A recent article at Healthcare Packaging claims that findings in the 2016 PMMI Pharmaceutical & Medical Devices: Trends and Opportunities in Packaging Operations survey indicate that the entire healthcare industry will be impacted by serialization implementation and compliance deadlines. Serialization and aggregation are expected to drive a transition for all drug makers.

The survey points out the biggest barriers to serialization implementation, which include:

Time. Considering the exceptions and challenges, the time to ramp up to full-scale production is substantial.

Cost. A huge consideration for most companies (particularly those that are smaller), serialization implementation costs range in the area of $1 to $4 million for a single manufacturing plant.

Acquiring equipment. With equipment delivery time taking as long as two years in some cases and a limited number of suppliers, manufacturers face difficulty in procuring equipment – not to mention the ROI can be as long as 30 years on some equipment.

Internal infrastructure. Communication infrastructure and integration of the database; optimizing communication infrastructure is critical in determining the most effective method for capturing data and managing/transmitting that data.

The PMMI survey found that 52% of manufacturers required to serialize products have already adopted aggregation, and that almost half of participants were more than halfway prepared in terms of compliance to meet advancing deadlines in aggregation and serialization.

One survey participant who is an expert in pharmaceutical serialization said that due to the fact serialization information cannot fit on some products, packaging changes would be necessary. The participant also noted that companies would improve upon packaging, manufacturing, and handling processes in an effort to recover costs of implementation.

PMMI members can download the executive summary for free.

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