Location: Bloomington, Indiana, USA
Project: Flexible Filling Line (FFL)
Seeing a shift in industry to extend the ready-to-use vials platform and utilize new capabilities for filling flexibility, Cook Pharmica combined activities of what would traditionally be three filling lines into one line under barrier isolation in a single filling suite. This project was a collaboration between owner, suppliers and engineering expertise, realizing a complex manufacturing upgrade executed within an existing operation, to complement its existing syringe and vial lines with first-of-its-kind flexible filling technology. An exceptional example of a company helping to lead industry in the adoption of ready-to-use vials (and cartridges) and applying next generation filling, automation and robotics technology uniquely to create unparalleled flexibility. This innovation in flexible filling not only added additional capacity and capability, but enabled better supply service to its customers and patients.
The project team applied multiple Equipment Innovations end-to-end throughout multiple processes. Robotics technology and automation created ultimate flexibility to serve clinical and commercial manufacturing needs as well as augment the capacity of an existing full scale vial line, including:
- Use of “No touch” transfers of ready to use components
- Multiple format flexibility (vials, syringes, cartridges), component sizes and dosing options (peristaltic or time-pressure pumps)
- Denesting and detraying of ready-to-use vials that facilitated 100% In-Process Control (IPC) checkweighing with filling speeds up to 140 vials/minute
- Applied latest dosing and re-dosing technology to increase yield and 2017 Facility of the Year Award Winner - Cook Pharmciaplace zero rejects within the realm of possibility, and increase product yield by minimizing line losses
- Use of Re-stoppering features that eliminates missing stopper rejects
- Discrete component handling through most of the process to avoid glass-to-glass contact, and avoiding damage
- Ability to utilize various multi-product manufacturing scenarios, connection to existing capping and packaging lines (both Liquid & lyophilized vials)
- Ability to use Single use product path or product dedicated stainless steel surge tank with Steam-In-Place (SIP) capability
- Nitrogen gas overlay and amber lighting for oxygen or light sensitive products
- Ability for Syringe filling or lyo loading, while vial capping from existing freeze dryer
- Ability to utilize Syringe cartridge or vial filling, while freeze drying another product
This unique collaboration between Cook Pharmica, OPTIMA Pharma, Nuova Ompi and IPS-Integrated Project Services, LLC, delivered a novel application of commercially available and custom developed equipment innovation manufacturing solutions that drove superior commercial market changing technology and supply chain flexibility in a unique “ready-to-use” platform.
For this accomplishment, Cook Pharmica Bloomington is awarded the Equipment Innovation Category Winner.
- Engineer/Architect: IPS – Integrated Project Services, LLC
- Construction Manager: Cook Pharmica
- Construction Manager: Commissioning Agents, Inc.
- HVAC Subcontractor: Poytner Sheet Metal
- Major Equipment Suppliers/Contractors: Optima Group
- Process Engineer: Core-Reliance
- Civil/Architectural Contractor: Fox Construction
- Mechanical Contractor: HFI
- HVAC Automation Contractor: Thermo Systems
- Electrical Contractor: Cassady Electrical Contractors
- Modular/Clean Room Contractor: AES Clean Technologies, Inc.
- Equipment Move-in Contractor: Cardinal Contracting
- Roofing Contractor: Building Associates
- Flooring Contractor: Cornerstone Flooring
- Fabrication/Steel Setting Contractors: Wilhelm Construction
- Insulation Contractor: Gribbons Insulation
- Fire Protection Contractor: Ryan Fire Protection
- Telecommunications Contractor: Indiana Voice & Data