Pharma Facilities: Modular Gains Momentum

While modular drug facilities have had inconsistent results to date, they are an inevitable part of pharma’s future. We speak with modular construction expert Pär Almhem.

By Paul Thomas, Senior Editor

Pär Almhem has been on the cutting edge of the modular construction trend in the pharmaceutical industry. (See "Modular Manufacturing: A Paradigm Shift for Pharma Plants.") Almhem was previously the driving force behind Pharmadule, and recently helped to start ModularPartners. We speak with Almhem to get a sense of where “mod con” is today in pharma, and where it’s going.

PhM: Modular construction continues to grow in popularity within pharma and biopharma. How far along are we in terms of a “paradigm shift”?

P.A.: I think we are still in an early stage. Modular solutions have gone from being a novelty and something very few would consider, to now being discussed and considered in many (most?) cases. However, few have started to take advantage of the real opportunities in modularization in the way that, for example, the software and electronics industries do. This requires a change toward much more standardization of building blocks (not necessarily the complete process or facility), use of configurable systems rather than customized systems, etc. Only when we adopt these strategies can we talk about a paradigm shift.

PhM: What’s been the most significant change you’ve seen in the past ten years in regards to the industry’s understanding and acceptance of modular construction?

P.A.: The biggest change is that in the last few years, most end-users have become aware of modular solutions and more and more service provider are now saying they offer modular solutions. Modular solutions have become an established methodology.

PhM: What have been the most significant hurdles to adoption? Are there limitations to modular facilities that you didn’t foresee in the past?

P.A.: The most significant hurdles have been the tradition of how projects are planned and executed. Modular solutions need to be considered in the early stages of a project in order to get the full benefit of them. Many times, if the question about modularization has been asked, it has been too late. Modular facilities have also had a reputation for being expensive. This has sometimes been true, partially because there hasn’t in the past been enough volume to really drive down cost. Other limitations like layouts and flexibility have for the most part been solved by new engineering solutions.

PhM: You previously wrote: “Team building, interface management, automation, and integrated validation must be incorporated into the plan at the pre-project planning phase.” Has this been a challenge for manufacturers?

P.A.: This is actually relevant for all fast-track projects, not just modular projects. It has been a challenge for Owners, but there is an increasing understanding that this is mostly a matter of good project management.

PhM: Modular facilities have different regulatory considerations, especially in regards to commissioning and validation. Are FDA and other regulators in tune with the differing needs of modular construction sites?

P.A.: I don’t see that there would be different regulatory consideration from an FDA or similar perspective. Where there may be a difference is in building codes and how these are regulated. We have never experienced any issues with the FDA or their counterparts worldwide.

PhM: Are major manufacturers gravitating towards modular design for emerging markets in particular, as a way to better standardize, control, and maintain facilities there?

P.A.: Yes, modular solutions are even more valuable in these markets. This is for the reasons you mentioned, with addition of risk mitigation for quality, schedule, and so one when a facility or process is built, as well as the ability to better keep intellectual property in house and under control.

PhM: Have you collected data on time and cost savings of modular vs. traditional projects? What specifics can you share?

P.A.: There are case studies and some statistics, but unfortunately very few really relevant, objective reports. CII has done benchmarking, but only members have access to this. Merck made a detailed benchmark for their Summit S6 project that was one of the ISPE Facility of the Year category winners this year. This was presented at the ISPE Annual Meeting 2009 and published by ISPE.

PhM: Have there been advances/changes in how modules are shipped and transported? Are they typically moved in the same fashion as standard shipping containers?

P.A.: Building modules are generally shipped in a fashion similar to shipping containers. The main differences are that the modules are larger, and shipped with greater care (weather protection, etc.). There have been thousands of modules shipped around the world with very few incidents. Process modules are shipped in similar ways, but varying depending on the size, sensitivity, etc. of these modules.

PhM: Finally, can you clarify the circumstances of your leaving Pharmadule and helping to start Modular Partners?

P.A.: Pharmadule AB, the Swedish parent company of the Pharmadule group, was owned by a European Private Equity firm. After a couple of difficult years in 2009 and 2010, they decided in early 2011 to close Pharmadule, and Pharmadule AB filed for bankruptcy in February 2011. Pharmadule AB is now closed. Pharmadule, Inc., the U.S. subsidiary that I ran, is also closed. We did not file for bankruptcy, however. Instead, we performed an orderly windup and closure of Pharmadule, Inc. The other subsidiary, Pharmadule Oü, the manufacturing plant in the Pharmadule group, was taken over by local management in a management buyout from the bankruptcy. Pharmadule Oü is now owned partly by management, and partly by Telstar of Spain, and is core part of the ModularPartners network.

After closing Pharmadule, Inc., I started a company ModWave (www.modwave.com), with a colleague from Pharmadule, Camilla Sivertsson. From that platform, we took the initiative to form ModularPartners with KeyPlants of Stockholm, Sweden, and Yonkers Industries of Cary, NC. Please see www.modularpartners.com for additional information. KeyPlants is  a spin-off from Pharmadule AB, formed in mid 2010. Just like Pharmadule Oü, they are owned by management and Telstar. Yonkers Industries is a privately held Construction Management firm.

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