SOP for Cleaning of Oven for Depyrogenation
Standard Operating Procedure (SOP) for Cleaning of Depyrogenation Oven
1.0 Purpose
To establish a procedure for the cleaning of the hot air depyrogenation oven used for removal of pyrogens from glassware and equipment, ensuring compliance with cGMP requirements and preventing contamination.
2.0 Scope
This SOP applies to all depyrogenation ovens located in the Microbiology/Quality Control/Production areas of the facility.
3.0 Responsibility
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Operator/Analyst: To perform cleaning as per this SOP and record details.
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QC/Production Head: To verify cleaning and ensure compliance.
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Engineering/Maintenance: For servicing and preventive maintenance.
4.0 Definitions
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Depyrogenation Oven: A controlled hot-air oven used to remove pyrogens and sterilize heat-resistant materials at high temperatures (≥ 250°C).
5.0 Procedure
5.1 Pre-Cleaning Checks
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Ensure the oven cycle is complete and the equipment has cooled (< 40°C).
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Switch OFF the power supply and disconnect from the main supply.
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Wear appropriate PPE (lab coat, sterile gloves, goggles, mask).
5.2 Internal Cleaning
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Remove detachable trays, racks, and shelves carefully.
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Clean all detachable parts using a lint-free cloth soaked in 70% Isopropyl Alcohol (IPA) or approved disinfectant.
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Wipe the interior surfaces (walls, floor, ceiling, and door gasket area) with lint-free cloth and 70% IPA.
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Ensure no fibers, residues, or cleaning agent droplets are left inside.
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Allow surfaces to dry completely before reassembling trays/shelves.
5.3 External Cleaning
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Wipe external surfaces of the oven with a lint-free cloth dampened with 70% IPA or mild detergent solution.
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Pay attention to control panel and handles; do not allow liquid to enter electronic parts.
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Dry thoroughly with a clean, lint-free cloth.
5.4 Post-Cleaning
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Reassemble trays/racks inside the oven.
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Close the oven door properly.
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Switch ON the oven for 15–30 minutes at ~100°C (dry heat cycle) to remove any residual disinfectant vapors.
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Record cleaning activity in the Equipment Cleaning Logbook (date, time, cleaned by, checked by).
6.0 Frequency
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Routine Cleaning: Once a week.
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Deep Cleaning: Once a month or after any major spillage/contamination.
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Immediate Cleaning: After visible dust, breakage, or contamination incident.
7.0 Precautions
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Do not use abrasive scrubbers, strong acids, or alkalis.
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Avoid excess liquid inside the chamber to prevent damage to heating elements.
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Ensure oven is completely cooled before cleaning.
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Always use approved cleaning agents only.
8.0 Documentation
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Record all cleaning activities in the Oven Cleaning Logbook.
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Cross-check and sign by a supervisor/QA representative.
9.0 References
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Manufacturer’s Instruction Manual
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cGMP Guidelines
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WHO Laboratory Biosafety Manual
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