Methods for controlling the sterilization process

Control is carried out by verifying that what is planned according to the standards of the service is fulfilled. The process should be controlled at every stage and this control should be recorded. In order to adequately control sterilization processes, it is necessary to have in-depth knowledge of:

  • the way the equipment works,
  • its current state,
  • deficiencies that it can have,
  • ways to control it, and
  • its tolerance to materials.

In order to approach a control method we should first ask ourselves:

Was it processed?

Was it processed correctly?

A control system should meet the following objectives:

  • Identify each material.
  • Confirm that the process was carried out using a chemical control.
  • Establish an acceptable operating point.
  • Detect deficiencies in the equipment beforehand.

Control of the process includes the control of inputs used at each stage,n the raw material (gauze, paper, cotton, ethylene oxide capsules, etc.), biological monitors, chemical indicators, etc.

When the result of the control is satisfactory, it will pass to the following stage.

Sterilizing equipment is validated both in a chamber that is empty and in a loaded chamber at least once a year and whenever it is repaired.

Such repairs should be carried out by trained personnel. A plan for corrective and preventive maintenance is recommended.

User manuals (in the appropriate language) for each type of equipment should be on hand in the SP.

The reading instrument should be exact, which is why it is necessary to calibrate it periodically.

The sterilization process is complex. We can discuss a degree of reliability in the processed material only when strictly respecting the conditions involved in each stage.

Sterility cannot be ensured only through tests. It is obtained through a system of total control throughout the process.

A good infection control program involves the continuous validation of the conditions of the process.

Validation can be defined as “a systematic, documented study that provides a high degree of certainty that a procedure, piece of equipment, process, material, activity or system will actually behave within certain predefined limits.”

The validation and observation of good manufacturing practices are the fundamental pillars of quality assurance.

In order to obtain sufficient safety, the program should include: adequate training of personnel and adequate preparation of the location, the equipment and the system for circulating materials. Equipment should also be adequately monitored.

The air filters, the water for washing, the measures of biosafety, the physical plant, the clothing of the personnel, the quality of the steam, etc., also integrate quality control.

The Bowie Dick (specific indicator) test is carried out before the first sterilization cycle each day and for each steam autoclave with:

  • a standard package according to predetermined standards (AAMI, CEN –European Committee for Standardization).
  • a single-use commercial package adjusted to the characteristics of the cycle, or
  • an independently-prepared package that adjusts to the requirements of the test.

Tuesday, January 16, 2024


Sterilization manual for health centers

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Factors affecting the efficacy of sterilization.

Resistance of microorganisms

Basic guidelines for disinfection and sterilization

Techniques for opening sterile packages

Identification or labeling of the sterile packaged