Pristine

Processing
Department Editor: Kate Torzewski Equipment

P
rocesses in the pharmaceutical, biotechnology, food and semiconductor industries must Valves
meet a high set of standards to ensure high product purity. Equipment criteria specific to Valves should not harbor contaminants and
high-purity processes are established to minimize contamination and maintain prod- must be easy to clean. By these criteria,
uct integrity. In designing a pristine process, material and equipment style are of upmost diaphragm and pinch valves are excellent
importance. Bacteria is the main cause of contamination and is prone to growing in the dead choices for ultrapure processes, as they
cavities of equipment created by sharp corners, crevices, seams and rough surfaces. Another have smooth, gently curved surfaces that
source of contamination is leaking, which allows undesirable chemicals to compromise the will not harbor contaminants. Ball check,
quality of the process ingredients, by causing contamination, rusting and particle generation. full-port plug and full-port ball valves are
good choices as well, while butterfly, spring
MATERIALS OF CONSTRUCTION check, gate and swing check valves are all
unacceptable, since contamination can col-
Many factors must be taken into consideration when selecting materials of construction for lect in the corners that are essential to their
use in pristine process applications where high-purity and sanitation are paramount. All sur- design. Though several valves are appropri-
faces should be constructed of a smooth material that will not corrode, generate particles ate for pristine processes, certain valves
or harbor dead cavities. These criteria can be met with three standard materials: 316L are better suited for particular applications.
stainless steel (SS), polyvinylidene fluoride (PVDF) and polytetrafluoroethylene (PTFE). The Diaphragm valves are the most widely used
advantages and disadvantages of these materials are summarized below to facilitate the in high-purity systems for their resistance
material selection process for a given application with consideration of chemical compat- to contamination and ability to be used as
ibility, cost, and temperature stability. a control valve. Ball and plug valves, on
the other hand, are less costly and are not
MATERIALS OF CONSTRUCTION limited by temperature and pressure. Also,
Material Advantages Disadvantages in applications using sterile steam and
• Mechanical strength Vulnerability to corrosion by
freeze-drying, ball valves are preferred over
Stainless diaphragm valves because they eliminate
• Functions at 121°C certain chemicals, which
Steel the risk of catastrophic seat failure.
(steam-sterilization temperature) increases with temperature
• Chemically inert
• Resistant to corrosion and leaching Functions only intermittently Seals
PVDF As with all pristine processing equipment,
• Durable and long-lasting at 121°C
• Retains circumferential strength high-purity seals should not have any
• The most chemically inert plastic cavities where contaminants can breed. By
• Resistant to corrosion and leaching Complex shapes are choosing a seal with gland rings that do not
PTFE
• Avoids leaching difficult to form need to be threaded or ported, the areas
• Suitable for coating equipment where bacteria can breed are minimized. In
choosing a seal material, it is important to
EQUIPMENT STYLE SELECTION find a compound that will not swell, crack,
pit or flake, thus reducing seal failure and
Critical factors in high-purity equipment selection include cleanability, cost, flow capabili- contamination. To ensure the success of
ties and product compatibility. With these considerations in mind, criteria useful for choos- seals, fluroelastomers are a top choice in
ing pumps, valves, seals and piping are described in this section. pristine processing applications for their ex-
cellent thermal stability, chemical resistance
Pumps and mechanical durability.
A fundamental requirement of pristine processing pumps is the ability to clean a pump in
place without disassembly. Pump seals, gaskets and internal surfaces should eliminate the Piping
buildup of material and should clean out easily during wash cycles. The most common pump The surface of piping, as well as any wet-
styles for high-purity processes are centrifugal, lobe-style and peristaltic pumps, which are ted equipment parts, should have a very
outlined below. smooth surface. When 316 SS is being
PUMPS used, electropolishing is a good method
Pump Applications best for achieving an ultra-smooth finish. Joining
Advantages Disadvantages methods should minimize crevices and dead
style suited for this style
• Handling low- cavities, and all materials should be free of
Efficiency and flow de-
• Low cost viscosity products biological degradable substances, leachable
Centrifugal crease with increasing
• Easy cleanability • Handling high flowrates substances, and glues and solvents that may
pressure and volume
(40–1,500 gal/min) migrate into the product stream.
• Low cost The need for hoses may
• Easy cleanability cause issues in elastomeric • Small, batch-oriented References
• No mechanical compatibility, temperature applications
Peristaltics 1. Smith, B., What Makes a Pump for High-Purity
seals and pressure limitations, • Laboratory or pilot-
Fluids?, Chem. Eng., pp. 87–89, April 2002.
• Non-damaging to and a need to change scale plants
delicate products hose regularly 2. Schmidt, M., Selecting Clean Valves, Chem.
Eng., pp. 107–111, June 2001.
• Higher pressure
• Large, continuous 3. Wulf, B., Pristine Processing: Designing Sanitary
and flow Systems, Chem. Eng., pp. 76–79, Nov. 1996.
Rotary duty applications
capabilities High cost
Lobes • Steaming and high 4. Weeks, D. T. and Bennett, T., Specifying Equip-
• Unaffected by
pressure applications ment for High-Purity Process Flow, Chem. Eng.,
pressure variations pp. 27–30, Aug. 2006.