All pharmaceutical freeze-drying vials are the same! Aren't they?
25 Sep 2017
Whether it’s a fad or the future, 100% vial traceability is becoming an increasingly important consideration in the pharmaceutical freeze drying industry. Keeping a close eye on developments is GEA. We’re investigating possible solutions and, what’s more, we have the experience, expertise and know-how to implement them.
Some of the most valuable products in the pharmaceutical industry are produced by freeze drying (or lyophilization). Normally a batch-based process, this ensures that only a limited amount of product is affected if any quality problems occur.
As such, quality assurance procedures only need to examine a small number of vials and, based on a positive outcome, the entire batch can then be released … assuming that all vials are identical.
This was common practice in tablet production until the early 1990s when it first became clear that not all tablets in a batch have the same absolute weight. Then, as technology advanced, manufacturers started measuring the weight of individual tablets during the process, which enabled them to reject non-compliant ones and adjust the process conditions when necessary.
Freeze drying in 2017
The current situation is that traceability can only be done in batch mode, which provides very little information about the time, position or condition (moisture content, for example) of a vial. Essentially, all vials are equal and anonymous. The ideal situation is that “every vial has a name” and can be individually tracked and traced.
For years, it has been known that the residual moisture content of individual vials in a batch is not always consistent. Modern analytical methods now make it possible to non-destructively measure this value and to reject out-of-specification vials.
However, as these tests are done after the freeze dryer is unloaded, it’s not actually possible to assign the non-compliant vials to specific positions in the chamber and determine the cause of the moisture content deviation.
The future
A co-operation between GEA, Heuft and Schott has, however, delivered a quantum leap forward in total vial traceability. Every single Schott vial can be marked with an individual 2D-code that Heuft sensors can read at various locations in the GEA process line. This means that every individual vial can be tracked throughout the entire process and deviations can be assigned to specific positions.
As well as being able to quickly resolve any manufacturing issues, further benefits of such systems include low implementation costs, mass serialization, an IP-protected solution, preservation of glass integrity and a reliable anticounterfeiting system with easy identification and customizable marking.
Of course, every innovation has its pros and cons. A total vial traceability system could add additional risk and would certainly involve intensive validation and financial investment. On the plus side, however, such a system would offer 100% traceability during the production process and provide an item-level batch report; it would prevent mix ups and cross-contamination, improve line clearance, help to resolve system-based faults and support patent protection.
