Image processing plays an important role in the pharmaceutical industry: to protect the patient against forged pharmaceuticals. Often patients and retailers are deceived over the actual content by deceptively real looking packaging or a new original outer packaging of falsified drugs.
Abiding the WHO regulations with image processing
The World Health Organization WHO estimates, that currently no less than 10 % of all drugs are produced and sold illegally. As the forged pharmaceuticals are most often harmful to health, the respective verification is very important.
The possible results of forged drugs are: patients take ineffective or harmful drugs without their knowledge, which can damage their health drastically.
The danger of illegal and forged drugs for consumers and companies are reason for legal concern and for several years now national and supranational regulations have been legislated. To effectively implement those regulations, it also needs real actions in production and quality management.
Pharmaceutical manufacturers and packaging service providers have to know how to guarantee that their products are conform to those regulations so that they can be sold on smoothly. The latest EU regulation specifies exactly, where and how the security features have to be applied and how the bar code data has to be saved. This requires a significant investment for pharmaceutical companies, because many internal processes are effected by the new serialization processes, such as the IT department, and of course especially the production and quality management.
How can image processing help to implement the regulations?
Image processing software and hardware can make sure that packaging, sealing and bar codes are intact. And also that all drugs are saved in a bar code data base and therefore an uninterrupted retracing can be guaranteed by the producer.
During the production sealing and packaging can be checked continuously. Presence, position and color inspection are typical applications for the EyeVision software. Also the reading and verification of codes as well as OCR and OCV. The image processing based inspection can identification solution by EVT can help to:
- ensure the security and sound condition of the packaging
- guarantee the consumer protection
- prevent product forgery
- stop parallel trade and sales through illegal channels
- protect the brand and increase the efficiency in callbacks
What are the new regulations 2019?
Since February 9, 2019 pharmaceutical companies are only allowed to sell drugs that feature two new security characteristics on the packaging:
FIRSTLY, on the packaging has to be a 2D bar code. The code has to contain a serial number for the respective contries market and a product code (with integrated pharmaceutical number), as well as the charge number and the expiration date. This information also has to be printed in plain writing on the package. Therefore the pharmacy can ensure, that the package is neither forged nor stolen.
Additionally with a central verifications system the pharmaceuticals can be tracked. And all data of the drugs are transferred in to a data base starting from place of production. Therefore all pharmacies, producers and suppliers are connected with each other.
SECONDLY, each packaging has to be sealed, to ensure that no illegal withdrawal and possible forgery has taken place. Each package needs an individual serial number and a seal, to ensure the intactness of the packaging. The so called “Tamper-Evident” seal makes manipulation of the packed drug impossible and also the covering of forged drugs in an original package. It is important that in case the seal is damaged or opened at the point of the sale, the drug must not be passed on to the customer.
What Hardware is used for the quality inspection?
With two GigE or USB 3.0 cameras with 2 to 4 Megapixel, a frame rate of 50-60 fps and an endocentric lens the packaging can be simultaneously inspected for code, expiration date and seal. Concerning the camera selection, cameras with a global shutter sensor are to prefer. EVT image processing systems can inspect up to 40 packages in one second. Therefore it also needs the right processing unit. Here EVT uses the new EyeVBox B2, which allows for a maximum flexibility of hardware choice, with its QuadCore 1.91 GHz processor, 4 GigE ports with Power over Ethernet (PoE) support and 2 USB ports as well as RS232 interface. Additionally the box has 8 in- and 8 outputs for an optimal hardware trigger, as well as a DIN rail housing to easily integrate it into a control enclosure.
EyeVision also offers a wide selection of supported communication protocols such as e.g. Siemens Profinet, Modbus, Ehternet/IP, etc. With Linux there is the so called Profinet Stack that allows the user to run EyeVision with a Siemens PLC. Whereas under Windows, Profinet boards such as boards from Hilscher work fine for this application.
Also a feature of the software is the possible inspection program switch with just one scan of a bar code. This makes it easy and fast to change the inspection program on the same packaging machine for different product lines, such as different kinds of pharmaceutical packaging.
The EyeVision software then takes care of the complete evaluation. Codes such as bar codes, DMC and QR codes can be read and verified in high speed. OCR/OCV commands inspect the plain written information on the packaging for correctness and readability. And commands such as the Blob or for pattern matching check the Tamper-Evident seal for presence, position and intactness. Faulty packages are discharged with a respective signal to the control unit.
EVT offers all the necessary products from low-cost and effective sensors for the inspection of the intactness of the packaging, to tracking serialized products from the manufacturer to the patient, to the insurance of the correctness of the label with bar code and character verification.
Innovative EVT technologies allow for precision and reliability to:
- prevent defects
- improve quality
- increase profit and productivity
- fulfill the latest regulations concerning traceability