In response to market forces and competitive imperatives, pharmaceutical manufacturers are consolidating manufacturing and packaging into fewer and fewer plants to reduce costs. At the same time, the number of unique packages required to meet market and regulatory requirements is increasing. These trends are rapidly rendering obsolete the traditional approach where pharmaceutical products are packaged and labeled at the time of production.
There is a more efficient approach to traditional labeling/packaging operations called bright stock manufacturing in which products are produced in large efficient batches and stored in unlabeled individual containers. These containers are then labeled just prior to shipment. The main challenge of implementing a bright stock manufacturing strategy is ensuring that the contents of every container are known with 100% certainty before applying the label and having the ability to demonstrate this fact via the pharmaceutical manufacturer’s quality assurance, quality control (QA/QC) regime.
NEED FOR JUST-IN-TIME LABELING
The pharmaceutical industry’s strategy of consolidating manufacturing operations into a smaller number of high-volume plants is challenged by the need for these plants to distribute its products effectively and reliably deliver shipments to meet the varying demand from local and global markets. To meet such market diversity and complexity each product requires an increasing number of unique labels to meet the regulatory and societal requirements of a given country or region.
The traditional approach of labeling and packaging the product at the time of production is becoming increasingly untenable because manufacturers are forced to estimate the demand for each of the different labels applied to its products. This approach usually requires that production be in relatively small batches, which is less efficient and more costly to produce than larger batches.
For example, when market demand doesn’t match the forecast, product rapidly loses its value as it moves closer to its expiration date. Even while labeled product is losing value sitting on the shelf, a given manufacturer may be forced to produce and label the same drug to meet unexpectedly high demand for the same product with different labels.
Pharmaceutical manufacturers have long wanted to move to the more efficient approach of producing bright stock in large efficient quantities and labeling and packaging the product just prior to shipment—when demand is known for certain. But making certain that the contents of each and every bottle match its label on application is a significant technical challenge.
How can the manufacturer be certain that a handful of bottles containing a different product haven’t been mixed together with the batch being labeled? Just a single bottle with the wrong contents could have enormous consequences including harm to a patient, damage to the manufacturer’s reputation, a multimillion dollar recall and so on. This same concern, it should be noted, also applies to the increasingly large number of pharmaceutical manufacturers that due to plant consolidation are now making products in one facility and shipping them to another for labeling.
VALUE OF MARKING EACH CONTAINER
An obvious solution to this problem is to mark each container at the time of production to eliminate any doubt as to its contents. This code is then read just prior to applying the label and packaging in order to ensure that the bottle contains exactly what the label says it does. This raises the challenge of generating a mark on each bottle, often made of high density polyethylene (HDPE), recognizable with certainty during downstream processing. Traditional marking solutions such as CO2 and fiber lasers cannot generate much contrast on HDPE materials, rendering bar codes nearly unreadable. Ultraviolet (UV) lasers can generate a darker mark but it is still challenging to maintain the high read rates due to the many variables in the marking and reading process.