6 Degrees of Separation: 121°C (Part 6)


Are you ready to talk about extremely hot temperatures and high pressures? Well you have come to the right place as we talk about the +121°C sterilization temperature. This temperature is not only crucial to sterilization and cleaning of integral products in manufacturing, but also in quality control testing and validation studies.

In life science manufacturing facilities, autoclaves are heavily used to sterilize or clean materials that will be used in the manufacturing and quality control processes. During the manufacturing process, raw materials used in process can either be purchased from vendors not sterilized or sterilized. Most vendors provide options to sterilize or gamma irradiate the raw material at higher prices.  Anything that will touch drug product will need to be sterilized or free from microorganisms that can affect final drug product. Autoclaves can be introduced to sterilize raw materials by using high pressure and hot steam (+121°C) to kill all microorganisms over a certain period.

In order to test the effectiveness of autoclave sterilization, validation studies intertwined with quality control testing is performed to “validate” the autoclave cycles.  Validation representatives perform validation on the programmed autoclave cycles.  The cycle parameters on the autoclave can be customized to each product or material that will need to be sterilized.  This includes time of the holding or exposure phase.  The time in the exposure phase is important in giving the product or raw material enough “exposure” to high heat, steam and pressure to kill all living microorganisms within the autoclave. If you want to learn more about autoclave cycle validation, check out our White Paper.

Validation representatives will monitor and record the entire autoclave cycle's temperature (and in some cases pressure) profile from start to finish with robust data loggers and 21 CFR Part 11 compliant software.   This gives the whole temperature profile picture of the autoclave cycle being validated as well as a snapshot of the holding or exposure phase.  The holding or exposure phase is calculated for lethality within the software.  Certain lethality will need to be obtained depending on company standard operating procedures.  Quality Control will then test the biological indicators that were placed within the material that was sterilized, in order to see no growth of microorganisms.  This process is then repeated for anything that will be sterilized within the autoclave.

Autoclaves need to have pressure and temperature monitored during cycle runs and need to be validated.  Validation and monitoring of the autoclave should include robust data loggers and FDA compliant 21 CFR Part 11 software that can consistently record temperature and pressure under extreme conditions.

Tune in next week for our discussion about –20°C and -40°C freezer storage temperatures!


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