2025年 6月 11日 (星期三）
就算已经不在 biopharmaceutical 的公司里工作了，但是依然想把自己填满知识。
恰巧在 linked in 里看到 FC-BIOS 有给关于 freezer 的 webinar, 索性就参与。
以前比较少这一类型的 webinar, 加上没有经验，真的很无知。
从 FC-BIOs presentation 里取出重要的，方便阅读。
用了 chat gpt，收集而来的资料：
Maintaining consistent freezer performance is critical for preventing temperature excursions, which can compromise the quality and safety of stored products, especially in sensitive fields like pharmaceuticals, food and biotechnology.
Temperature excursions refer to any fluctuation in temperature that deviates from the required storage conditions, and they can lead to spoilage, degradation or loss of efficacy.
How to Prevent Temperature Excursions & Ensure Consistent Freezer Performance?
1. Regular Monitoring of Temperature
> Use Real-time Monitoring Systems: Install temperature sensors inside the freezer that continuously record and monitor temperatures. Many modern systems send real-time alerts via email or SMS if temperatures deviate from the set range
> Set up Automated Alerts: Automated alerts help you immediately identify and respond to any temperature fluctuations, ensuring that you can take quick corrective actions
> Periodic Manual Checks: Even with automated systems, perform manual temperature checks to ensure the digital system is working correctly
2. Proper Freezer Calibration and Maintenance
> Calibrate Regularly: Freezers should be calibrated at least once a year or more frequently if they're used to store critical materials. Calibration ensures that the thermometer or temperature sensor is providing accurate readings
> Clean and Defrost: Regular cleaning and defrosting of freezers prevent ice build-up, which can impair the freezer's efficiency and cause temperature fluctuations
> Inspect and Replace Gaskets: Check the freezer's door gaskets for wear and tear. Gaskets that aren't sealing properly allow cold air to escape and warm air to enter, leading to temperature inconsistencies
> Maintenance Schedule: Follow the manufacturer's guidelines for routine maintenance, such as checking the compressor, evaporator coils, and condenser. Neglecting these components can lead to poor cooling performance
3. Optimize Freezer Load
> Avoid Overloading or Underloading: Overloading a freezer reduces air circulation, which can lead to uneven temperatures. Similarly, an underloaded freezer might struggle to maintain a consistent temperature because the cold air circulates too freely without enough items to stabilize it
> Allow Proper Airflow: Ensure that items are not packed too tightly, allowing cold air to circulate properly around the contents. If possible, use shelving to organize items and improve air circulation
4. Use Backup Power Systems
> Install Uninterruptible Power Supply (UPS): In case of a power failure, a UPS can provide enough backup power to maintain the temperature in the freezer long enough for you to take corrective actions, such as moving the contents to another freezer
> Consider Backup Generators: For critical facilities or those located in areas prone to power outages, backup generations can be a worthwhile investment, ensuring that the freezer runs smoothly even during an outage
5. Freezer Location
> Avoid Direct Sunlight and Heat Sources: Place the freezer in a cool, dry and well-ventilated area. Exposure to direct sunlight or proximity to heat sources (like ovens or machinery) can affect the freezer's performance
> Ensure Proper Ventilation: Freezers need goof airflow to function efficiently. Ensure that there's enough space around the freezer to allow air circulation, particularly around the vents and compressor
6. Monitor and Adjust Set Points
> Know Ideal Temperature Ranges: Make sure you are aware of the required temperature range for your products and set the freezer to those precise settings
> Allow for a Buffer Zone: While setting the temperature, account for small variations to avoid excursions
> Avoid Frequent Temperature Changes: Do not constantly adjust the temperature. Frequent changes can cause instability and strain the system, which can lead to performance problems
7. Implement Emergency Protocols
> Develop and Train on Standard Operating Procedures (SOPs): Establish clear SOPs for handling temperature excursions, such as how to respond to a temperature deviation, how to document the event, and how to mitigate potential risks to stored products
> Establish Contingency Plans: Have a backup freezer or off-site storage solution in case of equipment failure or temperature excursions
> Log All Events: Record any temperature excursions, the length of time the temperature deviated, and the corrective actions taken, This will help in tracking and improving the storage process
8. Use Backup Freezer Equipment
> Install Multiple Freezers for Redundancy: in highly critical environments, having multiple freezers allow you to distribute products and reduce the risk of loss due to a single freezer failure
> Invest in Secondary Monitoring: Some companies install secondary, independent temperature logging systems to cross-check the readings of the primary system, ensuring more reliability in case of malfunctions
9. Document and Report
> Maintain Records: Regularly document all temperature readings and maintenance activities. This will ensure traceability in case of an audit or investigation and can be valuable for quality control
> Audit Your Equipment: Conduct regular audits to check whether the freezer is performing according to standards and whether any potential upgrades or replacements are needed
Maintaining consistent freezer performance is a critical aspect of preventing temperature excursions. Regular monitoring, proper maintenance, and creating an environment that supports efficient freezer operation will ensure optimal performance. By taking the necessary steps to prevent temperature fluctuations, you can protect the integrity of your products and avoid the risk of spoilage or degradation
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