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User Guidelines & Standard Operating Procedure

for the
STERIS Century Series Autoclave
Autoclave Standard Operating Procedure ii

TABLE OF CONTENTS

DISCLAIMER....................................................................................................................... iv

ACKNOWLEDGEMENTS...................................................................................................... v

1. INTRODUCTION ......................................................................................................... 1
1.1 Purpose of the Standard Operating Procedure........................................... 1
1.2 Theoretical Background .................................................................................. 1

2. POTENTIAL HAZARDS ............................................................................................... 4

3. PERSONAL PROTECTIVE EQUIPMENT ..................................................................... 5

4. SPILL AND ACCIDENT PROCEDURES ....................................................................... 6


4.1 Accidents ........................................................................................................... 6
4.2 Spills ................................................................................................................... 6
4.2.1 Spills Inside the Autoclave...................................................................... 6
4.2.2 Spills Outside the Autoclave .................................................................. 7
4.3 Power Failure.................................................................................................... 9

5. WASTE DISPOSAL PROCEDURES .............................................................................. 9

6. PROTOCOL ............................................................................................................... 10
6.1 Media/Glassware/Waste Preparation......................................................... 10
6.2 Loading the Autoclave................................................................................... 12
6.3 Cycle Selection and Operation .................................................................... 13
6.4 Unloading the Autoclave............................................................................... 15

7. STANDBY AND SHUTDOWN .................................................................................... 16

8. QUALITY CONTROL ................................................................................................. 17


8.1 Efficiency Testing........................................................................................... 17
8.1.1 Air Removal Testing............................................................................... 17
8.1.2 Chemical Indicators ............................................................................... 17
8.1.3 Biological Indicators .............................................................................. 17
8.2 Leak Testing .................................................................................................... 18
8.3 Cleaning ........................................................................................................... 18
8.4 Certification .................................................................................................... 18

9. TROUBLESHOOTING................................................................................................ 19
9.1 Equipment Malfunction ................................................................................. 19
9.2 User Errors Leading to Incomplete Sterilization....................................... 20
Autoclave Standard Operating Procedure iii

10. PREVENTATIVE MAINTENANCE.......................................................................... 21


10.1 Daily.................................................................................................................. 21
10.2 Weekly.............................................................................................................. 21
10.3 Monthly ............................................................................................................ 21
10.4 Three Months .................................................................................................. 21
10.5 Six Months........................................................................................................ 21
10.6 Annually ........................................................................................................... 21

11. QUICK REFERENCE GUIDE.................................................................................. 22

12. REFERENCES ........................................................................................................ 23

APPENDIX 1: DEFINITIONS ............................................................................................. 24

APPENDIX 2: VERIFY BIOLOGICAL INDICATORS.......................................................... 25


A2.1 Purpose ............................................................................................................... 25
A2.2 Safety Considerations....................................................................................... 25
A2.3 Procedure ........................................................................................................... 25

APPENDIX 3: DART/BOWIE DICK STEAM PENETRATION TEST .................................. 27


A2.1 Purpose ............................................................................................................... 27
A2.2 Safety Considerations....................................................................................... 27
A2.3 Procedure ........................................................................................................... 27

APPENDIX 4: TRAINING FORM ....................................................................................... 28

APPENDIX 5: AUTOCLAVE USER LOG ........................................................................... 29

APPENDIX 6: PREVENTATIVE MAINTENANCE LOG...................................................... 31


Autoclave Standard Operating Procedure iv

DISCLAIMER
The materials contained in this document have been compiled from sources
believed to be reliable and to represent the best opinions on the subject. This
document is intended to serve only as a starting point for good practices and
does not purport to specify minimal legal standards. No warranty, guarantee,
or representation is made by Laurier as to the accuracy or sufficiency of
information contained herein, and Laurier assumes no responsibility in
connection therewith.
Autoclave Standard Operating Procedure v

ACKNOWLEDGEMENTS
The following individuals of Laurier contributed to the writing, editing, and
production of this manual: Gena Braun (Instrumentation Technician); Stephanie
Kibbee (Environmental/Occupational Health and Safety Office); Laura England,
Robin Slawson, Bruce Wolff (Biology).

This manual was prepared for Laurier. Any corrections, additions or comments
should be brought to the attention of the Instrumentation Technician at
519-884-0710 ext. 2361.

Issued: February 2008 Revision: 2


Autoclave Standard Operating Procedure 1

1. INTRODUCTION

1.1 Purpose of the Standard Operating Procedure

This standard operating procedure (SOP) is NOT a substitute for training


and/or reading the appropriate manuals before use. All principle
investigators and supervisors must document that training has been
received by students and staff who will be using an autoclave.

A list of authorized users will be kept by the Instrumentation Technician in


SR314A.

This SOP is intended to promote consistent and safe use of the STERIS Century
autoclaves within the Faculty of Science. This SOP covers the potential
hazards, personal protection requirements, spill and accident procedures,
waste disposal considerations, and instrument operation for the STERIS Century
autoclave.

The Faculty of Science has two STERIS Century autoclaves [henceforth referred
to simply as autoclave(s)]. The autoclave located in the Science Building, room
N3032B, is intended primarily for teaching purposes; the autoclave in the
Science Research Building, room SR410, is intended primarily for research.

1.2 Theoretical Background


An autoclave delivers heat and steam under pressure to decontaminate or
sterilize laboratory media, equipment, and waste. Decontamination occurs
when the contamination level is reduced to a point where it is no longer a
hazard to people or the environment. Sterilization is the complete destruction
of the microorganisms present by rendering the cell no longer viable.
Sterilization will only occur if the material is heated to a specific temperature
for a given period of time.

Steam sterilization is non-toxic, inexpensive, rapidly microbicidal, sporicidal,


and rapidly heats and penetrates fabric. There are four main parameters to
effect successful steam sterilization: steam, pressure, temperature, and time.
Steam improves heat transfer and is ideally dry and saturated. The use of high
pressure allows higher temperatures to be reached as required to kill
microorganisms. The accepted temperatures for steam sterilization are 121˚C
in a gravity sterilizer for a minimum of 15 minutes at 15psig, or 132˚C in a
prevacuum sterilizer for a minimum of 4 minutes at 15psig. For all
biohazardous waste, the minimum sterilization time is increased to 30
minutes at 121˚C and 15psig. Finally, the total time required for sterilization
Autoclave Standard Operating Procedure 2

is dependant on the type of item (solid or liquid, dense or porous, and total
mass or volume), how the item is packaged, and the type of sterilization
applied. The combination of steam, pressure, and the correct temperature and
time allow for successful sterilization.

The autoclave in SR410 is capable of two different types of steam sterilization:


gravity and prevacuum. The autoclave in N3032 is only capable of gravity
sterilization. During gravity sterilization, steam is admitted at the top or side
of the chamber and, because steam is lighter than air, it forces air out the
bottom of the chamber through the drain vent. As a result, air can remain
trapped in upright containers or bottles and lead to ineffective sterilization.
Prevacuum sterilization is similar to gravity sterilization, except that air is
removed from the chamber by several vacuum pulses before the saturated
steam enters the chamber. This resolves the problems of air entrapment that
can occur when air is removed by gravity displacement. Prevacuum cycles can
be used for wastes containing liquids, but these materials must be properly
contained. Liquid sterilization cycles operate in a similar manner to Gravity
displacement cycles; however they do not undergo a vacuum dry period.

Gravity sterilization is useful for sterilizing heat and moisture stable goods
that are NON-POROUS, including laboratory media and wastes. This type or
sterilization is NOT suitable for liquids, or anything that will BECOME liquid
when heated.

Prevacuum sterilization increases the speed and efficiency of sterilization and


is more effective on POROUS heat and moisture stable materials. This type or
sterilization is NOT suitable for liquids, or anything that will BECOME liquid
when heated.

Liquid sterilization is useful for sterilizing any liquid samples, items that will
become liquid when heated, or wastes containing a significant amount of
liquid.

The cycles currently available on the autoclaves are presented in Table 1-1 and
Table 1-2. If you require a custom autoclave cycle, please contact the
Instrumentation Technician for programming support.
Autoclave Standard Operating Procedure 3

Table 1-1: Sterilization cycles available on the autoclave located in SR410.*


Cycle Type Pulses Maximum Minimum Sterilization Vacuum Dry
Pressure Pressure Time (min) Dry Time
(psig) (inHg) (min) (min)
PV20 Prevacuum 4 15 10 20 10 10
PV60 Prevacuum 4 15 10 60 10 0
L15 Liquid ------ ------ ------ 15 ------ ------
L30 Liquid ------ ------ ------ 30 ------ ------
L75 Liquid ------ ------ ------ 75 ------ ------
G45 Gravity ------ ------ ------ 45 10 15
*All cycles are carried out at 121oC with a purge time of 1 minute, an overdrive of 1.5oC, an
undertemp of 1oC resulting in a restart, and an overtemp of 6oC.

Table 1-2: Sterilization cycles available on the autoclave located in N3032B.*


Dry Time
Cycle Type Sterilization Time (min) Vacuum Dry (min)
(min)
L15 Liquid 15 ------ ------
L25 Liquid 25 ------ ------
L30 Liquid 30 ------ ------
L75 Liquid 75 ------ ------
G25 Gravity 25 10 15
*All cycles are carried out at 121oC with a purge time of 1 minute, an overdrive of 1.5oC, an
undertemp of 1oC resulting in a restart, and an overtemp of 6oC.

The effectiveness of sterilization is assessed using both chemical and biological


indicators. Typically, chemical indicators such as heat tape are affixed to the
outside and incorporated into the pack to monitor the temperature only, or
time and temperature simultaneously. Chemical indicators do not indicate if a
load was successfully sterilized, they simply track exposure of the load to a
given temperature. The effectiveness of steam sterilization is monitored with
a biological indicator containing spores of Bacillus stearothermophilus and
Bacillus subtilis var. niger. For further details on chemical and biological
indicators, see Appendix 2.
Autoclave Standard Operating Procedure 4

2. POTENTIAL HAZARDS

The autoclave operates under high pressure and temperature; therefore,


there is significant danger of burns and scalds. Wear the appropriate
personal protective equipment (refer to section 3) to avoid the following
injuries:

Heat burns may occur when the operator comes in contact with hot materials
or the autoclave chamber walls and door.

Steam burns can be caused by contact with residual steam coming out of the
autoclave or autoclaved materials upon completion of a cycle.

Hot fluid scalding can result from boiling liquids or spillage in the autoclave.

The door opening is surrounded by a bezel that does not conduct heat to
protect the operator from burns, but care must too be used as all inside walls
and shelving can be very hot.

When sterilizing liquids, the Liquid cycle MUST be used. Use only vented
closures on liquid containers, and do not allow hot bottles to be jostled as this
can cause the bottle to break or explode.

DO NOT attempt to open the sterilizer door if a WATER IN CHAMBER alarm


condition exists. Contact the Instrumentation Technician.

DO NOT process flammable liquids, oils, waxes, radioactive materials, or


substances that may emit toxic fumes.

Keep arms and hands away from the door when it is closing. The door will
automatically stop moving if it meets an obstruction while opening or closing.
Autoclave Standard Operating Procedure 5

3. PERSONAL PROTECTIVE EQUIPMENT

Often material to be loaded contains potentially infectious


material, so standard laboratory protective equipment must be
worn (latex or nitrile gloves, approved safety glasses or goggles
if autoclaving liquids, lab coat).

The autoclave uses steam, heat, and pressure, therefore


additional heat insulating gloves are required for loading,
unloading, and handling autoclaved material (these are available
in SR410). Do not wear previously used latex or nitrile gloves
inside the heat insulating gloves as this may contaminate the
inside of the heat insulating gloves. Heat resistant gloves must
provide complete coverage of hands and forearms. Closed-toe
and heel footwear constructed of resistant material is also
required for all laboratory activities, including use of the
autoclave. It is advisable to wear a full face shield in addition
to safety glasses/goggles if a splash hazard exists.

Dedicated lab coats, heat resistant gloves, and a full face shield are
provided in SR410 for autoclave use only.

See the WLU Laboratory Health and Safety Manual for additional information on
personal protective equipment:
http://www.wlu.ca/documents/23120/Laboratory_Health_%26_Safety_Manual_
_Feb_2007_Final.pdf.
Autoclave Standard Operating Procedure 6

4. SPILL AND ACCIDENT PROCEDURES

4.1 Accidents
If hot liquids are spilled onto clothing, or clothing is soaked in steam:
1. Remove clothing and cool the injured part in cool water.
2. Seek first aid if necessary. A list of people trained to provide first aid
will be posted in the autoclave room.*
3. Report the incident to the Instrumentation Technician.
4. The Instrumentation Technician will place a notice on the autoclave
indicating that it is not to be used until the accident investigation is
complete, procedures enacted to prevent future incidents, and the
autoclave is deemed safe for operation.

All incidents must be reported to the Instrumentation Technician and if


applicable, a student’s supervisor.

The Instrumentation Technician will insure that all accidents, incidents and
near misses are reported to the Environmental/Occupational Health and Safety
(EOHS) Office via the WLU Employee Accident/Incident/Occupational Disease
Report form (www.wlu.ca/eohs/forms). To meet regulatory requirements,
these forms must be submitted to EOHS within 24 hours of occurrence, with the
exception of critical injuries, which must be reported immediately to the EOHS
Office by telephone. Critical injuries include any of the following; place life in
jeopardy, produce unconsciousness, result in substantial loss of blood, involve
fracture of a leg or arm but not a finger or toe, involve amputation of a leg,
arm, hand or foot, but not a finger or toe, consist of burns to a major portion
of the body, or cause the loss of sight in an eye.

Additional details regarding incident reporting can be found in the WLU


Accident Incident Procedure (www.wlu.ca/eohs).

4.2 Spills
4.2.1 Spills Inside the Autoclave
Spills inside the autoclave may occur from a boil over or breakage of
containers. No operation of the autoclave is allowed until the spill is cleaned
up.
1. Review the MSDS, if not done so before commencing the sterilization
cycle, to determine the protective equipment, spill cleanup, and
disposal protocols that are necessary.
2. Wear appropriate personal protective equipment, and contain the spilled
material first using an appropriate spill kit.
*
The First Aid list is maintained by the Instrumentation Technician in consultation with the
Environmental/Occupational Health and Safety Office.
Autoclave Standard Operating Procedure 7

3. Report the spill to the Instrumentation Technician, who will advise


the user on the best way to clean up the spill. This may involve the
following:
a. Turn off the autoclave.
b. Wait until the autoclave and materials have cooled to room
temperature, before completing clean up.
c. Dispose of the waste following the protocol appropriate for the
material. If materials have been intermingled, follow the cleanup
and disposal protocol for the most hazardous component of the
mixture. This may require re-sterilization of the waste.
d. Cracked glassware must be disposed of properly in a biohazard
“Broken Glass” disposal pail.
4. Record the spill and cleanup procedure in the autoclave log book.

4.2.2 Spills Outside the Autoclave


The WLU Laboratory Health and Safety Manual provides detailed instructions
for dealing with major and minor spills. Do not attempt to clean up a spill if
you have not been properly trained, or if you are unsure of the proper
procedures. Before using ANY hazardous materials, make sure you
understand the proper clean-up procedure. The Environmental/Occupational
Health and Safety Office is also available to provide guidance at ext. 2874. The
guidelines below are summarized from the WLU Laboratory Health and Safety
Manual.

Determine if the spill is a major or minor spill (see Table 4-1).


1) For major spills:
a) Evacuate the lab, close the doors, restrict the area, and notify others in
the area of spill, including your supervisor and the Instrumentation
Technician if possible.
b) Call ext 3333 (Community Safety and Security).
c) Activate the fire alarm if there is risk to the safety of other people in
the building.
d) Be available to provide technical information to emergency responders.
2) For minor spills:
a) Attend to injured or contaminated personnel.
b) Restrict the area and notify others in the lab of the spill, including your
supervisor and the Instrumentation Technician if possible.
c) Take action to minimize the extent of the spill.
d) If flammable material is involved, turn of ignition sources (power,
Bunsen burners).
e) Select and wear all appropriate personal protective equipment.
f) It is the responsibility of the user of the hazardous material to clean up
the spill if he/she feels it is safe to do so.
g) All personal protective equipment must be disposed of correctly, and
must not be worn outside the laboratory.
Autoclave Standard Operating Procedure 8

h) Apply spill pillow/pads or other absorbent material, first around the


outside of the spill, encircling the material, then absorb to the center of
the spill.
i) Dispose of all materials used to clean up the spill in a sealed container.
j) Label and dispose of all bags or containers as hazardous waste.
3) For chemical spills on the body:
a) Remove all contaminated clothing.
b) Flood exposed area with running water form a safety shower for at least
15 minutes.
c) Have another individual contact 9-911 and ext 3333 to obtain medical
attention.
d) Report the incident to your supervisor and the Instrumentation
Technician.
4) For chemicals splashed in the eye(s):
a) Immediately rinse eyeball and inner surface of eyelid with water
continuously for 15 minutes. Forcibly hold eye lid(s) open to ensure
effective wash behind eyelids.
b) Have another individual contact 9-911 and ext 3333 to obtain medical
attention.
5) Report the incident to your supervisor and the Instrumentation
Technician.

Table 4-1: Guidelines for classification of a major spill


Material Quantity
Air and water reactive materials All quantities
Flammable liquids Greater than 4L
Combustible liquids Greater than 4L
Non-flammable organic liquids Greater than 4L
Concentrated acids Liquids greater than 1L
Solids greater than 1kg
Concentrated bases and alkalis Liquids greater than 1L
Solids greater than 1kg
Mercury Greater than 30 ml
Oxidizers Liquids greater than 1L
Solids greater than 500g
Highly toxic, highly malodorous Liquids greater than 100 ml
material Solids greater than 50g
Low hazard material At the discretion of laboratory
personnel
Compressed gas leaks If the leak cannot be stopped by
closing the valve on the gas cylinder
Autoclave Standard Operating Procedure 9

4.3 Power Failure


In an emergency, or if electrical power or water supply has been lost during the
autoclave cycle, contact the Instrumentation Technician. The Technician will:
1. Shut off the main steam supply valve.
2. Open the emergency exhaust valve to exhaust the chamber to
atmospheric pressure.
3. Remove the door release tool from the upper left inside of the door
frame and use it to press on the upper left then upper right corner of
the door to push the gasket back into the groove.
4. Push the door down.
Remove items carefully as they are very hot and will need to be re-sterilized.

5. WASTE DISPOSAL PROCEDURES


All biohazardous items to be disposed of as regular waste MUST be
autoclaved for a minimum of 30 minutes before disposal.
Autoclave Standard Operating Procedure 10

6. PROTOCOL
The autoclave is unavailable on Thursday mornings before 9:30 AM for regular
maintenance (carried out by the Instrumentation Technician).

Note: The autoclave will turn itself off at 8:00 PM. If you have a run started
just before 8:00 pm, the autoclave will finish your run before shutting down.
If you need to run the autoclave after the autoclave has shut down, touch the
STERIS symbol to start the autoclave again. Remember after logging in to let
the autoclave warm up for 10-15 minutes.

6.1 Media/Glassware/Waste Preparation


1. Before preparing items for sterilization or decontamination, ensure that
each item can be autoclaved; see Table 6-1.
2. Review the MSDS if you are unsure of the proper safety precautions and
personal protective equipment required for the material to be sterilized.
3. All items to be autoclaved should be placed inside a suitable primary
container (i.e. flasks, wrapping paper or muslin for instruments, or
biohazard bags), which in turn is put into a secondary container (i.e. an
autoclave pan).
Note: Prepare materials for sterilization carefully as this will strongly
influence the success of sterilization:
a. The primary container (that contains the substance to be autoclaved)
should be heat resistant, thermally conductive, puncture proof and
water proof. Suitable primary containers include:
i. Borosilicate glass (Pyrex); Inspect glassware prior to using to
ensure it is not cracked;
ii. Polypropylene (PP) and polycarbonate (PC) plastics;
iii. Teflon (PTFE);
iv. Stainless steel;
v. Polypropylene biohazard bags for waste.
b. Unsuitable primary containers are made of polystyrene (PS),
polyethylene (PE), and high density polyethylene (HDPE). These types of
plastic may melt in the autoclave.
c. When packaging materials into primary containers, take into account
possible water absorption during the autoclave cycle.
d. Do not fill primary containers beyond 75% of their holding capacity.
e. All primary containers must be unsealed by loosening screw or vent caps,
capping open containers with aluminum foil, opening plastic bags slightly
prior to loading into the autoclave.
DO NOT AUTOCLAVE SEALED CONTAINERS OR BAGS.
Ensure that lids to all containers are loosened to prevent pressure build-
up during heating and a vacuum on cooling. Caps should be finger
tightened and then turned back a ¼ turn; if they are too loose they will
pop off during sterilization.
Autoclave Standard Operating Procedure 11

f. Optional: It can be useful to add 250 mL of water to the contents of bags


containing solids (more if the bag is large) to create additional steam
that will displace any air in the bag during the cycle. This method is
particularly useful for polypropylene autoclave bags which have poor
steam permeability.
4. Place the primary container, i.e. bag or flask, into a secondary container,
i.e. autoclave pan.
a. Secondary containers must be large enough to contain any leaks in
the primary containers (i.e. they must contain the same volume as
the total volume of the materials to be sterilized, see Table 6-2), and
they must be heat resistant.
b. Check older secondary containers before use as repeated autoclaving
can cause the plastic to become brittle or soft.
c. Optional: If intending to use a gravity sterilization cycle, 1 to 2 mL of
water can be added to each item separately. This will fill insulating air
pockets that may be generated when the glassware is placed in the pan.
5. All material to be autoclaved MUST be properly labeled prior to
autoclaving, in case of an emergency or power failure.
a. Labels must include: Name of person responsible; contact info;
identification; and volume of contents.
6. Temperature sensitive tape must be affixed to all bags and individual items
to indicate that the material has been autoclaved. This tape DOES NOT
prove that the item has been successfully sterilized or decontaminated; it
simply indicates that a given temperature was achieved.
7. Optional: If possible, avoid autoclaving re-usable materials in the same load
as waste, or place these items in separate secondary containers (pans).

Table 6-1: Autoclaveable items


Items that CANNOT be autoclaved Items that CAN be autoclaved
- Containers with loosened caps or lids
- Sealed containers - Discarded live and attenuated vaccines
- Oils, waxes - Contaminated solid items such as: Petri
- Flammable materials dishes, eppendorf tips, pipettes, gloves,
- Materials containing: solvents, volatile paper towel
chlorinated compounds (i.e. HCl or - Items for sterilization, such as: glassware,
bleach) or corrosive chemicals (i.e. media, aqueous solutions, equipment
phenol, trichloroacetic acid, ether, - Loose dry materials wrapped or bagged in
chloroform) steam-penetrable paper or loosely
- Radioactive materials (without prior covered with aluminum foil
approval) - Biohazard materials must be labeled as
- Some plastics such and secured in containment vessels
or autoclavable bags
Autoclave Standard Operating Procedure 12

A B Table 6-2: Size and volume of autoclave pans


Size (cm) Size (cm) Maximum
volume (L)
Small pan 36.1 x 31.1 x 14.3 15
Large pan 54.3 x 43.5 x 13 25
Figure 6-1: Examples of a
primary container (A) and a
secondary container (B).

6.2 Loading the Autoclave


1. Check the log book first to ensure that the autoclave is functioning
properly (i.e. no serious problems are listed), and that it has been tested
for efficiency by the Instrumentation Technician within the last week.
2. Wear heat-insulating gloves, and closed toed shoes.
Note: autoclave door and chamber may be hot from a previously run cycle.
3. The autoclave turns on automatically at 7:00 AM every morning except
Thursday when it is turned on following regular maintenance by the
Instrumentation Technician. If you are using the autoclave shortly after it
has turned on, allow it to warm up for 10-15 minutes before proceeding.
4. If the autoclave is in standby mode (i.e. The STERIS icon is displayed), press
the center of the screen to proceed to the main menu screen. NOTE: Do not
flush the generator; press cancel if this screen appears. The generator is
flushed once a week by the Instrumentation Technician.
5. Select your assigned operator name, and access the autoclave using the
code you have been given. (If the autoclave is logged on already, select
Option, choose Next, and then choose Standby. Touch the STERIS symbol
when in appears, and proceed to log in as usual).
6. Press the foot pedal to open the door.
7. Check the inside of the autoclave to ensure that it is clean, and that the
drain strainer is in place.
8. Place material in autoclave, observing the following precautions:
a. Do not mix incompatible materials.
b. Do not autoclave items which are too large or very heavy as this will
stress the structure of the autoclave.
c. Do not overload; leave sufficient room for steam circulation. Load the
items to allow as much passage of air from the top to the bottom of the
load. For large loads, a rule of thumb is that if a space greater than six
inches is between each item, the run time can be set for the weight of
the heaviest item; however, if the items are less than six inches apart,
they are considered to be one, and must be sterilized according to the
mass of the two objects combined.
d. Avoid crowding or stacking.
Autoclave Standard Operating Procedure 13

e. Optional: Place empty flasks, test tubes, or other non-porous containers


on their sides with loose covers to prevent air trapping and air pockets.
f. Liquids and dry goods should be processed separately as they require
different types of cycles. If this is not possible, a liquid cycle must be
used.
g. A load of liquids should be of approximately the same size, content,
shape, and volume. If this is not possible, base the required autoclave
time on the largest volume in the load.
9. Press the foot petal to close the door.

6.3 Cycle Selection and Operation


1. Select an appropriate cycle based on the materials to be sterilized. See
Table 6-3 for a description of the cycles available on the research
autoclave, and Table 6-4 for a guide on mass vs. sterilization time for dry
goods.
a. All waste must be autoclaved for a minimum of 30 minutes before
disposal, regardless of the volume/mass being sterilized (Le et al.,
2005).
b. Anything particulate (soil, vermiculite, etc) must be run in a
prevacuum or liquid cycle only; the rapid exhaust of a gravity cycle
could cause the particulate to ‘coat’ the inside of the autoclave
chamber. The best type of cycle for assuring sterilization of containers
and porous objects is the prevacuum cycle.
Note: The prevacuum cycle CANNOT be used for liquids.
c. All liquids and any media that will melt during sterilization must be
processed using a liquid cycle. Liquid cycles have slow exhaust cycles
to minimize boiling and evaporation of the material being autoclaved;
there is no drying time associated with liquid cycles.
d. Repeated sterilization for short periods of time does not have the
same effect as a single longer sterilization cycle.
2. Press “Start Cycle”. Do not leave immediately; remain in the room until the
autoclave has finished the ‘PURGE’ portion of the cycle; if the cycle is going
to fail (usually due to incomplete warm-up) it will happen in this first step.
a. If the run starts successfully, make sure you have signed into the log
book, and return promptly to retrieve your autoclaved material (time to
completion of run is displayed on the autoclave touch screen); make
sure to include your extension so that you may be contacted if needed.
b. If the run doesn’t start, the autoclave will begin to audibly alarm.
Select ‘Silence Alarm’ and then ‘Service Help’. From this menu choose
‘Clear Alarm’; the autoclave will exhaust the chamber and then unseal
the door. You will be prompted to open the door to finish clearing the
alarm. Start over with the ‘Cycle Select’ button, as above. RECORD THE
PROBLEM IN THE LOG BOOK.
3. If the autoclave alarms again on your second attempt, contact the
Instrumentation Technician.
4. Do not attempt to open the door while autoclave is operating.
Autoclave Standard Operating Procedure 14

Table 6-3: Sterilization cycles available on the research autoclave located in


SR410.
Cycle Appropriate Items Common Use
Glassware, media,
PV20 tips/tubes, solids up to 5
Any goods which can be sterilized with
lbs
steam EXCLUDING liquids or items
which will liquefy when heated. Soil, vermiculate, and
any other solid or
PV60
particulate waste up to
15 lbs
Liquids in vented flasks, up to approx 40
L15 Media and liquids
ml per flask.
Liquids in vented flasks, up to 250 ml Media and liquids, liquid
L30
per flask. waste
Liquids and liquid
waste (for extremely
Liquids in vented flasks, up to 4 L per
L75 large liquid loads, a
flask.
DART warm up cycle
may be required).
G45 Wrapped hard and non-porous goods. Glassware

Table 6-4: Minimum sterilization time for dry goods based on weight
(University of Nevada, 2004).
Item Weight (lbs) Sterilization Time(min)

<5 30
5 – 15 60
>15 90
Autoclave Standard Operating Procedure 15

6.4 Unloading the Autoclave


1. Wear heat-insulating gloves, and closed toed shoes. CAUTION: The greatest
risk of personal injury occurs during autoclave unloading.
a. High risk of burns or scalds from autoclaved materials.
b. Exposure to vapours and gases due to inadvertent autoclaving of volatile
chemicals.
2. Standing away and to the side of the door, step on the foot pedal to open
the door. Stand back from the door to avoid the escaping steam.
a. If samples are boiling or bubbling, wait until they subside before
removing them.
b. Do not agitate containers of super-heated liquids or remove caps before
unloading. Super heated liquids can “bump” when they are removed
from the autoclave causing a spray of boiling liquid if proper containers
are not used.
3. Using heat resistant gloves, carefully transfer the autoclave pans to a cart.
Be careful not to jolt the containers as this may lead to breakage. (Keep in
mind that if the gloves are fabric and get wet, they will transfer almost all
of the heat).
4. Use the foot pedal to close the autoclave door. Keep the chamber door
closed between cycles and when not in use.
5. Verify that the temperature sensitive tape has changed colour or that
diagonal lines have appeared. If not, new tape needs to be applied, and the
load autoclaved again. If the tape does not change a second time, notify the
Instrumentation Technician of the problem.
6. Record the cycle parameters and any problems in the autoclave log-book.
7. Return the autoclave to standby mode by selecting “Options” from the main
menu page, followed by “Standby”.
8. Transport the items to a safe location and wait for the autoclaved items to
cool before storing or disposing.
a. Placing hot glassware onto a cool surface may cause the glass to break.
b. Use extra care when moving hot liquids to avoid bumping and spraying.
c. Before disposing autoclaved waste, deface the biohazard symbols on the
bag or packaging, and affix a label indicating that the waste is
“Autoclaved Biomedical Waste – Non-Hazardous”. Place the autoclaved
waste bag into a regular black garbage bag and tie securely. Autoclaved
waste can then be disposed of to the appropriate municipal waste
stream.
9. Rinse out the autoclave pan before returning it to the storage shelf.
Autoclave Standard Operating Procedure 16

7. STANDBY AND SHUTDOWN

After a run is complete the autoclave should always be left in standby mode.
The autoclave also automatically goes into standby mode overnight and on the
weekends.

If the autoclave will not be used for a week or more, both the autoclave and
the generator (N3032B only) should be shutdown. The shutdown procedure is
carried out by the Instrumentation Technician as follows:

1. Put the autoclave in standby overnight to allow it too cool and residual
steam to evaporate.
2. Manually turn off the power to the steam generator (N3032B autoclave only)
and the autoclave.
Autoclave Standard Operating Procedure 17

8. QUALITY CONTROL
Quality control testing is conducted to ensure that the autoclave is functioning
properly, and sterilization is being carried out effectively. All quality control
tests are completed by the Instrumentation Technician, and recorded in the
Quality Control Log (Appendix 6).

8.1 Efficiency Testing


8.1.1 Air Removal Testing
The prevacuum cycle should be tested weekly using a Bowie-Dick Test. The
SteriTech Bowie-Dick Test sheet is used to evaluate the effectiveness of air
removal from the sterilizer chamber during a multi-pulse prevacuum steam
sterilizer cycle. This test is only conducted on the autoclave in SR416.

8.1.2 Chemical Indicators


Chemical indicators are used to demonstrate that the material has been
exposed to the desired temperature by changing colour (i.e. heat sensitive
tape). A chemical indicator does not prove the success of sterilization; it simply
indicates that the load has been processed. Chemical indicators are meant to
be used in conjunction with biological indicators.

Every load that is placed in the autoclave should be accompanied by an


internal or external chemical indicator.

8.1.3 Biological Indicators


Biological indicators are the most accepted means of monitoring the
sterilization process because they directly determine whether the most
resistant microorganisms (e.g., Geobacillus or Bacillus species) are destroyed
rather than simply revealing whether the physical and chemical conditions
necessary for sterilization are met. Bacillus stearothermophilus are the most
resistant organism to steam autoclaving.

Verify ™ Biological/Chemical Indicators (BIs) are used for monitoring the steam
sterilization processes in the research and teaching autoclaves. Each indicator
vial contains a disc inoculated with spores of Bacillus stearothermophilus and
Bacillus subtilis var. niger. These indicators are inserted into a typical
autoclave load (solid or liquid) by the Instrumentation Technician and then
incubated to promote spore growth. If the autoclave is working properly and
exposure times are correct the spores will be killed and no growth will occur.

Biological indicators are run weekly in a test load as designated by the


Instrumentation Technician to confirm that complete sterilization is
occurring. See Appendix 2 for the full testing procedure.
Autoclave Standard Operating Procedure 18

8.2 Leak Testing


The ability of the autoclave to maintain a vacuum is tested weekly using a leak
test. This test measures the integrity of the sealed pressure vessel and
associated piping to assure air is not being admitted to the sterilizer during
vacuum dry downs. This test should be run when the autoclave is empty. The
leak test is run by selecting “Cycles”, followed by “Test Cycles”, and then
“Leak Test”. The measured leak rate is printed out at the end of the run and
should not be higher than 1 mm Hg/min. A higher leak rate indicates a
problem with the sterilizer that must be addressed.

8.3 Cleaning
The autoclave must be cleaned following any spill:
1. Contact the Instrumentation Technician for assistance to clean up the spill.
2. Turn off the autoclave.
3. Let the spilled material cool and then wipe up as much as possible and
dispose of all waste properly (may need to be placed in a biohazard bag to
be re-autoclaved).
4. Let the autoclave cool to room temperature (overnight).
5. Remove the chamber shelf assembly and wipe up any remaining spilled
material
6. Clean the inside of the chamber and the shelf using a soft cloth or sponge
and Liqui-Jet detergent diluted 1:10 with tap water.
7. Rinse all of the detergent out of the autoclave before it is restarted.

8.4 Certification
Every autoclave must be inspected at the time of installation and should have a
valid certificate from TSSA (Technical Safety and Standards Authority) of
Ontario.

The autoclaves in SR410 and N3032B are inspected annually by a Boiler


Inspector as required by the Boilers and Pressure Vessels Act of Ontario. These
inspections are the responsibility of the Physical Plant and Planning
Department at Wilfrid Laurier University. The scope of inspection will include
a visual inspection, a review of the conditions of operation and the protective
devices such as the pressure relief valves, temperature controls (if any), steam
quality control, and the measures being taken by the user for its safe and
efficient operation.
Autoclave Standard Operating Procedure 19

9. TROUBLESHOOTING

9.1 Equipment Malfunction


Users are not to make repairs. Autoclaves shall be maintained and repaired
by qualified persons only.

If the autoclave does not operate exactly as expected, do not attempt to fix
the problem. Record the problem in the autoclave log book and contact the
Instrumentation Technician immediately. Table 9-1 lists some of the common
problems that may occur. A notice shall be placed on the autoclave indicating
that it is not to be used until the problem is diagnosed and corrected.

Repair of autoclaves shall be performed by qualified persons only. The Physical


Resources department at Laurier may be consulted about the repair.

Table 9-1: Autoclave problems and causes.


Problem Cause
The cycle will not The door close switch will not allow a run to begin if
start the door is not fully closed.

The door will not The chamber may still be under pressure, or there may
open be water in the chamber.
Autoclave Standard Operating Procedure 20

9.2 User Errors Leading to Incomplete Sterilization


Incomplete sterilization can result from a number of common user errors. See
Table 9-2 for common errors and the resulting problems that occur.

Table 9-2: Sterilization errors and consequences

User Error Resulting Problem

Protein and salt debris may insulate


organisms from direct contact with the
Improper cleaning of instruments
sterilizing agent and interfere with the
efficacy of the sterilization agent.

Improper packaging
Prevents penetration of the sterilizing
agent; packaging material may melt.
Wrong packaging material for the
method of sterilization
Retards penetration of the sterilizing
agent.
Excessive packaging material

Improper loading of the sterilizer Increases heat-up time and will retard
penetration of the sterilizing agent to
the center of the sterilizer load.
Overloading
May prevent or retard thorough
No separation between packages or contact of the sterilizing agent with all
cassettes even without overloading items in the chamber.

Improper timing and temperature


Insufficient time at proper
temperature to kill organisms.
Incorrect operation of the sterilizer
Autoclave Standard Operating Procedure 21

10.PREVENTATIVE MAINTENANCE
Users are not to perform maintenance. These procedures are carried out by
the Instrumentation Technician (IT) or Physical Plant and Planning (PP&P)
personnel.

10.1 Daily
- Clean the chamber drain filter (SR416 only, IT)
- Check the log book for any problems or concerns (IT)
- Check the printout to make sure the ink and paper are not running out (IT)
- Run the Dart/Bowie Dick test (SR416 only, see Appendix 3) (IT)

10.2 Weekly
- Flush the steam generator (IT – may be taken over by PP&P in autumn 2007)
- Check door gaskets for wear (IT)
- Check the sight glass for leaks (IT)
- Check the door for smooth operation (IT)
- Flush the chamber drain using dilute (1:10) Liqui-jet detergent (IT)
- Run the vacuum leak test; a leak rate of 1 mm/Hg or less is acceptable (IT)
- Test the efficiency using a Verify Biological Indicator (Appendix 2) (IT)
- Clean the chamber drain filter (N3032 only, IT)

10.3 Monthly
- Clean the interior walls using dilute (1:10) Liqui-jet detergent (IT)
- Disinfect the exterior surfaces of the autoclave (IT)
- Clean the steam supply and water supply strainers (PP&P)

10.4 Three Months


- Check the autoclave pans for structural integrity (IT)
- Rebuild the pressure regulating valve and jacket trap (PP&P)
- Replace the electric steam generator check valves, inspect pressure control
switches and gauge, clean heating element and boiler chamber (PP&P)

10.5 Six Months


- Test the safety valve for proper operation (PP&P)
- Replace air inlet filter cartridge (PP&P)
- Check chamber and jacket pressure gauges for accuracy (PP&P)
- Confirm control calibration (PP&P)
- Rebuild steam generator solenoid valves, water valves, and fan filter; check
safety valve; clean strainers; replace sight glass and washers; clean water
level controls rods and de-scale generator (PP&P)

10.6 Annually
- Inspection by a Boiler Inspector (PP&P)
- Rebuild exhaust and steam supply manifold components (PP&P)
Autoclave Standard Operating Procedure 22

11.QUICK REFERENCE GUIDE

WEAR PERSONAL PROTECTIVE EQUIPMENT


Eye and face protection, heat resistant gloves, and lab coat

1. Check log book first to ensure that the autoclave is functioning properly.
2. Select your assigned operator name, and access the autoclave using the
code you have been given.
3. Press the foot pedal to open the door.
4. Check the inside of the autoclave to ensure that it is clean, and that the
drain strainer is in place.
5. Place AUTOCLAVABLE material in autoclave inside a secondary container.
6. Press the foot petal to close the door.
7. Select an appropriate cycle based on the materials to be sterilized. See
Table 6-3.
a. The best type of cycle for assuring sterilization of containers and
porous objects is the prevacuum cycle.
Note: This cycle CANNOT be used for liquids.
8. Press “Start Cycle”.
Do not attempt to open the door while autoclave is operating.
9. When the cycle is complete, standing away and to the side of the door, step
on the foot pedal.
10.If any liquids are boiling, let autoclaved items stand for at least 10 minutes
before unloading.
11.Unload using heat resistant gloves.
12.Use the foot pedal to close the autoclave door.
Keep the chamber door closed between cycles and when not in use.
13.Verify that the temperature sensitive tape has changed colour or that
diagonal lines have appeared.
14.Record the cycle parameters and any problems in the autoclave log-book.
15.Return the autoclave to standby mode by selecting “Options” from the main
menu page, followed by “Standby”.
16.Transport the items to a safe location and wait for the autoclaved items to
cool before storing or disposing.
17.Rinse out the autoclave pan before returning it to the storage shelf.
Autoclave Standard Operating Procedure 23

12.REFERENCES

A guideline for the safe use of autoclaves. 2003. Environmental Health and
Safety Service. The University of Ottawa.

Amsco Century Series Sterilizer In-Service Video. 2002. STERIS Corporation.

Disinfection and Sterilization in Healthcare, a comprehensive chapter by


William A. Rutala, Ph.D., M.P.H.,
http://www.unc.edu/depts/spice/dis/chapter.html. Accessed March 23,
2007.

EVB SOP #04-1: Standard Operating Procedure for Autoclave Operation. 2005.
Department of Environmental Biology, University of Guelph.

Infection Control: Frequently Asked Questions, Sterilization — Monitoring. 2005.


Department of Health and Human Service. Center for Disease Control and
Prevention.
http://www.cdc.gov/oralhealth/infectioncontrol/faq/sterilization_monitori
ng.htm. Accessed March 23, 2007.

Laboratory Biosafety Guidelines. 3rd Edition 2004. Public Health Agency of


Canada

Laboratory Health and Safety Manual. 2007. Wilfrid Laurier University


Environmental/Occupational Health and Safety Office.

STERIS Verify™ Biological/Chemical Indicator pamphlet.

Le, R.N., et al (2005) Autoclave Testing in a University Setting. Applied


Biosafety, 10(4), 248-252. Found on:
https://vprgsecure.web.virginia.edu/bio/Autoclaving%20Guidelines.doc.
Accessed May 25, 2007.

University of Nevada. 2004. Autoclave Safety Manual.

World Forum for Hospital Sterile Supply: Bowie Dick Test.


http://www.efhss.com/html/educ/qtg/qtg0018_en.htm. Accessed August
2, 2007.
Autoclave Standard Operating Procedure 24

APPENDIX 1: DEFINITIONS

Autoclave:
An autoclave is an instrument that operates under high temperature and
pressure, and uses steam or ethylene oxide to effect the sterilization or
decontamination of a given substance. For the purposes of this SOP,
“autoclave” refers to the STERIS Century autoclaves located in the
Science and Science Research Buildings.

Decontamination:
Decontamination occurs when the contamination level is reduced to a
point where it is no longer a hazard to people or the environment.

Sterilization:
Sterilization is the complete destruction or inactivation of all living
organisms. Spores must be autoclaved twice to achieve complete
sterilization.
Autoclave Standard Operating Procedure 25

APPENDIX 2: VERIFY BIOLOGICAL INDICATORS

A2.1 Purpose
Verify™ Biological/Chemical Indicators are used for monitoring the steam
sterilization processes in autoclaves, specifically whether or not complete
sterilization has occurred. Each indicator vial contains a disc inoculated with
spores of Bacillus stearothermophilus and Bacillus subtilis var. niger. These
indicators are inserted into the center of an autoclave load and then incubated
by the Instrumentation Technician to check for spore growth. If the autoclave
is working properly and exposure times are correct, the spores will be killed
and no growth will occur.

A2.2 Safety Considerations


Care should be taken when removing Verify Indicators from sterilized loads, as
they can be hot. Let the items cool before removing the indicators. Heat
resistant autoclave gloves should be worn whenever removing a load from the
autoclave.

A properly operating autoclave is essential for safety. Perceived problems


should be reported to the Instrumentation Technician immediately.

A2.3 Procedure
1. Once a week Verify biological indicators should be placed in a gravity or
vacuum cycle in the middle cage, bag, etc. of each load level.
2. Remove the appropriate number of Verify Biological/Chemical Indicators
from the dispenser box.
3. Label the Verify Indicators with the pertinent process information including
the date, load level and autoclave used.
4. Place one or more properly labeled Verify Indicator(s) in the load to be
autoclaved, at least one per load level.
5. Sterilize according to the contents of the test load.
6. After sterilization processing has been completed, allow cages or equipment
to cool until safe to handle and open.
7. Remove the Verify Indicators from the cages, biohazard bag, etc. and allow
to cool and additional 10-15 minutes.
8. Observe the chemical process exposure indicator (a blue vertical bar)
located on the side of each vial label to verify color change corresponding
to the sterilization cycle, i.e. steam turns the steam process exposure
indicator line to brown.
a) If the chemical process exposure indicator is unchanged, exposure to the
sterilization process may have not occurred. Check sterilization
procedures.
9. If the chemical process exposure indicator on the vial label did change to
the proper brown color and the Verify Indicator has cooled to the touch,
Autoclave Standard Operating Procedure 26

firmly seal the Verify Indicator by placing the Verify Indicator inside the
Verify Activator Cap (Crusher). The Verify Indicator is properly sealed when
the cap is pushed down to the second horizontal black bar on the vial label.
If the Verify Indicator is not going to be incubated soon after activation, it
is recommended that it not be activated, but kept in sealed condition at
room temperature.
10.To activate, push or pull the Verify Indicator completely through the
restricted space on the Verify Activator as shown in figures 3 and 4 in the
pamphlet. The Verify Indicator is properly activated when the growth
medium is released from the crushed ampoule and is in contact with the
spore disc. It is not necessary to shake or invert the activated Verify
Indicator after removal from the Verify Activator.
11.Place the activated Verify Indicators in the incubator block. The incubator
contains a dry heating block for incubation at 55-590 C.
12.At least one well should be used for incubation of a positive growth control,
by incubating a non-sterilized Verify Indicator of the same lot number as
used in the autoclaved cages and equipment.
a) Seal and activate the control Verify Indicator as described in steps 9 and
10 above.
b) Place the control in the same Verify incubator as the test indicator.
c) The non-sterilized positive control will indicate growth within 24 hours
by a change in the color of the medium from deep blue to bright yellow
and turbidity will be evident.
13.The incubator is equipped with a blinking red light on the top indicating
that the correct temperature is achieved for incubation.
14.Check Verify Indicators the morning after and approximately 24 hours later
for steam test results.
a) If sterilization of the indicator was achieved, the test indicator will show
no change during the incubation period, i.e., there will be no turbidity,
and the growth medium will remain deep blue.
b) Verify indicator contain adequate growth medium for incubation up to
seven days if desired. Incubating beyond seven days is not
recommended. If a positive test indicator is observed, there may be a
problem with the procedure or the autoclave.
15.Record results in Appendix 6. If the indicator failed, a second indicator
should be run as soon as possible. If the second test also fails, the
autoclave should not be used until the source of the problem is
corrected or repaired.
16.Following incubation, dispose of processed indicators as you would other
trash. Each package of indicators has an expiration date on the bottom. Be
sure not to use outdated vials.
Autoclave Standard Operating Procedure 27

APPENDIX 3: DART/BOWIE DICK STEAM PENETRATION TEST

A2.1 Purpose
The Bowie Dick test, or the DART (daily air removal test) are used to confirm
that the vacuum system in the autoclave is operating properly. A test pack is
placed in the autoclave chamber in the most difficult area to sterilize, and the
results of the test indicate if there are leaks or air pockets leak in the
autoclave during a prevacuum cycle. This test should be run on a daily basis on
the autoclave in SR410. The autoclave in N3032B cannot be used for
prevaccuum cycles.

The Bowie Dick test was originally developed by J. Dick and J.H. Bowie and
described in The Lancet (1963, pp 586-587) and currently recommend by the
Association for the Advancement of Medical Instrumentation (AAMI).

A2.2 Safety Considerations


Care should be taken when removing test packs following sterilization, as they
will be hot. Heat resistant autoclave gloves should be worn whenever removing
a load from the autoclave.

A properly operating autoclave is essential for safety. Perceived problems


should be reported to the Instrumentation Technician immediately.

A2.3 Procedure
1. The Dart/Bowie Dick test should be run daily.
2. Place the test sheet in a test pack that meets the following specifications
(based on EN 867, Part 3):
a) Composed of smooth bleached cotton towels;
b) Folded to completely cover the test sheet (Approximately 9.5” X 11”);
c) Piled to a height of 10-11 inches;
d) Weighing ~7kg.
3. Run a DART warm up cycle on the autoclave (listed as one of the test
cycles).
4. Place the test pack including the test sheet into the center of the
autoclave, on the bottom shelf and over the drain, and the DART cycle
(132oC with a sterilization time of 3.5 minutes and a dry time of 1 minute).
5. After the cycle is complete, carefully removed the test sheet from the hot
test pack and examine it for uniform colour changes:
a) Non-uniform colour changes or patches of bright blue indicate that
autoclave has failed the test and may not be functioning properly and
the test should be re-run.
b) A second failed test indicates that the autoclave must not be used until
the problem is examined and solved by the Instrumentation Technician
and PPP if required.
6. All BD test results must be recorded in Appendix 6.
Autoclave Standard Operating Procedure 28

APPENDIX 4: TRAINING FORM

Training Sign Off

By signing below, I confirm that I have:

1. Read and understood the Standard Operating Procedure for the STERIS
Century autoclave;
2. Received training on the safe use and proper care of the STERIS Century
autoclave.

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date

__________________ __________________ _________________ ____________


Trainee (print name) Trainee (Signature) Trainer Date
Autoclave Standard Operating Procedure 29

APPENDIX 5: AUTOCLAVE USER LOG


Autoclave Standard Operating Procedure 30

DATE NAME EXT # SUPERVISOR TIME IN MATERIAL TYPE OF TIME OUT PROBLEMS /
STERILIZED RUN COMMENTS
Autoclave Standard Operating Procedure 31

APPENDIX 6: PREVENTATIVE MAINTENANCE LOG


Autoclave Standard Operating Procedure 32

DATE NAME EXT # TYPE OF MAINTENANCE FREQUENCY OF MAINTENANCE PROBLEMS / COMMENTS


(I.E. WEEKLY)
Autoclave Standard Operating Procedure 33

SAMPLE REGULAR MAINTENANCE SCHEDUALE FOR THE RESEARCH AUTOCLAVE IN SR410


SUN MONDAY TUESDAY WEDNESDAY THURSDAY FRIDAY SAT
1 2 3 4 5 6
Clean chamber filter Clean chamber filter Clean chamber filter Door gaskets Clean chamber filter
Check the log book Check the log book Check the log book Sight glass Check the log book
Check the printout Check the printout Check the printout Door operation Check the printout
Flush steam generator
Flush chamber drain
Vacuum leak test
Dart/Bowie Dick test
Biological Indicator
7 8 9 10 11 12 13
Clean chamber filter Clean chamber filter Clean chamber filter Door gaskets Clean chamber filter
Check the log book Check the log book Check the log book Sight glass Check the log book
Check the printout Check the printout Check the printout Door operation Check the printout
Flush steam generator
Flush chamber drain
Vacuum leak test
Dart/Bowie Dick test
Biological Indicator
14 15 16 17 18 19 20
Clean chamber filter Clean chamber filter Clean chamber filter Door gaskets Clean chamber filter
Check the log book Check the log book Check the log book Sight glass Check the log book
Check the printout Check the printout Check the printout Door operation Check the printout
Flush steam generator
Flush chamber drain
Vacuum leak test
Dart/Bowie Dick test
Biological Indicator
21 22 23 24 25 26 27
Clean chamber filter Clean chamber filter Clean chamber filter Door gaskets Clean interior chamber
Check the log book Check the log book Check the log book Sight glass Disinfect exterior
Check the printout Check the printout Check the printout Door operation Steam supply strainer
Flush steam generator Water supply strainers
Flush chamber drain
Vacuum leak test
Dart/Bowie Dick test
Biological Indicator

28 29 30 31
Clean chamber filter Clean chamber filter Clean chamber filter
Check the log book Check the log book Check the log book
Check the printout Check the printout Check the printout

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