Pharmaceutical Packaging: Key Considerations When Shipping Your Temperature-Sensitive Pharmaceutical Products

The pharmaceutical cold chain market has experienced significant growth in recent years, driven by various factors including advancements in pharmaceuticals, increasing demand for temperature- sensitive drugs and vaccines, and stringent regulatory requirements.

In this article we will look at the factors driving this growth, the role of temperature-controlled pharmaceutical packaging in successful pharmaceutical cold chains, and how temperature-controlled packaging works to keep your pharmaceutical payload safe.

Here are some key trends and drivers contributing to the growth of this market:

Biopharmaceutical Advancements

The pharmaceutical industry has seen a shift towards biopharmaceuticals, which are often more sensitive to temperature fluctuations. This has led to an increased need for robust cold chain logistics to maintain the integrity of these products.

Vaccine Distribution

Vaccines are a critical component of public health programs globally. The need for effective vaccine distribution, especially during events like the COVID-19 pandemic, has driven the growth of the cold chain market.

Emerging Markets

Growing healthcare infrastructure in emerging markets has created new opportunities for pharmaceutical companies. These markets open lack well-established distribution networks, making the cold chain a crucial aspect of ensuring the quality of pharmaceutical products.

Stringent Regulatory Requirements

Regulatory bodies, such as the FDA in the United States and the EMA in Europe, have introduced stringent requirements for the storage and transportation of pharmaceuticals. Compliance with these regulations has pushed companies to invest in advanced cold chain solutions.

Globalization of Supply Chains

Pharmaceutical supply chains have become increasingly global, with manufacturing and distribution taking place across borders. This has necessitated the development of robust and reliable cold chain networks.

Technological Advancements

The pharmaceutical cold chain market has benefited from advancements in temperature monitoring, tracking, and data management technologies. These innovations have improved the ability to monitor and control temperature-sensitive shipments.

Environmental Concerns

There is a growing emphasis on sustainability in the pharmaceutical industry. Cold chain providers are exploring eco-friendly solutions to reduce the environmental impact of temperature-controlled logistics.

Specialized Packaging

The development of specialized pharmaceutical packaging solutions, including advanced refrigeration units and insulation materials, has improved the efficiency of cold chain logistics.

Public-Private Partnerships

Collaborations between pharmaceutical companies, governments, and non-profit organizations have played a vital role in expanding the pharmaceutical cold chain infrastructure, particularly in resource-constrained regions. The pharmaceutical cold chain market is expected to continue growing as new therapies and vaccines are developed, and as healthcare systems continue to evolve. However, it also faces challenges, such as the need for maintaining cold chain integrity in remote and resource-constrained areas, as well as the ongoing need for compliance with ever-evolving regulatory requirements. To stay competitive, companies operating in this sector will need to invest in technology, infrastructure, and expertise to meet the increasing demands of the global pharmaceutical industry.

Temperature-Controlled Pharmaceutical Packaging: Functions

Temperature-controlled pharmaceutical packaging plays a crucial role in ensuring the safety, integrity, and efficacy of pharmaceutical products from the point of manufacture to the point of use. Pharmaceutical packaging serves several important functions:

Protection

Pharmaceutical packaging is designed to protect the product from external factors that could compromise its quality, such as moisture, light, air, and contaminants. It helps prevent degradation, contamination, and tampering of the medication.

Security

When you combine your pharmaceutical temperature-controlled packaging with onboard data logger devices, you can gather key information about your payload such as external and internal temperature, shock, light exposure, and open/close data.

Compliance

Pharmaceutical packaging must adhere to regulatory standards and requirements established by government agencies, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe. Compliance ensures that the product is safe and effective for consumers.

Temperature-Controlled Pharmaceutical Packaging: Features

Temperature-controlled packaging, also known as cold chain packaging or thermal packaging, is a specialized type of packaging designed to maintain a specific temperature range for products that are sensitive to temperature variations. This type of packaging is crucial for preserving the integrity, safety, and efficacy of temperature-sensitive products, such as pharmaceuticals, vaccines, biologics, food, and other perishable goods during storage and transportation. Key features of temperature-controlled packaging include:

Insulation

Temperature-controlled packaging typically includes insulated materials that help regulate and maintain the temperature inside the packaging. Common insulation materials include expanded polystyrene (EPS), polyurethane foam as used in Intelsius BioTherm and PharmaTherm packaging, and vacuum-insulated panels utilized in all high-performance ORCA solutions.

Temperature Control

Some temperature-controlled packaging systems incorporate phase change materials (PCM) or refrigerants like gel packs, ice packs, or dry ice to actively control the temperature inside the package. PCM materials change from solid to liquid (or vice versa) at specific temperatures, helping to absorb or release heat as needed.

Outer Shell

The outer shell of temperature-controlled packaging is usually made from sturdy materials like cardboard, corrugated board, or plastic to provide protection and structural integrity.

Thermal Labels or Indicators

Some packages may include temperature indicators or labels that provide a visual indication of whether the desired temperature range has been maintained. The effectiveness of temperature-controlled packaging is critical in maintaining the cold chain. Properly designed and maintained temperature-controlled packaging helps ensure product quality, safety, and compliance with regulatory requirements. The choice of packaging system and temperature-control methods depends on the specific requirements of the product and the logistics of the supply chain.

Intelsius Temperature-Controlled Pharmaceutical Packaging

Intelsius temperature-controlled pharmaceutical packaging spans two primary ranges or brands: PharmaTherm and ORCA. Both ranges provide high-performance temperature control when shipping pharmaceutical products, but do have some key differences and options that we’ll cover in more detail below.

ORCA

ORCA temperature-controlled packaging is carefully designed to transport high-value temperature- sensitive payloads anywhere in the cold chain, maintaining the efficacy of your payload no mater the external temperature demand. Combining vacuum insulated panel (VIP) technology and advanced phase change materials (PCM), we’ve put your needs at the forefront of design to create our highest performing range of temperature-controlled packaging yet. The range is split into six distinct product types: ORCA Single Use, ORCA Multi-Use, ORCA Connect, ORCA Response, ORCA Pallet and ORCA Rental, and comes in a variety of sizes and temperature ranges.

ORCA Single Use

Dry Ice, 2-8°C, 15-25°C | 120+ Hours Temperature Protection | 1.5L - 50.6L

ORCA Single Use is a high-performance, passive temperature-controlled packaging solution ideal for one-off or infrequent shipments.

ORCA Multi-Use

Dry Ice, 2-8°C, 15-25°C | 120+ Hours Temperature Protection | 1.5L - 50.2L

ORCA Multi-Use is designed to last for up to 5 years, keeping materials in the supply chain for longer, reducing cost and your environmental footprint.

ORCA Connect

Dry Ice, 2-8°C, 15-25°C | 120+ Hours | 1.5L - 50.2L

ORCA Connect combines high-performance, passive, temperature-controlled packaging with a flexible, open platform concept allowing for various data loggers, ensuring real-time tracking of your payloads anywhere in the cold chain.

ORCA Response

Dry Ice, 2-8°C, 15-25°C | 60+ Hours Temperature Protection | 1L - 7.7L

ORCA Response is a handheld temperature-controlled packaging solution designed for personal medicines and blood packs. Ideal for consumers transporting their own medicines, or couriers transporting blood. Comes with a handy carry bag for ease of use.

ORCA Pallet

2-8°C, 15-25°C, Dry Ice | 96+ Hours Temperature Protection | 100L - 345L

The latest in the ORCA family, ORCA Pallet combines high-performance VIP and PCM technology at a bigger scale, allowing customers to ship high-volume pharmaceutical shipments with confidence across the globe.

ORCA Rental

Dry Ice, 2-8°C, 15-25°C | 120+ Hours Temperature Protection | 1.5L – 345L

ORCA Rental utilizes all of the above packaging solutions except ORCA Single Use, and is the ultimate environmentally friendly temperature-controlled packaging solution, enabling customers to access high-performance ORCA packaging as and when demand requires it. And, when you project is complete, the packaging is returned to us where it’s cleaned, refurbished, and made ready for re- use.

PharmaTherm

PharmaTherm insulated shipping systems are designed to offer optimal thermal protection for pharmaceutical products. PharmaTherm systems are pre-qualified to maintain payload integrity during shipments for up to 120+ hours and are tested against Intelsius’ demanding High-Performance Dry Ice temperature, 2-8°C profiles and 15-25°C profiles. This test profile is designed to give users confidence that the quality and efficacy of their payloads will not be compromised during even the most demanding of global cold chain shipping lanes.

PharmaTherm

Dry Ice, 2-8C, 15-25C | 120+ Hours Temperature Protection | 1.4L - 39L

PharmaTherm utilizes high-density EPS as its insulation and provides a lighter alternative than the VIPs used in ORCA packaging, minimizing freight costs. PharmaChill and BioChill PCM provide up to 120 hours of temperature performance, and a new improved data logger lid cut out space ensures compatibility with a wide range of logger types and brands, ensuring you can track your pharmaceutical payload throughout its journey.

PharmaTherm Pallet

Dry Ice, 2-8°C | 120+ Hours | 115L - 450L

PharmaTherm Pallet is designed for transporting larger temperature-sensitive pharmaceutical shipments. PharmaTherm Pallet utilizes the same EPS insulation and PharmaChill and BioChill PCM as PharmaTherm and will give you a minimum of 120 hours of temperature control, ensuring safe and compliant shipment of your temperature-sensitive shipments across local and international cold chains.

ORCA Cloud and Tracking Your Shipments

An important part of delivering a safe, compliant and cost-efficient pharmaceutical cold chain is how you monitor your payload in transit. It’s essential you understand when and where any temperature excursions, or other potentially damaging events such as high levels of shock or light exposure occur in the supply chain, so you can tackle issues and reduce the amount of spoiled and damaged products that arrive with your customer.

At Intelsius, we design our packaging with onboard data logger integration and seamless tracking through our ORCA Cloud dashboard in mind. Both ORCA and PharmaTherm ranges are logger agnostic, meaning you can use an existing logger device, or suggest a device to track your payload.

These devices monitor a range of metrics including:

• External temperature

• Internal temperature

• Exact location

• Orientation (Optional)

• Shock (Optional)

• Light (Optional

  All these metrics can be live-monitored using ORCA Cloud; a universal logger portal that makes tracking your shipments easy.

  ORCA Cloud allows you to track and report on multiple loggers anywhere in the world, simplifying the supply chain tracking process and giving you complete visibility of your payload without needing to access multiple portals.

  No mater what packaging you use or which logger device you’re working with, you can monitor your payload throughout its journey and download reports all in one place.

  What distinguishes ORCA Cloud from other data logger portals is its universality and adaptability; all your logger devices are recorded in one place, with data presented how and when you need it, no mater which or how many loggers you use, or what packaging solution you want to use. ORCA Cloud has been created with you, the customer, in mind, giving you complete oversight of all your payloads, packaging, and loggers in one place.

  Core ORCA Cloud benefits include:

• All data logger types are compatible

• Compatible with your specific packaging, or we can create project-specific packaging

• All data is presented in one, consistent way, no mater how many logger types you use

• You can share access with as many people as you choose to, and you control permissions

Get in Touch

For more information about our pharmaceutical temperature-controlled packaging solutions, data loggers, ORCA Cloud, or to speak to our team about any other cold chain requirements, please get in touch americasorders@intelsius.com or visit our contact us age here for more details: htps://intelsiussolutions.com/contact-us.html