Ensuring quality in pharma production

Didier Lacroix

Product safety and packaging integrity is a stringent aspect in the pharma industry. They are “early adopters” in the deployment and use of machine vision technology to stay compliant with regulations and mitigate risks.

Track and trace

Center for Medicine in the Public Interest (CMPI) estimates that more than 25,000 pharma packaging lines globally require modification to implement effective track and trace technologies. This presents challenges to manufacturers and machine builders.

Track and trace solution requires implementing three levels of functionality:

• print and verify marking numbers on all products
• mark each product with a unique serial number and create a central database
• track, store the location and status of each product as it travels through the supply chain until it is sold to the customer

Serialisation data is got from four layers of supply chain operations, from individual medicine to manufacturing and final delivery. Any hierarchy-level information appearing on packaging such as blisters, folder cartons, bundles, cartons, packages or container also is recorded on production floor. Information is collected at internal supply chain level where product data on shipments between manufacturing facilities is recorded for further distribution. Product delivery is recorded at external supply chain level, allowing for an end-to-end product verification process.

Counterfeiting

WHO estimates that about 15 per cent of medicinal products in the world are counterfeit. CMPI estimates that activities related to counterfeit drugs generate $75 billion annually and expects to grow by 20 per cent annually in coming years.

Defect detection and quality control

21 CFR Part 11

Complying with US Food and Drug administration (FDA) regulations on electronic records/ electronic signatures and pharma inspection cooperation schemes has created challenges for pharma manufacturers. It includes fortifying access control measures while providing an electronic trail for all transactions.

FDA suggests that procedures and controls should include:

1. Validation of systems to ensure accuracy, reliability, consistent intended performance and ability to discern invalid or altered records. Generate, accurate and complete copies of records in both human readable and electronic form.
2. Protection of records to enable their accurate and ready retrieval throughout the records retention period. Limiting system access to authorised individuals. Use of secure, computer-generated, time-stamped audit trails to independently record operator entries and actions that create, modify or delete electronic records. Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
3. Use of authority checks to ensure that only authorised individual scan use the system. Determine that person who develop, maintain, or use electronic record/ electronic signature systems have education, training and experience to perform their assigned tasks. Establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.

Machine vision meets the following challenges of the pharma industry

Serialisation and Tracking: Advanco serialisation and tracking solutions deployed a traceability solution using Cognex In-Sight ID readers for a manufacturer that produces and distributes 60 million medicine boxes annually. In 1.4 seconds, it decodes all 2-D code sprinted with inkjet onto the surface of each medicine package. An alarm trigger removes defective products ensuring that all shipment packages are traceable and improves production processes.

Defect detection: Product testing company, EISAI Machinery GmbH used two Cognex In-Sight vision systems to inspect delicate glass vials in fraction of a second. It determines the cake height of freeze-dried contents and detects the presence of any foreign objects on their surface and for “splashings” caused by unwanted boiling during the freeze-drying process. In-Sight system inspects the underside of glass vials for cracks. In-Sight Color Vision system checks both vial cap and flip-offseal, inspecting for parts presence, cover colour and for aluminum caps, correct crimp processing. It ensures that only glass vials with 100 per cent product quality are distributed to clinics, pharmacies, and medical practices.

Process automation: Automated Systems of Tacoma, Inc (AST) used Cognex Vision System for developing a single-platform machine to fill vials, syringes and other containers. It eliminates the need to purchase multiple filling machines and can handle all liquid packaging needs.

Code verification: Pharma products manufacturer Sanofi-Aventis used Cognex vision systems to implement a print and code verification solution to comply with GS1 codes readability regulations. Designed as a mobile system, it can be adapted for packing lines and installed along the production process. It, with track and trace software, provides information to a PC database to create an audit trail. It reads printed data and verifies against selected information camera at a speed of 300 parts per minute.

Machine vision tools for the pharma industry

• PatMax uses a set of boundary curves, not tied to a pixel grid, and looks for similar shapes in image without relying on speci?c gray levels. Result is an ability to find objects despite changes in angle, size and shading.
• Test Run delivers quality improvement. If it fails to inspect properly, quality manager can add to Test Run database and make required modifications.
• OCRMax prevents misreads, handles process variations and provides easy font management. It’s easy to set up and simple to use across all platforms.

Packaging Quality Control: Boehringer Ingelheim uses Cognex vision to achieve printing quality inspection on a production line churning out around 300,000 blister packs and 100,000 folding packs every day. Challenge was high speeds at which blister packs move on the production line, variable accuracy of inkjet printing on foils with irregular surfaces and dirt, pressure, and sharp edges. Depending on product type, examination is made of varying details, including lot number, expiry date and pre-printed information. It recognises relevant symbols and letters and on previous parameters and tolerance limits, assesses product quality.

Label verification: ArturTheis GmbH has a machine that inspects labels with different identification and information carriers including 1-D codes, genuine lettering and holograms and bollinos. It can affix labels, stickers and bollinosupto200 different types of folding cartons and check their position. If not aligned, then information such as use-by date, product and lot numbers cannot be applied correctly.

PatMax technology in In-Sight Micro system helps to inspect product variety with different label shapes and colors by orienting itself to geometric features of the cartons. It determines position values without errors—even under variable lighting and position conditions and despite changing angles, sizes, and shading.