Automated, GAMP-Compliant Production Monitoring in the Pharmaceutical Industry

Digitalization does not stop in the pharmaceutical industry. Opportunities for process optimization along the entire life cycle of pharmaceuticals and pharmaceutical products, from research into new active substances and therapies to production, packaging, distribution and application, come about from the utilization of new technologies.

Yet, digital innovation not only provides many opportunities but due to the strong regulation of drug production, it also poses key challenges for the industry. Anyone who violates guidelines when developing medical devices or drugs not only puts a lot of money and their reputation at risk but also the patient’s health.

This means that it is vital for companies to have access to reliable systems which support them in adhering to legal requirements, for example, Good Automated Manufacturing Practice (GAMP).

Application

The GAMP regulation is intended to ensure the quality of the production of active ingredients, pharmaceuticals and cosmetics. Quality demands are also placed on packaging, processing, and storage.

One of the more stringent guidelines is that the marking and printing of packaging and products have to be recorded and tested reliably. Among other things, this is intended to ensure traceability of ingredients and end products, stop product mix-ups from incorrect labeling and as protection against counterfeiting.

The German company i-mation GmbH based in Rottweil, GampBOX, has developed a Plug & Play image processing system that facilitates process optimization for manufacturers in the pharmaceutical industry and suppliers (for equipment and packaging materials) which complies with GAMP guidelines.

The maximum configuration level of the system is made up of a GAMP-compliant user interface, a space-saving BoxPC, up to four robust GigE uEye FA industrial cameras from IDS combined with the HALCON image processing software.

Forgery-proof: GAMP-compliant image processing according to FDA and GMP guidelines.

Forgery-proof: GAMP-compliant image processing according to FDA and GMP guidelines. Image Credit: IDS Imaging Development Systems GmbH

The one-time allocation of a serial number in connection with individual production data (e.g., product identification GTIN, expiry date and batch number) is crucial in order to protect a medicine from counterfeiting. It is vital for complete traceability in the entire logistics chain from production to distribution and wholesale to the customer.

The GampBOX is a compact and reliable solution to adhere to the legal requirements of Directive 2011/62/EU regarding the protection against counterfeiting of prescription-only drugs.

The system provides the creation of audit trails (for monitoring and recording process changes), complete traceability of operating actions (by users with a timestamp) and the safeguarding of important process steps with electronic signatures or electronic approvals, among other things.

Recipe management and versioning, archiving of user actions subject to verification of a serial number in connection with individual production data are also viable. The GampBOX series is split into three expansion stages: the first stage integrates smart cameras into single batch production.

The second stage involves integrating smart cameras into a serialized production, for instance, to verify a serial number in connection with individual production data.

The third stage integrates classic industrial cameras, like the IDS GigE uEye FA camera, into a PC-supported system with database synchronization (for ePedigree and GS1) in a serialized production.

Up to four cameras can be connected to a GampBOX via Ethernet, such as the IDS GigE uEye FA camera. The GampBOX takes complete control of the cameras and supplies an OPC UA interface for the host computer to the outside or the higher-level control. The HALCON image processing software implements the inspection task.

Partnership

i-mation GmbH decided to cooperate with industrial camera manufacturer IDS for the development of the GampBOX: "Optimized process flows at IDS make cooperation very effective. Fast support for any challenges guarantees prompt solutions for our common customers", explains project manager of i-mation GmbH, Kai Weisser, and underlines the "excellent camera design especially for rough industrial environments."

"With many years of experience, i-mation is one of our best solution partners for the medical/pharmaceutical sector," emphasizes Florian Nadolny, Sales Manager System Integration at IDS.

We are a well-rehearsed team, not only looking for the optimal, individual camera solution for every GampBOX user. In this way, we ensure the most economical, reliable and simple GAMP-compliant integration into the respective customer-specific environment possible.

Florian Nadolny, Sales Manager System Integration, IDS

Camera

The models of the uEye FA camera family from IDS which are available for this purpose, are ideally suited for the above-mentioned utilization in factory automation as they are particularly robust.

Lens tubes, camera housings and the screwable connectors (8-pin Binder connector for GPIO, trigger and flash and 8-pin M12 connector with X-coding for data transmission and Power-over-Ethernet) adhere to the requirements of protection class IP65/67. This means that the models can withstand even the harshest industrial environments.

The extensive accessories, like drag chain cables and lens tubes, are equally as tough. The required computing power is decreased since functions like LUT, pixel pre-processing, or gamma are already integrated into the camera.

The cameras are also suitable for large format sensors and are usually utilized for machine vision tasks in quality assurance and industrial plants. The reliable solution of the testing task is also guaranteed in this application because of this.

GigE uEye FA - robust industrial camera for factory automation

GigE uEye FA - robust industrial camera for factory automation. Image Credit: IDS Imaging Development Systems GmbH

Benefit

However, the main concern of i-mation is the GAMP and FDA (US Food and Drug Administration) compliant integration of this system solution for the pharmaceutical industry, both in the form of retrofits in existing plants and in new plants.

At present, the GampBOX is the only plug-and-play system globally for implementing image processing applications according to the GAMP guidelines. The system also provides traceability of user actions and decreased validation and engineering effort.

It is ideal for machine builders who must adhere to high-quality requirements, for instance, when supplying subsystems and machines to applications requiring validation.

Machine builders and end customers from a large variety of industrial sectors are able to obtain their individual solutions for the increasingly stricter guidelines and demanding requirements from a single source, including serialization where needed.

Automated, GAMP-Compliant Production Monitoring in the Pharmaceutical Industry

Image Credit: IDS Imaging Development Systems GmbH

Outlook

The constant entry of new competitors into the market requires pharmaceutical companies to increasingly differentiate themselves to distinguish themselves in terms of shortened time to market and high quality. Digital innovations are vital for this.

Digital technologies have further potential and are already creating high added value. At the same time, as in the case of counterfeit protection (in Directive 2011/62/EU), the strong regulation poses new challenges for these and other sectors.

Traceability is also required by law in the medical technology, food and explosives industries. Due to the increased increase in counterfeit industrial and consumer goods on the global markets, these demands are growing in importance.

The GampBOX enables GMP-compliant implementation for various industries, including the necessary serialisation.

The GampBOX enables GMP-compliant implementation for various industries, including the necessary serialisation. Image Credit: IDS Imaging Development Systems GmbH

GigE uEye FA - Robust Industrial Camera for Factory Automation

Only with IDS: by choosing cameras of the new GigE uEye FA series, there is the freedom to choose between the proven IDS Software Suite or support of the GigE Vision standard.

Real USB plug and play can also be experienced thanks to the unique IDS software, even for GigE cameras: The cameras are ready for use immediately as they are automatically detected in the system.

Automated, GAMP-Compliant Production Monitoring in the Pharmaceutical Industry

Image Credit: IDS Imaging Development Systems GmbH

Client

Individual solutions for industrial image processing as a system integrator are developed and implemented by i-mation GmbH, Germany, with manufacturer-neutral consulting, technologies from leading suppliers and self-developed solutions for the electrical, pharmaceutical, automotive, packaging, solar, printing and robotics industries.

The company is split into three divisions:

  • Smart Factory Machine Vision
  • Human-Like Machine Vision
  • 3D Machine Vision.

This information has been sourced, reviewed and adapted from materials provided by IDS Imaging Development Systems GmbH.

For more information on this source, please visit IDS Imaging Development Systems GmbH.

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