Converting from Single to Multi Product Production Lines |

Converting from Single to Multi Product Production Lines

June 082012
Converting from Single to Multi Product Production Lines Exclusive – Part 5 from Pharmaceutical Automation Roundtable (PAR) 2011
June 2012
By Bill Lydon – Editor
This article about the conversion of production lines from single product to multiproduct, which ultimately creates flexible manufacturing pharmaceutical plants, is the fifth article in a series covering the recent annual Pharmaceutical Automation Roundtable (PAR).
About PAR
I had the privilege of attending the Pharmaceutical Automation Roundtable as an observer in November 2011. This PAR was hosted by Johnson & Johnson in Spring House, PA, with Dave Stauffer, Terry Murphy, and Joel Hanson of Johnson & Johnson participating.
Lead automation engineers from various parts of the world attended the invitation-only, two-day event. This is the most knowledgeable group of automation professionals gathered in one place at any one time focused on discussing automation issues.  A range of companies participated including Abbott, Amgen, Biogen Idec, BMS, Genentech, Genzyme, Glaxo, Imclone, Johnson & Johnson, Eli Lilly, Lonza, NNE Pharmaplan, Novo Nordisk, Pfizer, and Sanofi-Aventis.
The PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company at the time, as a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, or plans to do business or not do business with specific suppliers, contractors, or other companies.
The individual PAR group members have a wealth of practical knowledge and knowhow to share with other participants, truly learning from each other.
Topics are agreed upon prior to the meeting and a member with make a presentation on their organizations views and approach to the topic. After this presentation others comment on their organizations situation.
Single to Multi Product Production
The presentation focused on automation to support the trend toward flexible manufacturing with multiproduct production lines. The presenter pointed out that in their company fill/finish lines are often multiproduct already today, the next most likely multiproduct area are clinical lines with typically 4-6 products a year, and commercial lines (high volume) with typically 2-4 products per facility. In addition, they are turning commercial facilities into dual clinical/commercial which is an even more complex challenge.
Good Design Practice Suggestions (Single to multiproduct)
  • Keep batch recipes simple for each product and strive for common CIP (Clean In Place) and SIP (Sterilization In Place) recipes. 
  • Minimize recipe variables as much as possible along with good parameter naming conventions. 
  • The large phases for single product designs are typically low cost for a single product but do not provide recipe flexibility. In order to support more flexibility, work towards good modular S88 design with smaller phases for distinct functionality or process steps. 
  • Flexibility for unit to unit transfers and communications is often overlooked in single product design but is very important for multiproduct production.
  • Multiproduct design must also address operational requirements including SOPs (Standard Operating Procedures), work orders, manual vs. automated steps, HMI screens, messaging, batch status, operations reviews, product context, and user acceptance testing while maintaining simplicity.
Regression Testing
Regression testing is important to be sure each product in a multiproduct facility is not impacted to insure product integrity and quality. Also risk assessments become paramount and may span areas or units previously not considered.
Product Changeover
Product changeover time and cost need to be considered in the design since it directly impacts labor, operating costs, and opportunity costs.   For example, are changeovers done on planned shutdowns or are they required at other times?
Economics (Single to Multiproduct)
Their experience is the first couple of additions and changes on a production line for producing multiple products are very expensive.    The addition of subsequent products should get less costly but may remain high if initial design practices are not improved to support recipe and process flexibility. The implication is that there should be time and care taken in the first couple of conversions to multiproduct that will payoff in subsequent projects. The presenter illustrated with statistics that the conversion of a specific production line took less effort to add a 3rd product than the 2nd product. This was done on a process already controlled with a traditional DCS system using batch recipe software.  This is only a single example so may not be representative of other conversions.
“The goal is be able to add products with only a recipe change but we are not there yet,” said the presenter.  This facility has a fourth and fifth product that will be added in the near term. 
Lessons Learned
  • Simplify phase and batch recipe code.
  • Naming conventions need to be reconsidered to be more equipment specific, not tied to single product process, for example “Chrom skid 1605” rather than “Protein A Chrom skid.”
  • Don’t be afraid to break phase classes at unit boundaries. In some cases it makes sense to break classes to reduce complexity or allow more flexibility.
  • Simplify shared equipment where possible.  For example, does CIP need to be batch based?
Issues & Experience Discussion
The following comments came out of the discussion by PAR members on this topic:
“Educate product and process development on modular S88 design concepts.”
“Ask product development groups to design modular process models and unit operations. This will enable easier configuration of multiproduct plants. The intention is that automation should never be the bottleneck in the process.   Success relies on people heavily embracing that consistent model. Automation cannot fix poor process design, only adds cost and complexity.”
“Most of our product variations are done in the formulations making for simple automation and product change overs.”
“Fill finish has been historically multiproduct and the biggest headaches are “change parts” and we are looking at different types of equipment that can reduce the number of change parts. That is fascinating because we are looking into robotics, and some other innovative approaches.” 
“A new facility had been designed from the “ground up” to be multiproduct and the first iteration was extremely flexible to the point of almost impossible to maintain. A big complexity is too many small phases that run simultaneously because there are multi-parallel phases running. After this experience new facilities are now more simplified.”
“Facilities that are single product today and moving to multiproduct have taken months and required massive deconstruction.   These are facilities running for over 20 years where quality is requiring detailed visual inspection when changes are made to make sure the facility is safe for multiproduct production.”
“The Automation group has been staffing multiproduct changeovers 24/7 to help out the process engineers and maintenance technicians because there are so many non-routine interlocks and overrides that have to be performed at a lower level.”
“A number of facilities that do not have an MES or other software for batch recipe management may have a problem managing multiproduct recipes and making sure they are properly synchronized to factory production schedules.”
“Experience using a SCADA/PLC based batch installation is that it is more flexible. But when you consider the cost to configure and support it, the SCADA/PLC option is expensive because it doesn’t come with the typical DCS engineering tools. You live with your sins especially in this economic environment. The lack of a holistic structure leads to unstructured applications with a great deal of duplication.”
“In fill finish we have a large amount of variability of packaging (bottles, blisters, etc.) with over 20 variations. The goal is to have less physical packaging designs and artwork to lower changeover labor and time and thus increase yield and lower per unit costs.”
“We have a huge initiative called packaging harmonization. It is amazing the variation of packaging that has created so many complex packaging lines.”
Thoughts & Observations
The shift to multiproduct manufacturing across the globe is here to stay and requires good upfront, top down design thinking centered on S88 concepts. It seems clear that investing in sound, front end loaded engineering of facility conversions from single to multiproduct production yields overall lower lifecycle cost and far less head-aches for all.
Your thoughts and comments are welcomed.
Links to other articles in this series:
Part 5: Converting Single to Multi Product Production (You are currently reading this article)
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