Sterile Barrier System – Best Practices

FOCUS ON
STERILIZATION CONTAINERS

REUSABLE STERILIZATION CONTAINER IS A COMPLEX PACKAGING SOLUTION AND REQUIRES THAT ALL IT’S PARTS WORK FLAWLESSLY TOGETHER.

FROM LID TO BOTTOM, FROM FILTER TO GASKET.

sterilization container

What happened with the container after it’s being used multiple times?
Do we still have the same performance and reliable microbial barrier? 

Where is the risk?

  • Improperly sealed lids can lead to loss of integrity
  • Dents and other damages in lid and bottom increase the risk of a loss of sterility

If gasket integrity has been compromised, reusable container shall not be used according to manufacturer’s instructions

What does the EN ISO 11607-1 say about critical points for reusable containers?

  • Implement the procedure that can determine the container damage
  • Establish a performance process validation to anticipate potential degradation

Considering the visual check as the only available method to control integrity, can we rely on this according to EN ISO 11607?

How we can be sure that containers guarantee protection without any compromises?

Here is an easy test that gives the answer immediately.

sterilization container EN ISO 11607

WATER TEST FOR GASKET INTEGRITY:

  • Easy to implement in CSSD
  • Test to be conducted in case of doubt of the tank/lid sealing & integrity
  • Test dedicated to all standard reusable containers with filtration system located in the lid
  • Test to decide if a container should be sent for maintenance

PRINCIPLE:

1

°

Pour water in the bottom of container until a level of 5 mm is reached

level of 5 mm

2

°

Close the lid

3

°

Wipe the outside of container with a towel

wipe the container

4

°

Put the container on its edge standing vertically

put the container vertically

5

°

Verify the presence of leakage after 30 seconds

Verify the presence of leakage

6

°

Change the side, running the container along its edge

change the side

7

°

Repeat the test after turning the lid around

repeat

RESULTS?

LEAKAGE

FAIL

failed leakage container

Microorganisms are carried by water or air.

If water can find its way through air certainly too
and it means a risk of contamination.

IMMEDIATE SOLUTION

IN CASE OF FAILING THE WATER LEAK TEST, PATIENT SAFETY REQUIRES TO IMPLEMENT AN INNER STERILIZATION WRAP INSIDE CONTAINER

WHY:

  • Combination of the best characteristics and benefi ts of each product
  • Create the longest tortuous path to avoid recontamination until opening
  • Requirements for 2 separate layers are met
  • Secure aseptic opening at the point of use

NO LEAKAGE

PASS

IMMEDIATE SOLUTION

IN CASE OF FAILING THE WATER LEAK TEST, PATIENT SAFETY REQUIRES TO IMPLEMENT AN INNER STERILIZATION WRAP INSIDE CONTAINER

Container Water Leak Test – guideline

SOMEONE'S LIFE IS IN YOUR HANDS,
HOW WOULD YOU ACT IF IT WAS YOURS?

Have you tried the Water Leak Test?
Share with us the results:

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