secondary packaging

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Meeting the challenges in serialization to win in the battle against counterfeiting

The World Health Organization (WHO) estimates that medicine counterfeiting causes one million deaths a year and that 10% of all drugs sold globally are fake. Events such as Covid-19 increase these risks by disrupting the supply chain and increasing internet purchases.  A key weapon in the battle against counterfeiting is track and trace (T&T), which is the ability to track and trace products through a supply chain – with ‘track’...

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Connecting vision systems with how the patient reads a label

The packaging of pharmaceutical products is regulated in most countries. Authorities expect that any printed information – such as product, use and storage data on the packaging material artwork or batch-specific data (e.g., expiration date) – is readable by the patient.   Batch-specific data is commonly checked by vision systems using optical character verification. Pharmaceutical companies must be able to document traceability...

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Protocol and report for human readability study of single characters – application for biopharmaceutical vision system settings

The packaging of pharmaceutical products is regulated in most countries. Authorities expect that any printed information – such as product, use and storage data on the packaging material artwork or batch-specific data (e.g., expiration date) – is readable by the patient. Batch-specific data is commonly checked by vision systems using optical character verification. Pharmaceutical companies must be able to document traceability between what patients can read and understand, and how much of single characters can be ‘missing’ before they may be misread. While the term ‘readability’ in various regulations relates to the contrast between the background color and the text color (or to the font size), it does not consider how much that any missing parts of single characters may impact human interpretation of what is printed.

The purpose of the protocol is to use supporting data to establish how much of each single character can be missing before it is no longer perceived as the intended character. The report supplies the basis for defining acceptable character defects and supports setting up limits for vision systems to detect good/bad characters and minimize labeling errors.

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Serialization – challenges and good practices in packaging operations based on experience of track and trace systems

This paper provides an overview of points to consider and good practices relating to the most challenging areas identified following an industry benchmark on the serialization of sellable units. The purpose of this benchmark was to identify common industry challenges with serialization and to broaden the knowledge of good practice, industry capabilities and to identify the quickest route to implementation and compliance with global serialization requirements. The paper also seeks to encourage dialogue between industry, regulatory agencies, and track and trace system providers, by adding the unique perspective of secondary packaging customer, summarized after several years of using such serialization systems

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Secondary Packaging: Electronic product information

BioPhorum has created a structure and approach to respond to the challenge of developing ePI solutions that add value to patients and healthcare providers alike highlighting the benefits and challenges of the broad range of factors surrounding the design and implementation of ePI, supporting the objective of finding a solution that can be implemented globally . The packaging perspective on ePI is simple: agree on an ePI format, and packaging functions can agree on how to apply it to product packaging. This paper looks at the opportunities and challenges and recommends the adoption and use of GS1 standards and recommendations both to meet supply chain and point of care needs and as a way to harmonize implementation of regulatory requirements.

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Driving the evolution of secondary packaging

How do we transition from large-batch manufacture to small-batch, high-value packaging runs? This is the question driving the discussion and scoping activities of the Fill Finish Secondary Packaging program that was agreed at the FF20 meeting in March 2019. After initially focusing its activities on aseptic filling and lyophilization, Phorum leaders decided to explore collaborative opportunities in secondary packaging. “Secondary packaging is a...

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Changing mindsets with a modular approach

“We sense fear of the unknown… yes, the future may appear scary, but the future of our industry needs us to act now.” These are the words of Stefan Merkle, Senior Director Sterility Assurance at Janssen at last year’s Fill Finish Technologies to Reduce Drug Release Times event (FF18). While this comment was in relation to a discussion on whether to pursue in-line monitoring/real-time release (ILM/RTR) technologies, it is equally applicable to...

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