INTRODUCTION:

One of the industries with the strictest regulations is the manufacturing of pharmaceuticals, which has stringent standards for the environment, the workforce, and the product. Pharmaceutical manufacturing takes place in a GMP area.

GMP aims to ensure that the organization and the production process are designed with quality in mind. Well-documented specifications must be provided for the product's packaging, materials, and construction.¹ Since packaging and labelling activities are also part of pharmaceutical production operations, inspections of the products should be performed during batch operations to ensure that the process parameters are within the limit and that the final product complies with quality standards. Packaging is one technique that allows the containment of dosage form from its unit production to its use. Pharmaceutical packaging primarily provides transportation convenience, drug safety, identity, and containment.²

As per the Annexure 9 “Guidelines on packaging for pharmaceutical products” documented by the World Health Organisation provides comprehensive information about the role of packaging in pharmaceutical manufacturing.³ The Pharmaceutical Industry (PI), Packaging lines are a combination of production engineering and materials technology. This association paves the way for innovations in pharmaceutical packaging operations. There are currently fully operational packaging lines where plastic bottles are filled, sealed, labeled, cartonned, and palletized with a high degree of automation control and inspection.⁴ To maintain product safety, quality, strength, and identity to reduce material wastage and increase productivity during production, a wide variety of equipment embedded with the latest technologies is utilized.⁵

Pharmaceutical packaging plays a crucial role in ensuring the stability of the packaged formulation under all environmental conditions, and product handling during storage, and transportation. Packaging has to ensure that the product remains in it’s the rapeutic effectiveness from the time it is packaged till it is used by consumers. ⁶Based on the industry experience and knowledge of authors, since ancient times primitive materials like natural fibers, and animal hides were used to preserve medical substances. The early 17^th century marked the beginning of pharmaceutical packaging using glass bottles. The end of World War II gave birth to the introduction of plastics and pharmaceutical blister packs to develop something unbreakable, solid, and flexible. In today’s era, pharmaceutical packaging has reached advancements in terms of machine-based vision learning and much more high-resolution technology to make packaging much easier without compromising compliance.

The Industrial Revolution began in the 18^th century. During the 19th century, independent pharmacies, chemical, and dye industries started large-scale manufacturing of drugs utilizing non-electric power-driven equipment, leading to the establishment of pharmaceutical industries. During the second industrial revolution, pharmaceutical industries started using primeval electronic machines in operation line with pre-set controls that included simple automation and process controls. During the third industrial revolution, pharmaceutical companies embraced more sophisticated technologies like human-computer interaction, Quality by Design (QbD), and Process Analytical Technology (PAT).⁷In recent times, there has been the emergence of the fourth industrial revolution, commonly referred to as Industry 4.0, has been focusing on automation in conventional manufacturing using artificial intelligence that uses real-time camera detection of defects in production lines.⁸Automation and digitalization in production lines can reduce mistakes arising due to human supervision irregularities in packaging and prevent incidents such as product recalls.⁹

One such advancement in the packaging line is ‘Machine Vision Systems.’ The technology enabling machines to visually comprehend their environment using one or more vision sensors and application-specific software is known as machine vision, also called computer vision in general. Machine vision has superseded human vision in many industries and other fields.¹⁰Machine Vision is found to be practically applicable in pharmaceutical manufacturing and packaging operations, e.g., process control, object identification, code recognition, text reading, automated visual inspection, and robotic guidance¹¹In this paper, applications of machine vision in pharmaceutical bottle packaging of solid dosage forms capsules/tablets are briefly discussed.

Basic Working of Machine Vision:

One of the simplest and fastest methods of product evaluation is visual inspection, either done by the naked eye or magnifying glasses. Because of its apparent disadvantages, automation defect detection in the operation line is preferred.

Basic Principle:

· Acquisition of Images

· Image processing

· Decision making

· Execution of operation¹²

Image sensors generate an optical representation upon illumination by a light source. A photodetector is employed to convert this optical representation into a digital format during image acquisition. These processes encompass image sensing, data representation, and digitization within machine vision. Pixel values of a digital image are adjusted and refined during image processing to ensure suitability for subsequent operations.¹³

Selecting a suitable image acquisition technique is important as it is one of the important steps in automated visual inspection. ¹²The selection of a camera for machine vision is crucial and depends on various factors including desired resolution, number of frames per second, and the necessity for grayscale or color images. The camera should require an objective with the appropriate magnification and focal length. Industrial cameras typically use complementary metal oxide semiconductor (CMOS) or charge-coupled device (CCD) chips as their primary photosensitive components.¹⁴

Lighting is essential; the light sources should be positioned to provide a uniform dispersion of light throughout the sample.¹⁵The amount of light necessary to illuminate an item or scene to get the desired outcomes might also differ from application to application and, in some situations, from machine vision system manufacturer to manufacturer. However, the level of illumination must be fixed for a specific purpose. Ensuring the reliability of the light source to maintain consistent, unaltered illumination is essential within the pharmaceutical industry, given its stringent quality assurance standards.¹⁶An optical lens can image the surface of an object on a camera sensor.The process of acquiring an image of the product surface involves converting the optical signal into an electrical signal, followed by further conversion into a digital signal compatible with computer processing. Numerous operations are conducted on the images to extract features and execute actions such as classification, localization, segmentation, and other related operations. These operations are based on specific classic image processing methods or deep learning algorithms. Suitable software automatically comprehends, evaluates, and judges image features using image processing and analysis and then directs the actuator of an automatic production line to continue operating.¹⁷All these systems are connected to the Human Machine Interface (HMI) with the latest touchscreen technologies. Modern HMIreceives data from numerous sources, does complex calculations, and makes them accessible for operators to visualize and provide information in decision-making.¹⁸

Challenges in image acquisition technology:

· Variations in illumination that produce uneven image brightness make identification more challenging.

· After being acquired from various angles and distances, the picture of the QR codes will be rotated, zoomed, and stretched due to the image capture device's geometric and flat distortion.¹⁹

· The effectiveness of the AI algorithms determines how well inspection systems perform. It might not be possible to directly apply the method created for one operation to the other.²⁰

Machine Vision in Pharmaceutical Bottle Packaging Line:

Pharmaceutical Bottle Packaging:

Based on the market requirements, oral solid drug products are usually in blister packaging (Europe, Asia) and plastic bottles (US). In bottle packaging, polyethylene terephthalate (PET) and high-density polyethylene (HDPE) or polypropylene (PP) bottle containers are usually used ²¹. Since the container is in direct contact with the product, its chemical and physical characteristics are crucial for maintaining the drug product's stability. HDPE containers, caps, and desiccants are all primary packaging materials, and labels, cartons, and outserts /inserts are secondary packaging materials in bottle packaging. Packaging material characteristics, Process parameters, and equipment utilized in the process are essential in maintaining Product safety, quality, strength, and identity. Throughout the packaging and labelling process to ensure product quality, every step of bottle packaging equipment has different sensors and computer visions for monitoring and controlling purposes.Online or offline techniques can be used for quality control testing. For offline integrity testing, a statistical sample of the output from the packaging processes is selected at specified intervals. In some instances, destructive test techniques are used to evaluate the effectiveness of the package seals. Conversely, online testing is created to test every item generated using non-destructive testing techniques. Establishing both minimum and maximum limitations for defect identification and rejection criteria within the equipment is essential when programming it for online non-destructive testing.²²

Figure 1. Important steps in pharmaceutical bottle packaging

Based on the industry experience and knowledge of the authors, majority of pharmaceutical industry has adopted Optical Character Recognition (OCR) and Optical Character Verification (OCV) at all levels of packaging. Different vision inspection systems based on machine vision are implemented for verification purposes. Labels of the manufactured finished products have information about the batch number, manufacturing date, expiration date, and MRP. These details have to be recorded for tracking and traceability.

By the implementation of machine vision-based application:

· Prevent incorrect track and trace producing false positives while reading printed labels

· Prevent misrupts of MRP, batch number, and expiry date.

Applications of MV in bottle packaging inspection:

A wide range of applications can be observed with the association of machine learning in bottle packaging inspection: One of the prime importance of bottle packaging is to keep a count and record the number of tablet formulations. Any violation or deviation in the tablet count could lead to market complaints. The ideal fit of the bottle opening and the cap is an extremely compliant and delicate task. Utilization of machine vision could identify even the tiniest shift in the bottle cap's position and identify the quality of sealing integrity to avoid leakage during product handling. The cameras used in image-capturing technology can be used to scan barcodes and improve the readability of products. Optical Character Recognition (OCR) conducted by high-resolutioncameras with the inculcation of MV can aid in decoding the GTINs on packaging work. Any mismatch in the printed information can be automatically rejected.

1. Tablet counting and filling.:

Tablet counting is one of the essential apparatuses in bottle packaging lines, as count variation in the packaging leads to deviations or market complaints. To avoid such incidents, inspections should be done. Photoelectric sensors are usually used to identify the quantity insufficiency of tablets or capsules during bottle filling.²³Machine vision could be employed for tablet counting. Automatic counting will provide a count of the items packed into the product. If this count differs from the predetermined number of items being packed, the product sample will be deemed defective and discarded. When the count produced by automatic object counting matches the predetermined count, the product sample is good.⁽²⁴⁾Machine vision is also employed to determine if the produced capsules/tablets are intact or damaged. A computer that performs counting function is integrated with the computer vision system. If the capsule/tablets appear to be defective, this information directs a signal to the counting functionality, and during bottle packaging, it helps to eliminate the possibility of defective medical capsules/tablets.²⁵

An experiment designed a standard method for material counting equipment using motion control and machine vision. Vibration frequency and speed control of materials with various specifications were accomplished using the equipment's two-stage conveyor belt. The camera gathers the image of the material, recognizes the item to be inspected, and automatically counts the material's quantity by estimating the material's area because of the employment of precision motion control technology. This study was conducted using many objects and tablets, and the detection rate was 100% accurate. The developed system was found to have achieved automatic counting that is high-speed, high-efficient, and high-accurate with a wide range of useful applications.²⁶

2. Bottle Cap Fitting:

On an assembly line, handling bottles is a highly delicate task. For various reasons, the bottle cap may not be correctly attached when these bottles are packaged. A bottle with a defective/misplaced cap deviates from quality attributes. Numerous flaws can appear during fitting, including loose-fitting caps, scratches on caps, the possibility of the cap ring breaking, and many others²⁷. A quality control inspection system can perform several functions, including automatically determining cap fit.²⁸

A research was conducted employing image-processing techniques such as pattern recognition, object detection, line detection, and clustering to complete the operation. This technology could identify even the tiniest shift in the bottle cap's position from its proper location, assisting in the bottle's disposal. The goal was to throw away as many ill-fitting bottles as possible. The system quickly determined which bottle it was by comparing the image with the learned data in real time.²⁹

Another study used edge sharpening in image processing design to remove the blur effect on the border, considerably enhancing system accuracy and cap detection speed. The system's algorithm is also straightforward, efficient, and simple to use for industrial cap detection.³⁰

It is challenging to capture the entire bottle cap with one camera simultaneously. Hence, this study employed the image stitching technique. Four calibrated cameras were arranged at 90^ointervals horizontally to the bottle cap, and images were captured and transmitted to the PC. A 3D mapping point on the cap is established. Images of the cap were captured and stitched, and the cylindrical bottle cap images were projected onto rectangular planes. This resulted in good imaging and fast performance speed.³¹

3. Bottle Cap Sealing Integrity:

High-quality packaging design is necessary for improved product protection and network system stability during manufacture and distribution. The primary objective of pharmaceutical packaging quality assurance is to ensure that patients and buyers receive medications of high quality, enclosed in packaging of quality standards. ³¹Container integrity primarily concentrates on the capping/sealing type's quality and the closure technique.To ensure that bottled products are safe to transport and store, it is crucial to control the quality of the bottle sealing during the production process. ³³Pharmaceutical bottle packaging uses such tamper-proof induction sealing technique in packaging.³⁴

An energy-efficient method of precisely delivering energy to metal objects in a non-contact mode is Induction Heating (IH). The coil head of the induction sealer facilitates the transfer of energy to the aluminum foil moving beneath it. The coil head is maintained at the proper current level such that, as containers pass beneath the coil, power is delivered to each foil to accomplish a dual task: secure bottle sealing and remove wax from the foil's top surface.³⁵

The water test method and the negative pressure method are the two primary traditional methods for finding the sealed closed area of a heat seal. Sealing instrument detection, displacement leak detection, single-point temperature measurement, manual detection, and more are additional popular leak detection techniques available on the market.Besides these traditional inspection methods, machine vision is used for sealing integrity testing.The aluminium foil seal's infrared picture was captured by an infrared camera, and an algorithm was utilized to process the captured image. The infrared camera's infrared image contained few pixels and blurry borders. A study was conducted to process infrared images using bit plane slicing with deep learning. Neural networks were trained and classified using various planes. The algorithm with the best accuracy rate was chosen as the final algorithm once accuracy rates were calculated. The final algorithm provided more accuracy and a faster recognition speed than earlier conventional approaches, which could satisfy the demands of actual production lines.³⁶

4. Controls in Labelling:

Labelling is a critical part of the packaging as it is the only source of information for the customer. According to FDA regulations, some human pharmaceutical and biological product labels must include a bar code, the National Drug Code (NDC) number (21 CFR 201.25), serial number, lot number, and expiration date.³⁷The phrase "labelling" is used in the pharmaceutical sector, which is the information printed on a bottle packaging.All labels and other written, printed, or visual material on or in a package or wrapper are referred to as labeling.³⁸

A barcode is a self-contained machine-readable identification label or a predefined format of dark bars and white spaces of different widths, structured to contain (or encode) a particular piece of information (as alphanumeric and other punctuation symbols), allowing real-time data to be collected accurately and quickly for an item or object. Data was encoded by altering the width and spacing of parallel lines in linear barcodes (1D). Later, in two-dimensional matrix codes, they developed into rectangles, dots, hexagons, and other geometric patterns. (2D) (book reference) Many types of barcode scanners include hand-held, pen-type, laser scanner, and camera-based scanners.Camera-based scanners utilize image capture technology to scan barcodes and employ digital image processing capabilities to decode them.³⁹

Camera-based image acquisition techniques inspect label details. Industrial cameras capture the image, and then specially created higher software locates the production data and batch number and analyses it. This aids in real-time high-speed detection of errors in packaging.⁴⁰

Figure 2. Camera Vision System in Label/Barcode inspection

5. Bottle packaging Track & Trace:

Government rules now demand a higher level of security for the delivery of pharmaceutical products due to the rapid increase in public awareness of the problem of counterfeit pharmaceuticals in recent decades.⁽⁴¹⁾This can be accomplished by printing information on labels such as serial numbers, expiry dates, and manufacturing dates, among other things, or printing codes on the bottom of bottles. A globally unique identifier also called a GTIN (Global Trade Item Number), is commonly utilized to enable global shipment tracking.⁽⁴²⁾Manufacturing systems can automatically generate these identifiers within a master database and then utilize them during the production process, where they are sprayed onto containers. Verification of this information is performed by machine vision. High-tech cameras that conduct optical character recognition (OCR) to read printed text and can read data from labels are used for this purpose. Once the printed text has been scanned, the system can verify that the labelling it generated matches the information in the master database by comparing it to the printed text. Packages or cartons are rejected if any written codes are illegible or don't match existing codes in the master database.¹

Quality and cost:

Organizations have to remember that cost of failure of products in the market is large and sometimes irreparable if it’s a medicine. Non-compliance to quality is not acceptable in the market especially in the case of medicine (Omachonu et al., 2003). Deviations from standard manufacturing processes, procedures and quality defects detected during the manufacturing, distribution and use of medicinal products require assessment by pharmacovigilance for potential impact on product safety and efficacy (Sardella et al.,2021). The current study citing the use of updated or advanced technology during manufacturing of drugs can help in reducing manufacturing defects as well as customer complaints. It will also help in building a good brand image and at the same time ensure patient satisfaction which will guarantee a good market position. Quality influences the nature of products as well as it determines the total budget allocated on manufacturing of the product. (Ali et al., 2012).The primary goal of any industry, including the pharmaceutical sector, is to achieve customer satisfaction. Customer satisfaction has two major components, namely customer focus (CF) and customer relationship that get enhanced when there is quality. (Sharma and Modgil, 2020)

CONCLUSION:

In the Pharmaceutical Industry, preventing defects in manufactured items and ensuring quality assurance (QA) is crucial during production. Before shipping, a product must undergo a careful inspection.⁴³ Recent developments in technologies and the implementation of Pharma 4.0 have made inspections of drug packaging more digital and less time-consuming. Implementation of MV-aided inspection of bottle packaging of tablets/capsules resulted in streamlining of the packaging process, hence reducing waste and increasing efficiency and productivity while maintaining product quality. This provides reliability and high-accuracy results. As MV has applications in various industries for defect detection, the diversity of the industrial process must be considered when designing a machine vision system. Developing more flexible and user-friendly MV designs, which could be implemented in pharmaceutical bottle packaging operations to control process variability and quality measurement, will be an add-on for the digitalization of the pharmaceutical industry. Also, filling the gap between technical domain and industry usage or creating conditions for a cost-effective technology, especially in developing nations, is one of the significant challenges facing this field.⁴⁴

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Received on 01.04.2024 Modified on 10.05.2024

Research J. Pharm. and Tech 2024; 17(10):5154-5160.

DOI: 10.52711/0974-360X.2024.00789