Tag Archives: processes

  • Should we be using iPhone video procedures?

    … for the 1940-50’s. Other industries have long since moved on and so should the pharmaceutical industry. Use of modern video records, diaries and commands should become the new accepted practice bringing our industry into the 21st century. Scientific studies prove that these types of tools are much more effective in assuring that processes are properly operated compared to written procedures which frequently collect dust on the shelves. Perhaps the time is right to be more interactive and …

  • WHO Ebola Vaccine Meeting

    … vaccination campaigns The meeting concluded that funding issues should not be allowed to dictate the vaccine agenda. The funds will be found.” *Check out the full article on WHO’s website.   For further technical information regarding the Ebola vaccine debate, reference Dr. Nigel J. Smart’s publication, Lean Biomanufacturing. His noteworthy publication provides a high-level understanding of the various scientific approaches that can be utilized within manufacturing processes of this …

  • Waste Removal

    … obvious form of waste is much less than with the most technical waste removal processes that often come after. At the same token, it’s important to understand which components will take too much effort and time, as those are probably not worth your time due to little return of investment or other unavoidable factors. A decision tree process is helpful in deciding what can or cannot be eliminated, but still, a certain level of skill and experience will be necessary in order for this technique …

  • Kaizen Events

    Implementing Kaizen Events into Your Research Team’s Methodology Lean Biomanufacturing, Dr. Nigel J. Smart In lean biomanufacturing the term Kaizen events “refers to the impact of the outcome relative to the cost expended.” Much different than most constructive concepts, in a Kaizen event once the main event is complete, the researchers’ work is far from over.  In fact, their work has only just begun. These processes are quite complex and require strong attention to detail. A vital …

  • Flow Charting

    … developing in a very systematic manner, involving products and processes that were initially defined by R&D-based bench scientists. The cost constraints involved when developing pharmaceutical and biopharmaceutical products are significant, which is why final methods, ideals for development and production are not established until there is some sort of understanding, or rather proof, that the material in question will be an effective medical product. Here is a list of the basic operating …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … things in a certain way. The whys, the where’s and the how’s of the situation are examples of where a Lean consultant to can play a significant role in your program. As an experienced extension of your team the consultant can quickly run a diagnostic assessment of key processes, gaps and weaknesses associated with your Current State and can get you tracking quickly. Deciding what tools to use and how to use them and provide the largest bang for your buck is also not always immediately …

  • Metrics and their Importance in Lean Biomanufacturing

    There is no doubt that metrics are an important component of any well run pharmaceutical process. Without knowledge derived from the data that details the critical process parameters, it is like running blind into a storm without a compass or GPS with which to navigate. Modern biopharmaceutical processes are extremely complex and require synchronization of many process parameters. Without this attention to detail, it is impossible to generate the type of operating capability that produces a …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    The deployment of any successful Lean initiative will be largely dependent upon the capacity of the organization to adopt the changes that are part of the overall approach and a major driver for this will be how the workforce chooses to embrace the methodology involved. Within the Life sciences Industry, this effect is often even more pronounced due to the highly regulated nature of the business processes involved. No matter how effective the methodology is, if it is not welcomed, embraced and …

  • Visual Factory Methodology to improve Lean Manufacturing in Life Science Product Companies

    … implementation of new practices driven from data gathered through metrics collection and analysis processes. Such new practices often include the implementation of new signs, charts and andons. Andons are mechanisms which employ light to indicate/transmit information such as with the use of Real-Time controllers for example. Pharmaceutical Consultants & Life Science Consultants skilled in these ideas and their use in Lean Manufacturing strategies understand that the use of these visual …

  • The Use of Process Mapping, Value Stream Mapping and Score Cards in developing a Lean Culture in Life Sciences Companies.

    … (in the EU). This plays a significant role in changing how certain elements are used and makes the opportunity for successful implementation more of a challenge. That said simple techniques such as Process Mapping, Value Stream Mapping & the use of Score Cards are often employed sparingly to the detriment of the operating company. In our experience, simply by initiating the use of these tools and techniques, massive gains can be made in the streamlining of processes which result in huge …

  • Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields

    It’s probably no surprise to many skilled practitioners that one of the major lean initiatives in bioprocessing is to improve throughput and reduce cycle time. Apparently this is all very obvious but it’s really surprising how many manufacturing operations fall down over this relatively simple concept. AND this applies equally to both clinical production as well as commercial manufacturing. Very often there are points of failure in processes that are associated with variability at both the …