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Pharmaceutical Packaging

Packaging is an essential part of every manufacturing and production process. Pharmaceutical packaging involves the provision of an appealing presentation, portable containment, reliable protection, convenience, and identification information for a product for storage, distribution, and sales. This containment is essential for preserving drugs and drug products during storage, transportation, and display, till the drug or drug product is consumed or administered.

Pharmaceutical packaging must be designed in such a way that it protects the drug or drug products from external factors such as temperature, sunlight, micro-organisms, etc., and maintains its stability. In the healthcare sector and the pharmaceutical industry, pharma packaging plays a significant role in the safe procurement and administration of pharmaceutical products. Here, we have carefully examined the types, categories, the market size of pharmaceutical packaging, and its importance to the pharmaceutical industry.

Categories of pharmaceutical packaging

In the healthcare and pharmaceutical sectors, close attention is given to pharmaceutical packaging as it is used to complete the medical prescription of various drugs for identification, storage, and consumption. There are three categories of pharmaceutical packaging used for every pharmaceutical product regardless of the dosage form. These categories include primary, secondary, and tertiary packaging.

Primary packaging consists of materials that have direct contact with the drug or pharmaceutical product packaged. This is the material surrounding the drug. The materials must be inert, safe, and capable of protecting the product from external factors such as moisture, climatic changes, biological contaminations, etc. Some primary pharmaceutical packaging types include sachet packaging, bottles, glass vial, injectables, blister pack, ampoules, etc.

Secondary packaging refers to boxes or cartons where the package is kept. This usually contains information and directions of the pharmaceutical product. Tertiary packaging refers to the last stage or level of packaging carried out to aid transportation, shipping, and wholesale storage. Tertiary packaging primarily protects the product, primary and secondary packaging from external factors during transit.

What are the types of pharmaceutical dosage form containers?

There are different types of pharmaceutical dosage form containers, and these containers are classified based on the dosage form ranging from solid to gas formulations. Based on dosage forms, there are solid dosage form containers, liquid dosage form containers, and gas dosage form containers. Solid dosage form containers consist of tamper-resistant packaging such as Bottle seals, strip packages, blister packages, sealed tubes, breakable caps, tape seals, shrink seals and bands, film wrappers, foil paper, child resistant packaging, etc. Liquid dosage form containers consist of glass bottles, ampoules, cartridges, vials, syringes, plastic container, etc.

These containers can either be single-dose or multiple-dose containers, airtight containers, well-closed containers, or light-resistant, depending on the drug packaged. Gas dosage form containers include sprays, vaporizers, prefillable inhalers, aerosols, and nebulizers—the majority of these containers consisting of airtight plastic or glass container with spray pumps. For semi-solids, plastic containers, pressurized packages, and metallic collapsible tubes are used.

Other dosage form containers such as liposome packaging include hermetically sealed borosilicate glass ampoules and narrow and wide-mouth borosilicate glass bottles.

What is the global market size of pharmaceutical packaging?

The size of the global pharmaceutical packaging market plays a valuable role in the global pharmaceutical industry market. The increasing need for drugs has positively affected the growth of the global pharmaceutical market size. Based on Precedence research, the global market size in 2019 was valued at US $98.83 billion.

In the following forecast period from 2020 – 2027, it is expected to experience a compound annual growth rate (CAGR) of 8.6%, surpassing the value of US $191.21 billion by 2027. The growth of the global pharmaceuticals packaging market size has been contributed to by various key factors such as the increasing demand for blister packaging, patient-oriented drug, increasing aged population, rising health awareness, etc. Pharmaceutical packaging and contract packaging companies have significantly propelled the growth of the pharmaceutical industry.

In 2019, the global market was led by North America, with a value share of about 38% due to the presence of leading pharmaceutical packaging companies within that region. Also, the primary pharmaceutical packaging segment had an estimated value share of 75%, and this is expected to continue over the forecast period. The Asia Pacific is expected to witness a rapid growth rate over the forecast of 12% due to the rapid increase in population size.

How many types of pharmaceutical packaging are there?

Each of the categories/levels of packaging has different types, and the nature of these packages are dependent on the drug dosage form – solid, semi-solid, liquid, and gas. There are numerous types of pharmaceutical packaging based on three different categories. A few of them include:

-blister packs

-vial packaging

-ampoules

-prefilled syringes

-latitudes

-plastic bottle

-glass bottle

-cartons and boxes

-plastic pouches

-strip package

-fin sealed package

-shrink seals

Materials used in pharmaceutical packaging

Just as the types of packaging vary, the raw material used in the production of these packaging containments also vary. Various pharmaceutical packaging companies produce different packaging types, and they are made from other raw materials, organic and inorganic. The choice of pharmaceutical packaging material used for the production of packaging containers is usually dependent on the type of drug to be packaged and specific patient needs. In some cases, these materials can be referred to as primary packaging when they directly contact the drug formulation. Some examples of materials used include glass, plastics, elastomeric material such as rubber, etc.

What are the various packaging materials used in the pharmaceutical industries?

Pharmaceutical companies manufacture drug packaging using various raw materials. Due to technology and research advancement, the range of material options continues to increase. As new materials are discovered and chosen for use, factors such as cost, convenience, dosage form, degree of protection required, sterilization methods, drug-material compatibility, and filling methods are considered. Each material considered or chosen for packaging must be a sustainable material to improve safety and drug usage.

Given the different types of dosage forms, stability, and effect of drugs, a wide range of pharmaceutical packaging materials are used, such as glass, rubber, plastics, metals, paper, films, aluminium foil, and laminates, and fibrous material.

What are the main packaging materials used in pharmaceutical industries?

Although there are various packaging materials, there are a few major ones used by almost all pharmaceutical companies and for most packaging. Glass and plastic are some of the most commonly used materials in drug packaging.

Glass has been used for drug packaging for several years now due to the numerous benefits it offers. Glasses (glass bottles) are transparent, economical, have adequate protection power, can be labeled easily, come in various shapes and sizes, and durable. They are thought to possess high protection power due to their inert composition, which eliminates or reduces the chances of drug-material interactions. The most commonly used glass packaging is amber glass because it offers more protection from U.V. rays than clear glass.

Plastics are also commonly used because of their versatility, flexibility, ease of use, durability, and light weightiness. However, the downside to its use is the possibility of drug-material interactions through the transfer of leachable. Some types of plastics used include polypropylene (P.P.), polyethylene terephthalate (PET), high-density polyethylene (HDPE), and several others.

What are the organic packaging materials available that are used in the pharmaceutical industries?

Pharma packaging companies are progressing to the use of eco-friendly, organic, and biodegradable materials for packaging production. This innovation is considered more appealing to consumers, environment-friendly, and a plus for brand reputation.

Organic raw materials used for packaging production can be derived from plants, animals, agricultural feedstocks waste, and marine food processing industry waste. The use of organic and biodegradable materials helps to maintain a safe environment and atmosphere. Some popularly used organic packaging materials include paper, cork, starch, chitin, cellulose, gelatin, collagen, gluten, soy, keratin, etc.

Accountability of pharmaceutical packaging manufacturers

The development, manufacturing, and production process of drugs and drug products are carefully monitored and inspected to ensure that regulatory policies are duly recognized and followed. Pharmaceutical packaging manufacturers are held accountable by regulatory organizations such as the World Health Organization (WHO) and the Food and Drug Administration Agency (FDA). 

Accountability of these packaging companies ensures that the raw materials used for the production of packaging and the final products do not affect the stability, safety, and effectiveness of the drug or drug product.

What are the risk factors in the packaging of pharmaceutical products?

Although pharmaceutical packaging is essential and the benefits of pharmaceutical packaging are enormous, there are various risks associated with packaging. With every step of the manufacturing process comes a risk to the drug's safety and integrity. In addition to consumer safety, drug stability, drug delivery, and integrity, other factors such as brand name, reputation, and profitability face various risks associated with packaging.

Risk factors associated with package design and production include wrong labeling, incorrect or incomplete product information, material-product interaction (containment-drug reaction), contamination, poor seal integrity, supply-chain interference, destruction of products as a result of mishandling, incorrect product count or fill-level, etc.

Other factors influence these risks, and they can become sources of paramount concern when these factors come into play. Some of these factors include a non-sterile processing environment, faulty machines and equipment, damaged raw materials, incompetent staff, and many others.

These risk factors put the company's reputation and profits at risk and the health of patients (consumers).

Who regulates the pharmaceutical industry?

Given the importance of pharma packaging and its effect on drugs, drug products, and consumer safety, strict regulatory guidelines and policies are put in place for pharmaceutical manufacturing companies. These regulatory guidelines and procedures are put in place by regulatory agencies and organizations such as the U.S. Food and Drug Administration (FDA) to ensure good manufacturing practice (GMP) in each pharma company. They ensure that pharma companies provide standard packaging systems, through the use of  standard pharmaceutical packaging equipment (packaging machine) or medical devices.

 Although the regulatory agencies vary by country, they are global pharmacopeia standards set by the World Health Organization (WHO) which are globally acceptable.

The standards and policies created are implemented to ensure material-drug compatibility, prevent contamination, preserve drug integrity, maintain stability, and ensure patient safety. Pharmaceutical packaging standards deal with production location and its sterility, packaging labels, and packaging materials. Some guidelines that have been set in place across regions globally include Anti-tampering regulations issued by FDA, Labelling regulations (Fair Packaging and Labelling Act 1967), and others.

Pharmaceutical and biopharmaceutical supply chain expertise

The pharmaceutical supply chain consists of several government agencies, research organizations, clinics, hospitals, drug manufacturers and distributors, pharmacies, retailers, and regulatory agencies such as the FDA. This chain is responsible for manufacturing drugs, distribution of prescription and OTC drugs, biologics, and generics, and others.

In some cases, insurance companies, HMOs, and GPOs form part of the supply chain or packaging line, which further complicates it.

Due to the complexity of the supply chain, the supply chain's management and regulation may pose a challenge. However, several trusted partners and companies are well-versed and experienced in the management of the pharmaceutical and biopharmaceutical supply chain; a notable example includes Novartis.

Finding the right partners in a supply chain can be effectively carried out when due research and communication are conducted on the key players of the supply chain.

Latest trends in pharmaceutical packaging

Over time old trends have passed and given way to new ones. While the pharmaceutical packaging industry continues to evolve, various trends arise which are shaping and changing the future of the pharmaceutical packaging industry. These latest trends have come to modernize and transform the global pharmaceutical industry for the benefit of the manufacturers and the consumers.

These new trends have actively contributed to the growth of the global pharmaceutical market size in recent years. However, they are also projected to contribute a large percentage of the worldwide market size growth in the nearest future. These key trends have been identified based on collected data and insights gathered by pharmaceutical industry experts.

What are the new trends in pharmaceutical packaging?

The Global pharmaceutical industry has changed rapidly over the years and is still evolving. Due to the increasing population, demand for drugs, and many other factors, the need for new and modernized drugs is on the rise. As a result, there is need for a new pharmaceutical packaging solution and design to accompany the production of these new drugs.

Accompanying new drug developments are recent pharmaceutical packaging trends in the pharmaceutical manufacturing organizations to ensure consumer safety and convenience, manufacturer's profitability, and boost brand reputation.

Some of the newest trends impacting pharmaceutical packaging include Eco-friendly packaging, innovative packaging automation and machinery, sustainability, smart packaging, minute production lots, patient engagement through increased accessibility, and ease of production. Newer innovations directed at meeting patients' needs, ensuring the company's security needs, and maintaining quality include unit dose vials, child-resistant packs, prefilled syringes, and blow fill seal vials (BFS), etc., have also impacted pharmaceutical packaging.

What is new in the world of smart packaging?

Technology is rapidly evolving, and every sector is making efforts to step into the future early, the pharmaceutical industry inclusive. Smart packaging is an outstanding innovation in the pharma industry. With the invention of new pharmaceutical and biopharmaceutical products, pharma companies need to provide new means of storage and transport of drugs and drug products to maintain their integrity.

Wrongly or poorly packaged drugs can pose numerous health risks to the consumer. Also, damage to good packaging leaves drugs and drug products liable to damage and can even pose devastating health risks to the consumers. So, this is where smart packaging comes to play. Smart packaging provides tools that can help preserve pharmaceutical containers and improve consumer cooperation and use. Some new intelligent packaging trends include the use of time-measured indicators, bar code, temperature-oriented indicators, ultra-thin ICS, Near-Field Communication (NFC) tags, and chemicals or biosensors to indicate the safety of the drug.

These packaging innovations drive the brand or pharmaceutical company's success, improve consumers’ health, prevent drug counterfeiting and consumption of these counterfeit or damaged drugs and drug products.

Who are the leading companies operating in the global pharmaceutical packaging market?

Considering the importance of quality packaging and processing, it is no surprise that there is a rising competition between pharmaceutical processing and packaging companies within the pharmaceutical industry. These key players have actively contributed to the growth of the global pharmaceutical packaging market and the pharmaceutical industry.

These companies are considered to be leading players based on their yearly generated revenue, mergers and acquisitions, and their ability to stay at the top of key trends per time. Some of the leading packagers in the global pharmaceutical packaging market include Amcor Limited, Aptar Group Inc., Catalent, Bilcare Inc., ACIC Pharmaceuticals Inc., Marchesini Group S.p.A., COESIA S.p.A., IDEX Corporation, Kȍrber AG, GEA Group, Trucking Technology Limited, Berry Global Inc., Gerresheimer AG, Scott AG, Berry Global Inc., West Pharmaceutical Services, Inc., WestRock Company, and many others.

The importance of the right type of pharmaceutical packaging cannot be overemphasized. This applies not only to pharmaceutical formulations but other products in different industries. It is important to note that a specific packaging material may not be suitable for two different drugs because of its components.

Given the importance of pharmaceutical packaging, it is no surprise that the pharmaceutical packaging and processing company is a significant pharmaceutical industry sector. They largely influence the market growth of pharmaceutical industry.

References

https://blog.drupa.com/de/pharmaceutical-industry-benefit-intelligent-packaging/

https://www.originltd.com/useful-resources/product-information/types-of-pharmaceutical-packaging/

http://eprints.ugd.edu.mk/19277/3/10.%20FORMULATION%20AND%20PACKAGING.pptx

https://www.manufacturingchemist.com/news/article_page/Understanding_the_real_risks_of_packaging/123584

https://www.pharmatutor.org/articles/the-pharmaceutical-packaging-article?amp

https://www.pharmaguideline.com/2018/03/packaging-of-pharmaceutical-products.html?m=1

https://www.idosi.org/mejsr/mejsr12(5)12/16.pdf