Clinical Trial Packaging: Safeguarding Products, Patients, and the Planet
Imagine a tiny vial holding the potential to rewrite medical history. For that potential to be realised, it needs a journey that’s as precise as the science behind it. Clinical trial packaging is the key to that journey, ensuring the safe passage of this vial and countless other vital medications to clinical sites and the patients who need them.
In this insight we lift the lid on clinical trial packaging and its importance in protecting products, patients and the planet.
The Importance of Clinical Trial Packaging
Clinical trial packaging involves the design, preparation, and labelling of drug products to ensure their integrity, safety, and compliance with regulatory standards throughout the trial. Its importance lies in maintaining the quality and ensuring the efficacy of investigational medicinal products (IMPs) throughout transportation and whilst in storage. It is essential to protect products from contamination and ensure participating patient safety, enabling reliable research outcomes. This involves stringent procedures and high quality control measures.
Clinical Packaging Types
Clinical packaging varies depending on the products being stored. Generally, it can be broken into three types of packaging – primary, secondary and temperature controlled.
Primary packaging refers to the container that directly holds the investigational drug. It’s the first layer of protection for the medication and plays a vital role in ensuring its safety, efficacy and integrity. Common examples include blister packs, used for the storage of tablets and capsules. These offer individual dosage control and protect the medicine from light and moisture. Vials are used for injectable solutions, powders or liquid medications and bottles are typically used for larger quantities of oral liquids or capsules. Tubes contain ointments, creams or gels and pre-filled, ready-to-use syringes contain injectable medications supporting sterility and dosing accuracy.
Secondary packaging sits on top of the primary packaging acting as an additional layer of protection and organisation of the IMP. It can act as a cushion against physical damage during transportation and storage and also acts as a barrier against light, moisture and other environmental factors that could affect the drug. It’s also used for the organising and dispensing of drugs, grouping individual doses from primary packaging into kits for specific treatments, making it easier for patients and clinical trial staff to manage the medication.
The secondary packaging also includes labelling, giving clear instructions as to the use, storage and disposal of the medication in line with regulatory requirements. Examples of secondary packaging include cartons, trays and heat-sealed film pouches.
Temperature controlled packaging, in the form of insulated containers are contained within secondary packaging. These may include ice packs or temperature monitoring devices to maintain specific storage conditions over a specific period of time. These are crucial for the safe storage of sensitive products, which could include bio-samples, particularly, during transit.
Minimising our Environmental Footprint
While the focus of clinical trials lies in medical advancement, there’s a growing emphasis on conducting trials with a minimum impact on our environment. Packaging plays a significant role in this consideration. Sustainable solutions such as reuseable containers and recyclable materials offer a path forward.
However, implementing sustainable practices is not without its challenges. Initial investments in reusable containers may be higher and robust cleaning and sterilisation procedures need to be established. Fortunately these costs can be offset by reduced waste disposal fees. Additionally, ensuring compliance with environmental regulations for waste disposal is crucial. This requires proper segregation of recyclable materials, the responsible disposal of hazardous wastes and adherence to local regulations.
Packaging Solutions for Clinical Trials
At Oximio, we understand the importance of protecting the product, the sample and the patient at all times whilst, at the same time, acting responsibly to safeguard the environment. As part of our storage and distribution services we offer a comprehensive range of sustainable packaging solutions, including reusable containers, recyclable materials, and expert guidance on waste minimisation strategies. Our team can help you navigate the complexities of clinical trial packaging regulations and ensure your research adheres to the highest environmental standards.
Contact us today to discuss your project requirements and find out how we can support your next trial with sustainable and effective packaging solutions.
Further reading: Tackling Clinical Waste for a Greener Future