Machine Vision Protects Pharmaceutical Packaging
The vision system handles many functions, from reading ampoule labels to checking needle precision. Source: PPT Vision
Pharmaceutical and medical device manufacturing are among the most highly-regulated industries for good reason: a small defect in a heart catheter or mis-labeled product in a syringe can lead to tragedy and litigation for the families and the companies that produce the products.
Globalization further complicates the issue. The world’s largest pharmaceutical companies sell more than half of their product in foreign markets, where local regulations multiply the problems. For companies like B. Braun, global maker of pharmaceuticals and medical devices, it means developing current good manufacturing processes (cGMP) that meet the highest quality standards, while automating the documentation of production by creating an e-pedigree (electronic pedigree) for every product.
That’s why B. Braun Penang (Malaysia) turned to PPT Vision, developers and installers of machine vision systems for medical quality assurance and product tracking. PPT Vision’s Impact vision system running the Impact Software Suite helps B. Braun boost productivity, manage risk, and improve quality across multiple medical device and pharmaceutical production lines, including syringe needles, product labels, pharmaceutical vials, and Ecoflac intravenous (IV) infusion bottles.
Working with PPT Vision’s Malaysian integration partner, AVI Technology, B. Braun’s Penang facility installed several PPT Vision Impact systems to ensure efficiency and quality. The versatility of the vision platform combined with the ease of use and power of PPT’s Impact Software Suite means that the same system can inspect physical properties as well as read codes and labels. To keep B. Braun’s needle production line sharp, the Impact system inspects each needle for length, diameter, twist angle, and bevel angle based on more than 60 different needle types.
AVI Technologies suggested that B. Braun use a PPT9200 (1,600 x 1,200 pixel) high-resolution camera to measure needle length and insertion depth. The Impact system takes up to eight images along the length of the needle and stitches them together to make a final measurement. A high-precision reference plate next to the needle helps the vision system to precisely align the different pictures into a spatially accurate single image.
To make such precise measurements in a noisy plant environment, AVI Technology also installed indexing hardware, vibration isolators, and special shields to minimize environmental influences. According to Richard Goh, AVI Technology’s general manager, the system helped B. Braun reduce excess material waste and cut down on product returns due to dimensional drift and variation.
Strengthening the supply chain
Efficiency in medical manufacturing means being able to connect production, packaging, and offline laboratory testing while performing safety and quality inspection steps along the way.
Government regulations, such as the U.S. FDA’s 21 CFR Part 11, dictate how medical manufacturers should operate, from the layout of facilities, validation of production equipment, and 100% electronic documentation of medical products.
Among the many products B. Braun packages are small vials, or ampoules, of liquid medication. The Mini-Plasco vial is filled, then sterilized, and then labeled for packaging and shipping. Each step takes place in a different location, so the company marks the top of the ampoule with a product number, indicating the type of medication, and an alphabetic code for day and lot information.
“We have to make sure that the ampoules have the correct label applied,” explained a senior staff engineer at B. Braun. “Previously, we manually checked the code on the ampoules before labeling them, but a 100% check of each ampoule using a qualified electronic and camera system improves the level of assurance and safety. Now, every ampoule is checked as it passes the Impact camera, which reads every product number and alphabet code. If the code on the ampoule doesn’t check against the solution described by the label, the Impact system rejects it. The results are good with false rejects well below 1%.”
All the systems installed at the B. Braun Penang facility were designed with medical manufacturers in mind, explains AVI Technology’s Goh: “Special considerations were also incorporated into each system, such as a report generated after each batch, the ability for the supervisor to key in the solution/contents, the lot number, and also password for different level of users in order to meet or exceed the customer’s expectations based on the User Requirements Specification (URS).”
The Impact vision systems were thoroughly validated in four steps: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) by B. Braun’s independent validation team. “Strict adherence to user requirements and also the test plans meant our team had to put on their thinking caps every time to solve both vision and mechanical issues highlighted and observed by B. Braun’s Validation Team during each buy-off,” continued AVI Technology’s Goh. “With support from PPT Vision, we made it happen, which encouraged us to tackle more complex applications like the B. Braun installations.”
More than a label
Before the final label is applied to the Mini-Plasco ampoule, the label itself must be checked. The label represents the last line of communication between the healthcare provider and the patient. Any mistakes at this point could lead to tragic consequences. All labels are checked for accuracy, clarity, color tone, and number based on the lot size for a particular production run. Due to the many types of labels, a camera system provides a more secure recognition system for the labels than older solutions that might use fiber optic/photoeye counting systems, for example.
One of the most important aspects of the Impact label validation system was the flexibility of the OCR tool, and the ability to teach the software new fonts, labels, and configurations. This capability is particularly important for contract manufacturers that ship product to different countries, each with different label presentations.
The B. Braun Penang facility has several Ecoflac production lines next to each other. On some occasions, each line would package a different product into the Ecoflac infusion bottles. Before installing the Impact vision systems, bottles and labels were manually checked at each packaging line.
The Impact vision system gave B. Braun Penang additional assurance by electronically checking each bottle before a label is applied. This is especially important when two different products of same package are produced and labeled at the same time of the day. B. Braun Penang engineers say they are much more confident of their outgoing product and machine vision thanks to the PPT Vision experience.
|Bradley Weber is director of application engineering for PPT Vision.|