BlazeStability is a software module, fully integrated with BlazeLIMS EnterprisePlus, designed to organize and track the sampling protocols and data acquired from stability studies. Regulations on the food and pharmaceutical industries place strict requirements on demonstrating the “shelf life” of their products. This results in additional pressure on laboratories to conduct studies that track the stability of production lots or products in development. Many studies must be managed at the same time to satisfy the requirement to confirm the shelf life of each production batch, product intermediate, materials of various package types and new products under development. This places a significant volume of work on the Quality Control Laboratory as well as those laboratories supporting product development efforts.
BlazeStability tracks and manages the scheduling of samples, test protocols, product container information, storage chambers, chamber conditions and inventory of samples. Stability Study samples are logged as standard BlazeLIMS samples, which means the sample results are entered and approved like any other sample. Studies can be created from “scratch” or copied from other studies, then edited. Once activated, a study schedules the automatic logging of samples and assignment of tests. Data is tracked and accessed through standard BlazeLIMS screens. A significant feature of BlazeStability is the ability to modify Active studies. In fact, an existing schedule can also be modified, so long as its samples have not been logged.
All pertinent study setup information is handled from a single screen. From the Study Information screen, the user defines the product type, production lot/batch ID, container type (packaging), date the product was manufactured, and the protocols for storage and testing of the samples created in the study. The user “drills down” to each protocol to assign sampling frequencies, test regimens for each time point, sample orientation, and number of sample pulls. The whole study can be set up from scratch or copied from an existing study, then edited.
The protocol setup provides the added benefit of allowing the laboratory manager to view reports on how many samples will require testing at various times in the future. This provides the information necessary for the efficient planning of instrument use and assignment of work to laboratory personnel.
At any time during a study, the user can access status information through the Study Information screen and by selecting each protocol. All samples scheduled and automatically logged by the Stability Scheduler can be tracked, queried, and viewed using standard BlazeLIMS tools.
Each study contains multiple user-defined protocols. From the study information screen, users create each protocol by specifying an ID, storage code and container code.
With a click of a button, the user is presented with a Protocol setup screen on which to enter the details related to the testing, and sampling frequency for the protocol schedules. In the protocol, sampling frequency is specified in increments of days, weeks, or months. For each sampling time, a test list is specified so as each sample is logged, the laboratory immediately knows what methods are to be run. Based on the test lists, the system provides the user with a minimum inventory of containers and “sub units” to place into the storage chambers. The system also tracks the physical orientation of the containers as they are stored in the chambers. For each time point, the user can have the system log any number of samples and print as many labels as required.