SterilContainer™ Validation Summary

Steam, EtO and Low Temperature Sterilization Modalities

Aesculap Surgical Technologies - Sterile Processing

 Steam Sterilization Cycles

Aesculap components validated for use in SterilContainer Configuration for PreVac

dynamic-air removal (PreVac) steam Steam (Terminal and Immediate Use)
sterilization: Efficacy Testing
Tamperproof locks, indicator cards, bottom,
I SterilContainer™ 2000 System bottoms and basket with instacount® bar code label, silicone
aluminum lids (JN/JK series) instrument mat and surgical towel (to create
I PrimeLine lids with integrated reusable an extreme worst case), and instruments to a
PTFE filter (JP series) total weight of 35 pounds were tested with
I SterilContainer S™ System bottoms and PrimeLine lids, aluminum lids with single-use
aluminum lids (JM series) paper and polypropylene filters and aluminum
I Single-use paper filter (US series) lids with reusable PTFE filter.
I Single-use polypropylene filter (MD series)
I Reusable PTFE filter (JK series) Sterilization Efficacy Validation Test
Summary for Terminal and Immediate Use
The SterilContainer System was tested per
Aesculap components validated for use in method and configuration described and
immediate use PreVac steam sterilization: achieved sterility.

I SterilContainer 2000 System bottoms and Sterilization Efficacy Stacking Validation

aluminum lids (JK series) Test Summary
I PrimeLine® lids with integrated reusable Solid bottom SterilContainer Systems with
PTFE filter (JP series) aluminum lids, using either paper,
I Single-use paper filter (US series) polypropylene or reusable PTFE filters, were
I Reusable PTFE filter (JK series) validated per method and configuration
described in a stacked configuration of 18
inches maximum and sterility was achieved.
Steam Sterilization Efficacy Methodology Solid or perforated bottoms can be stacked to a
The SterilContainer System was validated using height not exceeding 18 inches.
the overkill method. The sterility assurance
level (SAL) of 10-6 was achieved by placing Sterilization Efficacy PrimeLine Lid
spores of Geobacillus stearothermophilus in the Stacking Validation Test Summary
most challenging locations and processing at PrimeLine lids with solid bottom
one-half the expected full cycle exposure time. SterilContainer Systems were validated per
method and configuration described in a
stacked configuration with a maximum height
of 18 inches and achieved sterility.

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Aesculap components validated for use in Recommended Cycle:
gravity terminal steam sterilization: Gravity Steam Sterilization

I SterilContainer™ 2000 System perforated Gravity Terminal Cycle

bottoms and aluminum lids (JN series)
I Single-use paper filter (US series)
Temperature 250° F

30-60 minutes
SterilContainer configuration for Gravity Exposure Time
depending on load size
Steam Efficacy Testing
Tamperproof locks, indicator cards, bottom, lid,
Cycle Dry Time 15 minutes (minimum)
basket with instacount® bar code label, and
instruments to a total weight of 25 pounds
tested with aluminum lids with single-use
paper filter.

Sterilization Efficacy Validation Test

Summary
Recommended Cycle:
The SterilContainer System was tested per
PreVac Steam Sterilization
method and configuration described and
achieved sterility.
PreVac Terminal Cycle
Real Time Event Related Shelf Life
Temperature 270° F
After steam or EtO sterilization (not Immediate
Use Steam sterilization) exposure, the Exposure Time 4 minutes
containers with a total load weight of 35 lbs,
were stored and handled in a manner which Cycle Dry Time 15 minutes (minimum)
represents a typical central service department
in a hospital setting. The containers maintained PreVac Immediate Use Cycle
sterility during the 360 day storage period.
This validation testing applies to perforated or Temperature 270° F
solid bottom containers with either PrimeLine®
lids, aluminum lids with single-use paper filter Exposure Time 4 minutes
and polypropylene filter, and aluminum lids
Cycle Dry Time No dry time
with reusable PTFE filter.

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 Ethylene Oxide Sterilization (EtO) Cycle

Aesculap components validated for use in EtO Real Time Event Related Shelf Life
sterilization: After sterilization (steam or EtO) exposure, the
containers with a total load weight of 35 lbs,
I SterilContainer™ 2000 System bottom and were stored and handled in a manner which
aluminum lid (JN/JK series) represents a typical central service department
I SterilContainer S™ xL Mini size container and in a hospital setting. The containers maintained
lid (JM021/JM020) sterility during the 360 day storage period.
I Single-use paper filter (US series) This validation testing applies to perforated or
solid bottom containers with either PrimeLine®
lids, aluminum lids with single-use paper filter
SterilContainer Configuration for EtO and polypropylene filter, and aluminum lids
Efficacy Testing with reusable PTFE filter.
Tamperproof locks, indicator cards, bottom, lid,
basket with instacount® bar code label, silicone
instrument mat and surgical towel (to create
an extreme worst case), and instruments to a
total weight of 35 pounds were tested. Recommended Cycle:
EtO Sterilization
Sterilization Efficacy Methodology
The SterilContainer System was validated using Ethylene Oxide Cycle
the overkill method. The SAL of 10-6 was
achieved by placing spores of Bacillus Temperature 131° F (55° C)
atrophaeus in the most challenging locations
Humidity ≥50%
and processing at one-half the expected full
cycle exposure time. Concentration 725 mg/L

Sterilization Efficacy Validation Test Exposure Time 60 minutes

Summary
Aeration 8 hours
The SterilContainer System was tested per
method and configuration described and
achieved sterility.

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Vapor Hydrogen Peroxide Sterilization Cycle

Aesculap components validated for use in Sterilization Efficacy Validation Test

Vapor Hydrogen Peroxide sterilization: Summary
The SterilContainer S System was tested per
I SterilContainer S™ System bottom and method described and achieved sterility.
aluminum lid (JM series) Please refer to www.aesculapusa.com for the
I Polypropylene single-use filter (MD series) most recent IFU containing recommended
STERRAD and V-PRO sterilization cycles.

Sterilization Efficacy Methodology The Aesculap SterilContainer System

The SterilContainer System was validated using successfully completed sterilization efficacy
the overkill method. The SAL of 10-6 was studies in the following sterilizer systems:
achieved by placing spores of Geobacillus I ASP STERRAD NX® System, ASP STERRAD®

stearothermophilus in the most challenging 100S System, ASP STERRAD 100NX™ System,
locations and processing at one-half the and ASP STERRAD® 200 System
expected full cycle exposure time. I STERIS Amsco® V-PRO™ 1 and STERIS Amsco®

V-PRO™ 1 Plus
SterilContainer configuration for Vapor
Hydrogen Peroxide Efficacy Testing Real Time Event Related Shelf Life
Tamperproof locks, indicator cards, bottom, lid, Aesculap SterilContainer S System container
basket with instacount® bar code label, silicone bottom, lid and polypropylene filter maintain
instrument mat, instruments and polypropylene sterility for up to 180 days in simulated central
filter to a total weight as listed in the service conditions following the recommended
Instructions for Use (IFU) for that particular Vapor Hydrogen Peroxide sterilization cycle, so
cycle and/or SterilContainer size. long as the container integrity is not
compromised.

Reuse testing up to 100 cycles showed no

effect on the function of the container after
processing.

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 SterilContainer™ System
Product-for-use summary for market leading sterilization modalities

STEAM EtO
Immediate Use Gravity
Aesculap Products PreVac Cycle All Forms
PreVac Cycle displacement
JK, JM, JN bottoms JK, JN bottoms only
JK bottoms only JM, JN bottoms only
Container System Y Y Y Y
SterilContainer™ 2000
PrimeLine® Lid Y Y
System
xL Mini Container Y Y
Container System Y Y
SterilContainer S™ System
xL Mini Container Y Y
Paper: Single-Use Y Y Y Y
Filters Polypropylene: Single-Use Y
PTFE Reusable Y Y
Silicone Instrument Organiz. Y Y Y Y
Metal Clamps Silicone Inlay Y Y Y Y
Accessories
Silicone Cushioning Mats Y Y Y Y
Nylon Coated Metal Clamps Y Y Y Y

LOW TEMPERATURE
ASP ASP ASP ASP STERIS STERIS
Aesculap Products STERRAD® STERRAD® STERRAD STERRAD Amsco® Amsco®
100S System 200 System NX® System 100NX™ System V-PRO™ 1 V-PRO™ 1 Plus
Container System
SterilContainer™ 2000
PrimeLine® Lid
System
xL Mini Container
Container System Y Y Y Y Y Y
SterilContainer S™ System
xL Mini Container Y Y Y Y Y Y
Paper: Single-Use
Filters Polypropylene: Single-Use Y Y Y Y Y Y
PTFE Reusable
Silicone Instrument Organiz. Y Y Y Y Y Y
Metal Clamps Silicone Inlay Y Y Y Y Y Y
Accessories
Silicone Cushioning Mats Y Y Y Y Y Y
Nylon Coated Metal Clamps

Y Aesculap product validated and FDA cleared.

Aesculap has not performed a validation test and/or material incompatible with sterilant/modality.

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SterilContainer™ System Component Codes

SterilContainer™ Bottoms Aluminum Lids PrimeLine® Lids*

2000 System

JN440, JK440, JN441, JK441,

JK485, JK486, JK487, JK488, JP001, JP002, JP003, JP004,
Full Size JN442, JK442, JN444, JK444,
JK489 JP005, JP006, JP007
JN446, JK446

JN740, JK740, JN741, JK741, JK785, JK786, JK787, JK788, JP011, JP012, JP013, JP014, JP015,
Three-Quarter Size
JN742, JK742, JN744 JK789 JP016, JP017

JN340, KK340, JN341, JK341,

JK385, JK386, JK387, JK388, JP021, JP022, JP023, JP024,
Half Size JN342, JK342, JN344, JK344,
JK389 JP025, JP026, JP027
JN346, JK346

Quarter Size JN092, JN094, JN095, JN096 JN091

Extra Long Size JN445, JN443, JK443 JK490

JK170, JK171, JK172, JK173,

Mini Size JN187, JK187, JN188, JK188
JK174

xL Mini Size JN021 JK020

Wide Body Size JN817, JK817, JN821, JK821 JE601

* Note: PrimeLine Lids must use PTFE reusable filter JP050

SterilContainer S™ Bottoms Aluminum Lids

System

Full Size JM440, JM441, JM442, JM444 JM489

Three-Quarter Size JM740, JM741, JM742 JM789
Half Size JM340, JM341, JM342 JM389
Mini Size JM188 JM174
xL Mini Size JM021 JM020

Filters

Single-use paper filter (US series) US751, US994, US992, US999, US756, US998
Single-use polypropylene filter (MD series) MD344, MD355
Reusable PTFE filter (JK series) JK089, JK090, JK091, JK092
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©2012 AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA.

Aesculap is an equal opportunity employer

STERRAD and STERRAD NX are registered trademarks and STERRAD 100NX is a trademark of Advanced Sterilization Products (ASP), a Division of Ethicon, Inc., a Johnson & Johnson company.
AMSCO is a registered trademark owned by STERIS Corporation and V-PRO is a trademark owned by STERIS Corporation.

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Phone 800-282-9000 | Fax 610-791-6886 | www.aesculapusa.com

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