Chapter 13 Sterile Packaging and Storage
Terms in this set (87)
Items are packaged
To help maintain the integrity - sterility of the sterile items until they are opened and used.
Seals - tamper evident
Sealing methods for sterile packaging that allows user to determine if the packaging has been opened. The seals allow the users to determine if packages have been opened - contaminated- and help them identify packages that are not safe for patient use.
Two basic catagories of sterility packaging
Objectives of Packaging Process
1. Must allow penetration of the chosen sterilant and must be compatible with any other requirements of the specific sterilization process such as drying.
2. Must be able to maintain the sterility of the package controls until It is opened.
3. Must create a package that can be opened aseptically-without contaminating the contents by the user.
4. Contents of a sterilized package must be sterile at the moment of use.
Class II Medical Device
FDA classifies sterilization packaging-those presenting a potential risk.
First step in packaging process
Select appropriate type of packing material and method
Material must be approved by
Packaging for Steam Sterilization
Must be capable of withstanding high temps. 250f to 275f or 121c to 135c. The packaging must allow air removal and steam penetration to the contents to be sterilized and must permit drying of the contents and packaging material.
Packaging for Ethylene Oxide sterilization
Allow adequate penetration of the gas sterilant and removal of the gas residue - airation
Packaging for Dry Heat sterilization
Muct be able to tolerate a deep vacuum draw with out absorbing the sterilant interrupting the cycle, or damaging the contents.
Desired results of sterilization packaging
1. Sterilant Penetration
2. Barrier Effectiveness
3. Aseptic Opening
Broad term describing a wide variety of plain weave cotton/polyester fabrics having approx. 140 thread per square inch.
Other woven fabrics used in sterilization
1. Duck Cloth
3. Barrier cloth
4. Treated Barrier Fabrics
The condition that arises when steam is at a temperature which exceeds that of saturated steam at the same pressure.
Contents must be packaged to enable steam and gases to reach all surfaces.
Will not allow for fiber swelling - expansion and the steam or vapor will not penetrate the material.
Rigid Container Systems
Box like structures with sealable and removable lids. Made of anodized aluminum, stainless steel, plastic or a combination of these materials.
Are regulated by the FDA and are required to have 510k certification
Rigid Container System
Instrument containers that hold medical devices during sterilization and also protect devices from contamination during storage and transport
A package of info submitted to and approved by the FDA relating to a device having substantial equivalence to one or more legally marketed "predicate" base of comparison devices.
A disadvantage of rigid container systems
Containers with moisture - inadequate drying- after sterilization process is completed.
Disposable flat wraps and Rigid Container Filters
Should be inspected for holes and tears
3 types of disposable packaging materials
2. Polyolefin Plastic
3. Disposable non woven wraps
Papers that contain cellulose
Can not be used in gas plasma sterilizers because cellulose absorbs the sterilant and reduces penetration.
Kraft Type Papers
Medical grade packaging material used for numerous sterilization applications.
Spunbound-Meltblown-Spunbound. Non woven packaging material which is the most popular flat wrpap.
Synthetic materials that are softened by heat and hardened by cooling.
2 types of peel pouches
Used for steam and ethylene oxide sterilization
Aluminum Foil and Borosilicate - Pyrex
Glass or solid metal containers are used for dry heat sterilization only
Purpose of Package closure seal
Seal the package securely, maintain the sterile integrity of the contact area during transport and storage, and prevent resealing if the package is opened or if the seal is compromised.
Floors in prep and pack area
Made from non-porous materials so micro organisms can not breed there.
Non particulate so no dust
Rigid as well should be at room temp for two hours before use.
Acceptable Closure Methods
1. Indicator Tape
2. Heat Seals
3. Self Adhesive Seals
4. Sealing Tape
5. Tamper evident seals for rigid containers
Indicator Tape or stickers
Change color after being exposed to steriliazation however do not provide proof that adequate sterilization of package contents has occured
Used for paper-plactics or plastic-plastic seals Peel Pouches
Self Adhesive Seals
Do not require heat. Paper-Plastic and Polyofen packages
Sometimes used for pouches
Rigid Container Seals
Designed to break when the seal on the container has been broken
Protects packaging from the sharp point of some instruments
Instruments must be carefully inspected to ensure cleanliness, proper functioning and alignment
After cleaning, before sterilization
Accessing deep veins fro intravenous fluid delivery
Opening the abdomen
Instrument Tray Packing List
An approved absorbant material that allows for air removal, steam penetration and facilitates drying.
Should be assembled in a way that allows moisture to drain from them during sterilization
ansi/aami standard ST 79-2006
States the weight of wrapped basin sets should not exceed 7 pounds to avoid wet pack.
To ensure sterilant contacts all surfaces
Stylets should be placed on there sides.
Are usually used for smaller lightweight items. They are also useful when it is important to see the contents of the package such as when a description of the contents is difficult to view or label.
Must be sized and applied properly to allow for adequate air removal, sterilant penetration and drying.
Acts as a barrier to heat and moisture so it is important to remove as much air as possible before sealing.
Excess Stress on the sides of Peel Pouches
Will compromise the integrity of the pouch.
Space needed for package contraction and proper circulation
Excess movement in peel pouches
Can break seals or puncture the pouches paper side.
Paper Plastic pouches
Plastic side to permit visibility of the contents and a paper side that may be penetrated by air, steam or sterilant. Only label on plastic side.
Heat seals must be observed for bubbles and creases
Seals that are not smooth and complete may allow bacterial contamination after sterilization
Rule for double pouching
Paper side to paper side and plastic side to plastic side to assure sterilant penetration, drying, and content visibility
Flat wrapping techniques
Sequential flat wrapping
The package is wrapped twice and is a package within a package. The term sequential indicates that the contents have been wrapped in sequence. One after the other
Simultaneous flat wrapping
The package is only wrapped once, but it requires a special double layered synthetic non woven material bound on two or four sides.
2 Techniques for wrapping
1. Square Fold
2. Envelope Fold
This is also called the in line or parallel fold, and it is most frequently used for larger packs and instrument trays.
This is more commonly used for small packs and most instrument sets and individual items.
Sequentially wrapped packages
1. Double wrapped muslin 140 count - two double layered wraps.
2. Double wrapped barrier cloth 280 count or above - two single thickness wraps
3. Double wrapped paper - two paper wraps
4. Double wrapped non woven - two single non woven wraps
Must be complete and correct before sterilization and must contain following information
1. Description of package contents
2. Initials of package assembler
3. Lot control number
4. Id of sterilizer and cycle to be used
5. Date of sterilization, unless inherent in lot control number
6. Requesting dept. or the surgeons name -special request items- may also be included on this label
7. Assigned storage location to prevent items from being misplaced.
Labeling is necessary
For the end user, and also for sterilization processing, quality assurance, stock rotation and inventory control purposes.
Labeling should be documented
On label sensitive tape or on commercially availiable pre printed adhesive labels.
Generally used for marking
Felt tipped markers
Protective plastic over wraps - dust wraps
Can be used to prevent dust, moisture and other contaminates. Must be 2 or 3 mils thick.
Permits adequate steam/sterilant penetration and prevents superheating of the fabric during sterilization
Packaging material must be kept at room temp 67f to 72 f - 18 c to 22 c and humidity 25 to 70 percent for a minimum of two hours before use
Recommends the maximum weight of 25 pounds for containerized instrument sets.
Sterility - time related
A package is considered sterile until a specific expiration date is reached.
Sterility - event related
Items are considered sterile unless the integrity of the package is compromised - damaged or suspected of being compromised - damaged regardless of the sterilization date. This is sometimes referred to as ERS - Event Related Sterility. Recognized by the the Joint Commission and AORN
Cleanest area to dirtiest area
Flow of cleaning tasks
Sterile storage should be under positive air pressure
To reduce airborne contamination from air outside the storage area
Storage temp and humidity
64f to 75f - 18c to 24 c
less than 75% humidity
4 air exchanges per hour
2 inches from exterior walls, 8 to 10 inches above the floor. 8 to 10 inches from highest package to ceiling
Packages should be kept
First in, First out
A stock rotation system in which oldest product is used first, often abbreviated FIFO
Can not be processed within a gas plasma sterilizer
Low Temperature Sterilization
Some plastics including formulations of spun bound polyolefin are intended for use in theses sterilization processes
Spunbound Polyolefin Plastic Combinations
Type of packaging that contains no cellulosic materials and would be used to package small items for low temperature sterilization
When using paper plastic pouches, package content information should be written on this side of the pouch.
Muslin is an example of this type of packaging material
Maximum density recommended per cubic foot of a linen pack