1. SteriTite Instructions for use

2. Case Medical
Innovative designer and manufacturer of high quality sterilization containers and instrument chemistries
Sterilization containers validated for all sterilization processes providing custom and modular options
Instrument chemistries composed of high levels of synergistic enzymes and chelating agents. Validated and environmentally friendly
New modern and integrated facility in South Hackensack, NJ
All of our products are manufactured under our roof in the USA.
FDA Registered, ISO Certified, WBE and Corporate Member of AAMI. 2

3. If a rigid container system is used, the manufacturers instructions regarding set preparation and assembly should be followed. -ANSI/AAMI ST79:

4. The Function of Packaging
It must allow the sterilant to penetrate.
The sterility of the contents must be maintained until the package is opened.
The item must be removed without contamination.
The packaging must be compatible with the sterilization method.

5. Purpose of Sealed Containers
Containment
Sterility maintenance
Protection of contents
Storage
Transport
Aseptic delivery

6. User’s Responsibilities
To ensure that a packaging system is suitable for use
To follow manufacturer’s written recommendations and instructions
Verify that the packaging system including sealed containers, works in the facility’s sterilizer

7. SteriTite Container IFU7

8. Decontamination
Decontamination is the process by which medical devices, instruments and equipment are rendered safe for personnel to handle.
All medical devices, including sealed containers, must be cleaned and thoroughly dried for further use.
This is necessary to preserve the integrity of the containers as well as the contents
And critical for patient care.

9. Decontamination Disassemble all components.
Remove the tray of instruments for decontamination.
Remove the filter retention plate, and discard the filter.
Place the filter retention plate in a basket for cleaning.

10. Cleaning Steps Discard used filters, load cards and other disposables
May be cleaned manually or in an automated washer or cart washer
Use pH neutral detergents only
Thoroughly rinse to avoid detergent residue
To avoid water collection, place the container upside down for drying
Dry thoroughly using a soft cloth or it will interfere with the sterilization process

11. Container Schematic

12. Assembly for Use Place disposable filter over each perforated vent.
Latch the filter retention plate over the filter.
Place the lid on top of base.
Secure the closure by latching the lid to the base.
Push the bottom section of the latch over the lock holder. 12

13. Assembly for Use Select the correct filter.
Paper or polypropylene filter for steam sterilization.
Polypropylene filter only for STERRAD Sterilization.
Polypropylene filter may be used for all sterilization methods except gravity steam.
Be sure all perforations in lid and base have a new disposable filter at each location.

14. Assembly for Use Arrange the clean instruments in the basket.
Use the partitions, brackets and posts for tray organization and protection.
Place the basket into the base of the container.
Place the appropriate ID tags in the label holders.
Thread the tamper evident seal with indicator facing forward through the lock holder.

15. Sterilizer Loading/Unloading
Place container flat on the shelf.
All containers can be stacked for storage.
Some containers can be stacked in the autoclave.
Place linen items above containers.

16. Inspection Inspection criteria should be performed after each use.
Check gaskets for cleanliness and for nicks and tears.
Adjust the tension of the retention plate.
Verify that filter retention posts and label holders are secure.
Check that lid and base of container fit securely.
Be sure that each vent has a retention plate and a new disposable filter.

17. Post-Sterilization
To minimize the potential of condensate formation within the sealed container
Crack the door to allow for gradual temperature reduction.
Allow for adequate cool down.
Then, distribute as needed or place in sterile storage.

18. SteriTite at Point of Use
Contents must be sterile at time of use.
Contents must be aseptically removed.
The interior of the container and its contents are sterile.
The outside of the container is not sterile.

19. SteriTite at Point of Use
Before opening the container…
Verify that tamper evident seals are intact.
Check the acceptability of the end point response.
That the correct set has been selected.

20. Point of Use Break open the seals, remove and discard.
Open the latches, the clasp will fall away from the container edge.
Remove the lid using the rings on top to avoid contaminating the contents of the container.

21. Caution If the seal is tampered with
THE SET MUST BE REPROCESSED…
If the seal is tampered with
If the disposable filter is missing
If the indicator did not turn
If moisture is observed
If the container is compromised in any way

22. Verification Steps: Check the hospital sterilizer.
Follow hospital procedures.
Try product in the sterilizer.
Verify with biological indicators.

23. In Sum
Whenever a new packaging method is introduced into a healthcare facility, all procedures should be carefully evaluated and adapted.
Case Medical recommends that each user of our products, refer to our Instructions for Use and become familiar with ANSI/AAMI ST79: