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Technical Tip: Overview of A Parametric Release Cycle For Eo Sterilization

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64 views3 pages

Technical Tip: Overview of A Parametric Release Cycle For Eo Sterilization

Uploaded by

Rakesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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TECHNICAL TIP

OV E RV I E W O F A PA RA M E T R I C R E L E AS E CYC L E
F O R E O S T E R I L I Z AT I O N

Background released to the market based on process records instead of the


traditional biological indicator sterility test. This is advantageous
Traditionally, ethylene oxide sterilization processes are routinely
in that it eliminates the routine costs associated with biological
monitored with biological indicators that are composed of the
indicators and laboratory testing. Also, there may be additional
microorganism Bacillus atrophaeus, usually inoculated onto a 1.5 X
savings associated with a reduced hold time of unreleased
0.25 inch paper carrier. A good example of a biological indicator is
inventory when using parametric release.
the Spordex® (STERIS) bacterial test strip.
Overview – Physical Requirements
For routine monitoring purposes, the biological indicators are
placed throughout the sterilizer load and subjected to the Multiple physical parameters must be analyzed during the validation
sterilization process. After the process, the biological indicators process in order to establish the tolerances for parametric release
are removed from the load and forwarded to the testing laboratory, on a routine basis. The following list taken from section 10.2
where they are placed into a special growth medium and subjected of ANSI/AAMI/ISO 11135 details the physical elements to be
to ideal growth conditions for 7 days (as addressed in USP1). After considered:
the 7-day incubation period, negative growth of the biological
Preconditioning Phase
indicators demonstrates that the sterilization process was effective.
The sterilizer load may then be considered for release to market, • The minimum temperature of the product entering the
provided all other release criteria are met. sterilization process and/or the defined conditions used to
acclimate the load
When using this traditional biological indicator monitoring of the
EO sterilization process, expenses are incurred in two ways. First, • Temperature and humidity within the preconditioning area (if
there is the expense of the biological indicators and the associated used), monitored and recorded from a specified position
laboratory testing; and secondly, there is a large amount of capital
• Time of commencement of preconditioning and of removal of
tied up in the inventory which must be held “in quarantine” until
load from preconditioning (if used) of each sterilization load
after the laboratory testing is complete (7 days).
Sterilization Phase
In addition to the expense, the use of biological indicators will
increase risks due to the possibility of contamination of the • Elapsed time between removal of the sterilization load from
indicator while being handled at the testing laboratory. In most preconditioning (if used) and the commencement of the
cases, a failure of a biological indicator, even though laboratory sterilization cycle
induced, would be considered a sterility failure and result in the
• Chamber humidity during conditioning and/or humidity
requirement for reprocessing of all of the materials which were
dwell phases by pressure, pressure rise (ΔP) and/or direct
contained in the sterilizer load. This increases costs to both the
monitoring
monitoring system and held inventory.
• Conditioning time
An Alternative Monitoring Method
• Indication of the satisfactory operation of the chamber gas
ANSI/AAMI/ISO 11135 defines parametric release as the
circulation system (if used) during EO injection and during
“declaration that product is sterile, based on records demonstrating
exposure
that the process parameters were delivered within specified
tolerances”. In short, parametric release allows product to be

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: www.steris-ast.com // Email: [email protected]
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #16 | Rev 2, 08/20


TECHNICAL TIP

OV E RV I E W O F A PA RA M E T R I C R E L E AS E CYC L E
F O R E O S T E R I L I Z AT I O N

• Temperature and pressure in the chamber throughout the Simulation of Winter Conditions
sterilization cycle
To assure that preconditioning (if used) and/or conditioning is
• If pressure is used as the primary control measure, the effective regardless of climatic conditions or facility location, each
requirement for the secondary measure is only to confirm half cycle validation load is exposed to simulated winter conditions
admission of EO to the chamber by at least one of the prior to half cycle processing. Successful biological results when
following: the mass of EO used; the direct measurement of the challenged with this worst case load conditioning assures that the
concentration of EO in the sterilization chamber; volume of EO process is effective for all conditions regardless of the time of the
used year or the location of the facility.

• EO injection time Load Configuration

• Inert gas injection (if used) Control of loading patterns and densities is required when
practicing parametric release. For those customers that present
• Exposure time
mixed loads to the sterilizing facility, a fourth half cycle is required
• Time taken to evacuate the chamber using the minimum loading configuration at minimum density.
This load is processed in a biological challenged half cycle using
• Time and pressure changes during post exposure flushing
minimum cycle conditions. Successful biological results using this
Aeration Phase minimum loading condition when supported by the successful
maximum loading half cycles, serves to validate the process for
• Time, temperature pressure changes (if any) during aeration
any load mix from the minimum loading qualified to the maximum
In addition, the following physical parameters must be included as loading qualified.
part of the parametric release criteria as directed in section 10.5 of
the ANSI/AAMI/ISO 11135 document:

• Temperature in the chamber from a minimum of two locations


throughout the sterilization cycle

• Chamber humidity during conditioning as determined by direct


measurement

• The EO concentration, determined from direct analysis of


chamber atmosphere using analytical methods at defined
intervals sufficient to verify the required conditions throughout
the exposure time.

Special Considerations for Parametric Release

When designing a parametric release program, special


consideration is given to outside factors that can impact
the delivery of the sterilization process. Factors to take into
consideration include:

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: www.steris-ast.com // Email: [email protected]
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #16 | Rev 2, 08/20


TECHNICAL TIP

OV E RV I E W O F A PA RA M E T R I C R E L E AS E CYC L E
F O R E O S T E R I L I Z AT I O N

REFERENCES

1 . United States Pharmacopeia, 37th edition, 2014.

2 . ANSI/AAMI/ISO 11135, Medical devices – Validation and routine control of ethylene oxide sterilization, 2014.

F O R M O R E I N F O R M AT I O N
STERIS Applied Sterilization Technologies
Web: www.steris-ast.com // Email: [email protected]
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479

TechTip #16 | Rev 2, 08/20

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