Medical packaging 101: Basics medical device companies need to know

In the medical device industry, the product is the main thing. It has to be safe. It has to be efficacious. It has to be packaged?

This post from Packaging Digest & Neil Thompson at Sterilliant LLC really well illustrates the many considerations medical device companies need to factor in when designing and implementing new packaging.

Packaging projects in the medical and pharmaceutical industries need to be well planned and executed to avoid delays and manufacturing stoppages.

Packaging is now an important branding exercise that can result in a competitive advantage but furthermore for those in regulated markets that require sterile solutions it is a legal requirement. For medical devices package validation testing is outlined under ISO 11607.

The bottom line. Do not see packaging as a supporting act, start your development early on.

Medical Packaging Basics

In 2023, the pharmaceutical industry faces financial and strategic challenges. To overcome these hurdles, new approaches are needed to tackle regulatory and inflationary pressures. At the same time, the industry must meet sustainability goals, protect patient health, and promote innovation for the future of medicines and delivery systems. The key to achieving these objectives lies in the design and development of primary and secondary packaging.

Advocating Accessibility
In 2023, healthcare systems worldwide are under pressure due to factors like aging populations, staff shortages, rising costs, and inefficiencies. Empowering patients to self-administer medications at home is a solution to ease this burden. Primary packaging aims to provide a secure and user-friendly way to deliver medicines. Pre-filled syringes, for example, offer direct administration and contamination protection. Thorough testing of materials and packaging is essential to ensure patient safety, considering factors like temperature variations.
The evolution of pre-filled syringes continues, with the rise of wearable injector technologies. These devices enable treatment at home, with remote monitoring ensuring correct dosage adherence and enhanced patient care.

Active and Intelligent Packaging Design
The active and intelligent pharmaceutical packaging market is expected to grow by 9% annually by 2025. "Active" packaging responds to changes in the environment, actively protecting products from factors like moisture and oxygen. Market demand is increasing for solutions that proactively eliminate contaminants and impurities. Intelligent packaging, like QR codes and RFID technology, enhances user experience and aids in anti-counterfeiting efforts. Smart sensors can detect temperature and humidity variations and improve health outcomes by monitoring patient compliance.

A Cleaner, Greener Future
The pharmaceutical industry faces unique challenges when it comes to sustainable packaging. Medical packaging must protect products from various environmental factors while ensuring safety features. Advancements in 3D printing reduce material waste, and eco-friendly trends incorporate product features into packaging to minimise waste.
Reducing plastic waste is a growing trend, with research into biodegradable and recyclable bioplastics. The adoption of plant-based materials, like blister packaging derived from sugarcane, is on the rise.

Medical Packaging Serves Vital Functions
Medical packaging is designed to meet the highest standards and protect medical products. It comes in various forms, including blister packaging, individual-wrap packages, multi-compartmental trays, water-soluble packaging, pouches, and cartons.

Materials for Medical Packaging
Medical packaging relies on polymer films to protect against contaminants and maintain product integrity. Common materials include single films, laminations, and coextruded films. Tyvek material is used for gas-sterilised products.

Medical Packaging Standards
Of course, let's simplify the information on Medical Packaging Standards:

1. ISO 9000 (Quality Management Standard)This is a set of rules that many businesses follow to make sure they do things correctly. Even though it's not just for medical packaging, it helps companies create a system to make their packaging safe and good. It helps them keep doing a good job every time. For medical packaging, this means picking the right materials, making sure everything is clean, and always improving.
2. PSO 9000 (Pharmaceutical Packaging Materials Standard). This rule book is specifically for the materials used in medical packaging. It tells companies how to make sure their materials are good for keeping medicines safe and clean. It talks about things like the properties of the materials, how to make them, and how to check if they are clean and safe. Following PSO 9000 is important to make sure the materials used for medical packaging are high-quality and safe.

In simple terms, these standards make sure that companies create medical packaging that is safe and reliable. They guide how materials are chosen, how packaging is made, and how it's checked to ensure it meets the strict requirements of the medical industry. This way, we can trust that the packaging for medicines and medical supplies is always good and safe for patients. Rigorous testing and checks are done to be sure these standards are followed, making sure everything is safe for patients and follows the rules.

Conclusion: Medical Packaging Basics

In 2023, the pharmaceutical industry faces financial and strategic challenges, emphasising the need for innovative approaches. Medical packaging plays a crucial role in achieving sustainability, patient safety, and innovation goals. It ensures accessibility, active and intelligent packaging, and a cleaner, greener future for pharmaceutical products. Adherence to standards guarantees the quality and safety of medical packaging.