chapter 13 sterile packaging

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