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Volume 22, Issue 10
Small changes can have a big effect further downstream in your manufacturing processes.
A butterfly flapping its wings over Brazil can influence the direction and severity of a storm in New England. Called the "butterfly effect," mathematic models have shown that even very small changes in one area of a system can create large variations downstream.
Applied to the pharmaceutical manufacturing process, there is a "butterfly effect" that has the potential to create large savings for your operations when viewed from a more holistic perspective. It's not where you would normally look to free up working capital and reduce inventory requirements. Yet that's the effect of adopting a rapid screening method in the microbiology laboratory.
Consider this: If your company's products are free from contamination 99% or more of the time, then why are these products held up for an average of 5 to 14 days while traditional microbiological limits or sterility tests are conducted? If only the tiniest fraction, 1% of your products at most, needs to be detained for the full 5 to 14 days for further evaluation, then why subject the remaining 99% of your clean production to the same timeline? Isn't it smarter to release clean product as soon as you can determine it is, in fact, clean? What's needed is an absence or presence test, the results of which can be determined in as few as 18 hours.
Products testing negative for contamination can be released and shipped out to distribution and to customers faster, greatly streamlining your supply chain and reducing your working capital requirements. These efficiency improvements also reduce warehouse space requirements and even the amount of capital tied up in safety stock.
Recently, a Chicago-area manufacturer of a wide range of pharmaceutical and over-the-counter products found it was quickly outgrowing its 10 year-old facility. The need for warehouse space was far outstripping projections. The company faced a critical financial decision: Should they build or rent additional facilities? On examination, it became clear that an increasingly significant portion of their existing warehouse capacity was allocated to the micro-hold area. Here, formulated products were being held in sealed vats before bottling while samples from these vats were being checked for contamination. Using traditional microbiological testing methods, product samples from every batch, every day, were poured into agar plates and placed on racks where they would sit for several days, also taking up floor space. The plates could be checked at any time for organism growth, but the lot couldn't be released until there had been five days without growth.
The director of quality control was familiar with rapid methods. In fact, the company had a system in place, but it was capable of running only a few dozen tests per day. When pushed harder, it invariably broke down and needed service. Something had to change. The company selected a new, high-throughput screening system using adenylate kinase, which is used to enhance an adenosine triphosphate (ATP) bioluminescent reaction. The quality department now has the capacity to screen up to 120 incubated samples per hour. Lots are routinely tested; those absent contamination are packaged and released.
For this company, a capital investment of approximately $100,000 returned a five-year net present value of nearly a million dollars. This relatively small flap of a butterfly's wings in the microbiology laboratory to a new, more efficient and reliable system, made a large difference downstream, enabling the company to reclaim significant warehouse space and extending the life of its facility for at least another 10 years.
Cindy Lieberman is a vice president at Celsis International, Chicago, IL, 312.476.1200, firstname.lastname@example.org