Protecting sensitive medicine presents a conundrum for manufacturers. Packaging of drugs must simultaneously:
- Maintain drug safety, potency, and sterility
- Fit within the company’s budget
- Be ecologically responsible
Unfortunately, these goals can sometimes contradict each other, causing headaches for pharmaceutical companies. Medicine packaging is complex, and companies that produce primary packaging material are constantly developing and testing options to satisfy all requirements.
What Is Primary Packaging?
Pharmaceutical primary packaging is a crucial component in shipping pharmaceuticals. It is the first layer of material directly encasing the medicine. This packaging plays a pivotal role in maintaining the integrity of the pharmaceuticals, while secondary and tertiary packaging layers offer further safeguarding. Several materials are used for packaging pharmaceutical products, each serving distinct functions to ensure product preservation.
Primary Packaging Materials
These are responsible for keeping medicines and drugs sterile. These materials can include blister packs, vials, syringes, and other containers that come into direct contact with the drugs or medication. The materials used for packaging of pharmaceutical products present the most significant challenge to drugmakers since the demand for safe and sterile containers can contradict traditional solutions to reduce packaging or use sustainable options.
Secondary Packaging Materials
These materials are responsible for branding and communicating drug information. Secondary packaging may also contain some padding in case of falls and can protect against direct sunlight.
Tertiary Packaging Materials
When manufacturers ship their products, branding and logos are less of a concern than secure shipment. Tertiary packaging contains the appropriate padding or temperature control measures to safely transport the medicine or drugs.
What To Consider With Primary Packaging Materials for Pharmaceuticals
Pharmaceutical products can be sensitive to UV light, extreme temperatures, drops or falls, bending, or crushing. Manufacturers use primary packaging materials tailored to their products to keep them usable and potent.
Storage Conditions
Storage conditions for drugs must follow strict guidelines. The area must be temperature-controlled; some medications must be refrigerated or frozen. There must also be:
- Careful controls for light to avoid effects from UV radiation
- Enough room for staff to retrieve the drugs without knocking down containers
- Enough space so that packages aren’t being compressed
The storage conditions for drugs have a massive impact on shelf life.
Ease of Use
While packaging materials provide the necessary protection, consumers must be able to access the pharmaceuticals inside. Consider elderly patients who have difficulty with blister packs or tight bottles — but remember that packaging may also have to satisfy childproofing requirements.
It depends on how the consumer will use the pharmaceutical. Even the packaging of non-childproof medicine will need appropriate warnings to meet regulations.
Patient Compliance
Manufacturers and prescribers can ensure patients take their medication correctly by employing practical packaging techniques. Individual blister packs labeled with dates, clear and concise directions for use, and warnings indicating consequences for misuse provide the level of communication needed.
What Are Common Types of Packaging Materials in Pharmaceuticals?
The types of containers in pharmacy vary widely because medicine packaging requirements can be particular. Materials such as glass and plastic react with medicine differently, for instance.
That’s why relying on an expert packaging manufacturer like Pelton Shepherd is essential. With our innovative products, you can trust that you get sustainable, long-lasting, and safe pharmaceutical packaging.
Vial Packaging
Vials are popular for use with freeze-dried and liquid drugs. They may be made from glass or plastic. However, glass is most common for the following reasons:
- It can be sterilized more easily
- Its weight allows vials to move more predictably on automated fill lines
- It is less likely to interact with pharmaceutical products
- It allows for a more extended shelf life
Vials can accommodate multiple doses because they allow users to draw out medicine with a syringe directly through the cap.
Injection Packaging
Injection packaging or syringes can be made from plastic, glass, or composite, such as polypropylene or polycarbonate. Care must be taken to ensure the syringe barrel is compatible with the rest of the materials. For example, the plunger, typically rubber, may get stuck or interact unfavorably with certain plastics. Along with material considerations, needle gauges must match appropriately with the viscosity of the drug.
For pre-filled syringes, manufacturers must ensure that the filling processes are sterile. Then, the needles are securely enclosed in a sterile package to ensure the entire system is safe for transport and use.
Ampoule Packaging
While ampoules are excellent at hermetically sealing their contents, opening ampoules can be problematic. Ampoules are similar to glass vials but are sealed, so opening them requires breaking the container’s neck. That can add small glass particles to the medicine, which is why these containers are rare for pharmaceutical use.
Cartridge Packaging
Like syringes, cartridges use rubber plungers to draw the medicine through a needle. Unlike syringes, cartridges do not contain the needles themselves. Instead, cartridges fit into pens or other external devices that pierce the cartridge’s seal to deliver doses.
Pens may be single-use or allow for replacement cartridges and needles. The reason cartridges are becoming popular is that they offer highly accurate dosing.
Packaging for Bottles
Bottles are usually made of glass or plastic, though glass is more prevalent for the above reasons. With large capacities of 100 milliliters or more, bottles can contain single or multiple doses. If a bottle is intended for delivering a single dose, it will generally have a delivery system, such as a needle, built in.
Packaging for Bags
Bags come in many sizes, from as large as a liter to as small as 25 milliliters, and they are usually made of flexible plastic. Manufacturers must avoid potentially toxic or carcinogenic materials such as PVC.
Bags are typically used for administering fluids intravenously via a needle outlet. While printing labels on bags can be challenging without the right equipment, bags are strong and easy to transport.
What Are Primary Packaging Material Challenges In Shipping Pharma?
Pharmaceutical companies must strike a balance with the various medicine packaging types, considering multiple factors. Packaging must be sterile, undergo thorough testing, and meet strict requirements for each country where pharmaceutical companies plan to market their products.
Regulatory Requirements
Federal regulations offer strict guidelines for medical packaging to ensure pharmaceuticals are safe for patients. When designing medical packaging, manufacturers must consider the following:
- Harsh treatment during shipping
- Safe storage procedures
- Tamper evidence
- Seal strength
- Ease of opening
Manufacturers should consult with compliance experts to ensure the packaging meets the appropriate regulations.
International Standards
Not all countries have the same rules regarding medical packaging, and some have strict import and export regulations for certain medications that may affect package designs.
For example, while the USA and the EU recognize ISO 11607 sterile barrier packaging regulations, the EU also requires packaging to conform to CE (Conformité Européenne) standards and contain the CE mark.
Quality Assurance
Medical packaging must adhere to good manufacturing practice (GMP) requirements and undergo rigorous testing. Meticulous testing will determine whether seals will prevent leaks, whether packages are easily openable by patients, and whether the packaging will withstand shipping and storage.
Environmental Impact
While medicine requires stable and long-lasting packaging, those qualities make certain packaging materials — especially plastics — damaging to the environment because they won’t degrade or break down. That is why manufacturers are pushing for increased use of sustainable, recycled, and reused materials and reducing the amount of secondary and tertiary materials.
Find Innovative Primary Packing Materials from Pelton Shepherd
Ensuring patient safety is the number one goal of medical packaging. Every vial, cartridge, and bottle must be able to protect its contents through transit, storage, and use. That’s why pharmaceutical companies trust Pelton Shepherd to ensure their medications arrive safely and securely.
Our innovative cold packs ensure your pharmaceuticals maintain a constant temperature throughout their journey. Take a look at our shipping ice packs catalog and see why Pelton Shepherd’s high-performance cold packs are the gold standard in the industry.
