Over the years, various advances in drug / therapy development strategies have caused the pharmaceutical industry to gradually shift from a one-drug treats all model to a more personalized approach of treatment. Similar trend is likely to be seen in pharmaceutical packaging domain. For instance, biologics are relatively less stable than small molecule drugs, and therefore, have specific fill / finish and packaging demands that may not necessarily be required for the latter type of products. Moreover, it is equally important to make sure that the chosen packaging is compatible with the fill / finish equipment used and meets end-users’ requirements as well. An upcoming trend in pharmaceutical primary packaging is the shift towards flexible filling, and the use of ready-to-use (RTU) containers and closure systems. While the RTU syringes have been a part of the mainstream industry for some time now, other RTU container systems, such as vials and cartridges, are gradually becoming popular. Further, considering the pharmaceutical packaging and drug administration-related demands of the modern healthcare industry, experts believe that a modular approach to packaging methods would be beneficial, both in terms of time and cost. The global pre-sterilized / ready to use pharmaceutical packaging market is anticipated to grow at a CAGR of around 6.62%, till 2035, according to Roots Analysis. Driven by the rising demand for advanced packaging material and technology across various regions, the ready-to-use packaging market is anticipated to witness steady growth in the coming decade.
PHARMACEUTICAL PACKAGING AND FILLING OVERVIEW
In general, the term packaging refers to a set of components which envelope the drug product from the time of its production till its use by the patient. In addition to serving as a physical (storage) container for a drug, good pharmaceutical packaging should provide proper protection from the external environment along with being user friendly and easy to identify. However, the most important aspect of the packaging is that it should be inert and compatible with the dosage form.
The pharmaceutical filling process is well established with checkpoints at various steps in order to prevent product contamination and disruptions in the entire process. Further, such operations are required to be conducted in compliance to various regulatory guidelines, as applicable across different geographies. However, the previously acceptable open processing area filling lines without barrier technology are becoming obsolete. Due to an increase in personalized therapies and rising adoption of flexible filling technologies, almost every filling line that is being built features isolators / barriers technology. The barrier technology and flexible fillers currently in the industry aid the manufacturing process by eliminating all potential sources of human contamination and are suitable for filling small-scale filing of multiple types of container formats, such cartridges, syringes and vials.
TYPE OF PACKAGING
There are three types of packaging, namely primary packaging, secondary packaging, and tertiary packaging.
- Primary packaging: It refers to the material that is in direct contact with the drug product and therefore, has a direct impact on its shelf life. Examples include vials, ampoules, syringes and intravenous (IV) containers.
- Secondary packaging: It is the covering around the primary packaging that is used to collectively contain groups / sets of primary packages. Examples include cartons, boxes, and trays.
- Tertiary packaging: It refers to the type of packaging that is used when the product needs to be handled in bulk or shipped. Examples include barrels, containers, and edge protectors.
LIMITATIONS OF TRADITIONAL PRIMARY PACKAGING
Primary packaging, specifically glass and plastic container systems, play a pivotal role in the protection of the drug / therapy substance contained within, from a number of environmental factors. However, such containers usually have certain limitations associated with them, rendering them ineffective in providing adequate protection against specific conditions. Major limitations of conventional container closure systems include:
- Water vapor ingression into a lyophilized drug in a vial
- Leaching of elastomers from plastic containers
- Chances of contamination with endotoxins and microorganisms in the drug product
- Immense time consumption during the washing, sterilization and dehydrogenation steps
- Chances of chemical interactions between the drug product and the packaging material
- Adsorption and absorption of the drug product by plastic containers
In order to overcome the aforementioned limitations, the industry is shifting its focus towards Ready-To-Use Packaging.
OVERVIEW OF READY-TO-USE PACKAGING
Contrary to traditional packaging, RTU containers and closures can be used directly for aseptic filling of drug / therapy products. RTU vials, syringes and cartridges are pre-sterilized, enabling pharmaceutical companies to bypass all traditional container processing steps and use them directly in the aseptic filling step. This not only saves time (that would have otherwise been spent on aseptic processing), but also results in space saving, as equipment for aseptic processing is no longer required. Further, owing to the reduction in number of steps in the overall fill / finish process, companies are likely to save on labor cost as well. It is worth mentioning that presently stoppers and seals also come in an RTU format.
It is also worth highlighting that RTU container and closure systems come in nest / tub formats, which hold the vials while sterile material is being introduced in them. In addition, these nests reduce the risk of container breakage throughout the fill / finish process. Further, the nests allow the filling of multiple vials at a time. They also enable the quick and easy loading of vials into freeze dryers, without requiring additional loading tools.
ADVANTAGES OF READY-TO-USE PRIMARY PACKAGING
The various advantages of using RTU containers are briefly described below:
- They do not require additional facilities / equipment for carrying out washing and sterilization steps
- They enable a greater degree of automation to be implemented in the fill / finish process
- They allow a greater degree of flexibility while dealing with multiple container types (given that they are available in similar / compatible nest or tub formats)
- They reduce dependence on manual labor, consequently lowering risk of contamination (which has been shown to have a high correlation with the involvement of manual processing steps)
- They lower chances of container breakage
- They are also optimized for use in lyophilization steps
- They also enable significant cost and time savings (described in detail below)
KEY DRIVERS AND ENABLERS
Some of the key drivers and enablers of the adoption of RTU container and closure systems in pharmaceutical packaging are listed below:
- Rise in interest and development efforts related to personalized medicine
- Increasing stringency in regulatory guidelines
- Optimization of the production process and the need to reduce manufacturing cost
- Need for more flexible and possibly automated filling processes
As industry players look for methods in order to enhance production, minimize wastage and lower the total cost of development, demand for RTU container systems is expected to rise. Using nested packaging with automated filling lines is one such option that helps in meeting majority of the above listed demands. As a result, RTU closed containers packed within nests, or tubs, provide a complete solution to meet the demands of modern pharmaceutical manufacturers. Such systems are efficient as they serve to significantly accelerate the filling process and ensure quicker delivery to the market and customers.
CONCLUDING REMARKS
Pharmaceutical packaging plays a key role in ensuring the sterility and the quality of a drug product, while providing information related to its identity and, in certain cases, dosing instructions as well. The RTU, or pre-sterilized / pre-treated, container-closure systems have emerged as a promising alternative to conventional primary packaging, adding significant value to streamline pharmaceutical fill / finish operations. These packaging components eliminate multiple steps in the overall fill / finish process (mainly washing, sterilizing and preparing containers), thereby, helping improve operational efficiencies in compliance to existing regulatory standards. Owing to several other benefits, RTU container-closure systems have gradually gained popularity in the pharmaceutical industry. Moreover, many drug product manufacturers and fill / finish service providers have also adopted such systems to better serve their clients. In the future, as drug developers continue to strive to achieve greater flexibility in their operational protocols, RTU containers and closure systems are expected to play a key role.
About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.
