Things to Consider when Choosing a Drug Development Vial

What are the challenges when choosing a vial?

Choosing a vial which is right for your product and project can be extremely important and surprisingly complex. This container will have direct contact with your drug formulation throughout its shelf life, so it is important to ensure compatibility at the earliest opportunity.

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In our experience many start-ups don&#;t even consider what container to store their product in until much later in development, and yet this simple oversight can drastically alter the course of their drug discovery project, potentially resulting in costly revalidation work and increased time-to-market. This is why here at Adelphi Healthcare Packaging we specialise in helping you to specify the right packaging for your project from the very earliest stages of development. This includes discussing your product&#;s properties, sensitivities and fill volume, among other specifications.

Vials come in many materials, shapes and sizes, each serving a different purpose. Variants include neck finish, vial capacity, glass type and special features, such as internal coatings.

Parenteral drugs are typically filled into vials made from Type I glass. Type I is a pharmaceutical grade, borosilicate glass with a high melt point and excellent chemical resistance. However, not all drugs are compatible with standard glass vials, and later we evaluate potential alternatives.

Numerous considerations need to be taken into account, from vial integrity to storage conditions, and it can be a challenging process for any researcher or startup to find the ideal packaging.

In this article we will look at 5 things you need to consider before deciding which container is best suited to your project and why.

Drug composition

One of the first challenges is understanding the composition of your drug and how this might impact its compatibility with the vial. Drug composition refers to the chemical makeup of your formulation. A particularly aggressive formulation, for example, might react with or delaminate the internal surface of the container it is packaged within. For this we need to consider the following factors:

1. pH Level

pH is a measure of the acidity or alkalinity of a solution. It quantifies the concentration of hydrogen ions (H+) in a liquid, and is used to determine how acidic or basic (alkaline) that solution is. The pH scale ranges from 0 to 14, with 7 being considered neutral.

When it comes to vials, the pH level of your product can impact its compatibility with the container. If your formulation is more alkaline or acidic the wrong container choice could result in potential delamination or damage to the vial&#;s surface, leading to an unexpected leachables and extractables profile.

Type I, neutral, borosilicate glass is characteristically resistant to chemicals, however, for preparations outside of the 3-7 pH range a standard Type I Glass vial may struggle, making it either entirely unsuitable or dramatically affecting shelf life.

In these cases, we would recommend the use of a vial with an inert internal coating which will minimise interaction between the drug and its container. Products to consider depending on which side of the pH scale your product sits, include the SCHOTT Type 1 Plus® Vials, the SCHOTT EVERIC® care and EVERIC pure vials.

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2. Drug sensitivity

This concerns how reactive your product is to the composition of the glass itself. Glass contains a number of ingredients, and on testing your formulation you may discover sensitivities to some of these elements. Some examples include:

• Metals: these are elements, typically aluminum (Al203) that can possibly leach into the product depending on the chemical composition of your drug.
• Trace elements: this includes rarer metals such as iron and boron that can be picked up in the forming of the container. This has the potential to transfer into the product, leading to a loss of stability and a change inefficacy and shelf life.

If your product reacts with elements in the glass matrix, there are still suitable options available. These include glass vials with an inert internal coating, such as the SCHOTT Type I Plus® vial which features an internal surface of silicone dioxide (Si02), providing an effective barrier between your product and the potential extractables of the vial. Another benefit of a vial with a silicone dioxide coating is that there is no need for re-registration from a standard Type I glass vial. Alternatively, a pharmaceutical grade polymer vial, like the West/Daikyo Crystal Zenith vials are metal-free by design, have clarity comparable with glass. and provides additional benefits in areas such as cold storage.

3. Photosensitivity

Exposure to light is a concern to those developing drugs prone to photodegradation. Photodegradation is the process whereby a ray of external light (natural or artificial) changes the chemical composition of a product after a sustained period. This can affect the efficacy of the API and reduce shelf life. If photosensitivity is an issue for your product, it is advisable to use a container with UV blocking properties, such as an amber glass vial.

You&#;ll find most glass vials on the market are available in both clear and amber glass. Examples include: Standard Injection Vials, which can also be offered in a sterile format.

Drug storage and administration

Other factors to assess when selecting a drug container may include the state in which your product should be stored, as well as considerations relating to optimisation at the point of administration. For example, with high value or low-fill formulations you will want to ensure full extraction is possible, and for products which struggle to remain stable in a liquid state, you may need to consider options such as freeze drying.

4. Lyophilisation

Lyophilisation (freeze drying) is a process where the state of a liquid drug is changed to a solid, usually resulting in a dry powder. The process is separated into three distinct phases (Annealing, Sublimation, and Absorption) with the aim of drawing out as much water from the drug as possible. The benefit of freeze drying your drug is that it prolongs shelf life and inhibits reactive characteristics. At the time of administration, by a medical professional, the dried drug is reconstituted into a liquid form ready for injection.

If you are planning to freeze dry your product, the first thing you need to consider in your container is whether the vial provides good thermal transfer through the shelf of the lyo chamber. Tubular glass vials are preferable to moulded in this instance, as they feature a consistent thin base for optimal heat transfer.

A common challenge when freeze drying a drug product within a vial is product creep. This can happen in the case of proteins which tend to cling to the walls of the vial, affecting the results achieved. To avoid this phenomena you can opt for a container with a hydrophobic internal coating, such as the SCHOTT TopLyo® vial or the EVERIC® care vial. This will ensure all liquid remains at the bottom of the vial, increasing the probability of a neat lyo cake and maximum removal of the reconstituted product.

Visit our Information Centre for more Tips on Freeze Drying in the Vial.

5. Recoverability of High Value / Low Fill Drugs

Recoverability refers to the ease by which you can remove the entire contents of the container prior to administration. This is especially important for high value drugs, where the need to discard unused residual product could be extremely costly, and for low-fill drug preparations where it is crucial to administer the full dose. Often in cases such as these drug manufacturers are forced, by necessity, to overfill vials in order to ensure sufficient product can be drawn up into a syringe.

Fortunately, solutions do exist to help in these situations. For example vials with a hydrophobic internal coating, such as the TopLyo® or EVERIC® care vial, ensure liquid does not adhere to glass, but instead always runs to the base of the vial. In the case of low-fill drugs of 1ml or less, we recommend the use of a 2ml vial with a hydrophobic coating, which can be tilted to guide all of the liquid drug into the heel of the vial for easiest extraction by needle.

Conclusion

Selecting the right vial for your drug is a critical process with profound implications for your drug discovery project. We&#;d like to emphasise the importance of early consideration in the selection process to avoid potential setbacks such as increased time-to-market and costly revalidation work. The considerations in choosing a vial involve factors such as drug composition, pH level, sensitivity to elements in the glass matrix, photosensitivity, and suitability for lyophilisation.

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Adelphi Healthcare Packaging specialises in guiding clients through these considerations from the earliest stages of development, ensuring compatibility and optimal packaging choices for their specific needs.

Quality control is an important aspect of any business, especially when it comes to packaging solutions. Glass packaging, in particular, requires strict adherence to quality standards as it can have a direct impact on the safety and preservation of the product being packaged.

To ensure that the products being delivered meet the agreed upon quality standards, it is necessary to establish clear quality expectations and standards with the supplier.

One way to do this is by specifying an acceptable quality level (AQL). This article will explore the importance of asking for an AQL from a glass packaging solutions provider and how it can help to ensure that the products being delivered meet the agreed upon quality standards - But first...

What is AQL?

AQL stands for acceptable quality level and it is defined in ISO -1 as "the quality level that is the worst tolerable" in a sampling inspection of products. The AQL is used to set the maximum number of defects that are considered acceptable in a given sample size. The specific AQL value is determined by the customer and supplier, and it is generally agreed upon before the production process begins.

ISO -1 is an international standard that provides guidelines for the statistical sampling of products during the inspection process. It describes different sampling plans that can be used, depending on the level of quality desired and the size of the sample. The standard also provides tables that can be used to determine the sample size and the number of defects that are considered acceptable for a given AQL.

In summary, AQL is a standard used in the inspection of goods during the production process, as defined in ISO -1, it sets the maximum number of defects that are acceptable in a given sample size. It is agreed upon by the customer and supplier to ensure that the products being delivered meet the agreed upon quality standards. The AQL value is used in conjunction with sampling plans and tables provided in ISO -1 to determine the appropriate sample size and number of acceptable defects.

Source: Freepik

It's also important to note that AQL is usually expressed as a percentage, or in some cases as a ratio. The percentage of allowable defects is typically between 1% and 10%, but the exact percentage will depend on the specific product and industry. The lower the AQL value, the higher the quality requirements and the stricter the inspection standards.

Benefits of asking for AQL from glass packaging solutions provider

It is absolutely necessary to ask about AQL from the glass bottle vendor to establish common acceptable quality parameters between you and your glass bottle supplier. 

Having an AQL in place also helps to ensure that the supplier is taking the necessary steps to maintain quality control during the production process. For example, if a supplier is consistently delivering products that exceed the agreed upon AQL, it may indicate that they are not properly inspecting or testing their products before shipping them. This is particularly important when it comes to glass packaging, as any defects in the packaging can have a direct impact on the safety and preservation of the product being packaged.

While using AQL tables, the buyer should be clear about three parameters:

• The &#;lot size&#;: In case of different products being ordered, consider each product as a separate lot. The quantity of each product is the lot size.
• The inspection level: The variations in inspection levels will command different numbers of samples to inspect.
• The AQL limits: If your customers accept very few defects, you might want to set a lower AQL for both major and small defects.

AQL levels can vary for different organization, and it's important to determine the appropriate level for your own firm. Defects can be categorized as minor, major, or critical, which can help determine which defects can be fixed and which require immediate production halt. For instance, in inspections of cosmetics packaging, the standard AQL levels of 0/1.5/2.5 are typically applied to classify defects as critical, major, or minor. For instance, minor defects such as scratches or blemishes may be acceptable within the AQL level, but critical defects like cracks or punctures will result in a failed inspection as they have zero tolerance.

One thing to note is that AQL is not a one-time evaluation, it should be continuously monitored throughout the production process. It's essential to keep track of the supplier's performance over time, and to make adjustments to the AQL as necessary. For example, if a supplier is consistently delivering products that exceed the agreed upon AQL, it may indicate that they are not properly inspecting or testing their products before shipping them. In this case, it may be necessary to adjust the AQL to a lower value, or to take other steps to improve the supplier's quality control processes.

Is AQL a sufficient parameter for Quality ControI?

In addition to setting an AQL, it is also important to conduct regular inspections of the products being delivered. This allows the customer to verify that the products meet the agreed upon quality standards, and to identify any issues that may need to be addressed. This can be done through random sampling or by checking a specific number of products from each batch. The customer can also request a pre-shipment inspection to ensure that the products meet the agreed upon quality standards before they are shipped.

Source: Freepik

Another important aspect of quality control when it comes to glass packaging is compliance with relevant regulations and standards. This includes compliance with safety and health regulations, as well as environmental regulations. Glass packaging providers should be able to provide documentation that demonstrates their compliance with these regulations and standards. This is important to ensure that the products being delivered are safe for use and do not pose a risk to human health or the environment.

During an interaction with a client, I shared an AQL and drawing of the bottle before supplying the bottle. The quality control (QC) head personally called me and congratulated me for the good practice being followed. On top of that, he informed us that since we were the first vendor to submit AQL, they have waived off the compulsory audit. He commented that if AQL is being followed, all processes must be in place.

The final word

In conclusion, asking for an AQL from a glass packaging solutions provider is necessary in order to ensure that the products being delivered meet the agreed upon quality standards. It helps to prevent misunderstandings and disputes over the quality of the products and helps to ensure that the supplier is taking the necessary steps to maintain quality control during the production process. In addition, regular inspections and compliance with relevant regulations and standards are also important to ensure that the products being delivered are safe for use and do not pose a risk to human health or the environment. It is important for customers to be vigilant and to work closely with their suppliers to ensure that the highest quality standards are met.

Have more questions related to AQL? Want to know what should be your checklist to select a glass packaging solutions provider? We have an expert support team to address all your questions. Connect with me on LinkedIn or at .

About the Author: Currently, Deepanker Agarwal is the Director at Ajanta Bottle Private Limited, a renowned name in the glass packaging industry for the past 41 years, with customers in India, South and Central Asia, the Middle-East, and Canada. Ajanta Bottle provides glass packaging solutions for all large, medium and small enterprises, along with design, consulting and decoration services for customers across all industries - cosmetics, food, beverage and pharmaceutical. In a career span of decade and a half, Mr. Agarwal, by providing right glass packaging solutions, has helped many leading food, beverage and pharmaceutical companies to build their brand, win customer confidence and increase their bottom-line. He is also an author of India's first ever and only book glass packaging - Through the Glass - Past. Present. Only Future.. Mr. Agarwal is a golfer, marathon runner, an avid reader and a traveler, and an angel investor. He has spoken at various industry conferences and events including those organized by the Trade Promotion Council of India. He has also been awarded by the All India Food Processors&#; Association (AIFPA) and the Ministry of Food Processing Industries for promotion of glass packaging in the country.

Image courtesy: Freepik

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