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Case Study – How Antibiotic Production Benefits from Modernisation Project

Posted on June 27, 2019 by Andrew Hill

Challenge: Modernising Antibiotic Production Under A Tight Budget

One of the world’s largest pharmaceutical companies, needed to modernise its antibiotic production in the South East, USA. Since the antibiotic is no longer under patent, they needed to bring the new facility online while rigorously controlling costs in order to successfully compete with generic drug manufacturers.

Antibiotic Production_
They were also looking for a software development partner that could provide exceptional levels of flexibility and expertise. The company uses an iterative (agile) software development process and needed to create a development team comfortable and experienced with these methods. They also needed to use their own quality management system for the entire project. These presented significant challenges, especially around cost control, as any outside software providers would have to work to their methods and standards rather than their own.

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The company chose Zenith because of the company’s expertise and its extensive experience of working with pharmaceutical companies worldwide. The knowledge of the Zenith teams meant they would be able to work according to the companies’ own software object library standards. Additional factors included Zenith’s ability to put a team in place in Philadelphia for the design phase and on site in Virginia for implementation.

Solution: Creating a ‘Vertical Slice’ Prototype

Effective project management was key to the success of the project. The Zenith team began by creating a ‘vertical slice’ prototype of one production unit to show how we would develop the software and investigate new and more efficient ways of doing Clean in Place (CIP).

The team was then able to choose a more efficient CIP software process from the proposed solutions. The prototype was also used to generate highly detailed and accurate cost and schedule performance indices. This was a vital component of project delivery because iterative software development involves an incremental build approach, rather than creating a complete design at the start and then simply writing the necessary code. As, the iterative approach makes is harder to define costs and schedules in advance, the prototyping process mitigated these risks and helped to ensure tight cost controls.

The Zenith team further reduced costs through a range of innovative methods, including:

  • Development of macros specific to the client’s existing Equipment Module library which could then be used for all future
  • Use of the client’s own document generation tools to create the necessary
  • Use of a GAMP 5 risk-based approach to This ensured testing only of those elements that had changed and needed to be verified.

Results: High Quality, Cost-effective Software

The software development work for the updated facility was successfully completed on time and on budget – an impressive achievement considering the challenges around adapting to the companies own methodologies and processes and the use of an iterative software development process.

They now benefit from high quality, cost-effective software, enabling the company to compete with generic providers and retain market share. The company also benefits from a thoroughly modern facility which meets compliance requirements, operated by a modern control system. Our client has also benefited from long-term improvements to its software library delivered as part of the overall development process along with innovative approaches to CIP.

At A Glance

 

Brief Challenges Solution Results
  • Company: Large Pharmaceutical Manufacturer
  • Location: USA
  • Project Mission:    Develop software for a new, modern facility for the production of an antibiotic
  • Product/Services:  Emerson, DeltaV
  • Modernisation of plant and processes
  • Generic drug manufacturing
  • Need for agile development method
  • Integration with their own QMS
  • Effective  Project Management
  • Process prototype and efficient CIP software process
  • Accurate cost & schedule performance
  • Incremental build approach
  • Gamp5 risk based approach to testing
  • Modern control system delivered on time and to budget processes
  • High quality cost effective software
  • Competitive advantage and increased market share
  • Meet compliance requirements
  • Innovative approaches to CIP


“We work very closely with our customer, trying to understand what the client wants from the beginning in order that deliver the best service. At zenith we want to be efficient in our performance: do our job, do it well and do it once.

Everyone knows or has someone in their family for who taking medicine is very important so being a little piece of that chain of the pharmaceutical industry is amazing. We know that our job will have a positive impact on the patient.”

Georgia Kotsala, MES Engineer, Zenith Technologies

 

 

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