Faster to market: Aseptic filling in prefabricated cleanrooms
Speed, flexibility, and scalability: the three key manufacturing metrics for successful pharmaceutical companies over the next 10 years. Vanrx outlined its case for speed, flexibility and scale through the Aseptic Filling Workcell approach to manufacturing injectables in a recent white paper.
But the Workcell is only one part of building a fill-finish facility. The benefits of purchasing a Workcell fade away if it’s waiting for a home. The facility design and construction process still lags behind the rapid production of these standardized machines, delaying customers’ go-to-market strategies. What if that bottleneck was removed?
Is it reasonable to design and build a fill-finish facility in 12 months or less? The answer is yes, utilizing pre-fabricated autonomous cleanrooms, which can be shipped anywhere in the world and placed into warehouse space.
Removing the facility design bottleneck
Using prefabricated building technologies can remove the bottleneck of custom facility design and construction. Modern versions are made by several manufacturers for the pharmaceutical industry. Similar approaches are used in housing for remote resource exploration.
Pre-fabricated modular manufacturers share Vanrx’s view that pharmaceutical manufacturing can be simplified, and integral drugs can reach the market faster, by moving past accepted conventions.
Prefabricated cleanroom modules can be made to suit fill-finish applications. They also support other types of applications such as lab space, cell and gene therapy applications, and other bioprocesses.
Modular cleanrooms are built and tested in a central factory, then shipped to their final installation location. They can be installed into warehouse space. They fulfill the three metrics of speed, flexibility and scale:
- Speed: Can be built and installed in 12 months or less.
- Flexibility: Used for various purposes, and can be repurposed, if needed.
- Scalability: Add capacity through additional modules, including duplicates for international sites.
An example of a company that offers this approach is G-CON Manufacturing, a company founded in Texas in 2009. Their versions of modular cleanrooms are called PODs. Each POD operates autonomously with its own HVAC system and utility connections. This is a key difference versus other modular systems, which are modular in their design stage, but not in their long-term usage. Other than receiving power and in some instances water, the POD is independent from the surrounding building, allowing it to be moved, repurposed or relocated to a different site as manufacturing demands change.
Financial benefits include faster time to revenue when using a combined POD / Aseptic Filling Workcell approach. Up to two years of additional revenue or time cut from a development process can be achieved with this approach. Plus, modular cleanrooms can be expensed and depreciated as equipment over 5-8 years, contributing positively to cash flow. This compares very favorably to the 30-40 year depreciation for buildings and capital equipment. They can also be re-purposed and/or sold if corporate priorities shift, or a product development program fails.
G-CON recently announced a partnership with Butler Manufacturing™ and Span Construction and Engineering that combines the surrounding building and PODs into a turnkey solution. With these companies working together, construction timelines can be even further condensed.
Aseptic Filling Workcells in PODs
The critical benefit of putting an Aseptic Filling Workcell within a modular cleanroom is speed to market. Companies that use the combination will reach production and revenue faster, simply because the facility will be completed and running sooner. Scale-out can also be much faster using this approach, as increased demand dictates.
Workcells function well within modular cleanrooms because they fit. That seems simple but a Workcell’s compact size is a difference maker. Using nested containers and closures and single use product contact components eliminates the need for washing, depyrogenation and autoclave equipment. The Workcell also requires less space and fewer supporting utilities. In a 24-foot (7.3 meter) wide G-CON POD, two Workcells can be installed.
Workcells can be installed into the POD at different points of the POD build schedule. They can be installed following the POD factory acceptance test (FAT) at Vanrx, or at the customer’s site. With either option, the two halves of the POD are connected once the machine is inside.
Putting Aseptic Filling Workcells into modular cleanrooms fulfills the three key metrics of speed, flexibility and scale. This combination is the fastest way to build fill-finish capacity, is highly flexible in its operation and is easily duplicated. Companies can produce a multi-product portfolio into vials, syringes and cartridges, and avoid the high cost of customized facilities and equipment.
Benefits Summary for Workcells and PODs
Combined Workcell & Modular Cleanroom
|Speed||Can be built and installed in less than one year. Process development can start earlier in product lifecycle.||Built and installed in less than one year.||Install fill-finish capacity anywhere in the world in 12 months or less.|
|Flexibility||Can fill and close vials, syringes or cartridges.||Multi-purpose and can be re-purposed.||Flexible fill-finish capacity for multi-product portfolio|
|Scale||Standard design for easy process duplication, rapid construction and deployment.||Add more modules for additional capacity.||Add more capacity in 12 months or less with more modules / Workcells.|
Duplicating capacity and entering international markets
The Workcell / modular cleanroom approach serves companies well with expanding international production, whether driven by regulations or economics. The benefits are amplified for countries with less infrastructure and/or skilled labor. Both approaches require less infrastructure than conventional facilities and equipment. The Workcell is less labor intensive, since it requires fewer people, and operators need not be skilled because of its automated robotic processes.
Process development can occur at a central location and then repeated at international locations. Having cleanrooms arrive ready to operate and with employees identically trained is a significant benefit for reaching the market faster. The process is highlight repeatable, with installation and validation according to a finalized standard process.
Modularity vs. flexibility
Maik Jornitz, G-CON’s CEO, recently wrote an article for Pharmaceutical Online about the difference between “modular” and “flexible.” Maik tied the shift to more flexible facilities to new categories like cell therapies and the industry’s desire to bring manufacturing costs down. The conclusion of the article was that flexible facilities, like PODs, could be built in a modular fashion, but that traditional modular designs ultimately become inflexible as soon as their construction is completed.
Inflexibility of the traditional modular system is primarily based on their reliance on the surrounding building’s HVAC system. POD designs are superior for this reason, as each POD is generally independent from the facility and from other PODs. As such, changing the function of one POD does not affect another POD or prevent it from operating. If the useful life of one POD comes to an end, that POD could be replaced with an updated version of the same unit without affecting the operation of the operations in the other PODs.
Vanrx raises this same concern in our recent white paper when discussing new “modular” concepts. These are still conventional, isolator-based fill-finish systems. Modularity in conventional systems means a system of building blocks (washing, depyrogenation, container-specific filling and handling equipment, etc.) are stitched together in order to achieve flexibility.
“Modular” filling systems are flexible in design, but not in operation, especially as large modules must be wheeled in and out of the cleanroom to support filling and closing different container formats. This changeover procedure makes these systems especially ill-suited for PODs installation, especially where these systems need bulk containers and closures processing, and multi-use product contact materials.
These conventional filling systems are still custom-designed, often from multiple vendors, creating longer lead times and more difficult scalability. They benefit the machine manufacturer and facility builder, but not the user. The user needs true flexibility in both design and operation, which is achieved by using combining Aseptic Filling Workcells within PODs facilities.
Winning conditions for pharmaceutical manufacturing in the 21st century
This article reviews how the combination of modular cleanroom architecture combined with the Aseptic Filling Workcell to help pharmaceutical companies reach the market with speed and flexibility. Companies that adopt this approach will also be able to scale or repurpose their operations in a period of uncertainty around competition, pricing and entry into international markets. Based on recent customer interest, we think this is an excellent combination, and look forward to sharing an implemented example of this new way of approaching the creation of fill-finish capacity.
If you would like more information on the combination with Vanrx’s Workcell with G-CON or other modular cleanroom systems, please contact us.