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Fridge Guard - The Requirement.

‘Refrigerated Storage of Controlled Drugs’.

Fridge Guard - The consequences of drugs being stored in out of specification temperatures, is alarming. The very thought of staff working in highly contagious situations relying for protection on vaccines that may have been rendered useless, by faulty storage, is horrendous.

The specification given for most drugs is 3°C to 8°C, this should be easily achieved using a properly monitored and controlled refrigerator.(one using Fridge Guard.)

When a drug is developed, tested, and approved by the regulators, all aspects of its manufacture, performance and storage are defined. The approval of the drug is therefore directly tied to this definition. Deviate from it, and the original proven drug efficacy cannot be guaranteed. Storage conditions are one of the defined parameters, deviation from them removes the guarantee that the drug will perform exactly as specified, or perform at all.

Expect Regulators to Examine Your Cold Chain

MANUFACTURE  -  STORAGE  -  WHOLSALE  -  RETAIL  -  DISPENSARY

* + 2 Degrees Centigrade -- to --  + 8 Degrees Centigrade *

Out of Control Refrigerators

There is a real problem with refrigerators that are used in clinics, wards, dispensaries and surgeries, without the protection of FRIDGE GUARD. Reading through the Grampian report show nearly a thousand damaged vacines administer over a relatively short period of time, by what is one of the smallest health authorities in the UK. An authority that has to be admired for its frankness.

So where does the problem lie?

Manufacturers of industrial refrigerators (machines with all the monitoring and protection that is really required) have never found a market for small fully compliant smaller refrigerators. End users when faced with purchasing a fully compliant (Pharmaceutical Regulatory) refrigerator, at a ten fold price premium over a household type machine, have often reneged, and opted for what they see as a more cost effective solution.

So what is the solution?

To understand the solution you must understand what is missing from the standard domestic type refrigerator and how FRIDGE GUARD. can make such a refrigerator compliant with cGMP requirments. These requirements are detailed in the practices and procedures manuals issued by every every regional Health Authority, so there is no excuse for not being aware of them. Europe, and USA, here is a very useful Vaccine Management Guide from Utah.. The standards given in these document must be applied to the storage of all medicines.

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CLICK HERE FOR THE - FRIDGE GUARD - SOLUTION.

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To comply with cGxP what does a standard refrigerator require to be fitted with?
An external indication of internal temperature.
An external indicator allows observation of trends, is it low? Is it high? Is it OK? Has some unauthorised person adjusted the thermostat?

A door not closed alarm.
Often the door bounces back when slammed shut, often it fails to close if not slammed. A warning to all users that the door should be open for the minimum amount of time. Adjustable, but normally set to 15 seconds delay before alarm is activated.

A power cord electric power on or off alarm.
Often unplugged accidentally by cleaners or trades men or inadvertently switched off. Has been known to be unplugged sometimes for months.

A temperature out of specification alarm.
Since the temperatures are not usually indicated, it is mainly guess work as to what the actual temperature range is. The normal thermostat is very vague in operation.

Secure controlled access.
A mandatory requirement, that ensures only authorised staff have access to the cabinet contents, and that the cabinet contents is managed in accordance with approved protocols.

A temperature data logger.
There is no record of thermal performance, no judgement can be made whether the contents have been safely stored. If it comes to proving your Cold-Chain is intact, you can not.


Fridge Guard


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