Packaging material in pharmaceutical industry plays an important role in the pharmaceutical industry. They help protect pharmaceutical products from changing their specifications.
Packaging material in pharmaceutical industry is used to pack the finished pharma products before it leaves the pharma manufacturing facility. The pharma product remains in the packaging material throughout its entire shelf life until consumed by its end user.
Packaging material encloses the pharma product in a way that it becomes airtight, sealed, and protected from contamination. There is no chance of air passage through it, and it becomes difficult for any foreign body to enter the packaged pharma product. Packaging material is carefully selected, considering the pharma product specification, and does not harm or change the product specifications.
There are two important considerations when selecting a packaging material for any pharma product.
- The packaging material does not harm or change the pharma product specifications.
- The pharma product must not damage or alter the packaging material specifications.
Packaging material in the pharmaceutical industry is an integral part of pharma products. Every finished pharma product must be packed with suitable packaging before being delivered to its end users. If a pharma product is not packed with the desired packaging material, it will lose its properties and fail to produce its therapeutic effects. It will become dangerous for its end users. Regulatory bodies, such s the United States FDA and the ISO, take packaging material seriously and can issue a warning, impose a fine, or shut down operations if they find any discrepancy with packaging materials.
Applications of Packaging material in pharmaceutical industry
Let’s discuss some diverse applications of packaging material in the pharmaceutical industry
Product containment means delivering the product to its end users, such as patients or doctors, in actual form, without altering the product specifications. It also means that the product should reach its end-user without physical damage. The packaging material must prevent the leaking of products or penetration of foreign bodies into the packaging material. The packaging material must hold the product safely during transportation and handling. The packaging material must also prevent altering or any change in the chemical composition of pharma product.
This becomes crucial when the point of delivery has different environmental conditions (temperature & humidity), is at a greater distance, and requires heavy transportation and frequent loading/unloading.
The packaging material protects the pharma product from all hazardous foreign elements. The packaging material must retain the product’s properties, potency, and quality and prevent product deterioration.
Examples of external factors from which packaging material helps to protect include the following
Light: Light-sensitive pharma products negatively react to exposure to light. Light exposure degrades these products’ chemical composition, and as a result, quality is compromised. For this product, specific packaging material helps prevent the product from light’s effects.
Moisture: Moisture content is dangerous for every pharma product – during the manufacturing phase and in finished form. Packaging protects the pharma product, as the material used is waterproof. The sealing effect prevents the penetration of moisture inside the packaging material.
Contamination: Packaging material protects the product from contamination by preventing air from crossing from and inside the packaging material.
Physical Damage: Packaging material helps in protecting the pharma product from physical damage. The packaging material forms a physically hardened layer of protection that protects against physical damage, for example, during transportation, distribution, and in pharmacies, picking and placing at their designated locations and handing over to patients.
Packaging is also used to convey critical information about the pharma product to its end user. The information is provided using direct printing on the packaging material and inserting labels and leaflets in the packaging material.
Contents of information include the following
- Product identification, such as name, batch number, and serial number
- Description of product and chemical composition
- Directions for use
- Manufacturing and expiry information
Primary and Secondary Packaging material in pharmaceutical industry
When packing a pharma product in packaging material, there is various configuration in which they are packed. Packaging material for every configuration differs and depends on the degree of contact between pharma products and packaging material. Commonly, there are two types of packaging material based on the degree of communication and include the following
- Primary Packaging material
- Secondary Packaging material
Primary Packaging Material
Primary packaging materials have direct contact with the pharma product. As discussed previously, they directly protect the pharma product from various external factors such as light and moisture.
Since primary packaging comes in direct contact with the product, they are carefully selected during the drug development and research stage. Safe interaction of packaging material and the product is first verified and then implemented in routine production processes. For a primary packaging material, it should not alter the product characteristics, nor should the product’s chemical composition affect the packaging material.
Examples of primary packaging material include Bottles, Ampoules, and Blisters.
Secondary Packaging Material
Secondary packaging material does not come in direct contact with the pharma product. It is used on a product that is packed with primary packaging material. The main purpose of secondary packaging material is to hold the primary packed product units together. Since the product does not come in direct contact with secondary packaging material, the packaging material can be safely removed without disturbing the packed finished form.
Examples of secondary packaging material include cardboard boxes and cartons.
Types of Packaging material in pharmaceutical industry
Some common types of packaging material in pharmaceuticals include the following
Glass: glass is a common packaging material in the pharmaceutical industry. They are commonly used for oral and injectables. Examples of glass packaging material include Ampoules, Vials, and Bottles
There are three standards of glass made for pharmaceutical applications – Type I, II & III.
Type I is natural glass and is the least reactive. It is made up of borosilicate and has good chemical resistance.
Type II is used for intravenous administration medication. This type is manufactured by treating the internal surface of a glass.
Type III is known as soda-lime glass and is suitable for less critical products such as Oral Solid Dosage.
Metals: They are used for non-parenteral products. An example includes tubes, blister packs, and cans. Common metal includes Aluminum and Stainless steel because they provide excellent corrosion resistance and ensure product safety.
Plastics are non-metallic packaging materials mainly used for nags for parenteral solutions and squeezable bottles for eye, ear, and nose drops. They are also used for pre-filled syringes, sachets, and strip packs