isolating Valve
without face contact, resulting in zero wear. This is I = Check Valve
accomplished by establishing a thin gas film to separate
the sealing faces. Face separation is developed by a com-
Figure 7. Control panel for a gas-lubricated seal.
bination of static opening forces generated by the barrier
gas pressure and dynamic opening forces generated by a
specially designed face geometry that produces a pressure
Drive Collar
gradient across the seal face with minimum barrier gas
Lip Seal
consumption. For agitators, the face separation develop-
Bearing
ment is dominated by the static-pressure lifting force, Locknut
allowing non-contacting operation even at very slow Bearing
speeds. The gas-lubricated seal can be either a unidirec-
Outboard Contact
tional or bidirectional design. Dry-Running Seal
Dual pressurized gas-lubricated seals require a simple Inboard
gas-control panel (Figure 7) to maintain a positive sealing Non-Contact
Gas-Lubricated
pressure against the tank pressure. Dry nitrogen is com- Seal
monly used as the barrier gas. The outboard seal maintains Debris
Well
control of leakage into the atmosphere. The gas-control
panel requires little space and is easy to operate.
The benefits of dual pressurized gas-lubricated seals
include longer operating life, higher reliability and lower
Figure 8. Combination contact dry-running seal (outboard) and
gas-lubricated seal (inboard).
maintenance costs than dual-pressurized wet seals.
Presently, gas-lubricated seals are limited to about 20 bar this problem. Normally, a fully contacting dry-running
sealing pressure; wet dual pressurized seals are needed for seal has almost zero leakage into the atmosphere.
higher sealing pressures.
Combination contact dry-running and gas-lubricated Options
seal (Figure 8). Although the normal leakage of a gas- Debris catcher (shown in Figure 8). Also called a car-
lubricated seal is very low, accumulation of nitrogen emis- bon catcher, debris well or sanitary gland, this option can
sions can cause hazardous nitrogen concentrations in an be added to single or double seals to prevent seal-wear
enclosed building. A combination of a contact dry-running particles from entering the process. Accumulated particles
outboard seal and a gas-lubricated inboard seal can reduce can be cleaned during seal change or during operation.

CEP January 2008 www.aiche.org/cep 47

Fluids and Solids Handling
Modular cartridge seal (Figure 9). Mechanical seals
have many components. Assembling them onto an agitator
shaft is not only time consuming, but may result in errors.
A cartridge seal is a preassembled, self-contained unit con-
sisting of seals with adaptive parts, including a sleeve,
gland and drive collar.
The advantage of cartridge seals is that the components
can be assembled in a clean environment and leak-tested
to ensure that they are correctly assembled. Installing a
cartridge seal onto an agitator shaft is simple, fast and
virtually error-free. End users can enjoy large savings in
installation and maintenance time plus improvements
in reliability.
A modular cartridge seal is one mechanical seal family to
suit all agitator applications. The seal faces can be inter-
changeably assembled as wet-lubricated, contact dry-running,
gas-lubricated, or a combination of contact dry-running on
the outboard seal and gas-lubricated on the inboard seal.
Modularization ensures maximum component flexibility.
Bearings. Agitator applications involve both axial and
radial loads. The radial load on the shaft is generally small,
but it can be high if the shaft bending moment is high. The
axial thrust can be very high at high tank pressures (which
is rare, except for hydrogenations such as the manufacture
of sorbitol). Because almost all agitator gear drives are
already designed to take axial thrust, it is not usually neces-
Non-Contact
Gas-Lubricated Seal
Liquid (Wet) Seal
Contact
Dry-Running Seal

Figure 9. Modular dual pressurized cartridge seal.
48 www.aiche.org/cep January 2008 CEP
sary to include a thrust bearing in the seal cartridge.
A radial bearing in the seal cartridge is used to steady
the shaft and reduce run-out for good seal performance.
The bearing is often designed to withstand the minor
thrust from the seal sleeve as well as radial loads.
Mechanical seals with bearings must be checked on an
individual basis, although manufacturers’ standard designs
will handle most service conditions.
Bearing selection should consider all loads, speed
range, temperature range, service life and lubricant.
Commonly used are deep-groove ball bearings, double-
row spherical roller bearings, and double-row tapered
roller bearings. Grease is usually a satisfactory lubricant.
Magnetic drive (Figure 10). Although not a seal, this
design is an alternative means to the same end — a sealed
tank. This design, by virtue of having no shaft penetration,
has absolute containment and isolation. However, the shaft
must be supported with some kind of in-tank bearing sys-
tem (typically food-grade Teflon or a ceramic material).
Contamination occurs due to particle shedding from the
bearing and also from trapped material remaining between
batches. It is quite difficult to make these designs sanitary.
High initial costs and long-term maintenance costs are
important considerations.
Material considerations
The purity of the product is always an important con-
sideration. Special grades of elastomers recognized by the
U.S. Food and Drug Administration (FDA) may be
required, as outlined in Title 21 of the U.S. Code of
Federal Regulations, Paragraph 177.2600.
The FDA will determine whether a substance is:
• a food additive
• generally recognized as safe (GRAS)
• a prior sanctioned or approved material under amendment
• not a food additive under the conditions of use.
Silicon carbide can usually be considered GRAS.
Reaction-bonded silicon carbide has free silicon, which
is dissolved by weak alkalies. For processes involving
an alkaline cleaning cycle, self-sintered silicon carbide
should be considered.
The FDA considers seal carbons and carbon-graphite
impregnated with a resin binder to be GRAS. This is based
on the ingredients and the fact that only small amounts of
wear debris pass into large amounts of product. For applica-
tions prohibiting carbon particles in the product, a debris
well should be incorporated into the mixer seal.
Elastomers are not GRAS. Elastomers may contain
substances that can be injurious to public health and there-
fore need specific FDA approval. 21 CFR 177.2600 covers
requirements for elastomers and gives lists of permitted
ingredients and extraction limits. FDA-approved nitrile,
ethylene propylene, fluoroelastomers and perfluoroelas-
tomers are commercially available. Seal manufacturers
purchasing elastomers for food applications may require a
statement that the elastomers supplied comply with the
requirements of the regulation.
The material for a seal’s metal parts is either the same
as the agitator shaft material or something that is more
corrosion-resistant. Some common agitator shaft materials
are stainless steel, Alloy C-276, and glass-lined (techni-
cally glass-coated) metal. Glass-lined agitators are used
for highly corrosive or high-purity processes where the
process fluid is not allowed to contact a metal surface. The
glass surface is non-porous and can be easily cleaned and
sterilized between batches. The seal’s wetted parts must
have the same hygiene standards as the agitator. Ceramic
or glass coatings may be used for the wetted part of the
shaft sleeve and the lower gland.
Pharmaceutical operations usually involve a cleaning
cycle during startup or between batches. The compatibility
of mechanical seal materials with cleaning media and their
temperature should be carefully reviewed.
For contact dry-running seals and gas-lubricated seals,
the face material is usually an FDA-GRAS carbon. This
material has a special impregnation that enhances dry-
running performance and provides good lubrication in a
dry nitrogen environment without squealing. The carbon
also generates negligible particles under steady conditions.
The face materials of a gas-lubricated seal must be able to
run in contact mode in the event of failure of the barrier-
gas supply or a large misalignment of the shaft. If two
hard faces are selected, diamond-coated silicon carbide is
used, as the diamond coating improves dry-running prop-
erties in case of contact for a limited period of time.
CIP/SIP and hygienic seals
Pharmaceutical plants commonly operate batch processes.
The equipment goes through a cleaning or sterilization cycle
after each batch. These cycles, combined with possible
pressure or temperature cycling, will increase face wear,
reducing seal life. The wetted parts of the seal components
must be suitable for the process fluid, barrier fluid and the
cleaning or sterilizing fluid. Common cleaning/sterilizing
fluids are steam, demineralized water and caustics.
Process purity may be the most important consideration
in production. FDA guidelines on materials for hygienic
service should be consulted, as the seal and its support
system must comply with FDA regulations. It is important
to limit process contamination to less than specified maxi-
mum values and to control process leakage to the atmos-
phere. When there is a concern about product purity, a
O-Ring
Impeller
Journal
Outer Rotor
Ceramic Bearing
Vessel
Weld Flange

Figure 10. A magnetic drive is an alternative to an agitator with
seals. Illustration courtesy of Magnasafe, Inc.
dual seal with a debris well may be specified to prevent
barrier fluid or wear particles from reaching the process.
For pharmaceutical and bioprocessing applications
requiring equipment suitable for CIP, the mechanical seal
parts exposed to the process must have a smooth surface
(Ra = 0.8 µm or better). The seal design must facilitate
easy cleaning with no residue remaining and no need to
remove or disassemble the seal. The seal parts must not
have close clearances, dead spaces or crevices where
microbes could accumulate or bacterial growth could
take place. The materials should be non-reactive with the
product and cleaning and barrier fluids, as well as wear-
resistant in service. The seal chamber must be self-
draining to ensure that no residue remains after CIP. A
seal with these features is called a hygienic seal.
SIP procedures are used to ensure that the process unit
is ready for aseptic or sterile production. Sterilizable-in-
place seals should have features allowing minimum sterili-
zation time, such as full steam flow to all parts in contact
with process or barrier fluids. All seal parts must be com-
patible with the sterilizing fluid and temperature. The seal
chamber must be self-draining so that no residue is left in
it after SIP unless the barrier fluid is also sterilized and
compatible with the process. Compatible fluids may
include steam condensate, food-grade mineral oil, glyc-
erin, propylene glycol or similar lubricants.
Methods of lubricating seals
The choice of lubrication method must balance safety,
sterility, seal life, boiling point, pouring point, heat-
transfer properties, process contamination potential,
CEP January 2008 www.aiche.org/cep 49
Fluids and Solids Handling

Drive Collar
mineral oils, glycerin, glycols and similar fluids. They pro-
Lip Seals
vide the best seal life for wet seals and a low leakage rate.
Usually a process-compatible liquid can be chosen. In the
Drain Connection case of fermenters, leaking barrier liquid is often consumed
Quench Out by the broth’s microorganisms or may act as an antifoaming
Connection Single Mechanical
(Wet) Seal agent. Sterility can be provided by using a steam jacket or
Quench In coil to heat the lubricant to the sterilization temperature.
Connection
Seal support systems
After the seal type, materials and lubricant are selected,

Figure 11. API Plan 62. the support system must be chosen to ensure proper opera-
tion and maximum service life. Many seal failures originate
compatibility with seal materials, availability and cost. in seal support systems, which must meet all operating con-
Some common types of lubrication fluids are: ditions during pre-commissioning, start up, normal opera-
• air or inert gas, or dry lubricant. This lubrication tion and shut down.
method has the lowest utility cost and has no process com- Although the amount of heat generated by a seal is not
patibility issues. Sterilization requires intermittent exposure high, if not dissipated, it will raise the temperature of the
to steam or steam condensate, so such seals will effectively seal liquid to its boiling point. If this occurs, the seal will
run wet at times. Dual pressurized gas-lubricated seals or have poor lubrication and may fail prematurely. Proper
contact dry-running seals must maintain the barrier gas control is needed to assure there is no pressure reversal.
pressure during the sterilization process. Contact dry- American Petroleum Institute (API) piping plans are com-
running seals do not last as long as lubricated seals. Non- monly used to specify the support system for mechanical
contact gas-lubricated seals have a long service life. seals. API piping plans can be found in ANSI/API Standard
• steam or steam condensate. This method assures con- 682 and ISO 21049, both entitled “Pumps — Shaft Sealing
tinuous sterilization, and rarely has any process compati- Systems for Centrifugal and Rotary Pumps.” The most com-
bility issues. Ideally, the condensing fluid should be mon API plans used in the pharmaceutical and bioprocessing
cooled to about 80°C to avoid flashing between seal industries are Plans 62, 53 and 74.
faces, which reduces seal life. Utility cost is higher than • API Plan 62 (Figure 11) is a method to protect the
for other sealing fluids. environment on the atmospheric side of a single seal. This
• food-grade grease. Used only with packing, food- can be a low-pressure-steam or water quench, or a gravity
grade grease extends packing life and lowers leakage com- dead-end seal oiler. It can provide cooling or sterilization.
pared to dry lubrication. However, it is difficult to sterilize, It is typically used on a top-entry single seal with a lip seal
and there may be process compatibility issues. or a segmented bushing to limit leakage of the seal fluid
• lubricating barrier liquid. These include FDA-approved into the atmosphere.
• API Plans 53A, 53B and 53C are the most
common ways to lubricate dual pressurized seals.
Nitrogen Barrier Plan 53A uses an external reservoir, while Plans
Gas Supply
53B and 53C have a closed circulation loop piped
to an atmospheric make-up unit for replenishment
Pressure Indicator
PI PS Pressure Switch of the barrier fluid. Plans 53B and 53C are used to
Barrier Fluid prevent pressurizing gas from dissolving in the
Out Connection
Level Switch (High) barrier fluid if the seal chamber pressure exceeds
LSH
10 bar-g. Most pharmaceutical applications
Level Switch (Low)
LSL
Barrier Fluid involve lower pressures, so only Plan 53A will be
V
Vent In Connection covered here. A Plan 53A seal can sometimes be
operated above 10 bar-g if the pressurizing gas
has negligible solubility in the barrier fluid.
In Plan 53A (Figure 12), the barrier fluid reser-
voir is pressurized by a gas, usually nitrogen, to at
least 10% above the normal process pressure and a

Figure 12. API Plan 53A. minimum of 1.4 bar above the maximum process

50 www.aiche.org/cep January 2008 CEP

pressure. The reservoir or the seal chamber Flow Indicator
may have an internal coil or a jacket to Flow Switch (High)
FSH
Coalescing Filter
F
remove heat, although sometimes atmos- Pressure Switch (Low) PSL FI I
PCV L
pheric cooling of the reservoir is sufficient. Pressure Indicator PI
Barrier Gas Outlet
If cooling water is used, it flows through (Normally Closed)
Check Valve
Pressure Control
the coils or jacket, and the barrier fluid Valve Barrier Gas Inlet
Vent
flows past the external surface of the coils. V GBO GBI
The coil or jacket may also be used to heat
the seal fluid to sterilization temperature. Barrier Gas Inlet
GBI
During normal operation, since agitator
speeds are low, circulation is maintained
by natural convection, or thermosyphon.
GBO
The flow of barrier fluid is determined Barrier Gas Outlet
primarily by the density difference (Normally Closed)
between the seal chamber and the reser-

Figure 13. API Plan 74.
voir, which is caused by a temperature
difference. Piping friction in the circulation loop (including This seal plan is becoming more common in pharmaceu-
viscosity effects) causes a resistance to flow. The flowrate tical plants due to its low risk of contamination and long seal
during thermosyphon operation is small and easily inter- life. Seal materials used for this plan must still be capable of
rupted by bubbles due to vaporization or dissolved gases, handling sterilization and cleaning media in most cases.
causing vapor-lock in the system. Large-diameter piping
and maximum drill-through on the seal gland connection Seal life expectations
should be used to maximize flow and prevent vapor-lock. Actual seal life depends on the seal type, lubricant, seal
The reservoir should be 0.5–1 m above the seal center, materials, shaft size and speed, shaft run-out, operating
and as close as possible radially (typically within 1 m). temperature and pressure, and mode of operation. For the
The liquid must enter the seal from the bottom and exit the purposes of this article, estimated seal life can be divided
top. The outlet connection of the reservoir to the seal into three categories:
should be located at least 5 cm from the bottom of the • low, < 6 mo. These include dry- or steam-lubricated
reservoir so that any wear particles denser than the barrier packing, single steam-lubricated mechanical seals, and
fluid will settle to the bottom. double steam-lubricated mechanical. Steam-lubricated
• API Plan 74 (Figure 13) is a new API piping plan for seals can be elevated to “good” if temperature-controlled
dual dry-running seals. An inert gas, usually nitrogen, is steam condensate is used.
used as a barrier to prevent process fluid from leaking into • good, 6 mo to 2 yr. Grease-lubricated packing, contact
the atmosphere. Dry-running seals need no circulation dry-running mechanical seals and mechanical seals with a
because they generate little heat. The piping is a dead-end non-lubricating barrier fluid.
arrangement. The flow into the seal cavity is the leakage of • excellent, > 2 yr. Mechanical seals with a glycol or
the inert gas past both sets of seal faces. Leakage from the similar lubricating barrier fluid and non-contacting gas
inboard seal into the process is an inert gas that can easily seals have the longest service lives.
be separated from the product with no contamination.
This piping plan is very simple and costs less than wet dual Special process considerations
pressurized systems. There is no drainage to clean up, so the Tanks containing solutions ready for packaging cannot
maintenance cost is also lower. However, the seals cost more have any biological contamination, so a sterile seal design
than those used for wet-running operation. (lubricated with steam or a hot lubricant) is required. A
Plan 74 is usually mounted on a control panel. It has a fil- sterile seal may be needed even if the product goes through
ter to remove moisture and fine particles and a regulator to a biostatic filter that removes all living organisms down to
control the gas pressure at 2–3 bar above the tank pressure. virus size. Inert particle contamination may be a problem,
The panel also contains a low-pressure alarm to alert opera- depending on product specifications and filtration. If no
tors if the gas supply pressure falls below the tank pressure filter is used and no particles are acceptable, a debris well
or a pre-set value. A flowmeter is used to monitor the seal is essential. In such a case, magnetic drives cannot be used,
leakage. An optional flow alarm can alert operators to exces- as the in-tank agitator bearing sheds particles.
sively high seal leakage. In some applications, filtration cannot be used prior to

CEP January 2008 www.aiche.org/cep 51

Fluids and Solids Handling

Comparison chart for seal selection.

Particle Relative Cost

or Other Seal 1 = lowest
Seal Type Lubricant Containment Isolation Sterilizability Contamination Life 8 = highest

Packing Dry Fair Fair Fair Fair Low 1

Steam Fair Fair Good Good Low 1
Grease Fair Fair Fair Fair Good 1
Single Seal Dry Good Good Fair Fair Good 3
Steam Good Good Good Good Low 2
Glycol or similar Good Good Good Good Excellent 2
Single Split Seal Dry Good Good Fair Fair Good 4
Steam Good Good Good Good Low 4
Glycol or similar Good Good Good Good Excellent 4
Dual Pressurized Seal Dry Good Good Good Fair Good 5
Steam Excellent Excellent Excellent Good Low 6
Glycol or similar Excellent Excellent Excellent Good Excellent 5
Dual Pressurized N/A Excellent Excellent Good Excellent Excellent 7
Gas-Lubricated Seal
(Non-Contacting)
Magnetic Drive Excellent Excellent Excellent Excellent Poor Excellent 8
Debris Well Option N/A N/A N/A N/A Excellent N/A +1

packaging because the product contains larger particles than
biostatic filters will pass. Examples include very large pro-
tein-based molecules, macro structures such as liposomes
used as drug-delivery systems, and slurries of large active
ingredients. In these cases, neither biological contamination
nor particle contamination is permitted. At present, the only
seal design meeting this requirement is the double wet
mechanical seal with a hot lubricant and a debris well.
These examples are geared toward product quality.
Another consideration is operator safety. If the tank contains
pathogens or toxins, government regulations might mandate
the use of a double back-to-back mechanical seal (dry or
wet) or a magnetic drive, in order to assure containment. For
double seals, agitator manufacturers may provide a seal shut-
off and purge to isolate tank contents during seal change.
Wet-Running Contacting
Cartridge/
Non-Cartridge
Agitator Single/Dual Seal
Seal
Contacting
Dry-Running
Gas-Lubricated
Cartridge
Dual Seal
Contacting (Outboard) and
Gas-Lubricated (Inboard)

Figure 14. Overview of mechanical seal types for agitators.
Pulling it all together
The chart summarizes key seal attributes — containment,
isolation, sterilizability, contamination, seal life and cost —
and may be used as a guide for most applications. Additional
guidance is available from seal and agitator manufacturers.
When reviewing this information, users should con-
sider the application in order to specify the seal types,
seal support systems and instrumentation needed to
ensure safety, optimum seal performance with high opera-
tional reliability, keeping in mind sterility, isolation and
contamination (Figure 14). CEP
GREGORY T. BENZ, P.E., is president of Benz Technology International, Inc.
(2305 Clarksville Rd., Clarksville, OH 45113; Phone: (937) 289-4504; Fax:
(937) 289-3914; E-mail benztech@mindspring.com; Website:
http://home.mindspring.com/~benztech/). He has over 30 years of
experience in the design of agitation systems. Currently, his company
offers general engineering and mixing consultation, including equipment
specification and bid evaluation, as well as courses on agitation with
CEU/PDH credits. Benz is also an instructor with the Univ. of Wisconsin
Continuing Education and Outreach progam, and is a registered
consulting expert with Intota (www.intota.com). He received his BSChE
from the Univ. of Cincinnati in 1976, and has taken a course on
fermentation biotechnology from the Center for Professional
Advancement. He is a registered professional engineer in Ohio, and is a
member of AIChE, Society for Industrial Microbiology (SIM), International
Society for Pharmaceutical Engineering (ISPE) and the American Chamber
of Commerce in Shanghai.
WILLIAM HO LIAM TENG is the engineering manager of John Crane Asia
Pacific, operating from John Crane (Singapore) Private Ltd. (Phone: (65)
65125280; E- mail: who@johncrane.com.sg). He has more than 20 years
of experience in the field of mechanical seal application design and field
troubleshooting. He gained his experience on rotating and static
equipment operation and maintenance in petroleum refineries, and on
pump design, performance testing, manufacturing and commissioning of
engineered pump projects while working with a pump manufacturer. He
also worked for an international engineering inspection company
specializing in third-party static and rotating equipment quality
inspection projects.

52 www.aiche.org/cep January 2008 CEP