Microbiology

Autoclave validation Chemical

Indicators
Tape Indicators
Tape indicators are adhesive-backed paper tape with heat sensitive, chemical indicator markings.  Tape
indicators change color or display diagonal stripes, the words “sterile” or “autoclaved” when exposed to
temperatures of 121°C.  Tape indicators are typically placed on the exterior of the waste load.  If the
temperature sensitive tape does not indicate that a temperature of at least 121°C was reached during the
sterilization process, the load is not considered decontaminated.   If tape indicators fail on two consecutive
loads, notify your Department Safety Manager.

Integrated Chemical Indicator Strips

Integrated chemical indicator strips provide a limited validation of temperature and time by displaying a
color change after exposure to  normal autoclave operating temperatures of 121ºC for several minutes. 
Chemical color change indicators can be placed within the waste load.  If the chemical indicators fail on
two consecutive loads, notify your Department Safety Manager.  

Biological Indicators
Biological indicator vials contain spores from B. stearothermophilus, a microorganism that is inactivated
when exposed to 121.1oC saturated steam for a minimum of 20 minutes. Autoclaves used to treat biological
waste will be evaluated with a biological indicator by EHS on a quarterly basis.

Procedure
 EHS will coordinate biological validation testing with laboratory staff.

 The indicators will be incubated by EHS for 24 hours at 60°C with a control that has been
maintained at room temperature.

Results
 If the autoclaved indicator exhibits growth, the validation has failed and will be repeated.
 If the second validation indicator fails, EHS will notify the Department Safety Manager and
request service on the autoclave.  Autoclave should not be used until service has been conducted and the
validation test passes.
 Validation tests results are emailed by EHS staff to the appropriate labs and the Department Safety
Manager.
 EHS maintains documentation of all validation tests.
 Microbiology

STERILIZATION INDICATOR TAPE

DESCRIPTION

Art. 1052 
is made by impregnated semi-creped paper and adhesive natural rubber. To be
used with individual units (i.e. packs, containers) to confirm sterilization treatment and to
distinguish between processed and unprocessed units. After sterilization, indicator strips
change from clear colour to brown. (minimum conditions for change are: steam 10 min
121°C or 2 min 134°C). Lead free. If correctly stocked, it can be used till 3 years from
production date.

Art. 1051
 is an adhesive tape with good resistance to heat and damp; it's
particularly recommended for indicating dry sterilization (POUPINEL method). Made by
semi-creped, impregnated paper and adhesive Silicone it is easy to remove after treatment.
After sterilization the “V” indicators strips changes colour from light green to brown
(minimum conditions for change are: dry heat 30 minutes at 155° C).
Lead free. If correctly stocked, it can be used till 2 years from production date.
NOT INTENDED FOR USE AS VALIDATION SYSTEM OF STERILIZATION
PROCESS.
 Both Tapes are in conformity with ISO 11140/2005