MANUFACTURING SCALE UP

Once past the early product development phase we can work concurrently with the R&D team to set up and scale up your manufacturing operations for clinical trials or commercialization. By focusing on pre-production and scale up, you will ensure a smoother transition from R&D to manufacturing.

Set up Manufacturing
We can help you

  • identifying and qualifying suppliers,
  • identifying and selecting materials
  • identifying and selecting equipment
  • transitioning from prototypes to manufacturing processes and products
  • performing design of experiments (DOEs) to optimize process parameters
  • increasing product throughput
  • improving yields
  • developing specifications
  • identifying, qualifying and determining AQL for destructive and non-destructive testing
  • implementing and expanding process controls

Companies that engage early in the product design and process planning tend to realize the greatest benefits. That’s because decisions made early in the product lifecycle define manufacturing options later. By acting concurrently, it will reduce development and operational costs by reducing risks of repeating long qualifications for example after changing a key supplier or a material property.

Manufacturing scale up

Going from a small scale operations to growing your volume by two or three folds is not just about buying twice or three times the same pieces of equipment.

In cooperation with your team we will perform an assessment of your current technology, manufacturing processes, specifications, process control, yields, bottle necks, materials and personnel flows.

Together, we will develop an optimal strategy to allow you to grow your throughput on the short term, but also looking forward to the longer term. We will take a modular approach in order for you to best manage your capital investment.

We will help you:

  • Optimize your processes
  • Identify, purchase and qualify new equipment
  • Implement more effective processes and process control
  • Train your manufacturing and quality control personnel
  • Identify and reduce waste
  • Focus on value added functions
  • Implement your manufacturing growth while ensuring regulatory compliance

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Gloster Biomedical International • 577 N. Hope Ave, Suite 101 • Santa Barbara, CA 93110 • USA • Tel: +1-805-679-1258
www.GlosterBiomedical.com

Copyright © 2008-2009 Catherine Gloster - Gloster Biomedical International - All rights reserved.