Standard Operating Procedure (SOP) For Autoclave Hirayama HVE-50

Objective

To provide a comprehensive guide for the operation, maintenance, and troubleshooting of the Autoclave Hirayama HVE-50, ensuring effective sterilization of media, glassware, laboratory equipment, and waste decontamination.

Scope

This SOP is applicable to all sterilization activities using the Autoclave Hirayama HVE-50, including media preparation, glassware sterilization, lab equipment sterilization, and waste decontamination.

Responsibilities

Roles and Tasks

• Analyst/User/Technical Staff
  • Perform tasks as outlined in the SOP.
  • Maintain and record all activities per the SOP.
• Analyst/DTM/TM/DQMSM
  • Draft and update the SOP to ensure compliance with Good Laboratory Practices (GLP).
• QMS Manager
  • Review and ensure SOP adherence to prescribed formats.
  • Monitor implementation of SOP-related activities.
• Technical Manager
  • Supervise technical procedures in line with the SOP.
• Head Of Organization
  • Authorize the SOP and verify activity implementation.

Terms & Definitions

• SOP: Standard Operating Procedure
• QMS: Quality Management System
• DQMSM: Deputy QMS Manager
• GLP: Good Laboratory Practices
• PSI: Pounds per Square Inch
• Calibration: Aligning measurement equipment to standard benchmarks.
• Validation: Assessing the performance of measurement equipment.

Procedure

Responsibilities and Tasks

• Installation: Service Engineer/Vendor
• Transportation: DMO/BME
• External Calibration: Vendor
• Preventive Maintenance: Analyst/DMO/BME
• Service: Service Engineer/Vendor
• Autoclaving: Analyst/Senior Microbiologist/Assistant Bacteriologist

Operating Procedure

1. Powering On:
   • Turn ON the breaker.
   • Press the power ON/OFF switch.
2. Water Pouring:
   • Ensure the water level is sufficient for the sterilization cycle.
3. Loading Items:
   • Place items in the chamber, leaving room for steam circulation.
4. Setting Parameters:
   • Adjust temperature (121°C), pressure (15 PSI), and time (5 minutes).
   • Use Mode 1 for default settings, including warming at 50°C and natural cooling (P-0).
5. Starting the Cycle:
   • Lock the lid and press the start button.
   • Monitor the sterilization cycle on the display.
6. Completion:
   • Allow temperature to drop to 50-65°C before unloading.
   • Loosen the pressure nozzle, if necessary.
7. Unloading:
   • Unlock and open the lid.
   • Use insulated gloves to remove items.

Precautions

• Maintain the exhaust water level between LOW and HIGH.
• Avoid overloading to ensure proper steam circulation.
• Do not open the chamber until the pressure and temperature are safe.
• Use heat-resistant gloves for handling hot items.
• Allow items to cool before transportation.

Troubleshooting

Error Code	Description
Error:1	Lack of water alarm
Error:2	Temperature sensor wire breakage
Error:3	Over-temperature alarm
Error:4	Over-cool alarm
Error:5	Over-pressure alarm
Error:6	Lid open alarm
Error:7	Automatic exhaust valve trouble alarm
Error:9	Sterilization heater trouble alarm
Error:L	Open/close lever locking failure
Error:E	Exhaust bottle anomaly alarm

For detailed troubleshooting, consult the instrument manual.

Verification

• Use steri tape or steri gauge to verify sterilization effectiveness.
• Ensure visible color change to confirm sterilization.

Calibration

• Perform annual external calibration to maintain accuracy.