Shifting drug prices, government healthcare mandates, regulatory requirements, calls for consumer customization—challenges such as these have driven pharmaceutical processors to look at ways to streamline operations and reduce costs.
One of the ways this is happening is through modular manufacturing. Modular manufacturing allows pharmaceutical processors to produce a variety of products from a single facility with faster changeovers, increased flexibility, and improved overall equipment effectiveness.
There are several key drivers moving pharmaceutical companies to seek the benefits of a modular format including the need to deploy manufacturing regionally rather than centralize it all in one location. The trend toward personalized medicine with smaller and more targeted batches increases the need for flexibility. Safety is also moving manufacturers to consider this approach, particularly when they are feeling the cost pressures of meeting the requirements of the global health care system.
How it Works
Modular manufacturing can be achieved in a number of ways, but when looking to increase flexibility many processors are looking at the ‘ballroom’ concept, often defined as a large manufacturing area with no fixed equipment. This approach allows for a facility to be broken down into functional building blocks or modules, creating opportunities to simplify, standardize, verify, and re-use designs as well as actual modules in different implementations.
The ballroom concept adds significant flexibility, as it allows for plug-and-play functionality to add or replace functional elements or process steps in a seamless way. It enables multiproduct manufacturing because of faster changeover. Additionally, there can be significant reductions in capital costs, including savings from the changes in overall facility footprint, like reduced HVAC and clean/steam-in-place utilities, as well as a reduced need for dedicated cleanroom space.
Many manufacturers are taking the modular concept a step further and looking at the use of self-contained unit operations. These self-contained units are often comprised of single-use equipment wrapped in an enclosure providing a local cleanroom environment in a multi-product facility. Other concepts include complete cleanroom suites for a certain process implemented in modules—either as self-contained units or as parts/modules making up an integrated process or facility.
These ‘podular’ cleanroom and facility designs can be used for laboratory purposes, unit operations or whole facilities. These podular structures can easily be cloned or used for new production needs, for example for the personalized medicine market.
Facilities of the Future
There is a movement toward modular facilities in combination with single-use technology. Processors are looking to optimize the modular single-use concept in conjunction with continuous processing because of the advantages it offers. These advantages include reduction in manufacturing footprint and capital expenditures, together with an opportunity for more robust processing because there is a higher degree of automation and reduction in manual interaction.
It is likely that the facilities of the future will combine single-use technology through the ‘ballroom’ manufacturing concept, taking advantage of the benefits from closed processing and continuous manufacturing.
But whatever the method, all pharmaceutical companies have to carefully consider parameters such as facility design, quality, time, and cost for construction and regulatory requirements. Companies taking advantage of these modular designs must remain focused on creating and implementing proper risk-management strategies to mitigate (and eliminate) potential product contamination, whether from planned or unplanned breaches in multiproduct production scenarios.
What is Driving this Move Toward Modular Manufacturing?
Bottom line, this trend toward modular manufacturing is being impacted by several key factors including cost of goods sold (COGS) and capacity utilization. Everybody wants to use their production capacity to the fullest, reducing the COGS. Drivers such as speed-to-market, multi-product campaigns requiring different production schedules, and the need for smaller batches of pharmaceuticals for new innovative personalized therapies or for rare diseases have all fueled the increased need for flexibility (and increased the interest in modular manufacturing).
With all that is happening in the pharmaceutical industry, modular manufacturing will be an important trend for exhibitors and attendees to keep an eye on at this year’s Pharma EXPO (McCormick Place, Chicago; Nov. 6 – 9, 2016), an event co-produced by PMMI, the Association for Processing and Packaging Technologies, and the International Society for Pharmaceutical Engineering (ISPE). Pharma EXPO will be co-located with PACK EXPO International 2016. Together, the shows will feature more than 2,500 exhibitors and draw 50,000 attendees.
To register for Pharma EXPO, visit www.pharmaexpo.com. Attendees will have access to both shows with one badge.
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components, and materials for processing and packaging. We work to advance a variety of industries by connecting consumer goods companies with manufacturing solutions through the world class PACK EXPO portfolio of trade shows, leading trade media and a wide range of resources to empower our members. The PACK EXPO trade shows unite the world of processing and packaging to advance the industries they serve: PACK EXPO International, PACK EXPO Las Vegas, Pharma EXPO, PACK EXPO East, EXPO PACK México, EXPO PACK Guadalajara, and ProFood Tech, launching in April 2017. PMMI Media Group connects manufacturers to the latest solutions, trends and innovations in processing and packaging year-round through brands including Packaging World, Automation World, Healthcare Packaging, Contract Packaging, and Packaging + Processing OEM. PMMI Business Drivers assist members in pursuing operational excellence through workforce development initiatives, deliver actionable business intelligence on economic, market, and industry trends to support members’ growth strategies, and actively connect the supply chain throughout the year. Learn more at PACKEXPO.com, PMMIMediaGroup.com, and PMMI.org.
Follow us on Twitter and Facebook for updates on the latest pharmaceutical and biopharmaceutical manufacturing news!