Technical Tip: Overview of A Gamma Irradition Validation

TECHNICAL TIP
O V E R V I E W O F A G A M M A I R R A D I T I O N VA L I D AT I O N
Prior to beginning routine gamma irradiation, a product with a samples of the product will be submitted to a microbiology
sterile claim needs to complete a validation process to ensure laboratory to quantize the population in Colony Forming Units
the Sterility Assurance Level claimed is met. ANSI/AAMI/ISO (CFU’s) through a Bioburden Determination.3
11137-2006 provides guidance for completing such a validation
through three parts that are included under the general title Verification and Material Testing Dose Determination
Sterilization of health care productions - Radiation: Based on the bioburden results, reference tables in ANSI/AAMI/
• Part 1: Requirements for development, validation, and ISO 11137 will provide guidance on the required radiation dose
routine control of a sterilization process for medical devices to apply to the product in KiloGrays (kGy) to achieve a specified
Sterility Assurance Level (SAL). The referenced SAL dose is
• Part 2: Establishing the sterilization dose termed the “Verification Dose”.
• Part 3: Guidance on dosimetric aspects Multiple methods are available for determining sterility within
This TechTip will provide a step-by-step overview of a gamma ANSI/AAMI/ISO 11137 based on the level of sterility assurance,
irradiation validation process that complies with the standards selected processing dose, and the number of samples which
established in ANSI/AAMI/ISO 11137-2006. can be used for testing.4
It is also recommended that a “high dose material test” be
Product Design Stage performed by irradiating the product at least 1.6-2.0 times the
When designing products to be treated for sterilization expected minimum sterilization dose (or 40 to 50 kGy if the
consideration should be given to the material challenges of the minimum dose is unknown) to evaluate the attributes of the
process on the product and packaging. The Gamma Irradiation product after processing.
process can modify polymers, add an ozone odor to the
package contents, or cause some discoloring; depending on Verification and Material Testing Experiments
the applied radiation level (dose) and material choices. These The ANSI/AAMI/ISO 11137 Verification Dose is generally very
effects should be considered while designing the product to be low and is required to be within +/- 10% of the Verification
sterilized.1 Dose reference values. This type of irradiation is very difficult
Another consideration is that a series of product cartons will to achieve in a large processing irradiator and typically requires
be loaded into an aluminum container (called a tote or carrier) a small research irradiator to achieve the ANSI/AAMI/ISO
which will convey the product around the radiation source. requirements. The research irradiator will apply the required
Standardizing product carton sizes and densities in an effective Verification Dose by monitoring the imparted dose by placing
manner will offer the most economical return on the irradiation quantitative measuring devices on the product package called
process.2 dosimeters. If Material Testing is also desired, it can also be
submitted at this time for irradiation.
Bioburden Determination
The typical Gamma Sterilization Validation process is unique Sterility Testing
in that the manufacturer uses the natural microbial load Once the Verification Dose has been applied, the product
present on the product and sealed packaging to determine the samples will be routed back to the microbiology laboratory to
processing parameters. Generally, statistically representative perform a Sterility Test. The sterility test will confirm
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: ast_info@steris.com
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479
TechTip #20 | Rev 2, 03/18

TECHNICAL TIP
whether all viable microbes present on the product sample measurements of the product carton and density will be
achieved lethality to deem the process successful. made. The facility will establish if like product density and
volume has been processed and will perform a Dose Mapping
Sterilization Dose Determination on the product, if required. Dose mapping is performed by
With a passing result on the Verification Dose, ANSI/AAMI/ISO determining the most efficient means of placing product in a
11137 will be reviewed again, and a Sterilization Dose (or the carrier or tote and placing numerous dosimeters throughout
minimum dose) will be determined to achieve a SAL based on the product load to establish the minimum and maximum areas
the product type. of imparted dose. Once these areas have been determined,
routine dosimeter placement will be limited to the minimum and
Dose Range Determination maximum dose zones in a select sampling of routine processing
During routine irradiation the product volume and density will totes or carriers.
increase as it is processed in a larger carrier or tote, thus a dose
“window or range” needs to be established for a large irradiator Routine Processing
to process product efficiently. The chosen Sterilization Dose Once the processing specifications are established, routine
range will be the minimum dose needed to achieve the sterility processing irradiations will be identified by the product code,
claim and a dose level value below the dose applied during the as received at the facility, and the irradiation process will
Material Test as the maximum end of the range, or generally commence without further requirements from the Customer.
a minimum of at least 1.6 times the Sterilization Dose. A dose Although it is recommended that if any product changes
level value below the dose applied during the Material Test is (size or density), or priority turn time requirements occur; the
recommended as the maximum end of the range, or generally a Customer contact the processing facility for communicating the
minimum of at least 1.6-2.0 times the Sterilization Dose. unique requirements.
Routine Processing Facility Determination Dose Audits

Once the Sterilization Dose Range is established a STERIS As the initial sterilization dose determination was based on the
Isomedix Services account manager will determine the best natural bioburden of the product and packaging, the ANSI/
Processing Facility to routinely process marketable product and AAMI/ISO 11137 standard recognizes that the microbial
introduce the manufacturer to the facility.2 population (quantity or type) can change with seasonal or
periodic manufacturing changes, thus the standard requires
Routine Sterilization Customer Set-Up a bioburden determination and Dose Audit at the Verification
The processing facility will ask that Processing Specifications Dose level to confirm that the minimum sterilization dose is still
and new Customer set-up documentation are completed to valid. These irradiations would be performed at the research
provide the means to identify all incoming products and the irradiator at the same tight constraints of the verification dose
required dose range to achieve the sterility claim. (+/- 10%) in addition to performing a Sterility Test to validate
effectiveness.3
Dose Mapping and Routine Dosimeter Placement
Determination
Once the product is received by the processing facility,
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479
TechTip #20 | Rev 2, 03/18

TECHNICAL TIP
REFERENCES
1 . See STERIS Applied Sterilization Technologies Tips #02, #04, and #09 at www.steris-ast.com for more information
2 . Consult the STERIS Applied Sterilization Technologies Sales staff at 877.783.7479 for assistance
3 . See ANSI/AAMI/ISO 11137-2006 or 11737 for more information
4. Consult the STERIS Applied Sterilization Technologies Radiation TechTeam at 847.247.4782 for assistance
(EMEAA) +44 (0) 8456 88 99 70
(Americas) 877.783.7479
TechTip #20 | Rev 2, 03/18

Technical Tip: Overview of A Gamma Irradition Validation

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TECHNICAL TIP

TechTip #20 | Rev 2, 03/18

Routine Processing Facility Determination Dose Audits

TechTip #20 | Rev 2, 03/18

3 . See ANSI/AAMI/ISO 11137-2006 or 11737 for more information

TechTip #20 | Rev 2, 03/18

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