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Optimization of moist heat sterilization

J P Mannermaa¹, J Yliruusi

¹Orion Corporation, Orion-Farmos Pharmaceuticals, Oulu, Finland.

Journal of Parenteral Science and Technology : a Publication of the Parenteral Drug Association

|November 1, 1993

Summary

Optimizing autoclave sterilization involves balancing temperature and time. Higher temperatures (e.g., 126°C) achieve effective sterilization (F0=15 min) faster, reducing overall process time.

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Area of Science:

* Pharmaceutical technology and sterile processing.
* Chemical engineering and process control.

Background:

* Autoclave sterilization is critical for ensuring product safety in pharmaceutical manufacturing.
* Optimizing sterilization cycles balances efficacy with process efficiency.

Purpose of the Study:

* To evaluate the impact of different temperature and time combinations on autoclave sterilization efficacy.
* To assess heat distribution and F0 value consistency within the autoclave chamber.
* To determine the feasibility of using higher sterilization temperatures to shorten cycle times.

Main Methods:

* Utilization of a pilot-scale autoclave (GEV 612 AR-2) with three distinct sterilization programs.
* Measurement of temperature, heat distribution, and F0 values across different settings.
* Determination of first-order temperature change constants for heating and cooling phases.

Main Results:

* All tested programs achieved the target sterilization efficacy (F0 = 15 minutes).
* Higher sterilization temperatures (116°C, 121°C, 126°C) resulted in shorter total process times (98, 57, and 44 minutes, respectively).
* Heat distribution was uniform (±0.5°C difference), and F0 values were consistent (±0.5 minutes).

Conclusions:

* The pilot autoclave demonstrates accurate process control, with acceptable variations in F0 values.
* Higher sterilization temperatures can be safely employed to significantly reduce cycle times.
* Precisely engineered and controlled autoclaves are essential for effective process optimization.

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