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