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Sterilization Exposure Cycles

Sterilization Exposure Cycles

The Sterilization Exposure Cycles test exposes samples to the given sterilization cycle to assess feasibility and functionality following the sterilization process. Various standards require the form, fit and function of a medical device or product to be assessed following all of the manufacturing processes up to and including sterilization.

ISO 11135-1:2007 recommends that the product and packaging meet safety, quality and performance at the “most challenging process parameters for the product/package.” New products, modifications to current products, packaging assessments, and even raw materials and components that are exposed to the given sterilization process should be tested to determine if any adverse effects are observed.

Nelson Laboratories has fully programmable ethylene oxide, steam, vaporized hydrogen peroxide and dry heat sterilizers that mimic customers’ sterilization processes. Samples tested can be exposed faster and less expensively than with the corresponding contract sterilization cycles.

Applicable Standards

  • ISO 11135

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
SEC105 Sterilization Exposure Cycles: Preconditioning (environ. chamber) 5 Add
SEC106 Sterilization Exposure Cycles: Extended aeration (per additional day) 15 Add
SEC110 Sterilization Exposure Cycles: BIER Cycle, 100% EO (5 hrs) 10 Add
SEC111 Sterilization Exposure Cycles: BIER Cycle, 100% EO (8 hrs) 10 Add
SEC112 Sterilization Exposure Cycles: BIER Cycle, 100% EO (12 hrs) 10 Add
SEC115 Sterilization Exposure Cycles: BIER Cycle, 100% EO (3 hrs) 10 Add
SEC120 Sterilization Exposure Cycles: BIER Cycle, 100% EO, additional time (per hour) 10 Add
SEC150 Exposure Cycles: Steam Sterilization Cycles, per cycle Add
SEC310 Sterilization Exposure Cycles: VHP standard cycle (per cycle) 10 Add
SEC410 Sterilization Exposure Cycles: Kill load 10 Add
SEC420 Sterilization Exposure Cycles: Kill load, in house transfer 7 Add
SEC105 - Sterilization Exposure Cycles: Preconditioning (environ. chamber)
5 days
SEC106 - Sterilization Exposure Cycles: Extended aeration (per additional day)
15 days
SEC110 - Sterilization Exposure Cycles: BIER Cycle, 100% EO (5 hrs)
10 days
SEC111 - Sterilization Exposure Cycles: BIER Cycle, 100% EO (8 hrs)
10 days
SEC112 - Sterilization Exposure Cycles: BIER Cycle, 100% EO (12 hrs)
10 days
SEC115 - Sterilization Exposure Cycles: BIER Cycle, 100% EO (3 hrs)
10 days
SEC120 - Sterilization Exposure Cycles: BIER Cycle, 100% EO, additional time (per hour)
10 days
SEC150 - Exposure Cycles: Steam Sterilization Cycles, per cycle
Standard TAT not available for this product
SEC310 - Sterilization Exposure Cycles: VHP standard cycle (per cycle)
10 days
SEC410 - Sterilization Exposure Cycles: Kill load
10 days
SEC420 - Sterilization Exposure Cycles: Kill load, in house transfer
7 days

Study Outline

The Sterilization Exposure Cycles test ensures feasibility and functionality following a product’s exposure to the worst-case sterilization cycle. This is essential, since sterilization processes can be damaging to the finished product and packaging due to exposure to high temperatures, pressure and vacuum changes, humidity and the sterilant.

Important note: There is an inherit risk of product damage during sterilization due to excess moisture and/or possible temperature spikes during steam addition. It is the responsibility of the sponsor to assess this risk and determine the suitability of their product. Nelson Laboratories does not assume responsibility for this risk.

Sample size required: The biggest EO chamber internal dimensions are 18 x 18 x 36 inches. If samples do not fit into sterilizers in a single load, they may be divided into different loads to accommodate the samples.

It is the responsibility of the sponsor to verify sample dimensions in order to prevent any delays with their exposure.