As the industry becomes more diversified and the demand for parenteral drugs rises, there has been a shift in the way facilities are structured. The industry has begun to lean toward wider adoption of multi-product or flexible facilities in an effort to maximize production and prove to customers that any request can be fulfilled by a singular company that is not bound to traditional methods of production.
Many pharmaceutical companies are looking to concentrate their outsourcing to one or a few contract firms that can handle the bulk of their production needs. If a contract developing and manufacturing organization (CDMO) is able to front-load the majority of their drug development and production, the pharmaceutical company sponsor eliminates major risks in the supply chain that can result from employing too many partners at all phases.
Instead, sponsor organizations are seeking long-term partnerships with a single CDMO when possible, and then developing and growing in conjunction with their supplier. This is ideal for the development organization that wins the contract — increased business translates to internal improvements, which will, in turn, beget more business and further financial gain. As such, symbiotic partnerships between sponsors and supplier organizations are increasingly sought throughout the drug development chain.
Thus, CDMOs that can successfully demonstrate their aptitude for flexibility in production have much to gain — especially in the current, ever-evolving pharma landscape. In order to prepare a facility and be able to rise to the challenge of the trend of flexible and multi-product facilities, one must have a full understanding of what it means to operate under these paradigms, including the difference between each type of facility and the integral role of equipment in any type of facility. Here, we highlight the trend of multi-product and flexible facilities, defining the different types of facilities and how working with a firm such as Federal Equipment Company is a strategic move for any company looking to achieve an internal update in the most cost-efficient manner possible.
Understanding and Differentiating Flexible Facilities
Having a designated equipment line for a single dedicated product has become an outdated practice. Companies that want to grow must be able to develop more –– and often different types of –– drug products and drug substances.1 Flexibility is achievable on many levels in a facility, which is part of what makes it so complex. Firstly, process flexibility must be taken into account. This includes the production mode and mix, as well as scale and volumes. Following this is suite-level flexibility, which is defined by how the suite is configured in the larger framework of the facility. This funnels into operational flexibility, or how the organization operates as a whole. Site and integration flexibility is yet another level, as is investment flexibility — the board of an organization is constantly working to meet flexibility on all fronts without crippling the company’s bottom line and going over budget, especially without a known payoff.1
Flexibility and Autonomy: Factoring Independence Into a Facility
In a flexible facility, multiple products are produced, and there is an ease of scalability.2 There is also an element of mobility that is usually associated with modular facilities. In modular facilities, however, the design often reverts to that of a traditional facility, which ultimately removes a degree of flexibility. Instead, the most flexible facilities are also engineered for autonomy.
As Maik W. Jornitz, COO of G-CON Manufacturing, Inc., writes, this is a key feature of the flexible definition. “True flexibility comes with autonomy of the critical cleanroom space; as such autonomous, compact cleanroom system can be painlessly decontaminated and sanitized, controlled and re-used. The cleaning and repurposing of autonomous cleanroom spaces make them ideal for multi-product processing, Furthermore, these systems can be deployed fast track and, if needed, moved.”2
This hedges on the concept of “mini-sites,” which resemble autonomous pods and are constructed off-site for use where they are needed. These pods can take any dimension and are modified for the project design needed. Their defining characteristics are mobility and containing an internal HVAC system.2
Facility Classification: From Traditional to Pod
Facilities fall under one of the following categories: brick and mortar, modular container, stick-built modular, isolator or controlled environment module and autonomous pod.2
Brick and mortar –– generally known as traditional –– facilities are often built for one product and at a large scale. As operations are dedicated to the lifecycle of a single product, the lifespan of the facility may be limited; the HVAC system is generally located in the mezzanine in order to reach many large areas.2
Modular containers have container systems built off-site that are connected at the final location to form a complete facility; they can be custom designed for the project and feature a central HVAC.2
In a stick-built modular facility, modular wall panels factor in prominently. The facility is finished with these panels and is designed differently to accommodate windows or a door pass-through; the HVAC system is in the mezzanine.2
Isolated or controlled environmental modules are built off-site and are mostly used in a cleanroom area because of the way it can be sanitized; the HVAC system can be either connected or stand-alone.2
Autonomous pods are built off-site and function as a stand-alone cleanroom module that is available in various sizes. These pods can be custom fitted for a project, are equipped with their own HVAC system and offer an ease of decontamination.2
Procuring Equipment for any Facility within Budget
For each facility, there is a need to procure equipment. The trend of the flexible facility has carried over to the trend of flexible equipment. Having a rigid brick and mortar plant with immobile equipment ––the traditional way to model a plant –– is no longer considered the best practice, based on the multitude of changes in the industry, coupled with the internal push towards improving processes and innovation on all fronts.
In a roundtable with the American Pharmaceutical Review, a panel of experts was asked to comment on the trend of flexible and multi-product facilities.3 They were further queried about the future of equipment when considering this bigger picture. The general consensus was that innovation on the equipment front is expected to match the facility trend.
“The adoption of flexible and portable equipment will continue to grow so that companies can acquire assets that can be used as broadly as possible to meet their needs,” noted Katherine A. Bakeev, Director of Application Support Services for B&W Tek, Inc. “As instrumentation miniaturization develops further, the advantages this brings in the ability to measure starting materials and products more easily, more frequently and with less movement of materials will result in higher assurance of product quality. This flexibility and increased testing ability will help to identify potential issues earlier, thus resulting in higher product quality reaching final customers,” she told the publication.3
Surendra Balekai, Product Manager for Thermo Fisher Scientific, highlighted the expense associated with both traditional facilities and equipment, which has placed an unnecessary burden on pharma. “As of today, industry is under pressure to build facilities for multi-products and have flexibility for capacities. Moving forward this will be standard. Molecules in the clinical phase need a couple of batches processed. Flexible equipment/facilities are the most economical way to build, manage and sustain. Millions of dollars are spent in maintenance of traditional facilities, industry can’t afford to and doesn’t want to continue down this path.”3
A Strategy of Partnership: Relying on a Used Equipment Expert
When procuring equipment for a flexible facility, it is best to work alongside a partner organization that understands all of your specific goals. It is also important to know how the equipment will fit within the facility, as well as with the other machinery already available — as well as the scale that is necessary and possible.
At Federal Equipment Company, we don’t just offer our customers what we have on the showroom floor — because of our size and business model, there is no limitation on what equipment we can provide. Not only do we sell a full range of equipment, but we have a comprehensive understanding of all of the equipment we carry. The breadth of knowledge that our experts offer sets us apart and allow the organizations we partner with to stand out — if a machine does malfunction, we are able to provide troubleshooting. We also train anyone who purchases equipment from us, ensuring that they are able to operate a machine on their own so that an operator will not be at fault for any mishaps.
When fitting a flexible facility, overhead cost is probably the single greatest issue. There is no appropriate way to innovate without investment; however, if the cost burden is too high, it might overwhelm the organization and undo any potential profit or progress. Balance is key when dealing with a major change in operations. To achieve the desired outcome without going over budget, an organization should rely on used equipment when possible.
Federal Equipment Company is the ideal partner in equipment selection. As we deal exclusively with used equipment, we have a full awareness of what is on the market and what works best, which will help equip any type of facility for any type of product. Our equipment covers a range of industries –– not only pharma but also chemical, plastics, packaging and food and beverage. This diverse background means we have an understanding of a range of manufacturing segments, which helps us better inform all customers we consult with. We not only know how the pharma industry does business, but also how all other sectors utilize their equipment and make it work — which translates to real outcomes and success for our partners.
- Thomas, Aeby, and Morten Munk. “Meeting the Demand for a New Generation of Flexible and Agile Manufacturing Facilities: An Engineering Challenge.” BioProcess International. 18 Dec. 2015. Web.
- Jornitz,Maik W. “Defining Flexible Facilities: When is a flexible facility being flexible?” Pharmaceutical Processing. 19 Apr. 2013. Web.
- “Flexible Facilities Roundtable.” American Pharmaceutical Review. 31 May 2015. Web.