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Sterilization Temperature and Humidity Distribution Studies

Sterilization Temperature and Humidity Distribution Studies

The Sterilization Temperature and Humidity Distribution test evaluates the temperature and humidity profile of a sterilization process. This study is useful in determining ranges, setting appropriate specifications and determining if cold spots or other difficult-to-sterilize locations exist in the sterilizer.

This test is performed in accordance with recommendations from ISO 11135, which states that the temperature and humidity data obtained from the validation cycles must be used to set appropriate ranges for the routine production cycle. Nelson Laboratories has performed temperature and humidity evaluations in contract sterilizer cycles as well as for customers sterilizing their own product in-house.

We can provide DATATRACE temperature and RH probes for use in the validation process or for special projects and provide a detailed breakdown and analysis of the sterilization cycle. We can also analyze data obtained from other sources and provide recommended specifications.

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
TDS110 Sterilization: Temp. & humidity distribution study 10 Add
TDS120 Sterilization: Temp & humidity distribution, review (third-party) 15 Add
TDS210 Sterilization: Temp. & humidity distribution study, probe rental 10 Add
TDS220 Sterilization: Temperature and humidity distribution study, on-site probe placement and study monito 15 Add
TDS110 - Sterilization: Temp. & humidity distribution study
10 days
TDS120 - Sterilization: Temp & humidity distribution, review (third-party)
15 days
TDS210 - Sterilization: Temp. & humidity distribution study, probe rental
10 days
TDS220 - Sterilization: Temperature and humidity distribution study, on-site probe placement and study monito
15 days

Study Outline

This test is performed to evaluate the temperature and humidity distribution during sterilization cycles. This may be performed in an empty sterilization chamber, or more commonly with the product load during half cycles and full cycles.

Intrinsically safe temperature and relative humidity probes are placed evenly throughout the product load before it is placed in preconditioning. Following aeration, the probes are removed, and the data is downloaded and analyzed for compliance with specifications or used to set ranges and tolerances.

The report includes a thorough analysis divided in the different sterilization phases with the High and Low readings in each phase. It also identifies the consistently cold and hot locations and probes and the difference in temperature. The data is color coded for easy reference and identification.