LEARNING OBJECTIVES:

1. State four basic objectives that must be attainable by acceptable sterile packaging material.
2. Provide an overview of rigid container system design and construction components.
3. Review advantages and disadvantages of rigid container systems.
4. Explain basic documentation requirements to be provided by manufacturers of rigid container
systems.
Objectives of the Packaging Process
To be effective, a packaging material must allow
the chosen sterilant to penetrate, and it must
be compatible with all other requirements of
the sterilization process in which it will be used.
It must also maintain the sterility of package
contents until opened and be accessible to
the user without contaminating the contents
so they remain sterile at the moment of use.
Since they present a potential risk, sterilization
packaging is classied as a Class II medical device
by the U.S. Food and Drug Administration
(FDA). Only materials specically designed for
sterilization packaging and cleared by the FDA
can be used. The FDA also requires that rigid
container systems have a 510k certication to
verify they have a substantial equivalence to
one or more legally marketed devices that can
be used as a base of comparison with them.
Rigid containers, like all other packaging
materials, must address the special concerns
applicable to the sterilization method in
which they will be used. Manufacturers of
rigid containers must document that their
Rigid Container Systems (Part 1)
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LESSON PLAN
LESSON NO. CIS 220
(Instrument Continuing Education-ICE)
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After instruments have been cleaned, inspected and re-assembled, they must be packaged
for sterilization. This is a critical processing step because packaging maintains the sterility
of the sterilized items until the packaging is opened for use on the sterile eld. Certied
Instrument Specialist (CIS) technicians can use several types of packaging materials, including
those that are disposable (pouches and nonwoven wrap) and reusable: woven textiles and
rigid sterilization containers. They must know about these alternatives and use the correct
packaging procedures to assure that sterilization is successful.
This rst of a two-part series will explore the basics of rigid container systems. In this lesson, you
will learn about objectives of the packaging process, receive an overview of rigid sterilization
container systems, and explore some of the most important documentation requirements for
their manufacturers.
1
Lesson Author
Susan Klacik, ACE, CHL, CRCST, FCS
CSS Manager
St. Elizabeth Health Center
Youngstown, Ohio
Rigid containers are available in alternative sizes and designs.
Photo courtesy of Aesculap

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CIS Self-Study Lesson Plan
containers will satisfactorily address these
issues that include:
Packaging for steam sterilization must be
able to withstand temperatures of 250F
275F (121C 135C). It must permit
air removal and steam penetration to the
containers contents and drying of the
contents and container.
Packaging for ethylene oxide (EtO)
sterilization must permit adequate
penetration of the gas sterilant and provide
for its aeration (removal of the gas residue).
Packaging for dry heat sterilization must
tolerate up to three hours of exposure
time at temperatures of 320F 400F
(160C 204C) without melting, burning
or otherwise being damaged.
Packaging for plasma sterilization must
tolerate a deep vacuum draw without
absorbing sterilant, interrupting the cycle or
damaging package contents.
Basics of Rigid Container Systems
Rigid sterilization container systems are box-
like structures with sealable and removable
lids. They consist of an inner basket to hold
the instruments to be sterilized and an outer
container that provides a protective barrier.
The inner basket and the outer container
have handles that make them easy to carry.
Containers are available in various sizes and
designs and are constructed of anodized
aluminum, stainless steel, high-temperature
plastics, ber glass, or combinations of these
materials. Baskets often have instrument
posts and dividers that help to organize the
instruments.
Each container design incorporates a method
for sterilant penetration and protection from
after-sterilization contamination. Containers
do not require outer wrappers since they
operate using valves and lters. Some container
designs provide perforations in the top lid and/
or bottom surfaces. These perforations may
be covered internally by sterilant-permeable,
microbial barrier lters made of single-use
(disposable) synthetic spunbond material held
in place by a retention plate. Other designs
use a bio-barrier comprised of ceramic lters
or a valve system. Designs that include both
lters and valves are also available. These allow
sterilant permeability by expansion during the
sterilization phase and positive closure during
the drying phase of sterilization.
A container system provides containment
of medical devices during preparation and
sterilization, protection from contamination
during storage and/or transport, aseptic
presentation at the surgical eld, and effective
containment of some used devices during their
return to the decontamination area. Note: most
containers cannot retain uids; therefore only
dry instruments can be transported.
The design and material construction of a
container system markedly affects its use for
sterilization. For example, metal containers
incorporating non-woven fabric lter systems
are acceptable for steam and ethylene
oxide (EtO) sterilization. As noted above,
documentation from container manufacturers
is critical. However, vacuum-closed valves can
inhibit complete aeration of the contents
after sterilization, so metal containers with
valve closures are not recommended for use
in EtO or plasma steri l i zati on. Addi ti onal l y,
contai ners constructed of plastic have not
been proven acceptable for repeated EtO
sterilization cycles, and plastics are less efcient
for drying than are metal materials. Another
problem with plastic containers: build-up and
retention of EtO residuals that unfavorably
affect aeration of both the container and its
contents.
Advantages and Disadvantages
Among the potential advantages to the
use of rigid container systems is their ease
of use, and they provide an excellent
barrier to microorganisms. Price relative to
alternative packaging systems is an important
consideration, and a detailed cost benet
analysis is important to assure their cost
effectiveness before purchase. Containers
eliminate the possibility of torn wrappers
that can delay a surgical case and the need
for reprocessing that occurs. They also provide
excellent protection for instruments during
their processing, storage, and transport.
Safety concerns are always important, and
the weight of loaded containers may be a
disadvantage to rigid container systems. CIS
technicians can be injured by lifting rigid
containers because an empty large container
(12 by 23 by 6) weighs approximately eight
to nine pounds. When baskets containing the
medical devices to be sterilized are considered,
the issue of total container weight becomes
important. Heavy baskets of orthopedic
instruments can pose an additional risk for staff
members especially when baskets are removed
from the container. Employees should be able
to comfortably carry a container or instrument
set at waist height, so a containers total
weight should normally be restricted to fewer
than 25 pounds. Then, because the containers
have handles, they will be relatively easy to
remove from the sterilizer cart and to carry.
Latching mechanisms on containers are a
potential source of problems. When latches
and welds break, containers cannot be used,
and sharp edges can cause employee injuries.
Processing challenges occur if fewer containers
are available while damaged containers are
being repaired, and costs are incurred for
container repair/replacement and/or a stand-
by inventory.
As with all packaging methods, users
of container systems must take special
precautions when handling sharps, which
Basic components of a rigid container system
should be placed in a separately designated part
of the container. Techniques to handle sharp
instruments after sterilization that consider the
protection of CIS technicians are also important.
If small instruments or parts must be packaged
within the container, only packaging validated
for use within the container can be used.
Additional cycle time may be needed to
thoroughly dry the container, and sterilization
efciency is also reduced as a containers
weight increases because of excess condensate.
In fact, some manufacturers of rigid container
systems recommend that times for instrument
sterilization, drying and aeration be extended.
The wet pack syndrome has been discussed
for many years, and it is difcult to generalize
about solutions. However, it is known that
heavier sets and those with greater metal mass
are more likely to experience this problem,
especially if they are not properly distributed
throughout the container. Also, plastic
containers may require longer drying times
because they lack metal that produces heat by
conduction to help drying.
Rigid container users sometimes report that
lter retention plates become dislodged and
contaminate instruments. Some manufacturers
have addressed this potential problem by
modifying or changing the design of the lter
retention plate. More space may be necessary to
store rigid containers than traditional wrapped
containers, and additional labor may be needed to
clean containers between uses. This may also affect
washer loads if a mechanical washer is used.
Documentation from Manufacturers
Rigid container manufacturers must provide
instructions that are a primary consideration
for the evaluation, purchase, processing,
and effective use of containers. They must
provide documentation of tested performance
qualications and complete written instructions
for use of their container system. This
information must include:
The methods of sterilization processing
(vacuum or gravity displacement steam
and/or EtO, gas plasma, or dry heat) for
which the system can be used. Note: unless
otherwise specied by the manufacturer,
containerized packaging should not be used
in gravity displacement steam sterilizers
because it is difcult to remove air from the
container and its contents.
The methods for validating essential
conditions for sterilization. These include
time, sterilant penetration, use of and
placement sites for biological and chemical
indicators, and recommendations for
effective drying and/or aeration times.
Testing procedures and recommendations
regarding the weight, density and uniform
distribution of the instruments/contents of
the container system. These include how, if at
all, contents should be separated into layered
baskets or other accessories. Also important
is information about the type, placement,
and rationale for use of moisture-absorbent
or moisture-wicking materials recommended
to help assure drying of the contents and
inner wrapping for aseptic presentation.
Note: weight of instruments in container
systems should be determined by study of
the container manufacturers instructions
and/or by individual studies/tests conducted
by the facility. It is the users responsibility to
determine that all wrapped or containerized
instrument sets and all loads can be effectively
sterilized and dried at a specic facility.
Methods for validating/testing the barrier
effectiveness and sterility maintenance of
lters or valves and design characteristics
that limit microbial migration and pen-
etration of contaminates to the containers
contents.
Recommendations and precautions regarding
disassembly for cleaning and decontamination,
including the types of cleaning agents and
the methods for decontamination processing.
Instructions should also address the inspection,
maintenance or reassembly of gaskets and lter
retention plates or valves. These are important
because a torn or fragmented gasket could
result in sterilization failure, and a broken plate
or valve could result in a contaminated tray.
Other recommendations about preparation
and assembly of contents, use of accessories,
and external processing indicators and
tamper-evident sealing devices. Also required
is information regarding placement of the
container in the sterilizer, after-sterilization
handling, storage, and transportation of
the container, and aseptic presentation of
its contents. Note: additional information
specic to the effective use of individual
container systems may also be necessary.
Within-facility testing, including verication
of the sterilization cycle for each method
of sterilization and each sterilizer for which
containerized product processing would be used,
is needed. Biological and chemical indicators
should consistently be used in accordance with
recommendations for sterilization container
testing, manufacturers directions, and quality
controls to validate sterilization conditions
within each sterilizer.
In Conclusion
Rigid sterilization containers are integral
components in the sterilization processes
used by many healthcare facilities. As with
any type of sterile packaging system, however,
comprehensive policies and procedures for their
use must be in place, and they must incorporate
the recommendations of the containers
manufacturers. As well, CIS technicians must
be trained in proper usage protocols with
additional periodic updates, as necessary.
Medical devices must be properly cleaned,
prepared, assembled, and loaded for the
sterilization process to be effective. Quality
monitoring of the sterilization process is critical
as is the need for applicable record keeping and
control procedures. These are the topics of the
second lesson in this two-part series.
Endnote
1. This lesson is adapted from: Central Service
Technical Manual. Seventh Edition. Chicago,
Il. International Association of Healthcare
Central Service Materiel Management.
2007, and Sterilization Principles for
Medical Devices: Rigid Container Systems.
Module 5 in EXX CELL 2000 Plus: Strategies
for Success. Chicago, Il. International
Association of Healthcare Central Service
Materiel Management. 2000.
IAHCSMM
CIS Self-Study Lesson Plan
Technical Editor
Carla McDermott, RN, ACE, CRCST
Educator
South Florida Baptist Hospital,
Lakeland, FL
Series Writer/Editor
Jack D. Ninemeier, Ph.D.
Michigan State University
East Lansing, MI
CIS SELF-STUDY LESSON PLANS
IAHCSMM is looking for volunteers to write or
contribute information for our CIS Self-Study Lessons.
Doing so is a great way to contribute to your own
professional development, to your Association, and
to your Central Sterile Supply Department peers.
Our team will provide guidelines and help you
with the lesson to assure it will be an enjoyable
process. For more information, please contact
Elizabeth Berrios (elizabeth@iahcsmm.org).
CIS Self-Study Lesson Plan Quiz
(Instrument Continuing Education-ICE)
Lesson No. CIS 220: Rigid Container Systems (Part 1)
Questions (circle correct answer):
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LESSON PLANS
1. Effective packaging materials:
a. must allow the chosen sterilant to
penetrate
b. must maintain package content sterility
until opened
c. must be the least expensive packaging
alternative available
d. a and b above
e. all the above
2. Sterilization packaging is classied as a
________ medical device by the FDA.
a. Class I
b. Class II
c. Class III
d. Class IV
3. Which part of a rigid container has
handles?
a. The outer container
b. The inner basket of the container
c. Both of the above
d. Neither of the above
4. Which is not correct?
a. Some containers require outer wrappers
because they do not use valves and lters
b. Container designs can include perforations
in the top lid and/or on bottom surfaces
c. Some containers use lters and valves
d. All of the above are correct
5. Policies and procedures applicable to
containers must:
a. address the desires of CIS technicians
b. incorporate the recommendations of
the containers manufacturers.
c. be reviewed every six years
d. b and c above
6. Metal containers using non-woven fabric
lter systems can be used for ________
sterilization.
a. plasma
b. steam
c. dry heat
d. b and c above
e. All of the above
7. Containers made of ________ have not
proven acceptable for repeated EtO
sterilization cycles.
a. metal
b. anodized aluminum
c. berglass
d. plastic
8. The weight of a loaded container should
normally be less than ________ pounds.
a. 15
b. 20
c. 25
d. 30
9. Sterilization efciency ________ as a
containers weight increases.
a. increases
b. decreases
10. It is normally difcult to remove air from
the container and its contents when a
(an) ________ sterilization process is used.
a. EtO
b. gravity displacement steam
c. gas plasma
d. dry heat
11. Documentation from container
manufacturers about instruments to be
processed must address the instruments:
a. Weight
b. Density
c. Uniform distribution of the instruments
d. a and b above
e. all of the above
12. Who must determine that container loads
can be effectively sterilized at a facility?
a. The manufacturer
b. Facility personnel
13. Documentation about biological and
chemical indicators supplied by container
manufacturers should address their:
a. proper use
b. proper placement
c. both of the above
d. neither of the above
14. Wet packs are more likely to occur when:
a. heavier sets are processed
b. sets with greater metal mass are processed
c. few instruments are placed in the set
d. a and b above
e. All of the above
15. Metal containers with valve closures are
not recommended for what type of
sterilization?
a. plasma
b. dry heat
c. steam
d. all of the above
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