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Similar to Chapter 13 sterile packaging
Chapter 13 sterile packaging
- 1.
- 2. Objectives: As a resultof 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 basicprocedures 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
- 4. Packaging Like food packaging, sterile packaging must: Protect contents from contamination Provide a tamper- evident seal Be appropriate for the type item being packaged
- 5. Objectives of theSterile 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 classifiedby 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 Differenttypes 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
- 8. Reusable Sterilization Packaging Materials WovenTextiles Rigid Sterilization Containers
- 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 DuckCloth Twills Barrier Cloth Treated Barrier Fabrics NOTE: Canvas should not be used as a sterile packaging material
- 11. Textile Packaging Must beinspected 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 beheld 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 thatarises when steam is at a temperature which exceeds that of saturated steam at the same pressure
- 14. Rigid Container Systems Box-like structuresthat 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 anexcellent 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 RigidSterilization 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 RigidContainers should be cleaned between uses Remove disposable components Disassemble Clean according to manufacturer’s recommendations
- 18. Rigid Container Inspection Inspect all components accordingto manufacturer’s guidelines each time the container is assembled Gasket
- 19. Disposable Sterilization Packaging Materials PouchesNonwoven Wrap
- 20. Disposable Packaging Materials Before Use: Inspect for tears, holes, or damage that may have occurred during transport and handling
- 21. Kraft-type Papers Medical-grade paper approvedfor use as sterilization packaging Used for small items
- 22. Non-woven Packaging Material Availablein 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 forsteam and ethylene oxide sterilization The plastic side allows the contents of the pack to be seen The paper side allows sterilant penetration
- 24. Spunbond Polyolefin-Plastic Combinations Allows visibilityof pack contents and penetration of sterilant Contains no cellulosic materials and is therefore compatible with gas plasma sterilization processes
- 25. Methods of PackageClosure
- 26. Package Closure Must securecontents Must be tamper-evident to prevent resealing the package
- 27. Tamper Evident Sealsfor Rigid Sterilization Containers
- 28. Self-Seal and Heat-Seal Closuresfor Pouches
- 29. Heat-Seal Caution Be sureto avoid creases or gaps in edges when heat- sealing pouches Those openings can allow bacteria to enter the package
- 30. Tape Seals onWrapped Packs
- 31. Preparation of PackContents 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
- 32. Protectors can protectpackaging from the sharp points of some instruments
- 33. Use devices designedto protect instruments and hold them in position for sterilization
- 34. Reusable holders canhelp keep ring-handled instruments open
- 35. Basic Packaging Procedures Information neededfor 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 forlightweight 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 onthe Sides of Peel- Pouches will Compromise the Integrity of the Pouch
- 38. Double-Pouching Use appropriately sized pouches. Neverfold the inner pouch Nest paper to paper and plastic to plastic for steam penetration
- 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 offlat 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 Slangand Nicknames should not be used Item information should be standardized Handwriting must be neat and legible
- 43. Sterility (Time-Related) A packageis considered sterile until a specific expiration date is reached
- 44. Time-Related Sterility (Expiration Dating) Usesa calendar theory Must be used in conjunction with an event-related philosophy Relies on Product Rotation
- 45. Time-Related Concepts mustbe 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 areconsidered 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
- 47. “Contents Sterile... …unless packageis damaged or opened”
- 48. Sterile Storage Standards Temperaturesshould 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 Sterileitems 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 arrangedneatly to reduce the number of times that they are handled Organization also makes locating items easier
- 51. Check ALL Packages BeforeDispensing Check External Indicators Check for Package Integrity Check Expiration Date, if one is provided on the package
- 52.
- 53. Product Rotation FIFO -First In-First Out Older packages should be used first.
- 54. Product Handling Clean, DryHands Handle gently Do not drop, crush, etc. Keep Storage area clean and organized
- 55. Even the mostminor break in protocol... …can cause great harm to our patient