Pharma Temperature Control Requirements

temperature control requirements

Temperature control requirements are required for many pharmaceutical products in order to maintain quality, potency, and efficacy. According to Good Distribution Practices (GDP), controlling temperature during freight is an essential part of logistics to prevent medical products from being damaged during the shipping process.

Thermal boxes are a critical component of pharmaceutical cold chain management. By controlling temperature conditions on mass transportation means such as trucks, boats, or trains, pharma thermo box solutions are integral to cold chain management. 

What is Cold Chain Management?

Pharmaceutical products undergo a time-consuming and volatile process from their place of manufacture to their destination. Cold chain management is a set of policies and procedures designed to maintain quality control for cold or frozen perishable products at various stages as they move through the supply chain. 

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What are “cold chain products”?

Pharmaceuticals that require low-temperature transport are typically referred to as “cold chain products”. These include vaccines, biologics, insulin, and oncology treatments. Most medical products in the cold chain category generally need to be kept at temperatures between 2-8 degrees Celsius. Other specialty pharmaceutical products – such as the COVID-19 vaccines – are classified as “ultra-cold chain” and must be held at temperatures below minus 80 degrees Celsius. 

Good Distribution (GDP) Temperature Control Requirements

GDP policies are a set of European Union (EU) policies that govern the wholesale distribution of pharmaceutical products. GDP standards are enforced to ensure that medicines maintain quality and integrity standards as they move through the global supply chain. 

According to GDP recommendations, factors that govern quality assurance throughout the transport process include temperature, turnover times, storage conditions, handling procedures, and measures that prevent cross-contamination.  

Logistics providers face numerous challenges in maintaining product integrity, such as the absence of stability data. Throughout the supply chain, temperatures can vary considerably, especially during the pack-out process where applications using dry ice (liquid nitrogen dioxide) or LN2 are used. Since managing temperature control requirements is an involved and complex process, shipping systems and policies – including data loggers – can provide adequate temperature monitoring throughout the entire cold supply chain. 

GDP Temperature Guidelines in the EU

The European Union outlines detailed requirements and expectations for transporting and distributing medicinal products in its EU GDP Guidelines (2013/C 343/01) documentation. According to the manual, maintaining set temperatures is not required for each transport. Guidelines specifically dictate that if no constant monitoring of temperature is carried out during the transport of medicinal products, a risk assessment of transportation routes must be made in advance. 

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EU GDP Transport Risk Assessments

The transport risk assessments must specify details such as the date, time of transport, travel duration, particular aspects of the route, weather forecast, type of vehicles, and any equipment used throughout the process. While GDP stipulates that monitoring must be conducted in the absence of a risk assessment, it also requires monitoring in the event a risk assessment confirms that temperature controls are necessary.

Pharmaceutical Transport Methods

There are varying methods of transporting temperature-sensitive pharmaceuticals. Some logistics companies invest in refrigerated trucks that share space with other companies to maximize freight space and minimize costs. These shared trucks can be monitored with software provided by the hired logistics company, removing the need to invest in special refrigerated trucks. Besides being a low-cost option, shared transport can benefit the environment and reduce a company’s carbon footprint.

Large-scale pharmaceutical providers typically purchase their own vehicles with temperature monitoring capabilities and temperature monitoring platforms and applications. Alternatively, some local firms opt for a relatively shorter cold chain and use refrigerated facilities with advanced monitoring systems for the purpose of delivering products to local locations.

Thermo Box Solutions FAQ

Pharmaceutical thermo boxes are thermal packaging solutions that maintain quality and offer protection from bacterial growth in compliance with Good Distribution Practice (GDP) standards. 

Expanded polystyrene (EPS) boxes use polystyrene to maintain and protect packaged pharmaceutical products during the transportation process.

Isothermal boxes maintain temperature with the use of eutectic plates that maintain constant diffusion of temperature-controlled air. 

No. According to the EU GDP documents, standard temperature control is not required for each individual transport. GDP requires that monitoring is conducted in the absence of a risk assessment, or if temperature controls are deemed necessary as a result of a risk assessment.

Good Distribution Practice (GDP) guidelines are EU standards that govern the wholesale distribution of pharmaceuticals and other products. 

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GDP-Compliant Thermo Boxes

Logistics firms adhering to GDP practices typically use thermal packaging solutions to maintain quality, offer protection from bacterial growth, and maintain efficacy and safety. Isothermal boxes make this possible with the use of eutectic plates that maintain a constant diffusion of temperature-monitored air. 

Thermo boxes are available in a variety of sizes for individual deliveries and large-scale shipments. Along with providing protection from temperature fluctuations, some isothermal containers come with high-pressure foam polyurethane insulation. Besides making it easy to keep the items temperature-controlled, this material also provides an additional degree of buffering protection from bumps and can prevent the products from toppling over throughout their journey on the supply chain. Additionally, since pharmaceutical products can be sensitive to varying conditions, thermo box solutions can provide temperature monitoring at strictly controlled temperatures.

Benefits of Pharma Thermo Box Solutions

Logistics companies that transport pharmaceutical products across extended supply chains can benefit from the use of thermo boxes in the following ways:

  • Compliance with EU GDP standards
  • Quality maintenance across long distances
  • Product protection 
  • Prevention of bacterial overgrowth
  • Enhanced storage and organization 

MedicaPharma Supplies Pharmaceuticals Shipped to GDP Temperature Standards

MedicaPharma is a leading supplier of pharmaceutical products to a wide range of businesses seeking professional product procurement. We are committed to shipping products that conform to Good Manufacturing Practices (GMP) without repacking or relabeling from the original manufacturers. All our products include the original documentation and complete tracing information in the event of product recalls. 

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