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 of primary packaging for a pharma product depends on the machine's readiness, performance, and specification. Packaging is a function of different physical variables applied at various stages of the machine; problems with the machine function deviate from applying these variables, and the resultant

packaging will drift from acceptable specifications.

For example, in a blister packaging machine, if there is a problem in forming station actuator, the cavities will not form accurately, affecting the placement of tablets in the cavities. As a result, the formed blister will fail in its quality attributes.

Mitigation - Machine problem-related challenges can be tackled through quality monitoring and the implementing maintenance strategies. Quality monitoring helps to immediately detect problems with the primary packaging, while maintenance helps to detect problems with the machine & rectify those immediately without a major breakdown.

Incompatible Machine specification

Machine specification plays an important role in the success of the machine’s product and must match the product requirements. One of the challenges related to primary packaging is the machine’s ability to pack the product in primary packaging.

It can occur, if the personnel involved in the machine’s procurement failed to analyze the current requirements or failed to sort out the appropriate machine from the available options. In such cases, the machine may fail to produce the required product attributes

For example, if a manufacturer buys a machine that cannot pack pharma products at high speeds, operating that machine at higher speeds will damage the machine and waste the primary packaged product.

Mitigation - machine specification-related problems can be solved by carefully studying your product’s needs

and comparing them with available options. If the machine fulfills your requirements, proceed to the procurement stage. On the other hand, if machine is not able to fulfill requirements, sit with manufacturer to discuss deviations, or else look for another machine supplier

Packaging Materia

Packaging material often pose challenges in the primary packaged product, such as .

● The raw material used in manufacturing packaging material is sub-standard, making the packaging process difficult.

● In - appropriate packaging material selection.

● Inappropriate storage conditions at the supplier end or the pharma manufacturer warehouse, affecting the packaging material's properties.

Mitigation - these types of problems can be solved by

● Always look for suppliers that have regulatory affiliation & accreditation, and good reputation in the industry.

● Look for relevant documentation, test results, and MSDS for the packaging material.

● Before ordering bulk packaging material, test the sample primary packaging on the machine with actual parameters to check its performance.

● Always ensure appropriate temperature is maintained at the source facility by visiting their warehouse. Or, if not possible, view relevant documentation, such as temperature mapping or validation.

● Checking the integrity of the packaged product through an integrity tester. If it fails, then personnel should implement respective corrective and preventive actions.

Regulatory challenges

Primary packaging requires compliance with the relevant regulatory authorities, like other pharma processes. This is in addition to other requirements such as packaging area, process, and quality.

For example, regulatory authorities require pharma manufacturers to print specific information on the packaging material when packed, such as drug identification, usage and ingredients, and manufacturing & expiry date. If pharma manufacturer fails to fulfill these requirements, the regulator will fine or give warning.

Mitigation - Regulatory challenges can be mitigated by

● Having effective quality functions with expertise related to primary packaging.

● Check every lot of packaging material for compliance before being released to the production department

● Having a good working relationship with the regulatory body to understand their requirements and fulfil them

Counterfeit and tampering

Counterfeit and tampering are among the problems being faced by the pharma industry. These two types of products pose threats to the patients and sometimes can become life-threatening. While the person making counterfeit & tapered drugs benefits, the real pharma manufacturers face financial, market, and reputation loss.

In tampering, the actual product or its packaging is altered. While, counterfeit medicine is fake and not manufactured through acceptable and safe procedures.

Mitigation - there are several precautionary measures to prevent the drug from counterfeiting and tampering. Some of them include, but are not limited to, the following

● Tamper evident labelling

● Digital watermarking of unique & invisible codes that can only be read by scanning devices

● Holograms, including images, giving the impression of three-dimensionally constructed

● Optically Variable Devices involving picture flips or transitions

● Color-shifting security inks

● Security graphics using overt and covert design.

Pharma product protection

The primary packaging must remain neutral to the packaged product and not alter its chemical properties. Because primary packaging materials such as glass and aluminum also have chemical compositions. For some products and/or conditions, they can react with the product, and hence, the product becomes dangerous for its patients.

For example, glass containers for injectables or oral have different chemical compositions and are identified by Types I, II, and III. These types have specific applications that must be considered before being used for primary packaging.

Mitigation - Before selecting primary packaging material,

● Always study the feasibility of primary packaging with the pharma product.  

● Study and consult the MSDS of the primary packaging material before selecting it

● Consult relevant regulatory and quality guidelines when deciding the primary packaging material for a specific product.

● Perform stability studies to study the relationship between the product & packaging material.