Maintenance

 

 Maintenance & Calibration Checks for Pharmacy Refrigerators

 

This is a cumulative guide based on information collated from legislative agencies

 

Why have calibration and maintenance checks?

 

To meet Cold Chain Compliance. Good Distribution  Practice (GDP)  states: Equipment, repair,    maintenance  and  calibration    operations  should  be  carried  out  in  such  a  way  that  the  integrity  of  the  medicinal  products  is  not  compromised.

In order to achieve this - legislative agencies such as. MHRA, RPS, and GPD recommends annual maintenance and calibration checks to ensure that pharmacy refrigerators are operating correctly. 

Between annual checks general maintenance is also required such as regular cleaning and defrosting. This guideline can be found in the Standard Operating Procedure Manual (SOP) which is designed to ensure maintenance of the cold supply chain of pharmaceuticals. The SOP States:   The fridge should be cleaned and, if not automatic, defrosted on a regular basis (monthly). Download Standard Operating Procedure (SOP).

It can be easily assumed that your pharmacy refrigerator is operating efficiently but a lot of things can affect its optimal performance. Potential maintenance issues include:

 

  • Over-packing which may result in the blocking of the fan which circulates the air and can lead to the pharmacy refrigerator freezing up. Products should be stored in an orderly fashion on shelves not on the floor of the unit — to ensure air circulation and consistent temperatures throughout. Ref: Steve Todd. GDP Medicines Inspector, MHRA.

  • The door left open for a long period of time.

  • An accumulation of dust and dirt around the compressor and condenser during standard operation which can affect operation of the cooling system.

  • Elevated environmental temperatures where the pharmacy refrigerator is situated. (To meet the demands of high temperature climates - some pharmacy refrigerators have a higher tolerance for high ambient temperature and superior CFC-Free Insulation, N/A to the UK).

  • Another potential hazard that may be overlooked is: ordering an appliance that is too much of a tight fit for the space it’s going into. Pharmacy refrigerators require sufficient space for air circulation and ventilation to avoid a rise in temperature surrounding the appliance.

Regular maintenance will increase the life span, reliability, and energy efficiency of your system. More importantly - Cold chain compliance is paramount to patient safety. Also essential for medicine recall wastage.

Temperature Monitoring

Attentive monitoring of your pharmacy refrigerator will soon flag up any fluctuation in temperatures and potential hazards that could affect operation. If your pharmacy refrigerator is fitted with an audible or visual alarm, don’t assume that it is working unless it has been routinely tested to confirm correct operation.

 

Specification required for a pharmacy refrigerator

 

1. Temperature between +2°C and +8°C: Temperature monitoring is recorded by a calibrated electronic min/max thermometer, with an accuracy of ±0.5C, which can be read without opening the refrigerator door.

2. Fan assisted: The air within this type of refrigerator is circulated by a fan, which provides a uniform temperature profile and a rapid temperature pull down after the door has been opened.

3. Lockable: Additional benefits are that these refrigerators can be locked.

4. Audible and visual/high and low alarm: These alert & alarm systems alert staff in the event of temperature deviations, for example, if the door is left open, giving you ample time to restore the inside of the fridge to the correct temperature without losing products or endangering health.

5. Maximum and minimum recording: The temperature should be checked a minimum of once a day using a minimum and maximum thermometer in accordance with the manufacturer’s instructions. FOR VACCINE STORAGE: (Each fridge will have its own internal thermometer).This is then checked with the digital fridge display. A loss of power will result in the loss of temperature display, hence the need for an internal thermometer as well. The Green Book, chapter 3’ states:At least one maximum-minimum thermometer that is independent of mains power should be used (as well as any integrated thermometer), so temperatures can be measured in the event of electricity loss.

Other features to consider:

Data Loggers: Temperature monitoring systems can record temperatures at configurable intervals (e.g. 30 or 60 minutes) to ensure that pharmaceuticals are stored at the correct temperature and that the pharmacy refrigerator is working properly. This feature is bonus for maintaining regulatory compliance as it provides a complete audit, and especially when clinics are closed or members of staff are unavailable to check and record refrigerator temperatures consistently.

A data logger can indicate the actual length of time a pharmacy refrigerator was out of range whereas a thermometer will only display whether it was out of range according to the parameters set. Considering the expense of high value medications the use of data loggers could serve as insurance against financial loss and mechanical failure.

Even though certain medications can exceed the labelled storage temperature requirements for brief periods, without a data logger, the length of time the pharmacy refrigerator has been out of range and therefore products are more likely to be destroyed.

Glass or solid door model: Many refrigerators have glass fronted doors giving greater visibility to stock levels, aiding stock management and also deterring the storage of non-medicinal products. A solid door pharmacy refrigerator will be a better option if it is to be located in direct sunlight or in a public area where the contents should be hidden.

 

 

Action to be taken in the event of temperature deviations:

Temperature records should identify any temperature deviations and give details of corrective actions taken as a result. For instances where there has been a temperature deviation, best practice would be to take a further reading later the same day, to ensure that it was a transient deviation and show that the temperature was now back within prescribed parameters. (Royal Pharmaceutical Society RPS).

 

QED Scientific® Maintenance and Health Checks.

On a maintenance visit we check:

 

-  Internal condition of chamber, shelves, shelf supports

-  Internal fan is working, check for signs of fan excessive wear or possible failure

-  External condition

-  Door hinges and door seals, and integrity of glazed doors

-  Feet, stability of cabinet

-  Temperature controls within prescribed limits +2C to +8C

-  Calibration check traceable to UKAS (we use approximate geometric mid point)

-  Alarm check

-  Clean evaporator and compressor area

-  Clean defrost drain

 

Plus -Issue a written report with UKAS traceable certificate

 

DOWNLOAD PDF VERSION

 

  


General Maintenance and Servicing on all QED products

 

In order to ensure that your QED items are always performing at their  best it is important that the equipment is inspected at least once each year. There could also be Health and Safety implications if equipment is not properly maintained and subsequently is found to be implicated in erroneous results or employee injury. In the litigious society that we all live in today to not have annual preventative maintenance inspections is short sighted and may well prove to be costly.

 

  • All electronic test equipment used by QED Scientific is re-calibrated annually to UKAS standards.
  • All items are marked with the UKAS sticker.
  • All calibrations come with a copy of the UKAS traceable certificate.
  • All in-house QED engineers are factory trained. We sometimes contract out to our supplier or manufacturer engineers or use specialist service organisations where their forensic abilities can be utilised more efficiently.
  • All QED engineers that visit hospitals carry the new MIA card that shows that each engineer has passed an examination on hospital etiquette and procedures.

 

This is especially relevant in operating theatres where admittance to sales and servicepersonnel is restricted past the reception desk to those with the MIA card. No card - No entry!

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