EO exposure cycles

Sterilization Exposure Cycles: Exposure of clinical samples

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. NLI does not assume responsibility for this risk.

Sterilization Exposure Cycles: STERIS EO cycle

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. NLI does not assume responsibility for this risk.

Notice:

Nelson Laboratories continues to find ways of process improvement. As a result, the Ethylene Oxide Exposure tests will be experiencing a minor change. Starting in February 2008, a label indicating exposure will be placed on the outer most packaging of all samples that have been exposed to EO. This will be done to effectively segregate non-sterile from sterile product to avoid any non-conformances.

NLI understands that the packaging may be a critical element of the product configuration. If placing a label on the samples to be processed represents any problem, please let us know so arrangements can be made.

Please find a sample of the label below. The labels do not stick permanently to most surfaces. Feel free to contact Dania Cortes (x. 7875) or Mark Fischer (x. 7865) with any questions or concerns.

Sterilization Exposure Cycles: BIER Cycle, 100% EO

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. NLI does not assume responsibility for this risk.

EO and VHP sterilization exposure cycles are performed as a functionality test.  The cycles are run using the Steris® ethylene oxide biological indicator evaluation resistometer  (BIER) model EB-001chamber as well as the Steris®/Joslyn® model 2038 EO sterilizers.  These provide accurate, square wave EO sterilization cycles for routine  processing and testing.  They provide the accuracy necessary to duplicate industrial cycles for exposures.

Notice:

Nelson Laboratories continues to find ways of process improvement. As a result, the Ethylene Oxide Exposure tests will be experiencing a minor change. Starting in February 2008, a label indicating exposure will be placed on the outer most packaging of all samples that have been exposed to EO. This will be done to effectively segregate non-sterile from sterile product to avoid any non-conformances.

NLI understands that the packaging may be a critical element of the product configuration. If placing a label on the samples to be processed represents any problem, please let us know so arrangements can be made.

Please find a sample of the label below. The labels do not stick permanently to most surfaces. Feel free to contact Dania Cortes (x. 7875) or Mark Fischer (x. 7865) with any questions or concerns.