What is a vial? Types, applications, and key considerations

A pharmaceutical vial is a universal glass or polymer container designed to safely store a vast range of drugs and medications, cosmetics, and chemicals, from manufacture of the formulation to point of use. With modern medicine rapidly developing new and increasingly sensitive drug formulations, pharmaceutical packaging companies such as SCHOTT Pharma are constantly developing their glass vials to ensure these new formulations remain safe and effective.

SCHOTT Pharma glass vial without stopper and seal

What are the different types of vials?

Around the world, millions of pharmaceutical vials are used every single day to deliver life-saving drugs to millions of people, as well as store medications, laboratory samples, and cosmetics. The current value of the global pharmaceutical vial market is $11bn and is expected to grow to more than $15bn by 2030 (Source: Global Pharmaceutical Vials Market Size, Share, Trends, Forecast (2030)).

Whether they are used as containers for liquids, tablets, or lyophilized drugs, vials provide the ideal environment for drugs, medications, and vaccines, as well as sample vessels for diagnostics. Now that we have explained what a vial is, let’s go into some of their applications:

• Parenteral drugs
  Vial containers are used around the world to store a vast range of parenteral drugs (drugs administered directly into the body without passing through the digestive system). Typically made of glass, they offer high chemical resistance and minimal drug-container interaction to ensure the drug remains stable and free of contamination until the point of use. Some of the most widely used parenteral drugs are vaccines, insulin, antibiotics, and emergency medications.
• Laboratory samples
  Since pharmaceutical vials offer high geometric precision, strong chemical resistance, and consistent quality, they are widely used in laboratories around the world in a broad range of diagnostic applications. Those applications include analytical chromatography as well as autosamplers for substances such as blood. Autosamplers enable laboratories to analyze a large volume of different samples for rapid results.
• Tablets
  As well as parenteral drugs and other liquids, vials are increasingly used to store tablets. Durable and portable, vial storage for tablets offer a more convenient and sustainable solution to storing medication than traditional blister packs. Just as vials for liquids provide secure protection from moisture and atmospheric gases, and offer low drug-container interaction, vial storage for tablets ensures that pills remain stable and effective.
• Nasal sprays
  Pharmaceutical vials are also widely used in nasal sprays, which deliver medications quickly and simply into the body as a fine mist through the nasal cavity. Used to treat a range of conditions, from hay fever to sinusitis, they require storage vials that offer high chemical resistance, precise dimensions, and the ability to filter out UV light. The recyclability of glass is also a strong advantage in the circular economy.

Lyophilization for parenteral drugs

SCHOTT Pharma is a global expert in vials manufactured for the storage and administering of parenteral drugs in both liquid and lyophilized form. A major share of biologics stored in lyophilized form, alongside a wide range of antibiotics, lyophilization involves the process of extracting water from a drug by freeze-drying under low pressure. The process is used to transport particularly sensitive drugs, with the lyophilized drug reconstituted before administration.

EVERIC® lyo as SCHOTT Pharma’s solution for lyophilized drugs

However, the lyophilization process presents a number of different challenges for the vial container, such as fogging and elevated stress during freezing. While fogging leads to an increase in the number of cosmetic rejects, increased stress can lead to breakage, reducing efficiency and increasing costs. The problem of fogging can be addressed by the formation of a hydrophobic inner surface on the vial, which also improves vial emptying.

Comparison between a convential vial and EVERIC® lyo

Why choose vials for parenteral drugs?

The pharmaceutical industry uses four key containers for the storage and transportation of drugs and medication: vials, ampoules, cartridges, and syringes. Using high-quality production processes, all four offer accurate dimensions, superior cosmetic quality, and secure container closure integrity.

However, vials remain the preferred choice when it comes to new drug development. With a large range of vial sizes, storing volumes from less than 2 ml up to 100 ml, they are suitable for a wide variety of filling volumes.

Vial containers are ideal for all stages of drug manufacture, from initial development to global distribution, providing scalability, flexibility, and low TCO for manufacturers of all sizes.

Components for injectable vials

Traditionally, injectable vials are made up of three components: vial container, vial cap, and vial stopper. Each one performs a vital function and is available in a number of different forms for a range of applications.

• Vial container
  As the component that’s in constant contact with the contents, the vial container must be highly stable in a range of conditions to ensure the drug, medication, or sample retains its original molecular structure and is uncontaminated through drug-container interaction so that it’s able to fulfil its intended purpose for the duration of its shelf life. Essential vial container properties include high strength, precise tolerances, chemical resistance, and reliability.
• Vial stopper
  A vial stopper adds a barrier to contamination and evaporation. Typically made of elastomer and with the option of coatings, the vial stopper is inserted into the top of the vial during the fill-and-finish process.
• Vial cap
  To keep the stopper in place, a vial cap must be added to ensure container closure integrity and prevent drug contamination. The vial cap needs to be sterile, highly stable, and form an airtight seal between the cap and container. Typically made of aluminum, vial caps are usually attached to vials for injectables by crimping.

Manufacturing and filling injectable vials

Pharmaceutical vials go through a number of processes during manufacture, with a series of stages of precise heating and shaping of a glass tube. Once formed, the vials can either be packaged as bulk vials or ready-to-use (RTU) sterile vials. For both configurations, SCHOTT Pharma uses the latest technology to deliver the highest levels of accuracy and surface quality, with 100% camera inspection along the process line, to ensure extremely low levels of geometrical and cosmetic defect.

While bulk vials require washing and depyrogenation before filling, RTU sterile vials are supplied pre-sterilized and pre-washed, and can go directly to the filling process, enabling pharmaceutical companies to remove prior process steps. This not only offers improved quality due to no glass-to-glass contact and increased flexibility for filling, but also reduces the total cost of ownership (TCO).

What do I need to consider when choosing a vial for injectables?

There are a number of considerations when it comes to choosing which type of vial container is right for your application. These considerations include:

• Composition and volume of contents
  The most important consideration when choosing the right vial container for a parenteral drug is what it will be used to store. If it’s a highly sensitive drug then you may need a vial with a special inner coating, such as EVERIC® plus, and if it’s sensitive to light then you may also want to consider using amber glass as opposed to clear.
• Application
  What you actually need to use the vial container for and your fill-and-finish process is crucial to choosing the right vial. So you should consider what volume your drug will be stored in. Also, does the formulation have a high, low or neutral pH level? Will you require a hydrophobic or hydrophilic inner surface? Will your drug need to be lyophilized or frozen, and do you need the vials to be delivered pre-washed and pre-sterilized in ready-to-use packaging that can be quickly loaded up to your fill-and-finish equipment? Think through every stage of your application to ensure your chosen vial fits your exact requirements.
• Drug-container interaction
  One of the main concerns for drug developers and manufacturers is drug-container interaction. This happens when leachables of the container material react with the drug formulation, potentially altering its composition and, ultimately, its effectiveness and safety. There are a number of ways a vial container can interact with a drug:

1. Glass delamination
   Glass delamination involves the appearance of glass-like flakes in the drug solution, caused by inhomogeneity in the near-bottom region of the glass vial. An outlier phenomenon induced by the hot forming process, glass delamination is hard to predict, but a lot of factors influence its likelihood, such as terminal sterilization, storage temperature, special treatments, and buffer type.
2. Leachables
   Leached ions from the glass vial can interfere with drug activity, posing a risk to highly sensitive drugs, such as biologics.
3. Protein adsorption
   Adhesion of proteins to the surface of the glass vial can lead to denaturation, aggregation, loss of biological activity, and inaccurate dosing.
4. pH shift
   An exchange process between ions of the inner glass surface and protons of the drug formulation can result in a change in pH value. The consequences of PH shift for a biologic can be protein denaturation, as well as changes in the protein structure.
5. Fogging
   The lyophilization process can result in fogging of the lyo vial, which increases the number of rejects and therefore costs, as well as potentially compromising Container Closure Integrity (CCI).
6. Aluminum-sensitive drugs
   As a component of Type I glass, aluminum can leach into the drug. While aluminum is present in the human body, it’s toxic in high amounts. This is especially relevant for parenteral nutrition applications containing amino acids that are stored in vials.

• Vial cap and stopper
  All vials used to store and transport parenteral drugs will require a vial cap and vial stopper, so consider the stability of your contents and which materials will offer the least risk of drug-container interaction. Also think about the most suitable attachment method for the vial cap and vial stopper.
• Availability and delivery
  Of course, once you have chosen your ideal vial container, you need to be confident that it’s available in the required amount in your area, with the shortest possible transport times. SCHOTT Pharma has a large portfolio of products and a global network of production sites to provide rapid and secure delivery of vial containers. In addition, our Online Shop offers fast and easy order processing and a range of fast-track kits that contain everything you need for the early stages of drug development.

Selecting the right vial for your needs

With such a large range of pharmaceutical vials available, each with their own unique set of properties and advantages, selecting the right vial can be a challenging process. At SCHOTT Pharma, we have a wide portfolio of vials and a dedicated team of experts with decades of experience in pharmaceutical glass packaging, who will be delighted to talk through your requirements. Working together, we can help you choose exactly the right vial container for your needs.