Primary Packaging In the Pharmaceutical Industry is a type that comes in direct contact with pharma product and is responsible for protecting & retaining therapeutic effects.
Packaging is a critical process in the pharmaceutical industry, where finished products are packaged in suitable packaging material. There are different categories of packaging, including the primary. It is the first layer of Packaging for pharmaceutical products. Due to its function and level of protection, primary Packaging In the Pharmaceutical Industry is always critical for pharma manufacturing operations.
What is Primary Packaging in the pharmaceutical industry
Primary Packaging is a type that directly encases & covers the pharma product. There is no barrier between the two, and product comes in direct contact with the packaging material. Its primary purpose is to protect products from contaminants, foreign bodies & environmental factors, and retain product characteristics within the span of its shelf life.
Like every other pharmaceutical process, primary Packaging is governed and controlled by strict regulatory regulations. Pharma manufacturers are required to follow these regulations in their design, packaging process and testing domains.
Depending on the packaging type, Primary Packaging is performed through dedicated machinery. It takes the primary packaging material in a raw form, packs the product, and seals it.
What is the function of primary Packaging in the pharmaceutical industry?
Some functions of primary Packaging in the pharmaceutical industry include, but are not limited to, the following.
- Primary Packaging is the first line of defense for a pharma product against a number of factors, such as contaminants, environmental factors, and foreign bodies. It plays an important role in retaining original product characteristics, physical appearance, and quality.
- Primary packing materials are used to ensure dosage accuracy. By designing the primary packaging material directly proportional to the dosage requirements, the pharmaceutical manufacturer can easily provide the dosage delivery.
- Primary Packaging can convey essential drug-related information, such as dosage requirements and chemical composition. It enables a pharma manufacturer to communicate critical product related information to its end users.
Primary Packaging in the Pharmaceutical Industry Examples
Let’s discuss some examples of primary Packaging in the pharmaceutical industry
Blister Packs
Blister packs are sealed cavities with pharma product in the form of a blister. They are formed by sealing two different packaging materials with pharmaceutical products in between. The size and shape of the cavity directly depend on the physical dimensions of the product.
They are commonly used for tablets and capsules. Some primary packaging is also blister-packed as secondary Packaging.
Ampoules
Commonly manufactured from glass, they are cylindrical with a thin neck and come in various volume sizes from 1ml to 10ml. They are filled from the top and are commonly used for sterile injectables. After filling, the top is sealed and airtight to provide sterile conditions.
When using liquid from the ampoules, the tip is broken to access the liquid inside.
Vials
Vials are small containers, similar in shape to vessels. They are manufactured from glass and require a rubber stopper and seal to provide airtight conditions.
They come in various fill volume ranges, commonly from 1 mL to 30 mL. They are used for storing injectable liquids, powders, and lyophilized products.
Bottles
Bottles for pharmaceutical applications are manufactured from pharmaceutical-grade plastic and glass. They come in relatively large sizes, such as 10 ml to 90 ml. After filling the product, they are sealed by sealing the head with pharmaceutical-grade caps.
They are used to pack liquids and powder products. They are made up of glass and plastic material.
Sachets
Sachets are small sealed pouches to pack powder and granules. They are sealed from three sides, and the fourth side bends to give its intended shape.
Equipment for primary Packaging in the pharmaceutical industry
Dedicated machines carry out primary Packaging in the pharmaceutical industry. Each packaging type requires a separate machine and commonly includes the following.
Blister Packaging Machine
The Blister Packaging Machine is used to produce blister packs. The product (tablets or capsules) is enclosed in the blister shaped cavities, and its packaging material is sealed from upper and lower sides.
It consists of a feeding system through which products are fed during the process. Packaging material from another station is conditioned to create cavities of the shape of the product. After conditioning, the product is placed inside the cavities and is sealed with another packaging material. After sealing, the blisters are cut to length as per the product requirement.
Ampoule / Vial Filling Machine
The Ampoule Filling Machine is used to fill ampoules with product inside and then seal them. Ampoules enter the filling station from one side and pass through the blowing & purging stations. The blowing station blows compressed air to remove foreign objects from the ampoules, while the purging station purges an inert gas, such as Nitrogen.
The next station is filling, where pumps precisely transfer the accurate volume of liquid into the container. After filling, the ampoules are sealed and discharged through the outfeed station.
Vial Filing Machine
The function of an Ampoule Filling machine is similar to that of a capsule filling machine, with the difference of a sealing station. Instead, seals are placed and then sealed in the final processing.
Bottle Filling Machine
Bottle filling Machines are used to fill liquids or powders into bottles. Empty bottles are fed into the machine, which passes through the filling station. A pump fills liquids or powders into the bottles through appropriately sized nozzles. After filling, bottles are capped and sealed to prevent contamination and the ingress of foreign bodies.
Sachet Machine
Sachet machines are used to fill powder, granules, and other suitable products into sachets. The foil for sachets passes through different mechanical structures to give it the shape of sachets, with one opening for inserting product in it.
After shaping, powder is fed and sealed. The sachet is cut from the remaining foil through the cutter to give it the required sachet shape.
Considerations for primary Packaging in the pharmaceutical industry
Some key considerations can include the following.
Product compatible
Since primary packaging comes in direct contact with the product, it is necessary to determine compatibility of packaging material with the product. Otherwise, there could be reaction between product & packaging, altering the product characteristics and therapeutic effects.
When selecting primary packaging material, the material of construction must be considered, and this information can be easily obtained from the Material Safety Data Sheet (MSDS).
For example, there are two main categories of glass used in glass containers: amber and transparent. Amber-colored glass containers are often used for light-sensitive products.
Ease of use
The packaging design and construction should facilitate patient ease of use. In addition to being tamper-evident and anti-counterfeit, the Packaging should be able to be opened without any difficulty or using tools.
Tamper evident
The Packaging must have added features to detect tampering with the medicine. It can be implemented through the application of security seals, breakable caps and tamper evident labels.
Child resistant
Child-resistant Packaging prevents accidental child ingestion of medicine and can only be opened by adults. Examples include push-and-turn caps & multi-layer blister packaging.