Tag Archives: size

  • 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 …

  • NDC codes: National Drug Codes and How They are Assigned

    … material. The second section identifies the product code which includes the specific strength, dosage form and formulation for the company. The third section identifies the packaging code and this corresponds to the package size and type. This part together with the product code is provided by the company filing the NDC application. In practice NDC codes follow the following convention: 4-4-2, 5-3-2 or 5-4-1, where the second and third parts are determined by the operating convention within each …

  • 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 …

  • Critical factors in Filing NDC numbers with the FDA

    … different formulations are put into the same size packaging it will require a new NDC number AND if different formulations are used in the same size packaging this will require a new NDC number. Clearly if a formulation changes, this will also trigger a new label too, but the point here is to recognize that these individual categories are individual triggers for new numbers and a regulatory filing. Contact us if you need assistance with this process. …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … The highly compartmentalized nature of the industry fosters a manufacturing process composed of many individual parts rather than one continuous, integrated flow. Improving a process that isn’t quite a process yet can be very challenging. Additionally, there’s a reluctance to make the necessary changes – batch size,for instance – when those changes result in the added burden of extensive documentation and testing. As with PAT, the very things that need improvement are …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … pharmaceutical consultant plenty of pertinent questions. This will aid you in clearly identifying early on exactly what you need, as well as determining whether the consultant can provide that, and how he/she will accomplish it. Good consultants will have instruments in place to help you through this process. 2. Forgetting About Flexibility Occasionally, consultants will come in and attempt to solve problems with a one-size-fits-all approach or just apply a quick fix, either of which is a …

  • Lean Manufacturing Implementation: Successfully Overcoming Obstacles

    The current economic climate, combined with increasing regulations has placed pharmaceutical manufacturers in the difficult position of having to reduce waste, improve processes, and increase productivity. Although lean manufacturing can absolutely be the answer, some companies have found lean manufacturing implementation to be an uphill battle. That is not to say, however, that there have not been some dramatic success stories.

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … place and in the right size, shape, and orientation. Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans. If scientists …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    … the right place and in the right size, shape, and orientation. Dr. Abbobaker’s team has had the opportunity to see the tissue regeneration process in a very simple animal that is capable of regenerating itself to an amazing extent and that does it regularly.  They want to understand how it is that adult stem cells can work together in any animal to form and replace damaged or missing organs and tissues, because any new understanding in animals can be very important, very fast, for humans. …

  • Key Elements of a Business Plan for a Pharmaceutical Business

    … description of your target market including size, demographics, and current needs.  Your product needs to be described in adequate detail to allow investors to understand its impact, without giving away any key intellectual property. You also need to include a strong exit plan, a plan for growth which includes new products and revenue streams for when patents expire and generics become available, and a plan for operations which is scalable yet able to meet small production needs. A well thought …

  • Important Information about Lab Ergonomics

    … adjustable to fit every size of person: –    Don’t use a microscope for more than 5 hours per day. –    Locate the microscope on the edge of the table to achieve an upright position. –    Use a cut-out work table. –    Elevate the microscope and place it at an angle at which you can look directly into the eyepiece. –    Keep neutral spine. –    Give arm rests for while using the adjustment knobs. –    Use an ergonomic chair with …

  • Emerging Trends in the Pharmaceutical Industry

    … pharmaceutical industry, over the next 20 years. Many pharmaceutical consulting firms are suggesting many other global trends that are factoring into this large boost in the pharmaceutical industry.  Some of these factors include growing market size, favorable government policies, expanding health coverage, and new developments in drug developing technology, just to name a few.  However, not everyone in the industry is convinced this unprecedented growth will sustain itself for much longer. …