Temperature control is important in the warehouse to maintain product integrity throughout its shelf life. Exposure to extreme temperatures can cause damage to medicinal products and/or loss in therapeutic effects. It may not even be obvious.
For temperature-controlled warehouses, companies are expected to create a temperature map of the facility. This map will help to determine the best areas in which to store goods. This map is created by a preliminary study. It will show you where potential problems might be.
Following initial mapping, the temperatures are monitored daily or continuously on a routine basis. Monitoring may show seasonal patterns that could indicate temperatures rising or falling outside of approved limits. It is crucial to monitor temperature profiles in MHRA approved warehousing UK throughout the year, especially during winter and summer. Several companies use an electronic building management system to monitor their buildings.
Ambient temperature storage
Different companies and regulators have different meanings for the terms “room” and “ambient” temperature storage conditions. The term “temperate storage” is now more commonly used. Temperate storage is defined as storage temperatures between 15 and 30 degrees Celsius, with occasional exceptions.
Although temperature storage regulations can vary from product to product, most licensed products have a maximum limit of 25degC and no lower limit other than “protect from freezing”. The temperature range for temperate storage is 8 to 15 degrees Celsius according to inspectors.
Additional requirements to temperature control
- The conditions of storage for goods must be compatible with those conditions as specified on the labels.
- Temperature recording devices should be used to monitor controlled storage areas. All records must be reviewed, filed, and their results tabulated.
- Both an alarm and visual signal should be installed in the freezer and frozen storage areas. Only an authorized person can reset this signal.
- If temperatures are found to be outside of the recommended temperature for a prolonged period, contact the manufacturer to resolve the issue.
- To ensure accuracy, temperature monitoring equipment should be calibrated regularly.
How do I create a temperature map?
One simple example of temperature control is the location of material stored within the warehouse. If material is stored higher in the warehouse, it will heat up more. Therefore, goods that require cooling will not be placed near the ceiling.
- Analyze the temperature profile and find potential hot and cold areas.
- Use calibrated temperature monitoring instruments to identify areas at greatest risk.
- Develop a temperature mapping validation protocol.
- Based on your initial findings, you can begin monitoring on a regular schedule.
- Create a temperature map of your premises.
- Consider the hot and cold zones when temperatures outside are extreme.
- Check out the controls for heating and cooling systems.
- If temperatures become compromised, ensure there is an action plan.
Cold storage is the storage of products that need to be kept at 2degC-8degC or when material must be frozen (e.g. Below -20degC and below -70degC
A successful cold storage operation requires that the facility selects the correct temperature recording instrumentation, validates its processes, and documents records and procedures. This includes responding to alarm conditions.
Tools used in the warehouse
It is crucial to choose the right recording instrument. It is important that the instruments can be read easily and that data can be retrieved. The calibrated instruments should conform to national standards (the company should keep a copy of the calibration certificate), and an alarm for high/low temperatures should be included. Usually, max/min thermometers will not be accepted.
It is important to record both product and air temperatures. It is important to note that product temperature can fluctuate significantly more than air temperature (often called “load”) temperature.
Documentation and validation of temperature control
Validation efforts should:
- You can prove that temperature mapping is accurate for extreme temperatures.
- Check on temperature variations during use.
- Demonstrate your ability to perform in the face of power failure.
- Demonstrate alarm function.
There are specific procedures that must be followed:
- Temperature records are checked at the beginning of each day and recorded in a log.
- What do you do if certain staff members are not available?
- Alarm conditions:
A program should be established to review the cold storage controls as part of a self-inspection program. It should include a weekly and monthly review of cold store temperature records.
Alarm signals sent out-of-hours are often sent to contractors or security personnel offsite. As false alarms can lead to a signal being ignored, the alarm system must work reliably. Many examples in the industry show stock that has been damaged by electrical failures in warehouses. The alarm system should be independent of the main electrical system.
A written procedure must be established for how to respond to a temperature alarm monitor signaling a problem. The procedure should include the initial actions (e.g. This procedure should cover both initial action (e.g., storing the product in cold storage) and any subsequent actions. A current and up-to-date list of emergency numbers should be available. There should also be a plan for relocating any products at risk of damage (e.g. frozen stock). The response must be immediate. This means that the process should not wait for weekends.
Protecting sensitive material
Many companies (particularly companies manufacturing biologicals and vaccines) handle, store, and transport temperature-sensitive raw materials and finished products. The protection of temperature-sensitive products is critical to their effectiveness and safety.
Excessive heat, moisture, light, or repeated freeze/thaw cycles can all lead to product degradation.
Frosted materials can be stored at temperatures below -20°C, but some materials need to be frozen at -80°C. Temperatures will rise slowly over many hours if they are high enough. Some of the frozen materials may begin to deteriorate or deteriorate once the temperature reaches a certain level. If the temperature rises, a written plan must include a contingency plan for relocation.
Auto defrost refrigerators
Some cold storage refrigerators come with an automatic nightly freeze cycle. However, they may not be suitable for some frozen products as they can melt and refreeze quickly, leading to deteriorating and degrading.
Heat and Moisture
Most medicinal products are sensitive and can degrade at higher temperatures. Some products can be degraded at room temperature while others can withstand higher temperatures for longer periods. It is difficult to determine which products are most at risk of degrading at what temperatures.
To prove they won’t degrade in storage, all products must pass stability tests
GMP regulations require that products are kept within the approved temperature ranges. A deviation notice should be issued if the product is subject to extreme heat.
If products are not sealed properly, they can absorb moisture from the air. Incorrect storage of products on concrete floors or walls can lead to moisture problems.