Sterile container system
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Transcript of Sterile container system
Today, surgical site infections have become common complications
Leading cause of postoperative morbidity and mortality
Preventing infection in the surgical site is a primary goal for all members of the operative team.
One key measure for reducing the risk for surgical site infection is to provide surgical instruments and devices that are sterile at the time of use;
This requires appropriate packaging of the items for sterilization.
Aesculap Sterile Technology
General requirements for packaging systems:
• Protection of Instruments
• Maintaining of the product quality
• Maintaining of sterility during transport and handling
• Maintaining of sterility for a long period
EN ISO 11607
EN 868
• Sterile Barrier System
Minimum package that prevents entry of micro organisms and allows
aseptic presentation of the product at the point of use.
• Protective Packaging
Configuration of materials designed to prevent damage to the sterile barrier
system and its contents from the time of their assembly until the point of use
• Packaging System
Combination of the sterile barrier system and protective packaging
EN ISO 11607
preformed barrier system + protective packaging =
Part 1: General requirements and test methods for all packaging materials
• Compatibility with the medical product to be packed
• Protection of medical devices
• Maintaining of the product quality
• Maintaining sterility during transport and handling (event related)
• Aseptically presentation in the OR must be possible
EN 868-1 & 8:
Part 8: Re-usable sterilization containers for steam sterilizers
conforming to EN 285- Requirements and test methods.
• Sealing system against unauthorised opening
• Gasket between lid and bottom part: bacterial barrier properties
• Stack ability
• Steam permeability
• Good drying capacity
• Bacterial barrier properties during transport and storage
• Maximum load: 10 kg
EN 868-8:
Why Aesculap Sterile Container
• Simple, Safe and quick sterile preparation
• Sterile goods container complies with EN 8681-8 & ISO regulations
• Shelf-life studies for 06 months available
• Storage and transport without risk of damage
• Packaging process can get validated (filter)
• Excellent labeling options
• Protects instruments in storage
Quality at a glance
Aesculap Sterile Container system
The Complete Aesculap Sterile Container System
Basis System Vario System PrimeLine System
Consisting of body and lid with filtersystem.
Consisting of body, inner lid with filtersystem and protective outer lid.
suitable for longer-distance
transports.
storage over extended periods,
Consisting of body and plastic lid with the integrated permanent germ barriersystem,
Mini Sterile Containers
The Complete Aesculap Sterile Container System
Scope Sterile containers
Containers with closed bottoms are suitable
for Fractioned vacuum processes: Pre-vacuum
Sterilizer
Containers with perforated bottoms are
suitable for Gravitational processes
Selection of Aesculap Container :
Work Process Requirement
Selection of Aesculap Container
Before After
Instrument Baskets
Accessories
Identification labels
Filter accessories
Indicator labels Seals
Maintenance products
Colour lids
Storage rack for MIC instruments and trocars Instrument racks
Silicone matsPositioning mat
Shelf cart
Aesculap® Sterile Container Functional Test
1. Metal parts not deformed
Check container base for dents,
especially rim of base
Aluminium lid not warped
2. Check filter retainers
Filter retainers must be prestressed andhave full surface contact at the edge.
Locating pin for filter retention platein lid must not be loose
Filter retainer snaps audibly intoposition
3. Intactness of seals
Seals are present and intactNo cracks, fractures etc.
4. Flawless plastic parts
No cracks or visible damage to plasticparts, no loose parts
5. Filter inspection
Filters undamaged (no kinks, holes, or cracks)
Remove cover for inspection (remove anticlockwise, replace clockwise)Leave filter in cartridge during inspection
6. Locking mechanism fully functional
The locking mechanism must be fully functional and show no damage
Lubricate the locking mechanism hinges with Sterilit® from time to time
7. Correct closure of lid
Locking mechanism of lid snaps audiblyinto place on the base counterpart
8. Carrying handles undamaged
Carrying handles are intact and showno visible damage
9.Flawless sterile containers 10. Labelling and sealing
Carrying handles are intact and showno visible damage
Sterile container closedEither sealed with production label, plastic seal