D-824

Operation and Cleaning of the Autoclaves in the QC Laboratory

Section D — Laboratory Operations and Specifications Revision 8 10 pages

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1.0 Purpose

The purpose of this procedure is to define the process for the cleaning and operation of the
autoclaves located in the QC Laboratory.

2.0 Scope

The procedure covers the weekly and monthly cleaning and quarterly testing of the autoclaves
when in use. Specific procedures are also given for sterilizing wrapped and unwrapped

utensils, glassware, plastics, and liquids.

3.0 Responsibility

301 It is the responsibility of QC Laboratory personnel to follow this procedure.

3.2 It is the responsibility of QC Laboratory Management to implement this procedure and
to ensure that the procedure is being followed.

3.3. It is the responsibility of QC Laboratory Management or designee to keep this
procedure aligned with current practices.

4.0 Definitions

4.1 QC — Quality Control

4.2. PQV-— Process Quality Verification

5.0 References

5.1 Tuttnauer EZ10 Operation and Maintenance Manual

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5.2. Tuttnauer 3850EA Operation and Maintenance Manual

5.3 C-502, SOP, Record Storage, Retention, and Destruction

5.4 C-501, SOP, Document Control Procedure

53 A-106, SOP, Documentation Guidelines for cGMP Records

5.6 D-824-F1, Form, Autoclave Usage Log

5.7 D-824-F2, Form, Autoclave Cleaning Log

5.8 D-824-F3, Quarterly Testing Log for Autoclave

6.0 Procedure

6.1 Weekly Cleaning

6.1.1 Each week of operation, the below defined tasks must be performed. Document

on Form D-824-F2 Autoclave Cleaning Log.

6.1.1.1 Cleaning the chamber and trays

6.1.1.1.1 Drain the water from the reservoir using the drain tube
located on the front of the unit.

6.1.1.1.2 Wash the inside of the chamber and trays with mild soap or

Speed-Clean and Millipore water.

6.1.1.1.3 Refill the reservoir with Millipore water.

Note: Do not use abrasive or bleaching agents in the chamber,
such as scouring powder, steel wool, bleach, or wire

brushes.

6.2. Monthly Cleaning

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6.2.1 Each month of operation, the below defined tasks must be performed.

Document on Form D-824-F2 Autoclave Cleaning Log.

6.2.1.1 Cleaning the chamber and plumbing

6.2.1.1.1 With a cooled chamber, drain the reservoir and fill it with

clean Millipore water.

6.2.1.1.2 Add one packet of Chamber Brite autoclave cleaner directly

to the bottom of the chamber.

6.2.1.1.3 Run one “Wrapped” cycle with dry time set at zero.

6.2.1.1.4 Drain the reservoir and refill it with Millipore water.

6.2.1.1.5 Rinse by running one “Unwrapped” cycle.

6.2.1.1.6 After the cycle has completed, drain and refill the reservoir
with Millipore water.

6.2.1.1.7 Allow the sterilizer to cool.

6.2.1.1.8 Remove the trays and tray rack and wipe off with a damp

cloth.

6.2.1.1.9 Wipe out the inside of the chamber, using care not to

damage the heating element, steam temperature probe, or

level sensor probe.

6.2.1.1.10 Reinstall the tray rack.

6.3 Quarterly testing for Bacillus stearothermophilus ATCC 7953 to ensure steam
production

6.3.1 Each quarter of operation, the below test is required to be performed. Document

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on Form D-824-F3 Quarterly Testing Log for Autoclave.

6.3.1.1 Place a test strip in autoclave (10° spore population) in a small sterile
tube with cap. Fill with TSB broth, making sure to completely

submerge the strip.

6.3.1.2 Press the program “3” button.

6.3.1.3 Press the “Start” button.

6.3.1.3.1 Conditions: 250°F (121°C), 16psi, sterilize 25min; dry
25min, slow vent.

6.3.1.4 Allow all liquids to cool for one hour before handling.

6.3.1.5 Prepare a second sterile tube with a test strip and TSB broth, but do not

autoclave. Place both tubes in a heating block set at 55°C for 5 days.

6.3.1.6 Analyze the autoclaved test strip for the presence of Bacillus

stearothermophilus. The test strip that was not autoclaved should
display luxuriant growth; if there is no growth, assess whether there

was a problem during sample preparation or incubation and repeat

testing.

6.4 Sterilizing unwrapped instruments (Program 1)

6.4.1 When appropriate, attach a piece of autoclave tape to each instrument.

6.4.2 Place the instruments or tubing loose on the tray.

6.4.3 Press the “Unwrapped” button.

6.4.4 Press the “Start” button.

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6.4.4.1 Conditions: 270°F (132°C), 28psi, sterilize 3min; dry Omin.

6.5 Sterilizing wrapped instruments and porous loads (Program 2)

6.5.1 Place the instruments or tubing in an appropriate sized autoclave pouch with an

indicator and seal.

6.5.2 Place the pouched or loosely wrapped instruments on the tray.

6.5.3. Press the “Wrapped” button.

6.5.4 Press the “Start” button.

6.5.4.1 Conditions: 270°F (132°C), 28psi, sterilize 7min; dry 30min.

6.6 Sterilizing glassware (Program 3)

6.6.1 Wrap the instruments in aluminum foil, cover the openings of the
glassware/plasticware with aluminum foil, cover capped bottles with aluminum

foil and make sure the cap is loosened % turn.

6.6.2 Attach a 1 to 2 inch strip of autoclave tape to each piece on the aluminum foil.

6.6.3 Place the packs, glassware and/or plasticware loosely spread out on the tray.

6.6.4 Press the “Glassware” button.

6.6.5 Press the “Start” button.

6.6.5.1 Conditions: 250°F (121°C), 16psi, sterilize 30min; dry Omin.

6.6.6 Allow all glassware to cool for fifteen minutes before handling.

6.7 Sterilizing liquids

6.7.1 Cover all openings on glassware containing liquids with aluminum foil, cover

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capped bottles with aluminum foil and make sure the cap is loosened % turn.

6.7.2 Place containers with liquids loosely on tray. Do not exceed 2.0 liter of total
liquid volume to be sterilized.in the small autoclave, and 4.0 liter of total liquid

volume to be sterilized in the large autoclave. Place autoclave tape on outside

of container.

6.7.3 Press the program “3” button.

6.7.4 Press the “Start” button.

6.7.4.1 Conditions: 250°F (121°C), 16psi, sterilize 25min; dry 25min, slow

vent. (PSI and Time may vary according to liquid being processed, see
manufacturer instructions)

6.7.5 Allow liquids to cool for one hour before handling. Check to see that autoclave
tape indicates sterilization.

6.8 Logging use and cleaning of the Tuttnauer Autoclaves

6.8.1 Prior to running the autoclave, complete the log book entries on Form D-824-F1
Autoclave Usage Log for description of process, program, temperature,

pressure, time, analyst and date.

6.8.2 At the completion of the autoclave cycle, review the tape and check that during

the sterilization phase the temperature did not exceed +/- 4°C from target and the
pressure did not exceed +/- 2psi the operation temperature and pressure. Log

information on Form D-842-F1 Autoclave Usage Log.

6.8.2.1 Alternatively, if no print-out is available from the autoclave, ensuring

the autoclave tape indicates sterilization was completed is also

acceptable.

6.9 Refer to manufacturer’s operation and maintenance manual for complete instructions on

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programming, cleaning and operating the autoclave.

6.10 Documentation will be maintained following SOP C-502 Record Storage, Retention,

and Destruction and C-501 Document Control Procedure.

6.11 A PQV check must be performed for each completed logbook page as outlined in SOP

A-106 Documentation Guidelines for cGMP Records.

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 1 | 01/17/13 | New - - | - | - |
| 2 | 04/03/13 | Changed SOP log. Added section 5.9. Changed monthly testing to quarterly testing in section 5.3 12/02/14 Updated format. Added Form D-824-F2. Updated Form D-824- 14-0969 B. Johns F1. Updated responsibilities. | 13-238 | B. Johns |
| 4 | 04/04/17 | Biennial review: Changed conditions in steps 6.3.3.1 and 6.7.4.1 Updated for new autoclave model and changed title to reflect. p) 04/18/18 Clarified quarterly testing for Bacillus stearothermophilus ATCC 18-0128 E. Johnson 7953. | 16-1101 | N. Zhan_g |
| 6 | 06/01/21 | Updated SOP to include both models of Autoclave CC- Updated SOP to ensure time is included as well as PSI, Added that | 21-0225 | G. Shaw |
| 7 | 02/02/23 | PSI and time can be changed according to manufacturer CC- instructions on liquid being autoclaved. Added Form D-824-F3 for clarity on quarterly testing. Other | 23-0060 | G. Shaw |
| 8 | 10/02/23 | minor edits. Made SOP more general. Added documentation CC- requirements. Updated logo. | 23-0514 | J. Sassman |

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Autoclave Usage Log
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py ruztiona Form: D-824-F1 CCRNo. -CC-23-0514 Revision: 8

Logbook Number: Logbook Page:

Pass Ol Fail

Items Autoclaved:
Item Name Lot Number Expiration Date Qty Size Notebook #/Page#

Comments:

Performed By/Date:

Reviewed By/Date:

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