Sterilization Monitors

Common Sterilization methods used in

• Moist heat
• Dry heat
• Ethylene oxide ( ETO )
• Gamma radiation

A. Mechanical monitoring: through assessing

• Cycle time
• Temperature
• Pressure
 Sterilizers have recording devices that print out these parameters.
 Correct readings do not ensure sterilization, but incorrect readings can be the first
indicator for a problem with the sterilization cycle.

B. Chemical indicators:

External chemical indicators (class 1):

• They are applied to the outside of a package (e.g., chemical indicator tape and labels).
• They change color rapidly when a specific parameter is reached, and they verify that the
package has been exposed to the sterilization process.
Internal chemical indicators and integrators (Class 3-6):
• They are used inside package to ensure the sterilizing agent has penetrated the packaging
material and actually reached the instruments inside.
Bowie-Dick Sheets inside test packs (class 2) :
• Sheets printed with a chemical indicator in the form of diagonal strips which change color to
dark brown or black.

• A satisfactory test is indicated by the development of uniform color change indicating rapid
steam penetration, adequate air removal and freedom from significant air.
• Chemical strip (Class 2) :
• Used inside a hollow load process challenge device (helix test) for testing the efficiency of
rapid steam penetration in pre vacuum sterilizers.

Class Description Use

Used to indicate that the pack or container has been exposed to the
Class 1 Process indicators sterilization process and to differentiate between processed and
unprocessed items (tape and labels)

Indicators for use in special e.g. BD sheets and strips used inside process challenge device (PCD) to test
Class 2
tests for air removal in vacuum assisted sterilizers

React to one of the critical parameter of sterilization and indicate exposure to

a sterilization cycle at stated values (SV) of the chosen parameter.
Class 3 Single variable indicators
Critical parameters typically chosen for steam sterilization processes are
time or temperature.
React to two or more of the critical variables (time, temperature and
saturated steam) to indicate exposure to a sterilization cycle as SVs of the
Class 4 Multi-variable indicators
chosen variables. They provide additional monitoring of the sterilization
cycle

React to all critical parameters over a specified range of sterilization cycles.

Their performance has been correlated to the performance of a biological
Class 5 Integrators indicator (BI) under its labeled conditions for use. This class of indicator can
be used in place of the BI in many applications, thereby reducing the overall
cost of sterile processing.

They are cycle verification indicators that are designed to react to all critical
Class 6 Emulating indicators variables of specified sterilization cycles. They emulate the cycle. They
have the most stringent tolerance levels of all chemical indicators.

External Chemical Indicator Tape

• Class I
Sterilization pack & pouch

Bowie Dick Test

 C. Biological indicators: (Spore Tests )
• They assess the sterilization process directly by killing known highly resistant
microorganisms.
• Contain Geobacillus stearothermophillus- Highly heat resistant, spore-forming bacteria does
not produce toxins and is non-pathogenic.
Process:
Biological indicators are often used for routine monitoring, qualification and load monitoring of
a steam sterilizer. Biological indicators are designed to demonstrate whether the conditions
during a steam (autoclave) cycle were adequate to achieve a defined level of microbial
inactivation.
A biological indicator is made up of a carrier material, on which bacterial spores with a defined
resistance to the sterilization process have been applied. The carrier material is enclosed within a
glassine envelope or a vial. The BI is exposed to the sterilization process and then incubated
under defined growth conditions to determine whether any spores survived the process. If no
spores survive, none grow and the test is a pass. If growth is detected, the test is a fail.

II. Levels of Sterilization Assurance

• Equipment Control
• Exposure control
• Pack Control
• Load Control
• Record Keeping
Levels of Sterilization Assurance
A. Equipment Control
• It includes:
 Testing of new autoclaves
 Testing after repair or maintenance
 Periodic testing
• It is done through:
 Mechanical parameters
 Tests for air removal in pre vacuum sterilizers
 Spore test can be used for equipment control

B. Exposure control
• They are placed on the external surface of (class 1 external chemical indicator, e.g. tape and
labels) or inside (class 3 internal single parameter chemical indicator) each sterilized pack.
• If the indicator is only inside the pack, it should be visible to the user examining the package.
They are used to identify packs and sets that have been processed in the sterilization process.

C. Pack Control
• Chemical indicators and integrators are used to verify the penetration of the sterilization
process inside the pack or set.
• Usually, two or more parameters are monitored (multiple parameter internal chemical
indicators and integrators).
• The indicator or integrator should be placed in the most difficult to penetrate location within
the pack or tray.
• Integrators are helpful in identifying packs or trays with too high a density or mass, incorrect
configuration of the load, or beginning failures of sterilization equipment.
• They can help the user to differentiate problems between packs or trays and the sterilizer
itself.

D. Load Control
1. Biological release
• The process by which a load is monitored and released based on the result of a biological
indicator in a test pack.
• Test the load with appropriate spore test
• Incubate test and control vials for the recommended time
• Read the result
• Use the result for releasing the load as sterile load
2. Parametric Release
• Parametric Release is “declaring the product as sterile based on physical or chemical (or
both) process data rather than on the basis of biological indicators results”.

E. Record Keeping
• The staff should document each sterilizer:
• Load number, date and time,
• Contents of load,
• Outcomes of chemical indicators, integrators, BIs & mechanical indicators
• Operator’s name or initial
• Any equipment maintenance, repairs, and calibration must be documented on each sterilizer.

Autoclave User Log:

• Complete User Log with Every Use
• Maintain User Logs for 1-2 Years

Autoclave Maintenance Log:

• Complete Maintenance Log for Every Repair
• Maintain records of Yearly Calibration
• Maintain Maintenance Logs for 3 – 5 Years