Leaning QC: Lonza Rolls Out Raman for Materials ID

PhM: Your ultimate goal is to process incoming materials with no sampling, but are there still some materials you’re testing via traditional sampling, and why has this been?

D.H.: Yes, there are still some materials that would require sampling. This is ultimately based on where the material is used in the process or if there is a critical attribute that needs to be analyzed for each shipment. For instance, microbial safety testing would always need to be performed if the material is capable of supporting microbial growth.  Also, excipients require more testing even if the material is qualified for a reduced testing strategy. Excipients require 100% container ID, so the time saved by not needing to sample 100% of the containers is significant; the remaining attribute testing would be performed using the number of containers required per our statistical sampling plan.

PhM: Another goal was to consolidate data, so that you could develop your own raw material specifications and testing procedures worldwide. What challenges did this present, given the diversity of Lonza’s facilities? To what extent has this harmonization across sites been realized?

D.H.: Currently the technology is being rolled out to the Biopharmaceutical divisions. The advantage in this is that the materials across the facilities are common, making the harmonization efforts less challenging. In addition, these facilities have begun harmonizing specifications and testing procedures so the challenges were expected.

Thus far, we have approximately 10 harmonized raw material specifications, which are shared between sites in the Biopharmaceutical division of Lonza, and have deployed the Raman units to five Lonza sites.

PhM: What are the next steps/challenges in your global rollout?

D.H.: The next step for Lonza regarding global deployment of the Raman instruments is the site-by-site evaluation. This involves determining if the instrument is a fit for the materials at that site, and evaluating the benefits seen thus far at the Portsmouth facility.  Currently these instruments have been deployed to five sites within Lonza. The challenges thus far are creating a system to share reference scans and harmonizing the operating SOP. The largest challenge was removed by using the one site qualification strategy.

Figure 1. Technology Evaluation at Lonza (Impact on Raw Material Process)
Dry Powder (e.g. 100 containers requiring 100% ID)

Figure 2. Technology Evaluation at Lonza (Impact on Raw Material Process)
Liquids