Credibility Is In The Box: The Impact Of Temperature Controlled Packaging On Drug Development
Arnab Bhattacharya
Senior Regional Director South APAC @ Marken | Country Manager, India @ UPS Healthcare | Pharma Logistics Expert
In the pharmaceutical industry, temperature-controlled packaging is essential to ensure the safety and effectiveness of drugs. It helps maintain the integrity of products during transportation and storage. Temperature-controlled packaging keeps drugs within a specific range of temperatures where they remain stable and safe for consumption. This also ensures that drug manufacturers meet regulatory requirements on quality assurance and product traceability. Not only does temperature control protect the efficacy of medications, but it also protects their credibility by ensuring they are safe to use in medical treatments and clinical trials. In addition, it enables drug developers to conduct successful research studies with greater confidence in their results since all drug batches will be held at consistent conditions throughout their shelf life.
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Types of Packaging
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Active packaging is a type of temperature-controlled packaging that includes components such as sensors and controllers. These components are designed to actively monitor and adjust the package's environment to maintain optimal temperatures for stored products. Packages may also include insulation materials or heating/cooling elements to help maintain desired temperatures. Active packaging is often used for pharmaceuticals, medical devices, food items, chemicals, and other sensitive products that require precise storage conditions for their preservation.
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Passive packaging refers to traditional methods of temperature control, which rely on insulating materials like bubble wrap or foam padding within packages, along with ice packs or cooling bricks placed around containers filled with goods requiring a specific temperature range during transportation. This type of packaging can provide sufficient protection from extreme temperatures.
Types of Passive Packaging
PCM Based Packaging
Phase change material (PCM) based packaging is a type of temperature-controlled packaging that utilizes materials that can absorb, store or release energy in the form of heat when transitioning between solid and liquid states. These materials are usually waxes, salts or other non-toxic substances, which can be incorporated into packages to provide insulation and maintain desired temperatures for stored products. The PCMs absorb excess heat when temperatures rise above a certain threshold and then release it as needed when temperatures fall below that threshold. This helps keep contents within an optimal temperature range over extended periods without requiring additional input from external sources such as cooling units or ice packs.
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The main advantage of using PCM-based packaging is its efficiency in terms of cost savings since it does not require any electricity for operation and the light in weight, providing more space for products.
However, there are some drawbacks associated with this method. For instance, the materials used may have limited lifespans which could decrease effectiveness over time if not replaced regularly; so they must be carefully monitored throughout transit.
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Water Based Gel Pack Packaging
Water Based Gel Pack Packaging is a type of temperature-controlled packaging that utilizes water-based gels to keep products within desired temperature ranges during transportation and storage. This type of packaging can be used with either insulated or non-insulated containers, making it an ideal solution for various applications, including pharmaceuticals, medical devices, food items and chemicals.
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The main advantage of using Water Based Gel Pack Packaging is its ease of use since no tools or electricity are required for operation; all you need to do is place the gel packs around your product before sealing your container. Additionally, this type of packaging offers superior insulation compared to traditional methods such as bubble wrap or foam padding, making it highly effective at maintaining temperatures exposure during transit. They are also very cost effective.
However, there are some drawbacks associated with Water Based Gel Pack Packaging as well; namely, their limited life span since they will eventually lose their effectiveness over time due to repeated temperature fluctuations and wear & tear on their components; also, they tend to increase package weights significantly so additional costs may occur when shipping large volumes overseas. In addition, depending on what types/brands you buy, some gel packs may contain toxic chemicals like formaldehyde, which could potentially leach into products if left too close together in one container, while others require specialized training for safe handling so make sure you check all safety precautions before purchasing them for your business needs.
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Shipping Regulations on Maintenance of Temperature During Transit
Regulations are an essential part of the pharmaceutical industry and must be followed to ensure the safety and efficacy of drugs. Pharmaceutical logistics operations are subject to international, regional, and local regulations governing how products can be shipped from one location to another. These regulations help protect consumers by ensuring that medications maintain their integrity throughout transportation and storage to remain effective for medical treatments and clinical trials.
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International regulations such as Good Distribution Practice (GDP) set guidelines for handling controlled substances worldwide, including requirements on temperature control during shipping. This helps ensure proper quality assurance throughout the entire supply chain while promoting better traceability practices which enable manufacturers to track shipments more accurately to detect any problems or potential delays.
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In addition, many regional laws governing pharmaceutical manufacturing must be met for companies to do business within specific countries or regions. For example, the European Union has its specific GDP titled "The Rules Governing Medicinal Products In The European Union" that sets out strict requirements on product transport via airfreight or sea freight depending on where it is being sent from/to as well as other details such as labelling instructions etcetera Local Regulations can differ significantly between different states/provinces due to varying health standards or cultural norms; therefore it is essential for all businesses involved with pharma logistics operations – whether shippers, couriers or distributors - understand any relevant local laws applicable before conducting business in those areas.
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Overall, compliance with Regulations is essential when dealing with sensitive items like pharmaceuticals since failure to do so could lead to hefty fines and put public health at risk if products become compromised due to improper handling techniques during transportation & storage, among other things.
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Conclusion
In conclusion, the importance of proper temperature-controlled packaging for pharma logistics cannot be overstated, and all pharmaceutical logistics operations must comply with international, regional and local regulations related to the transportation & storage of drugs to ensure public safety and maintain product integrity throughout transit.
Regional Manager - Instalimb India
1 年Well said Sir !! Should you need any assistance in cold chain packaging services, kindly contact us 9454977845
????? Temperature-controlled packaging plays a critical role in the pharmaceutical industry, safeguarding the safety and efficacy of drugs. By maintaining specific temperature ranges, we can confidently deliver high-quality drugs that meet regulatory standards and promote patient well-being. Truly an essential aspect of drug development! ???? #PharmaceuticalIndustry #TemperatureControlledPackaging
Cold Chain Enthusiast, Speaker,IATA Trainer
1 年Spot on Arnab!!
A senior logistics professional with 4 years' experience in clinical trial, time-sensitive logistics and supply chain industry.
1 年????