New Trends in Pharmaceutical Packaging

Pharmaceutical packaging is the critical stage of the drug manufacturing process. Its primary purpose is to maintain the drug’s properties until it reaches its intended user. It protects the drug from damaging external factors such as Human mishandling, counterfeiting, and tempering that could affect its properties. It maintains its efficacy throughout different stages of a drug supply chain, such as sampling, transportation, and storage. It also protects and possesses properties against various environmental factors such as Heat, Dust, and Moisture.

Regulatory bodies worldwide have special regulations for pharma packaging, and they keenly inspect the packaging practices of a pharmaceutical company during their routine inspections. They inspect to see whether the company has invested enough in quality packaging machinery, and the packaging processes are according to approved regulations. If the regulatory bodies find any major non-conformance in a pharma company’s packaging practices, it can result in a warning, fines, or complete shutdown of operations.

As with other pharmaceutical sectors, the packaging also witnessed new trends and innovation. The use of advanced engineering techniques such as Automation, improved mechanical design, and software solutions are the main building blocks behind the innovation.

Drivers of new Trends in Pharma Packaging

New trends in the Pharmaceutical sector is not overnight, but it is the result of tireless efforts of different experts to achieve improvements. These improvements pave the way for new trends. Some factors that have contributed significantly to packaging include the following.

· Research: Constant research in different areas of pharma packaging such as pharma packaging materials, engineering design has helped in creating new designs.

· Learning from past experiences

· Desire for improvement

Advantages of Innovation and New Trends

There are many advantages of new trends that have benefitted both the manufacturers and patients. Let’s look at some benefits of recent trends in pharmaceutical packaging.

Cost effective: It has enabled the manufacturers to increase their production capacities with fewer resources and less time. This helps to compete with their competitors and increases their market share. Similarly, patients also benefit by having low-cost medicines and drugs.

Reduced Operating Cost: It also results in reduced operating costs which is the most crucial benefit. New energy-efficient machines consume fewer energy resources, such as Electricity and Compressed Air, compared to older packaging machines.

Ease in Operation. New packaging machines can be operated with little expertise. It enables the manufacturers to hire manpower without highly technical knowledge and skills. It also eliminates the need for specialized training during commissioning. Manpower with the basic machine and engineering knowledge can be easily trained to operate these machines.

Lower changeover times: Changeover times are critical in every manufacturing process, and they are one of the main reasons for machine downtime. Additionally, they require skillful personnel to carry out changeover successfully, without creating problems for the machine and the operators. New technologies in packaging machines enable the operator to perform machine changeover in less time and at the same time prevent post-changeover problems.

New Trends

Let’s look at some latest trends in pharmaceutical packaging machine.

Blow fill seal (BFS)

Blow Fill Seal is the latest aseptic filling and offers many advantages over traditional ampoule filling. In this technology, the container is formed by placing the raw plastic in granules in a mold. In the mold, plastic undergoes a process known as Extrusion, in which it is forcefully pressed. This process causes the plastic to take the shape of the mold, which is essentially the shape of the container. After formation, the plastic container is filled with the product. Sterile air is injected into it before filling, and the plastic mold is closed and sealed.

The main advantage of the BFS technique is that filling is carried out without human intervention. This reduces the risks associated with human involvement, such as contamination. BFS is also common in the manufacturing of Biotech products such as Vaccines.

BFS prevents problems related to glass container such as glass particles, as the glass sealing process are eliminated.

In a BFS machine, only a small area of the machine is required to be under environmental control compared to traditional filling machines, where the entire machine needs to be under environmental control.

Plasma impulse chemical vapor deposition (PICVD) coating technology

This is a particular type of chemical vapor deposition, which uses low-pressure gas. This helps to lower the temperature of the reaction. The plasma is used to activate the deposition process, creating glass-friendly properties such as easy to clean and anti-scratch properties.

They are widely used in Biotechnology products due to low operating temperatures, as bioproducts require temperature in the lower range.

Despite the above-mentioned advantages, PICVD coating has two significant difficulties. The equipment is costly as compared to other alternative equipment. The maintenance of PICVD coating equipment is also expensive and requires specialized training and skills. Similarly, its parts are expensive, making any maintenance or replacement expensive.

Secondly, PUCVD coating technology uses Silicon Oxide and Silicon Nitride, which are not human and environmentally friendly. These gasses are toxic and can create harmful working conditions. Additionally, they require specialized protective arrangements during their coating process.

Unit dose vials

Unit dose vials are specialized packaging designs in which the medicine can only be used once. They are typically filled in the required quantity, utilized only once, and consumed by a single patient. The drug should be discarded if leftover. It can cause harmful effects if used again.

Unit dose vials often consist of a plastic bulb, which can be twisted to open. The vial body is squeezable, which is squeezed to administer the drug.

Unit dose filling is performed by a machine that operates under a controlled environment commonly called Cleanrooms. Their speed can range up to 120 vials per minute, and the speed decreases as the fill volume increases. Their fill volume can range up to 0.3 to 10 ml.

After the filling process is completed, the vials are labelled with the necessary product information. This is in contrast to traditional glass-based vials and ampoules where the product information is printed on the glass container.

Two-in-one prefilled vial design

Two in one design is a design that is used to protect the drug container against tampers. It easily indicates to the user if the drug has been tampered with.

There are two chambers on the upper and lower sides in this design. The lower chamber is separated by a spacer so that constituents do not mix with each other. This formation is used to pack the pharma product with the water for injection.

Prefilled syringes

The prefilled syringe is the latest method of administering injectables to humans. It is a single-dose drug delivery method in which the needle is placed in the container. There was a trend of using glass body in the past, but nowadays, plastic body is used. The syringes and plastic bodies are disposable and cannot be used more than once.          

They are safe and allow for easy handling. Transportation of Prefilled syringes is also easy, as there is no chance of breakage. This is in contrast to glass ampoules, which can break during transport. They are also lightweight, significantly reducing transportation costs and resources. They are also easy to use and can be administered easily as compared to glass-based containers. They have preferred delivery methods of different specialized drug types such as vaccines and erythroproteins.

There are two types of Prefilled syringes – Needle-free PFS and Needled PFS.

Needle-free PFS is commonly used for administering Vaccines and can be used for subcutaneous and intradermal injection. They are calibrated for a specific fill volume and can be used for a 0.5mL or 0.1mL dose. While this type can be used for consistent delivery, it is dependent on the provider’s handling capabilities. So it is recommended to have proper training of the technical personnel.

The Needled PFS is generally used for biotech and pharmaceutical products. They consist of a needle cannula inserted through a nozzle and require siliconization. The Silicon is applied at the syringe barrel and on the needle surface. Silicon on the needle helps in easy skin penetration during its usage on the patients.

The Silicon used must be of medical grade and should not contaminate or change the properties of the drug.

Child-resistant packaging

Child-resistant packaging is a packaging that is difficult for a child to open. However, adults, including those with disabilities, can easily open the packaging and consume the drug. Manufacturers implement child-resistant packages by an additional cap which is challenging to open. The cap comes with a locking mechanism, which can only be open with a specific opening technique. Examples of such techniques include Push & turn and Turn & lift

Blister packaging also comes in the variant of child-resistant, where manufacturers deploy an additional layer over the original blister layer. This extra layer makes it difficult for the children to open the blister packs, although the adult can easily open the blister packs.

Conclusion

As with other industries and sectors, Pharmaceuticals also witnessed innovations and trends. At first, they seem to be expensive and resource-intensive, but they benefit the company in the long run. Innovation helps a manufacturer remain at the top of their competitors and results in increased revenue.

About the Author:

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.