Packaging Equipment used in Pharmaceutical Industry

Packaging is an integral component of a pharmaceutical industry process, sometimes considered unnecessary. Regulatory bodies inspect the packaging as a necessary component and sometimes reject and cancel the license renewal or approval. It also requires the manufacturers to establish dedicated facilities, equipment, and test procedures for the packaging department.

Packaging is witnessing immense development, resulting in innovative solutions. These innovative solutions help manufacturers comply with regulatory requirements, helps in reducing cost, and ensure product safety. Pharmaceutical packaging keeps manufactured products safe and prevents specification changes from different external conditions.

Importance of Packaging in the current pharma manufacturing

Pharmaceutical finished products are packaged in compliant and safe packaging material to make sure the product reaches its intended end-user, i.e., patient, without affecting external conditions such as Environmental and transportation. The pharmaceutical packaging equipment protects the product from damage and containment. It is also used to protect the product's basic identification information, such as the manufacturing date and Expiration date.

Regulatory bodies such as the FDA and the WHO have their standards for the packaging industry. Any manufacturer accredited to these bodies must adhere to these regulatory body packaging requirements.

Some important areas where packaging plays an important role include the following.

Preventing Counterfeiting and Tampering

The worldwide pharmaceutical industry is facing challenges of counterfeit and tampered drugs. These drugs not only compromise the manufacturer’s credibility and reputation, but the danger it poses to the patient is inevitable. The pharmaceutical packaging industry is devising and innovating new ways to prevent the problem of counterfeit and tempering. Some advancement in packaging towards anti-tampering and anti-counterfeit includes

· Tamper – Proof seals. Tamper-proof seals ensure drug reliability by using a seal to indicate box opening. The seals are destroyed when removed from the drug and cannot be applied manually. It requires specialized equipment to apply the seal. This makes it easier for the user to know and identify if someone has opened the pack or box. Some drug manufacturers also use Holograms to prevent tampering with their medicines.

· QR Code. QR code allows the codification of the critical product information such as Manufacturing and Expiry date. The information can only be decoded with the scanner to read the product information. This codification allows the user to verify the product’s authenticity. It is not easy to generate QR codes. Instead, it requires specialized equipment to generate and print the QR code.

· Radio Frequency Identification (RFID) - RFID marks or tags are not visible to the naked eye. Instead, they require specialized equipment to read the RFID markings. RFID can effectively prevent counterfeiting as RFID tags cannot be copied easily without specialized equipment.

Packaging Machine in the Pharmaceutical Industry

There are different types of packaging machines used in the pharmaceutical industry. Implementation of each type depends upon the pharmaceutical product being packaged. The type selection also depends on the regulatory body requirements.

Let’s look at some common packaging machines in Pharmaceutical Industry

Blister Packing Machines

Blister Packing Machines pack the pharmaceutical product in between two packaging materials. After the product is placed between the two packaging materials, they are sealed together. The sealing helps to protect the product from different hazardous factors such as extreme environmental Conditions and Containment. The sealing action occurs at a high temperature, safe for both product and material. The blister’s sealing must be leak-proof and should not allow the passage of any particle through it.

Blister packing machine forms a blister or cavity in packaging material at machine’s Forming Station, followed by product insertion in the blister. After the product is carefully and precisely inserted into the blister, it is wrapped with other packaging material and is sealed at the machine’s Sealing Station. After sealing, the blister packs are cut according to their standard sizes at the machine’s Cutting Station. The formed blister drops at conveyors then transfer the final blister for collection in a container or bin. In some cases, the final blisters are directly transferred to the carton for packing.

 The packaging material in which a cavity is formed is called Forming Foil, and the packaging material used to seal the forming material is called Lidding Foil.

Commonly, there are two combinations of packaging material used in Blister Packaging Machine – Aluminum with Aluminum, often called ALU- ALU, and Aluminum with PVC, often called ALU - PVC.

In ALU – ALU formation, both the forming and lidding foils are made up of Aluminum. The cavity is formed by vacuuming Aluminum foil through the die of tablet size and shape. After filling the cavity with the product, another Aluminum foil is sealed to cover the blister.

In ALU – PVC formation, the forming foil is Aluminum, while the product containing material is PVC. PVC is first heated to soften it, and then vacuum sucked through the die of tablet size and shape to give the PVC the desired shape. After the product fills the cavity, Aluminum foil is used to seal the blister.

To make sure that there are no leaks in the blisters. The blisters are subject to a leak test, which checks the blister’s sealing integrity. To perform a leak test, samples of blisters are collected from a production batch. The sample blisters are placed inside a vacuum chamber containing colored liquid, and a vacuum is applied. After vacuum time completes, blisters are taken from the chamber and are examined. If traces of color are found inside the blister, indicating poor sealing, and fails the test. The production department immediately stops the machine, and the operator must fix the problem. If no traces of color are found inside a blister, the test is marked pass.

Bottle Filling Machines

Bottle Filling Machines pack different forms of pharmaceutical products in glass bottles. The glass bottle's chemical composition is specially manufactured for pharmaceutical products and is categorized into Type I, II, and III bottles. Their classification is based on the type of chemical used in glass manufacturing. The Machine fills the bottle with the required volume, which can be changed depending on the different product requirements. 

Bottle Filling Machines can fill bottles of any volume size, but commonly their minimum volume is 30 ml and can go up to the maximum level of 1000ml. The fill volume is controlled to avoid under or excessive filling. Before filling the bottle with the product, the bottles are cleaned to remove dirt particles or other contaminants. This is commonly done with the bottle blowing Machine, which uses clean compressed air to blow the bottle inside and remove any foreign particles.

Types of Bottle Filling Machine 

Operation wise, there are two types of Bottle Filling machines used in the industry – Semi-Automatic and Automatic. 

In semi-automatic, the operation is partially automatic and requires human assistance to complete the filling process. The bottles are placed manually in the filling station, and the operator initiates a signal to start filling. The bottle's fill volume is set according to the product requirement, and filling automatically stops when the product's required quantity is filled into the bottle. After filling, the bottles are manually removed from the filling machine. The bottles are also manually air blown to remove any foreign particles. 

In automatic type, the operation from bottle placement to filling, and finally to bottle removal occurs automatically. The bottles are fed through a conveyor on the filling station, which places the bottles below the filling nozzle. The filling mechanism is such that it automatically detects the bottle's presence and starts the process. If it does not detect the bottle, the filling is not started. After the required liquid volume is filled into the bottle, the filled bottles are transported to the next stage. The bottle-blowing action is also automatic. A conveyor automatically transfers the bottles from the blowing Machine to the filing machine.

Liquid and Dry Powder

Bottles Filling Machines fill two types of pharmaceutical products – Liquid and Dry powder. 

In liquid filling machines, pumps are used to fill the bottles. For volume control, pumps can be manually adjusted or automatic, such as servo-driven. The dry powder filling Machine uses the auger assembly or vacuum function to control the filling volume and execute the filling operations.

Ampoule Filling Machines

Ampoule Filling Machines are used to fill Small Volume Parenteral – SVP in ampoules with the range of fill volume up to 100ml. At the start of the filling operation, ampoules are fed to the conveyor, which transfers them to all stages of the filling operation. When ampules come beneath the filling station, filling automatically starts until the required volume is filled into the ampoule. After filling, ampoules are transferred into the sealing station.

The sealing station is used to seal the ampoule head. For sealing, the flame is used, which heats the ampoule tip to its melting point temperature. Then a mechanical arm or gripper plucks the ampoule opening from the remaining body, which automatically seals the ampoule tip. Sealing is performed in two stages, where first it is pre-heated and then finally at high temperatures to complete the sealing action. After sealing, ampoules are finally transferred to the machine outfeed, collected for another packing.

Ampoule Filling Machine also has a nitrogen purging system before and after filling. It is used as an anti-contamination before and after ampoules are filled with the solution. Pre-filling purges the nitrogen into empty ampoules, while post-purging purges the nitrogen after filling the ampoules with the solution.

The ampoule’s fill volume can be adjusted depending upon product requirements. The pumps can be manually adjusted for volume control or an automatic type such as a servo drive for volume control.

Ampoule filling machine can fill more than one ampoule in one cycle. This is possible by having multiple nozzles for filling. Multiple ampoules are placed beneath the nozzles during each cycle, and the solution comes in all these nozzles simultaneously. The number of filling nozzles determines the specification of the machine. For example, if a machine has six (6) nozzles for filling, the machine is called six head machine. Similarly, eight (8) nozzles are called an eight head machine. Higher the number of heads, the higher the machine filling speed.

Since Small Volume Parenteral – SVP is usually administered intravenously, such environmental conditions for filling operations are very strict, and filling operations are carried out under aseptic conditions. The temperature should be accurately maintained, with strict particle control to prevent contamination. Additionally, the filling station is placed under laminar flow to prevent turbulence in airflow.

Tube Filling Machines

Tube filling machines are used to fill gel in tubes. After filling, tubes are sealed and then go to machine outfeed. The filling capacity of the tube can be different depending upon the product requirement. The volume control method can be through the manual system or automatic such as servo-driven. Before filling gel inside the tube, clean compressed air is used to blow the tube to clean any foreign particles.

The tube direction should be positioned to correctly orient the printing material’s face to the tube’s physical appearance during the tube sealing. This allows the user to easily read the printed instructions and product information such as Batch Number and Expiry date. Secondly, it violates regulatory body regulations of printing is not oriented correctly with the tube’s physical appearance.  

The sealing tube correctly is executed by a system that detects the tube’s correct position before sealing action. The system continuously spins the tube until the sensor detects the tube’s right side. When the sensor detects the tube’s correct orientation, spinning stops, and the tube is sealed.

Capping Machines

Capping is one of the final stages of the pharmaceutical product packaging process. The container is capped to ensure product quality and safety. Latest capping techniques also ensure product anti-tampering and anti-counterfeit.

A capping machine is used to cap the pharmaceutical container with the product. The capping process ensures that once the cap is open, it is impossible to fix it manually. The cap can only be fixed with the machine.

The container is transferred beneath the capping station through a conveyor. Caps are transferred on the container head through the chute. When the container travels through the conveyor, it goes below the chute, which places the cap on the container head. The next stage is the capping station which consists of a rotating head. When the container goes beneath the capping station, the rotating head exerts pressure and forces the cap against the container head. As the cap is pushed down, it is fixed and jammed with the seal. The seal can only be a break when the cap opens. After the capping, the capped containers are transferred out of the machine.

Commonly, capping is performed for the following container types

Bottles: Both Glass and Pet types are capped. The caps used are called Roll On Pilfer Proof Caps (ROPP), containing a seal. The seal is enacted during the capping process and breaks when the cap is opened.

Vials; Vials are initially rubber-stoppered after the filling process. After rubber-stoppering, they go through a capping machine for the capping process.

Labelling Machine

Pharmaceutical product labeling is a critical process that shows vital information about the product, such as Dosage use and Expiration date. As with the other pharma manufacturing processes, labeling is a compliance requirement, and regulatory bodies inspect the labeling systems employed in the manufacturing plant as part of regulatory inspections.

A labeling machine is used to attach and fix the label to the product container. For labeling, the container passes through the labeling station containing labels. Initially, the labels are pre-cut according to the container’s required size. Before the labeling station, adhesive glue is pasted on the container wall. Finally, the container passes through a thin channel that forces the label against the glass container and permanently sticks to the container wall.

Sensor for detecting container is deployed for the label and container synchronization. The sensor continuously detects the container and only releases the label when it detects it. This helps prevent label wastage and allows to paste label at correct container position.

Cartoner Machines

Cartoner machines automatically place the packaged product such as Blister or filled bottles into the carton. The carton material, such as cardboard, is inserted from one machine, not finished. Instead, it is a piece of cardboard of suitable length with appropriate cuttings. The cardboard travels along different guides and rods to shape the cardboard. On another adjacent track, container travel along with carton guide rail. When the cardboard tells the shape of the carton correctly, the container is inserted into the carton. After insertion, the carton is closed and goes out through the outfeed conveyor.

In the Pharmaceutical industry, cartons are used in two types of configuration – Online and Offline.

In the online configuration, the product container is cartoned when the container is filled in the filling machine. In this configuration, the carton is connected with the filling machine through a conveyor belt which immediately transfers the filled container onto the carton. Additionally, the container filling machine is also synchronized with the cartoner operation, i.e., the container’s filling operation stops when the carton stops. It uses a feedback system from the carton, which signals the filling machine when the cartoner’s operation stops.

In Off-Line configuration, the containers are cautioned independently of the filling operation. The filled containers are stored as an inventory. When the whole filling operation is completed, all the filled container’s inventory is transferred to the cartoner area to perform cartooning.

Conclusion

The global pharmaceutical packaging market is expected to grow 6.1% from 2020 to 2027 at USD 144,233 million (*1). The growth is attributed to strict regulatory requirements and advancement in packaging technology. Modern industrial techniques such as Industrial Automation have enabled the manufacturers to increase their production capabilities with innovation resulting in cost-effective solutions.

Innovative solutions such as environmentally friendly materials and processes, trace & track, and anti-counterfeiting measures have evolved the packaging process.

(*1) : https://www.alliedmarketresearch.com/pharmaceutical-packaging-marke

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.