(301b) Continuous Manufacturing Control Strategy for Material Traceability

Material traceability plays an important role in pharmaceutical companies through root cause analysis, continuous improvement, value stream mapping, patient safety, regulatory compliances, and recalls. From a batch manufacturing perspective, the materials placed in the batch are easily known, as each batch is a separate set of material additions and operations. Consequently, if a non-conformance or recall event arise, the size of the lot to be placed in investigation or to be withdrawn from the market will be of the same order as its batch size.

However, when dealing with the same production in a continuous manufacturing line, the batch size is no longer tethered the equipment size or the material addition. Materials can be added to the continuous process many times during production. This can allow many lots of incoming raw material to be used during the process. In addition, the continuous process can be used to produce multiple batches of product without stopping or cleaning between each batch. This has the advantage of allowing the process to remain at steady state for longer, but many lots of incoming materials can be split amongst the produced batches. Tracking which batches have which lots of material is imperative.

This talk will detail a real-time method for determining lot locations within produced batches. This allows each batch’s constituent ingredient lots to be determined even as the batch is completed. It also enables continuous production from one batch to the next. The results of experiments using tracer data from dispensing station to the output of the process will be presented, which shows the timing needed for a lot of material to move through the system. The strategy for utilizing this data for material tracking will be discussed.