Chapter 13 sterile packaging


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Chapter 13 sterile packaging

  1. 1. Sterile Packaging and Storage Chapter 13
  2. 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. 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
  4. 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. 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. 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. 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
  8. 8. Reusable Sterilization Packaging Materials Woven Textiles Rigid Sterilization Containers
  9. 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. 10. Other Woven Textiles Duck Cloth Twills Barrier Cloth Treated Barrier Fabrics NOTE: Canvas should not be used as a sterile packaging material
  11. 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. 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. 13. Superheating The condition that arises when steam is at a temperature which exceeds that of saturated steam at the same pressure
  14. 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. 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. 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. 17. Cleaning of Rigid Containers Rigid Containers should be cleaned between uses Remove disposable components Disassemble Clean according to manufacturer’s recommendations
  18. 18. Rigid Container Inspection Inspect all components according to manufacturer’s guidelines each time the container is assembled Gasket
  19. 19. Disposable Sterilization Packaging Materials Pouches Nonwoven Wrap
  20. 20. Disposable Packaging Materials Before Use:  Inspect for tears, holes, or damage that may have occurred during transport and handling
  21. 21. Kraft-type Papers Medical-grade paper approved for use as sterilization packaging Used for small items
  22. 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. 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
  24. 24. 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
  25. 25. Methods of Package Closure
  26. 26. Package Closure Must secure contents Must be tamper-evident to prevent resealing the package
  27. 27. Tamper Evident Seals for Rigid Sterilization Containers
  28. 28. Self-Seal and Heat-Seal Closures for Pouches
  29. 29. 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
  30. 30. Tape Seals on Wrapped Packs
  31. 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
  32. 32. Protectors can protect packaging from the sharp points of some instruments
  33. 33. Use devices designed to protect instruments and hold them in position for sterilization
  34. 34. Reusable holders can help keep ring-handled instruments open
  35. 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. 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. 37. Excess Stress on the Sides of Peel- Pouches will Compromise the Integrity of the Pouch
  38. 38. Double-Pouching Use appropriately sized pouches. Never fold the inner pouch Nest paper to paper and plastic to plastic for steam penetration
  39. 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. 40. Flat Wrapping Diagrams of flat wrapping methods and techniques can be found on pages 256 – 258 of the text
  41. 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. 42. Terminology and Abbreviations Slang and Nicknames should not be used Item information should be standardized Handwriting must be neat and legible
  43. 43. Sterility (Time-Related) A package is considered sterile until a specific expiration date is reached
  44. 44. Time-Related Sterility (Expiration Dating) Uses a calendar theory Must be used in conjunction with an event-related philosophy Relies on Product Rotation
  45. 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. 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
  47. 47. “Contents Sterile... …unless package is damaged or opened”
  48. 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. 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. 50. Organization Items must be arranged neatly to reduce the number of times that they are handled Organization also makes locating items easier
  51. 51. Check ALL Packages Before Dispensing Check External Indicators Check for Package Integrity Check Expiration Date, if one is provided on the package
  52. 52. Package Integrity Clean Puncture Free Dry Undamaged Stress-Free Wear-Free
  53. 53. Product Rotation FIFO - First In-First Out Older packages should be used first.
  54. 54. Product Handling Clean, Dry Hands Handle gently Do not drop, crush, etc. Keep Storage area clean and organized
  55. 55. Even the most minor break in protocol... …can cause great harm to our patient