The Sterile Environment
Obtaining a Sterile Environment
0022 Establishing, maintaining, and validating sterility in
an aseptic system are essential. Processes used for
obtaining a sterile environment for products, equip-
ment, and packages include thermal, chemical,
irradiation, and mechanical treatments along with
combinations of these. Thermal processes include
saturated steam, superheated steam, hot air, mixtures
of hot air and steam, and extrusion/heat of forma-
tion (although extrusion may not be acceptable for
sterilization purposes). Heat is the most common
method for product sterilization and is often used
for equipment sterilization as well. The most
common chemical used for sterilization is hydrogen
peroxide (20–35% concentration), and a combin-
ation of hydrogen peroxide treatment followed by
hot air is often used to reduce the level of hydrogen
peroxide to less than 0.5 p.p.m. on packages and
equipment. Peracetic acid and ethylene oxide also
have applications; however, regulations for accept-
able chemicals, uses, and residue limits must be
checked. Chemicals are applied by dipping, spraying,
or rinsing, or in vapor form. Irradiation treatments
may include ultraviolet radiation, infrared radiation,
and ionizing gamma radiation. Mechanical processes
are generally designed to reduce initial microbial load
to a level the aseptic system is designed to handle. If
an initial microbial load is too high, sterility might
not be achieved during aseptic processing. Therefore,
water rinsing or flushing, air blasting, brushing, and
ultrasound methods are used to reduce the initial load
on equipment and packaging prior to other steriliza-
tion processes.
0023 Equipment and packages must attain the same
level of sterility as the products they will come into
contact with. Therefore, equipment is sterilized with
hydrogen peroxide or a time/temperature steam
sterilization at least equivalent to what the product
will receive. Thermal processes for equipment used
with low-acid foods will be higher, both time and
temperature, than for high-acid products. Packages,
other than metal cans, may not withstand high
temperature treatments; therefore, chemical and
irradiation sterilization procedures are commonly
used.
Maintaining a Sterile Environment
0024 Once equipment, packages, and products are steril-
ized, the challenge is to maintain sterility during
the filling and sealing operation. This is accom-
plished using either an overpressure of sterile air
or continuous flow of superheated steam, the latter
generally being used for the metal can aseptic pro-
cess. Air is sterilized by filtration, usually using a
series of high-efficiency particulate air (HEPA)
filters. Since all equipment must attain commercial
sterility, the HEPA air filters also must be sterilized.
The positive pressure maintained by a continuous
sterile air flow prevents contamination during the
filling process when the product may be exposed
to air. If the integrity of an aseptic zone is com-
promised because of line stoppages or other
occurrence, it is necessary to repeat the initial ster-
ilization process.
Validating Sterility
0025Validating sterility is a combination of implementing
an appropriate hazard analysis critical control point
program, documenting product and filler sterilization
procedures, filing the process with the appropriate
agency, maintaining accurate temperature, time,
pressure recording devices, and testing all aseptically
processed foods for sterility using appropriate micro-
biological sampling techniques. Challenge testing
with inoculated foods is part of validating a thermal
process.
The Sealing Process
0026At the end of the filling process, packages are often
sealed using heated sealing bars, jaws, and plates. The
temperature, pressure, and time of sealing must be
strictly controlled for each sealing compound to
maximize package integrity. Common heat sealant
polymers include polyethylene, polypropylene, ethyl-
ene vinyl acetate, and polyvinyl chloride. These com-
pounds have demonstrated a desirable mechanical
strength of the seal (impact strength, tensile strength,
tear strength, seal strength, puncture resistance)
and product holding properties (chemical resistance,
product compatibility, oxygen and moisture barrier
properties). Problems occur when particulates, fibers,
or other food contaminants are caught in the seal area
and prevent a completely fused seal. To avoid seal
contamination, especially with particulate foods, the
filler must be designed to avoid or remove product
from the seal area prior to fusion.
Types of Fillers
0027The filling method depends on both the type of prod-
uct (high or low acid, homogeneous liquid, viscous
product, size of particulates, etc.) and type of package
(retail, institutional, cup, pouch, bottle, etc.) desired
for the end product. Common filler classifications are
named for the processes that occur in the filler and
are outlined below.
4320 PACKAGING/Aseptic Filling