What is Pharmaceutical Primary Packaging?

24 January 2024 | Hannah Hogan

Primary Packaging Definition

The term primary packaging refers to the layer of packaging in direct contact with your pharmaceutical product. For example, a parenteral product stored in a glass vial is in direct contact with both the vial and the stopper. These components are designed not only to contain and protect but also to preserve the stability, quality and, where necessary, sterility of the product from the point of manufacture throughout the duration of its shelf life.

In Annex 9 of the WHO Technical Report Series 902, The World Health Organization provides Guidelines on Packaging for Pharmaceutical Packaging Products.

Importance of Selecting the Right Primary Packaging

As primary packaging remains in constant contact with your product it is extremely important to give it proper consideration:

Are there particular elements that your formulation might react with?
Have you considered whether this element might be found in your container of choice?

Does your product have challenging characteristics, such as proteins which have a tendency to cling to the walls of their container?

Does the combination of container/closure provide an effective barrier to liquid and air ingress and egress?

Do you require demonstrably low particulate levels? Or even sterility?

Other considerations include whether your packaging meets the criteria of the relevant pharmacopeia. Does it come with full batch traceability? Is it user-friendly in terms of access or administration: applied topically, parenterally or orally for example. Will it be administered by a trained medical professional or by the patient?

Need help navigating the answers to these questions? Our friendly team of pharmaceutical packaging experts are here to help: Get in Touch

“The kind of packaging and the materials used must be chosen in such a way that: —the packaging itself does not have an adverse effect on the product (e.g. through chemical reactions, leaching of packaging materials or absorption); —the product does not have an adverse effect on the packaging, changing its properties or affecting its protective function.”
Excerpt from WHO Annex 9: Guidelines on packaging for pharmaceutical packaging.

Primary and Secondary Packaging

USP 659 defines secondary packaging as “a Packaging component that is in direct contact with a Primary packaging component and may provide additional protection for the article.”

While primary packaging is any element of packaging that sits in direct contact with your product, secondary packaging, as the name suggests is the second level of packaging after this primary layer. Consider the aluminium seal used to hold the rubber stopper in place on a vial, or the carton containing the syrup bottle and oral syringe: it does not directly impact the composition of the drug itself, however it still has a significant role. As well as an additional level of protection for the primary layer, secondary packaging may assist ease of handling and can display safety information and branding.

Primary and secondary packaging go hand in hand and are often seen and handled by the end-user.

What is Tertiary Packaging?

Tertiary packaging is the outermost layer of packaging concerned with the safe and efficient transportation and warehousing of your product. This level of packaging might include bubble wrap, cardboard boxes and wooden pallets.

Tertiary packaging is designed to provide protection from the damage which can be sustained during the shipping process. Often when shipping goods nationally or globally, they will pass through many hubs and modes of transport, increasing the risk of loss and breakages. It is important to ensure your tertiary packaging is robust and provides sufficient protection from the knocks and drops that may occur on the journey to the end user

Examples of Medical Primary Packaging

Glass Vials

Crimp neck Type I glass vials are commonly used to store injectable drugs. They offer excellent hydrolytic resistance and are chemically stable. There are various coatings and optimisations available to tackle common challenges, and paired with a compatible stopper they offer an excellent container/closure option for most parenteral drug products.

Bottles

Glass and polymer bottles come in many shapes and sizes. They can be used to store oral syrups, capsules and topical solutions.

Prefillable Syringes

Prefillable syringes encompass both storage container and medical device in one package. They are prefilled with the correct dose, avoiding the risk of misdosage, and are ‘ready-to-go’ at the point of administration, making the process easier for the medical practitioner.

Ampoules

While declining in use, glass ampoules are low-cost and as such are still relatively popular in settings where minimising packaging costs is critical, for example in developing countries and the generics market.

Other benefits of a glass ampoule include its homogenous nature: the product is in contact with only one material, and is hermetically sealed; while risks to the user come as a result of the need to break glass to open the container.

Pumps

Pharmaceutical pump systems come in various forms. Often supplied sterile, they are used in a range of administration routes, including nasal, ophthalmic, topical and otological.

Pharmaceutical Closures

Closures are a crucial component of the ‘container/closure system’. Examples include rubber stoppers to close vials and screw caps for bottles and tubes.

Sustainability Challenges

Challenges exist with regards to sustainability for primary packaging for pharmaceutical products. As an example, Type I glass which is used to produce injection vials, ampoules and glass syringes, is not recyclable nor incinerable. This is due to its high-melt point: glass parenteral containers need to withstand high temperatures during sterilisation and depyrogenation. See USP 797 - Pharmaceutical Compounding – Sterile Preparations

There is also the issue of hazardous contents, such as cytotoxic and cytostatic materials which must be disposed of safely.

Pharmaceutical packaging manufacturers are taking their impact on the planet seriously however. Top pharmaceutical packaging manufacturers such as West Pharmaceutical Services and SCHOTT Pharma are making huge strides in more sustainable production and working practices. In 2022 West was named one of Barrons Top 100 Most Sustainable Companies, whilst SCHOTT Pharma has plans to be climate neutral by 2030, having already reduced carbon emissions by 60% since 2019.