Tag Archives: cycle

  • Bottlenecking Theory

    … make the most out of your research. You are experts in your industry so make sure to own this knowledge, for that will be the best way to reach your team’s goals.   The quantity that a manufacturing site can produce in unit time is defined as: Plant throughout: Batch size X Number of batches Plant throughout: Batch Size/cycle Time Clearly bottlenecking is not an ideal situation for your facility, so avoiding this or creating a logistical approach to offset this phenomenon is key in lean …

  • Kaizen Events

    … event. The process involves a “complete PDCA cycle performed within five business days, focusing on removing all forms of waste and bottlenecks from the process to create maximum value.” This should be normally factored into the process within 30 days of the event in order to capitalize on the work that was accomplished from there on out. It is important to note that the cost spent should be ever so modest compared to the significance of such events. Kaizen events are indeed a focused …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … global market where cost, time to market and short cycle times play such a critical role in the success of a product. However, with that being said, the focus on product quality has at least as much an impact on success because this is so tightly bound with product safety and the eventual successful deployment of the product as a medicinal agent. The social responsibility associated with making a safe medical product is extremely important as the consequences of a defect are connected to the …

  • Don’t keep failing, implement a LEAN Laboratory approach!

    … laboratory? Below is a short list of some of the more important features that you will need to build into the transformation plan. • A process to provide a consistent leveled supply of samples • A process that significantly reduces the lead times involved • A process that reduces the level of work in progress • A process that reduces the overall cycle-time for analysis • A process that streamlines data processing If these issues sound familiar to your situation and you want to …

  • Issues Connected with Device Combination Product Convenience Kits

    … they’re included in the paper convenience trays. If manufacturers are to use these types of device combinations, then an alternative material of construction may be required to avoid this issue or possibly a modified sterilization cycle will be required which provides assurance of the removal of the sterilant. As a first step testing is needed to quantify the extent of the problem. Only when the size of this issue is understood can a resolution be developed. These are complex issues which …

  • Reaching into Research and Development of a Supply Chain Strategy

    … selection of raw materials and components and their suppliers early in the development cycle. The strategy should be based on risk management principles and the needs and demands of the commercial market. The strategy would consider the unique attributes of the material and suppliers balanced against the potential risks that may be encountered when manufacturing for the commercial market. To read the full white paper, click on the following link: Reaching into Research and Development for …

  • Metrics and their Importance in Lean Biomanufacturing

    … their income stream is entirely tied to throughput from their plant and not through revenue generation from product sales, unlike innovator companies. Through careful application of process analytics, often with the help of pharmaceutical consultants, winning strategies can be developed to assure a “Right First Time” mentality is instilled in the operating culture, which enables this approach to make a meaningful impact on downtime reduction and production cycle time. …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … often the result and inefficiency together with an increase in work related mistakes is the eventual outcome. Whatever the outcome you choose to define, the impact on the manufacturability is to affect at least one of the following: decreased finished goods productivity, increased cycle times, raised error frequency, increased waste production, increased accumulation of WIP (work in progress) and a disruption in workplace organization. All of the above contribute to an unsatisfactory situation …

  • 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 …

  • Issues for Device Combination Products

    … they’re included in the paper convenience trays. If manufacturers are to use these types of devices, then an alternative material of construction may be required to avoid the issues, or alternatively a modified sterilization cycle will be required which assures the removal of the sterilant. As a first step however, testing is needed to quantify the extent of the problem before the right strategy can be developed. …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was designed to improve process efficiency of both manufacturing and regulatory phases, and is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT will reduce cycle time thus …

  • The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry

    … part of the entire pharmaceutical value chain, just as it is in other industries. However, the industry has historically placed an emphasis on the role of R&D and innovation, leaving manufacturing to take a back seat. Prior manufacturing knowledge must be integrated throughout the product life cycle so that manufacturing’s participation can move upstream. Bikash Chatterjee, President of PharmaTech Associates offers this assessment: “I think we are very, very early in our journey …