Bayer: Inspection and packing line

Bayer produces the radioactive cancer drug Xofigo at the Institute for Energy Technology in Norway (IFE). In 2016, Cody got the exciting assignment of developing and building an inspection and packing line for the medicine, based on past experience and collaboration with Bayer.

With a high focus on user-friendliness, operator safety and the demanding requirements that apply when building equipment for radiopharmaceutical production, Cody has created a solution that is tailored to IFE's production premises and needs. One of the challenges has been to create a machine with good operator accessibility while controlling the radiation hazard from the medicine at the same time.

In the development of the machine, the team need to meet the following criteria:

• Small footprint

• Measure radiation

• Operator safety

• Reducing radiation exposure

• User friendliness

The machine design ensures that the user doses are automatically inspected and packaged, as the radiation hazard indicates that this cannot be done manually. The control system is complex and manages all vital production steps, including visual control of labels and packaging through advanced camera technology.

Cody's proprietary database solution TITAAN handles batch reporting, reconciliation, logging of critical production instrumentation, electronic signatures, and more. This is made according to the current pharmaceutical production directives.

Core functionality

• Automated inspection and packaging
  Ensures user doses are inspected and packaged without manual handling, eliminating unnecessary radiation exposure.

• Integrated vision system
  Advanced technology verifies labels, packaging integrity, and product alignment in real time.

• Optical Character Verification (OCR)-based label verification
  Automatically reads and validates printed data to prevent labeling errors and ensure full traceability.

• TITAAN production database
  Cody’s proprietary system manages batch reporting, reconciliation, instrument logging, audit trails, and electronic signatures in line with pharmaceutical manufacturing requirements.

• GAMP 5–aligned system design
  Developed following Good Automated Manufacturing Practice guidelines to support validated and auditable production environments.

• 21 CFR Part 11 compliance
  Supports secure electronic records and signatures for regulated pharmaceutical manufacturing.