Primary packaging is an integral part of the pharma process and product’s first line of defense. It serves multiple purposes but faces many challenges. These challenges emphasize the need for timely and quality measures to make the product suitable for manufacturers, regulatory authorities, and end users.
What is primary Packaging in the pharma industry?
Primary packaging is critical in the pharma industry, where the product comes in direct contact with the packaging material. It directly seals the product and protects it from the external environment, humidity, dust, and other foreign particles.
In addition to product safety, it serves the following function
● Product marketing
● Guidance about product usage
● Provides basic information about the product’s constituents
● Notifies patients or end-users of its manufacturing & expiry date, for safety
Primary packaging is performed by specialized machines that pack, seal, and cut the product into their required specifications. There are different types of primary packaging material, and its application depends on the product specifications & requirements.
During production, the packaging must adhere to relevant safety, quality and regulatory regulations, which is also tested for satisfactory process. They must be free from any problems, and If found, must be rectified, or else packaging is rejected or discarded.
Type of primary packaging include the following
Blister packing - Blisters combine two different packaging materials with the enclosed product. The blisters are then cut to the appropriate size & shape by a cutter in the machine.
Common packaging material for blister includes PVC and Aluminum.
Blister packing is produced using a blister packaging machine. It consists of various stations where filling, cavity formation, sealing, and cutting are performed. The output is a finished blister containing the product, with appropriate physical dimensions.
Vials - Vials are cylindrical containers used to store injectable products. They have varying color and includes clear & amber. The color is selected based on the product stored inside.
They are mainly available in Type 1, 2, and 3 glass vials. After filling, they are sealed with a seal and stopper to prevent contamination and exposure to the external environment.
Vials are filled using a vial-filling machine.
Glass Ampoules - Glass ampoules are cylindrical glass containers to store injectable products. They are also available in different colors, and include clear & amber. Glass ampoules are available in Type I, Type II, and Type III glass configurations.
Ampoules are manufactured with an open top to fill ampoules with liquid. After filling, the head is sealed to make the container air-tight. Sealing prevents contamination and exposure of products to the outside environment.
Ampoules are filled with an Ampoule Filling Machine.
Bottles - Bottles are used to store oral liquid and come in varying capacity configurations, such as 30ml, 60ml, and 90ml.
Bottles in pharma packaging are made up of glass and Polyethylene Terephthalate(PET), the selection of which depends upon the application & product, per the quality department guidelines.
A bottle-filling machine is used to fill bottles. Empty bottles enter the machine from one side, which is then sealed with caps, and finished bottles are discharged from another end.
Sachets - Sachets are used to pack granulated or powdered medicine. It consists of foil, which is sealed from all sides after packing the product inside.
The capacity of sachets is expressed in grams, which can range from 3g to more than 100g.
Sachets are made with the sachet filling machine. Foil is made to guide through different mechanical frames that shape a sachet. The product is then filled during its movement and sealed to give its intended shape.
Some common challenges related to primary packaging
Let’s discuss some challenges faced by primary packaging in the pharma industry.
Machine problem
The performance...
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