Fast construction phase and shorter qualification processes will fast track your time to market.
At C-CUBE, we offer a complete turnkey solution which begins with process engineering, followed by facility design, through to construction, commissioning and finally cGMP qualification.
Our turnkey design/build solution leaves you with just a single-source responsibility for your project, while providing you both a fast-track scheduling and cost-effective solution.
Building a modular life science
facility is a fast
and sustainable option
Compared to traditional construction, 95% of the facility we create for your will be built off-site in a safe and controlled environment. Building our modules in a lean manufacturing environment reduces wastage, increases the quality of your product, and ensures the lead time is met. There is also no impact of external factors such as weather uncertainties. You will have peace of mind knowing that your product will be delivered on-time.
The remaining 5% of construction occurs on-site to interconnect the modules together and install side utilities, bringing together a fully operational facility. On-site work is minimal, limiting disruption to the surrounding environment in terms of noise and air pollution, as well as reducing safety risk exposure for workers.
Our objective at C-CUBE is to manufacture our solution for an industrial setup. To achieve this target, we ran a simplification and standardization exercise during the engineering of our concept. Our concept is based on three modules only with many common, interchangeable parts. Standardization helps reduce manufacture time, but it also simplifies the process of modifying a C-CUBE modular construction once completed.
Transportation is an important factor in modular solutions manufactured offsite. Transportation has been taken into account in the engineering of our modules. Their dimensions facilitate their transportation to anywhere in the world in accordance with sea and road freight regulations. Our manufacturing facility is based in a strategic location in Asia allowing us provide cGMP modular facilities at a fair price throughout both Asia and Europe. C-CUBE module transportability makes global deployment of our technology possible.
Modular construction helps speed up the qualification process
The Life Sciences industry is heavily regulated and pharmaceutical and biotech cleanroom environments must conform to stiff regulations so as to achieve a high level of success and sustainability. We know that Qualification and validation of a facility quite often takes a long time, increasing your time to market and possibly putting your sales figures at risk.
Applied Standards
Our modular concept conforms to EMA/FDA/SFDA/GMP regulatory requirements.
We can also adapt our concept to meet specific regulations that may be applicable in some countries.
Our module manufacturing is CE compliant, allowing us to sell our concept in Europe.
Clean areas comply with ISO 14644-1, guaranteeing you the requisite grade of cleanness, from ISO 5 to ISO 8 (Class B to D).
95% of your facility is built off-site in our safe and controlled environment following ISO standards.
This translates to logical and effective work procedures, enhanced quality of construction (ISO 9001), safety for our workforce (ISO 18001), and environmental management (ISO 14001).
Faster facility qualification
Based on our modular concept, your cGMP facility is based entirely upon the assembly of standard C-CUBE modules.
Once inspected by the applicable regulatory authority, a module will be no longer considered an unknown fabricated space. Rather, it will become very familiar to the regulator, leading to a significant reduction in inspection duration.
At our manufacturing site, your whole facility will pass the Factory Acceptance Test (FAT). In case of remarks or corrective measures being required by the auditor, these can be immediately addressed without impacting on the delivery schedule. Moreover, skilled technicians and a dedicated team of engineers are always available for immediate action at our manufacturing plant.
After the FAT comes the Installation Qualification (IQ) and the Operational Qualification (OQ). Building your facility off-site enables C-CUBE to perform a pre-IQ / OQ at our production unit prior to delivery of the modules to their final destination. This pre-qualification involves the C-CUBE team and will reduce the customer resource requirement for the final on-site IQ/OQ. The pre-qualification guarantees a quick and successful final on-site qualification.
Qualification simplified for the long life cycle of your facility
Our concept is designed for long term use and sustainability; it is part of a long-term life cycle strategy and initiative.
You have the opportunity to enlarge, relocate or repurpose the facility in-line with any new business requirements.
This will bring in a high and long return on your initial investment.
Each modification will require a new facility qualification.
However, as the entire construction had been operating prior to relocation/modification and was fully validated at the time, this will dramatically shorten the time required for the new IQ/OQ.
C-CUBE fast track modular concept emphasizes a critical qualification process, allowing an expedited availability of treatment for patients.
Discover the reasons why you should bring our modular concept into your business development strategy
We can provide modular Vaccine production units, Cell/Gene therapy units, BSL2 laboratories…
