For clients who have a short term requirement to perform headspace inspection for a large number of product samples, it is possible to lease an automated headspace inspection machine. Drivers for such an inspection activity include suspected container closure integrity (CCI) issues in commercial batches of sterile freeze dried vials, or suspected elevated headspace oxygen levels in commercial batches of oxygen-sensitive product. In addition to implementation for troubleshooting activities, the lease of an automated inspection machine can be used to do process studies. Analyzing and inspecting a large number of vials gives a statistically relevant data set for understanding the robustness and variability of the process.
A suspected CCI issue or process upset can result in a sterile drug manufacturer having to perform a risk analysis before releasing product to the market. For the case of a suspected CCI issue, a 100% container closure integrity inspection using an automated headspace inspection machine can guarantee the closure quality of suspect batches enabling the release of valuable product to the market. For the case of a process upset during the filling of oxygen-sensitive product, a 100% headspace oxygen inspection can confirm that all product samples indeed meet the oxygen specification for stability. Such inspection projects can be set up quickly and follow the general timeline desribed below.
Recent quality approaches and regulatory guidance stress a statistical understanding of the process. This requires the implementation of analytical tools for monitoring both the process and final product quality. During the scale-up of a product to commercial production can be an ideal time to collect statistical CCI data. Test batches, placebo batches, and validation batches can be 100% inspected providing statistical data sets. Deep process and product insight can be gained allowing for informed process optimization before commercial product launch.
LIGHTHOUSE has a number of automated machine systems that can be quickly configured for a short term inspection activity. Custom change parts are manufactured for the specific client containers and the machine configured for FAT in a timeline of 8-10 weeks. Installation and validation of the machine is accomplished within a two week time frame, meaning that inspection of product batches can usually begin within a timeline of 12-14 weeks. This flexible approach allows for quick confirmation of finished product quality and allows clients to meet critical deadlines for releasing product to the market. The inspection of large numbers of samples has also been used to quickly and efficiently characterize and then optimize the processing of finished sterile product.
LIGHTHOUSE Measurement Services
