MHRA outlines dos and don’ts for storing temperature sensitive medicines

The UK Medicine and Health Products Regulatory Agency (MHRA) has identified some crucial mistakes in how wholesalers source and handle freezers and fridges used to store medicines

They clarified that the main metrics to measure when sourcing GDP qualified equipment are:

•     The purpose – is it to store cold packs to be used in transit or to host frozen products?
•     Temperature bracket required.
•      Capacity.
•      Defrost capabilities.
•      Durability.
•      Sanitation access.
•      Speed of cooling materials to desired temperature.
•    Risk impact of the installation – how the heat produced by the freezer will impact the close environment.

“The first step is to acknowledge the problem, and then you can move on to risk management and analysis”

With insight from sector experts, learn how to identify weak points in your pharma supply chain and how you can secure them. Download the Pharma Logistics IQ report.

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The body clarified that domestic freezers may not have the capability to quickly freeze cold packs from room temperature because of their small compressors and fans. Also, automatic defrost settings may risk causing temperature excursions.

Don’t store products on the floor of the unit as this could block air circulation and consistent temperatures in the whole unit.

Do position probes in a central location amidst products and not in the door of the unit.

Do clean regularly and test audible or visual alarms to verify their function.

How to Store temperature sensitive medicines ?

On receiving medicines, handlers should question whether they have been distributed in acceptable conditions.

Dual freezer or refrigerator units are positive for reducing footprints and costs however, if that dual unit malfunctions that will impact both compartments and their contents. Also one compressor attached to two units may struggle to support both units adequately simultaneously.

There will not be a vast amount of medicines that require freezing and so small freezers are often used. The MHRA has seen some venture to store other items in the freezer next to the medicines to fully utilize the space, for example to condition cold packs. However, the authority warns that this can lead to contamination and temperature excursions if a lot of unconditioned cold packs are loaded in bulk. Excessive access to the freezer coudl also cause temperatures to dip.

What are some of the Tips for storing cold packs ?

When matching the type of cold pack to the needed temperature range, the MHRA notes that handlers must follow the manufacturer’s instructions, as each pack will have separate conditioning requirements.

Handlers should avoid mixing packs that are pre-conditioned with those that are ready for use.  Packs should be checked fully before every use, some packs can deteriorate from being exposed to supercooling. If supercooling needs to be avoided then packs can, on occasion, be conditioned at storage temperature.

When selecting cool packs the MHRA specifies that shippers should consider the following:

•           Amount of time the temperature can be maintained.
•           Whether they are reusable.
•           How robust are the packs to supercooling?
•           How does the pack appear once it is fully conditioned?
•           What are the telling signs that the pack needs to be replaced after thawing?
•           Any safety concerns with PCM leakage e.g. biohazard  risk, flammability, corrosiveness, any transport mode  limitations?
•           How will the pack be disposed or recycled?
•           How cost effective is the pack?
•           Is there a reliable supply from the provider?
  
  

How to Store on the move ?

A ruined shipment of temperature-controlled medicine can cost much more than lost revenue – it can cost lives.

Navigating routes to patients efficiently and cost effectively while transporting temperature sensitive materials is a labor-intensive task. It hinges on the investment in trustworthy equipment. Investment in packaging design and qualification is a critical part of the tool kit.

Pharma logistics IQ decided to investigate the key considerations when qualifying transit containers to safely store medicines on the move. 

What are Active & Hybrid Containers ?

Deploying a selection matrix can compare and analyze attributes, which are critical to your firm’s projects to verify decision-making – which is integral especially for leased solutions.

Categorizations made through generating data internally can consider the following: 

Temperature accuracy: Active shippers have the highest temperature accuracy in comparison to hybrid and passive shippers. They also provide the best flexibility when exposed to a temperature profile that does not match the qualification profile. 

Size availability: When compared to passive shippers, because of their increased complexity and cost, active and hybrid shippers have a narrower selection of payload sizes. This can complicate reducing the amount of unused space in containers when shipping. This also demands added planning to ensure the availability of the container is well timed. 

Ease of use: Active and hybrid shippers are easy to set up, but may need maintenance in transit, depending on the length of the shipment.

Cost: The increased size, weight and complexity of active and hybrid shippers make them typically very costly. This cost translates through to extended freight payments.

Hazard: Active shippers may use lithium batteries. 

Eco-impact: Consider the footprint active solutions are likely to produce. Alongside being compliant and controlling costs, life science companies are expected to reduce the environmental impact of their cold chain. 

Volumetric efficiency: Both active and hybrid shipping systems often  require a closed distribution loop. One way to reduce costs in planning phases is to evaluate the payload volumetric efficiency and leverage innovative techniques and metric calculations to maximize container utilization. Here you identify where deliveries can be consolidated and packaging can be downsized. This will reduce the cost per unit in packaging and should earn freight savings as less space is occupied. 

“The first step is to acknowledge the problem, and then you can move on to risk management and analysis”

With insight from sector experts, learn how to identify weak points in your pharma supply chain and how you can secure them. Download the Pharma Logistics IQ report.

Learn More

What are Passive Containers ?

Size: When recycling insulation materials to increase cost savings and sustainability, Beth Ruland, Associate Director of Global Packaging at Bristol Myers-Squibb, notes that it is productive to contemplate using larger passive units. Bulk passive units are not power source dependent and come in a wider choice of payload volume sizes. These strengths allow pharma firms to be more efficient when packing shipments and avoid over-spending because of ill-fitting containers.

Congruency in SKU management: Ensuring your SKU refrigerants are compatible with various passive solutions is a quick way to reduce the burden attached to managing inventory at different levels. This arduous management is a resource drain that can translate into delays or even missed shipments. Although, beneficial,  SKU congruency is hard to achieve as most passive systems are designed as unique entities.

Ease of Use: As passive shippers require pre-conditioning and specific assembly processes – look for systems that are user friendly in terms of the packing process they require. Alternatively look to train and re-train your system handlers to aid success.

Failures: Passive shippers have a lower amount of components liable to fail during transit in comparison to active and hybrid systems. However, the awareness of potential failures with passive systems will assist with qualification.  

The permeation of packaging material can occur due to a lack of compatibility with the phase change materials (PCM) used. This could escalate to the PCM physically eroding neighboring packaging materials.

PCMs are difficult to maintain and require more robust seal types in comparison to the water based refrigerants. 

Conditioning: Challenges and added costs can be encountered when the PCM being applied needs conditioning to the intended temperature range.