operators must meet the same requirements for sterilizability as the compartment (i.e., the garments must be aseptic).
Because of the high contamination risk,
it is recommended that only a minimum
number of employees are present in
Modern compartment designs exclude staff access. In this case, employees
must use hermetically sealed gloves to
handle equipment that is placed inside.
Those aseptic compartments are called
“isolators.” They can be cleaned and
sterilized in place.
To avoid contamination of aseptic
compartments, material, media and staff
must pass through sluices for decontamination. They must have one closable
opening to the lower hygienic area and
one to the aseptic area. The two openings must never be opened at the same
time. Examples of additional equipment
used as boundaries of aseptic compartments, as well as specific requirements,
are also discussed in the document.
(continued from page 23)
Within aseptic areas, the relevant
clean surfaces must make complete contact with the chosen sterilizing medium
for the prescribed length of time to assure the efficiency of the sterilization
procedure. Physical methods—such as
saturated or superheated steam, heat,
(pressurized) hot water and radiation—as
well as chemical methods involving disinfectants, such as halogens (e.g., chlorine), hydrogen peroxide, peracetic acid
or quaternary ammonium compounds,
can be applied.
It is evident that the cleanability and
sterilizability of all aseptic process
equipment and of the aseptic compart-
ments must be validated. Document 39
has been recently published as an
EHEDG Guideline to complete the es-
sential basic requirements for aseptic de-
sign of closed and open equipment
(Guidelines 10 and 13). When sensitive
food must be processed in an aseptic
way, it is essential to eliminate hazards
related to durable equipment and rele-
vant areas for closed and open process
operations that do not follow aseptic re-
quirements. The document is intended
to provide the equipment manufacturer
as well as the food industry consistent
definitions and rules.
EHEDG Subgroup Work
Guidelines like that discussed above
(to date, 39 in all) are drawn up by international groups of experts from user
companies, equipment producers and research institutes to promote safe food by
improving hygienic engineering and design in all facets of food manufacture.
Each subgroup is responsible for an area
of expertise, and within each area, certain specific scopes are defined. Experts
who would like to contribute their expertise to this process are heartily invited
to join EHEDG and do so. n
Hiroyuki Ohmura is the EHEDG Chairman of Regional Section Japan.
Gerhard Hauser, Ph.D., chairs the
EHEDG Subgroup on Design Principles.
He can be reached at +49893191267 or
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