Packaging is enclosing a product in a suitable material to ensure its protection during different post-manufacturing stages. Every product that is intended for human consumption must be packaged, and without it is not allowed by the regulatory bodies to distribute for its human consumption. The pharmaceutical industry has some of the highest standards and requirements for various manufacturing processes, and packaging is one of them.
Pharmaceutical products must be packed in a suitable packaging material after being manufactured in a manufacturing facility before being shipped or transported to their destination. The primary purpose of packaging material is to protect the pharma product from various external factors such as Environmental, human, contamination, and other unfavorable conditions. Packaging material also ensures that the medicine or drug reaches its intended user, such as Patients and Hospitals, with the required properties and efficacy.
The packaging of pharma products is essential for every dosage form. Every dosage form has its own specific packaging material type requirement. Packaging for one dosage cannot be used for another dosage type. For example, it is not possible to use injectable-type packaging material for solid oral dosage.
Purpose of packaging material in a Pharmaceutical Industry
Following are some of important functions of pharmaceutical packaging
Pharma product has to go through various stages before reaching their intended destination. In some cases, after manufacturing, the medicine is kept on hold in the manufacturing facility for necessary testing and approvals by the Quality department. The pharma products are stored in the warehouse before dispatching to the intended destination. Finally, during transportation, pharma product also faces many different environmental conditions. The packaging material protects the pharma product through different post-manufacturing stages.
Packaging material is used for product identification and to display critical information necessary for the product. For example, essential product information such as Batch ID, Expiry Date, and the product’s Constituents are indicated through the packaging material.
Packaging materials are also used to provide instructions for human consumption—for example, the method and quantity of administering the required medicine.
Pharma manufacturers use Packaging material for marketing purposes of medicines. The product packs reach every person, whether it requires medicines or not. Using appropriate and human-friendly materials attracts people’s attention. Different color combinations and schemes are also helpful techniques for attraction.
The marketing tactics used by the pharma manufacturers does not require technical or specialized knowledge to understand the content. however, the content and message can be easily understandable by the common people.
Types of Packaging Material
Pharmaceutical packaging material can be categorized according to different principles depending on the product type and application. The pharma packaging material is categorized into three main broad categories, i.e., Primary, Secondary, and Tertiary. They are named according to the degree of protection they provide to the product. Let’s look at each type of these packaging material type.
Primary Packaging Material
Primary packaging material is the first layer of material used to pack the pharma product and comes in direct contact. The main purpose of the primary packaging is to sell the product and protect the product against different hazards such as Contamination and chemical or physical deterioration.
The material of primary packaging must not react with the product. Otherwise, it will contaminate the product, and then the product will lose its benefit or properties. If the material reacts with the product, the purpose of packaging material will become useless. The compatibility of packaging material with the pharma product is necessary to determine during the product development stage.
An example of primary packaging material includes a Glass ampoule for filling injectable. Another example is Aluminium foil used to pack tablets in bister form.
Primary packaging is performed by machines used to fill the product directly into the primary packaging material and then seal it so that the product inside the material is not affected by external factors. Examples include Blister Packing machines used to pack tablets in the packaging material.
Secondary Packaging Material
The packaging material is used to pack the pharma product filled with the primary packaging material. Secondary packaging materials do not come in direct contact with the pharma product. Instead, they come in direct contact with the primary packaging material.
Their main purpose is to provide an additional and external layer of protection, mainly for storage or transportation purposes. They are also used to pack more than one primary packed pharma product into unit pieces.
Examples of secondary packaging include Cardboard boxes and cartons. They are packed with secondary packing machines such as Cartoners. Cartoners pack the product packed in primary packaging into cardboard cartons.
After the primary packing process, secondary packaging is carried out in the same facility. there are two methods of packing from primary to secondary – Online Packing and Offline packing
Online packing means the secondary packaging is carried out immediately after the primary packing is completed. A conveyor transfers the primary packed product to the secondary packing machine, which directly packs the product into the secondary packaging.
Offline packaging means the secondary packing is not performed immediately after the primary packaging. The primary packed products are stored in a container such as a bin. Then the bin is transferred to the secondary packing machine for competing for the secondary packaging.
Tertiary Packaging Material
Tertiary packaging material is the last packing layer for a pharmaceutical product. The main purpose of tertiary packaging is to enable the product’s bulk shipping by combining them into large units. Essentially, it also protects the critical pharma product during its transit stage from physical and chemical damages and hazards.
When tertiary packed, the pharma product can be easily transported from one place to another, outside the manufacturing facility, transporting the bulk of units from the manufacturing facility to the warehouse or the distributor facility.
The tertiary packing is only intended for transportation purposes, and the end-user rarely interacts with this packaging. Tertiary packing is commonly removed before being sent to the product’s users.
An example of tertiary packaging includes barrel drums to transport raw material. The raw material can be in solid form or liquid. Before transportation, tertiary packaging is a label for identifying the product and other relevant necessary information such as Batch No, Product’s constituents, and Expiry date.
Packing Materials commonly used in Pharmaceutical Industry.
There are various types of packaging materials used in the pharmaceutical industry. Their selection primarily depends on the product being packed in the container, such as Injectable or liquid. It also depends on the degree of protection required against different factors.
Following are some common packaging materials used in Pharmaceutical Industry according to packaging material type.
Vials: Vails are small vessels or bottles used to primary pack a medicine. Commonly they are used for aseptic filling of Injectable. They are also used to pack the product in Powder and Liquid. Capsules are also packed in the vials. Vials are made up of glass or plastic.
There are two standard colors for vials – Clear transparent and Amber. The amber color vials are used for pharma products sensitive to light. After filling, vials are enclosed with rubber stoppers sealed with caps. Vials also come in threaded type, on which screw caps are used to seal the vial. The vials are also labeled for necessary product information, such as Product Identification and Expiry Date.
Ampoules: Ampoules are primary packaging types used to pack injectable liquids in a sterile and aseptic environment. They are made of glass, and they are sealed after filling the ampoules with the desired quantity. When administering the drug inside the ampoule, its seal is broken, and injectable liquid is sucked through a syringe.
Ampoules are printed with the necessary information before filling, such as the product identification, Drug name, and logo. At the same time, the critical information such as batch number, expiry date, and other relevant information is printed through a portable printer after the filling process is completed and before being secondary packed.
Blister Packs: Blister packs pack tablet form of pharmaceutical dosage. A blister is formed by sealing two packaging materials against Forming Foil and Sealing Foil.
Forming foil consists of empty pockets, which contain tablets indie it. The sealing foil is used to seal the forming foil after filling it with the tablets. The combination of forming foil with the sealing foil is called Blister Pack.
There are two types of packaging material used for Blister Packaging – Alu Alu and Alu PVC
Alu-Alu refers to the blister packs that use Aluminium foil for both forming and sealing. Alu-PVC refers to the blister packs that use PVC for forming foil and Aluminium for sealing foil.
Glass bottles fill liquid for oral consumption in a non-sterile environment. After filling, they can be plugged or capped to ensure safety and prevent contamination. After filling, they are labeled for product identification and other critical information such as Batch Number and Expiry Date.
They are available in two colors- Amber and Clear. Amber color is used to fill liquid that is light sensitive and cannot survive exposure to it. They can be made up of either Glass or Plastic material.
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.
Stability testing is the process of analysing and monitoring the active pharmaceutical ingredients/APIs or the final pharmaceutical products/FPPs stability over time to ensure that it stays safe and effective during its shelf life and under that labelled