2. Objectives:
As a result of successfully completing this chapter,
students will be able to:
Explain the basic objectives of the packaging process, and
review basic selection factors for materials to be used with
specific sterilization methods
Provide an overview of reusable packaging materials
Provide an overview of disposable packaging materials
Discuss basic package closure methods
3. Objectives:
Review basic procedures to prepare pack contents for
packaging
Explain basic packaging procedures for peel pouches
and flat wrapping materials
Review general packaging concepts:
Package labeling
Special concerns
Sterility maintenance
Provide basic information about sterile packaging,
storage, and transport
5. Objectives of the Sterile
Packaging Process
Allow penetration of the sterilant and be
compatible with any other requirements of the
process ( such as drying)
Maintain the sterility of the package contents
until it is opened
Create a package that can be opened
aseptically
6. Sterilization Packaging
Is classified by
the FDA as a
Class II Medical
Device.
The
consequences of
a non-sterile item
being used
during surgery
can be life-
threatening.
7. Selecting a Packaging
Material
Different types of packaging are needed for
different types of sterilization
Styles of packaging may vary based on
package contents
Only packaging materials approved as
sterilization packaging by the FDA should be
used for sterilization
9. Woven Textiles
Muslin – Broad
term describing a
wide variety of plain-
weave cotton or
cotton/polyester
fabrics having
approximately 140
threads per square
inch.
10. Other Woven Textiles
Duck Cloth
Twills
Barrier Cloth
Treated Barrier Fabrics
NOTE: Canvas should not be used as
a sterile packaging material
11. Textile Packaging
Must be inspected
for holes between
uses using a light
table
Holes must be
patched using heat-
sealed patches
Textile packaging
requires more labor
than disposable
packaging
12. Textile Packaging
Materials
Should be held at room temperature (640
– 720
F, 180
– 220
C) and
at a relative humidity of 35% - 70% for a minimum of 2 hours
prior to sterilization
Failure to do so may cause superheating of the fabric during
sterilization
13. Superheating
The condition that arises when steam is at
a temperature which exceeds that of
saturated steam at the same pressure
14. Rigid Container
Systems
Box-like structures that
consist of an inner basket
(to hold instruments) and
an outer structure that acts
as a bacterial barrier
Rigid containers allow
sterilant penetration
through disposable filters,
ceramic filters, or valves
15. Rigid Container
Advantages
Provide an excellent
barrier
Easy to use
Eliminate torn
wrappers
Protect instruments
from damage
Disadvantages
Ergonomic concerns due to
container weight
Additional cycle time may be
needed for drying
Plastic containers may need
even more drying time
Additional storage space
required
Additional labor may be required
to clean containers between
uses
Latching mechanisms may
become damaged
Filter retention plates may become
dislodged
16. Example of a
Rigid Sterilization Container
Container Lid
Disposable Filter
Locking Mechanism
Filter Retention Plate
Gasket
Tray Label
Security Lock
Locking Mechanism
Carrying Handle
Container Bottom
17. Cleaning of Rigid
Containers
Rigid Containers should be
cleaned between uses
Remove disposable
components
Disassemble
Clean according to
manufacturer’s
recommendations
22. Non-woven Packaging Material
Available in a wide
variety of sizes and
weights
Used for various
items from small
single item packs, to
entire instrument
trays
23. Paper/Plastic
Combinations
Generally used for steam
and ethylene oxide
sterilization
The plastic side allows the
contents of the pack to be
seen
The paper side allows
sterilant penetration
31. Preparation of Pack Contents
Before packaging, inspect contents for
cleanliness and function
Apply lubrication or test as required by the
instrument manufacturer
Protect instruments from damage
Assemble a pack that is neat, complete, and
will facilitate the sterilization process
35. Basic Packaging
Procedures
Information needed for general
packaging procedures includes:
Name of device being packaged
Steps for preparation and assembly of pack
contents
Sterilization method to be used
Type and size of packaging to be used
Correct placement method for items within the
package
Type and placement requirements for internal
chemical process indicators
36. Peel Pouches
Used for lightweight items
Label only on the plastic side of the
pouch using an approved felt tip
marker
Package items so the end of the
item to be grasped first is presented
first when the package is opened
Place pouches on edge for
sterilization
37. Excess Stress on the Sides of Peel-
Pouches will Compromise the Integrity of
the Pouch
39. Flat Wrapping Techniques
Sequential – Applying 2 wraps in sequence
(one after the other). Creates a package
within a package
Simultaneous – The package is wrapped
once in double thickness wrap
Square-Fold – used for larger packs and
trays, it is also called in-line or parallel fold
Envelope Fold – Most commonly used for
small packs, most instrument sets and
individual items
40. Flat Wrapping
Diagrams of flat
wrapping methods
and techniques can
be found on pages
256 – 258 of the text
41. Package Labeling
Must contain:
Description of Package Contents
Initials of Package Assembler
Lot Control Numbers
Identification of Sterilizer and Cycle to be used
Date of Sterilization
Requesting Department or Physician
Assigned Storage Location
42. Terminology and Abbreviations
Slang and Nicknames should not be
used
Item information should be
standardized
Handwriting must be neat and legible
45. Time-Related Concepts must be
used with Event-Related Concepts
Milk has a shelf-life
Events, such as failure to
refrigerate the milk container, can
impact shelf-life and render the milk
unsafe, no matter what expiration
date is printed on the carton
Events that happen to sterile
packages may cause them to
become unsterile even if their
expiration date has not been
reached
46. Sterility (Event-
Related)
Items are considered sterile
unless the integrity of the
packaging is compromised or
suspected of being
compromised
Concerns include:
Moisture Contamination
Dirt, Dust, and Debris
Physical Damage
Breakdown of Packaging Material
due to Wear or Age
48. Sterile Storage Standards
Temperatures should be 640
-
750
F (180
– 240
C)
Humidity should be 35% - 75%
Items should not be stored
where they may become wet
Air should be as dust-free as
possible
The area should be under
positive air pressure
Work surfaces should be made
of easy to clean materials
Sterile Storage areas should
have restricted traffic
49. Sterile Storage Standards
Sterile items should
be stored:
at least 2” away from
exterior walls
8-10” above the floor
8-10” from the ceiling
Note: Fire codes may
specify 18” from
sprinkler heads
50. Organization
Items must be
arranged neatly
to reduce the
number of times
that they are
handled
Organization also
makes locating
items easier
51. Check ALL Packages
Before Dispensing
Check External
Indicators
Check for Package
Integrity
Check Expiration
Date, if one is
provided on the
package
