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Sterile Packaging and Storage
Chapter 13
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
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
PackagingLike food packaging, sterile packaging must: Protect contents
from contamination Provide a tamper-
evident seal Be appropriate for
the type item being packaged
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
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.
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
Reusable Sterilization Packaging Materials
Woven Textiles Rigid Sterilization Containers
Woven Textiles
Muslin – Broad term describing a wide variety of plain-weave cotton or cotton/polyester fabrics having approximately 140 threads per square inch.
Other Woven Textiles
Duck ClothTwillsBarrier ClothTreated Barrier Fabrics
NOTE: Canvas should not be used as a sterile packaging material
Textile PackagingMust 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
Textile Packaging Materials
Should be held at room temperature (640 – 720F, 180 – 220C) 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
Superheating
The condition that arises when steam is at a temperature which exceeds
that of saturated steam at the same pressure
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
Rigid Container
AdvantagesProvide an excellent barrierEasy to useEliminate torn wrappersProtect instruments from damage
DisadvantagesErgonomic concerns due to container weightAdditional cycle time may be needed for dryingPlastic containers may need even more drying timeAdditional storage space requiredAdditional labor may be required to clean containers between usesLatching mechanisms may become damaged
Filter retention plates may become dislodged
Example of a Rigid Sterilization
Container
Container Lid
Disposable Filter
Locking Mechanism
Filter Retention Plate
Gasket
Tray Label
Security Lock
Locking MechanismCarrying Handle
Container Bottom
Cleaning of Rigid Containers
Rigid Containers should be cleaned between uses
Remove disposable components
Disassemble
Clean according to manufacturer’s recommendations
Rigid Container Inspection
Inspect all components according to manufacturer’s guidelines each time the container is assembled
Gasket
Disposable Sterilization Packaging Materials
Pouches Nonwoven Wrap
Disposable Packaging Materials
Before Use: Inspect for
tears, holes, or damage that may have occurred during transport and handling
Kraft-type Papers
Medical-grade paper approved for use as sterilization packaging
Used for small items
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
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
Spunbond Polyolefin-Plastic Combinations
Allows visibility of pack contents and penetration of sterilant
Contains no cellulosic materials and is therefore compatible with gas plasma sterilization processes
Methods of Package Closure
Package Closure
Must secure contents
Must be tamper-evident to prevent resealing the package
Tamper Evident Seals for Rigid Sterilization
Containers
Self-Seal and Heat-Seal Closures for Pouches
Heat-Seal Caution
Be sure to avoid creases or gaps in edges when heat-sealing pouches
Those openings can allow bacteria to enter the package
Tape Seals on Wrapped Packs
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
Protectors can protect packaging from the sharp points of some
instruments
Use devices designed to protect instruments and hold them in position for
sterilization
Reusable holders can help keep ring-handled instruments open
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
Peel PouchesUsed 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
Excess Stress on the Sides of Peel-Pouches will Compromise the Integrity
of the Pouch
Double-PouchingUse appropriately sized pouches. Never fold the inner pouch
Nest paper to paper and plastic to plastic for steam penetration
Flat Wrapping Techniques
Sequential – Applying 2 wraps in sequence (one after the other). Creates a package within a packageSimultaneous – The package is wrapped once in double thickness wrapSquare-Fold – used for larger packs and trays, it is also called in-line or parallel foldEnvelope Fold – Most commonly used for small packs, most instrument sets and individual items
Flat Wrapping
Diagrams of flat wrapping methods and techniques can be found on pages 256 – 258 of the text
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
Terminology and Abbreviations
Slang and Nicknames should not be used
Item information should be standardized
Handwriting must be neat and legible
Sterility (Time-Related)
A package is considered sterile until a specific expiration date is reached
Time-Related Sterility(Expiration Dating)
Uses a calendar theory
Must be used in conjunction with an event-related philosophy
Relies on Product Rotation
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
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
“Contents Sterile...
…unless package is damaged or
opened”
Sterile Storage Standards
Temperatures should be 640 - 750 F (180 – 240C)Humidity should be 35% - 75%Items should not be stored where they may become wetAir should be as dust-free as possibleThe area should be under positive air pressureWork surfaces should be made of easy to clean materialsSterile Storage areas should have restricted traffic
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
Organization
Items must be arranged neatly to reduce the number of times that they are handled
Organization also makes locating items easier
Check ALL Packages Before Dispensing
Check External Indicators
Check for Package Integrity
Check Expiration Date, if one is provided on the package
Package Integrity
CleanPuncture FreeDryUndamagedStress-Free Wear-Free
Product Rotation
FIFO - First In-First Out
Older packages should be used first.
Product HandlingClean, Dry Hands
Handle gently
Do not drop, crush, etc.
Keep Storage area clean and organized
Even the most minor break in protocol...
…can cause great harm to our patient