In industries like pharmaceuticals, biotech, electronics, or medical devices, the smallest of particles or uncontrolled air can spoil the product or even result in a penalty. Cleanrooms help sensitive manufacturing and scientific experiments to proceed without any contamination or safety issues. It's important to construct the cleanroom to suit a particular application at hand.
However, before the construction even begins, there is a question that most industries need to answer: “whether to build a turnkey cleanroom or a non-turnkey cleanroom?” What’s the difference between the two?
Let’s find that out in this article, as we explore what turnkey and non-turnkey cleanrooms are, their key differences, and which one is right for you.
Cleanrooms, also known as controlled environments, are expected to contain a very small quantity of dust, particles and microbes. They find application in medical device GMP production line, biological laboratory, vaccine workshop, food production workshop, semiconductor, electronic. Even minor traces of contaminants would have a probable impact; hence designing and building cleanrooms is so critical.
Cleanroom is not just a matter of ceilings and walls. The essential items and cleanroom supplies are:
Air Filtration Systems: High-Efficiency Particulate Air (HEPA) or Ultra-Low Penetration Air(ULPA) filters eliminate dust, microbes, and chemical particles from the air.
Monitoring Controls: To ensure that the room is clean, there are particle counters, pressure sensors, and air flow sensors to monitor things.
Cleanroom supplies: Special garments, gloves, masks and shoe covers are used to make sure that contamination is not transferred in and out of the cleanroom.
Materials: Walls, ceilings, floors, and surfaces are constructed with materials that can be cleaned and disinfected without any damage.
Additionally, cleanrooms must meet cleanroom certification guidelines. For example, the standards of pharmaceutical cleanrooms include the ISO 14644-1 or the FDA regulations for the safety and purity of products.
Now that we know what cleanrooms are and their important components, it’s time that we talk about their types.
A turnkey cleanroom is a comprehensive, ready-to-use system provided by one manufacturer. By doing that, you are guaranteed that one provider will handle everything related to the cleanroom project, including design and construction as well as installation and certification. It is similar to buying an entire product, rather than collecting the parts individually.
Turnkey providers are in charge of everything about the cleanroom, including:
Design: The airflow, layout, and equipment placement to meet requirements.
Materials and Equipment: Selection of walls, floors, ceilings, HVAC and monitoring equipment.
Construction and Installation: Cleanroom construction and installation of all systems.
Testing and Certification: Confirming that the cleanroom meets cleanroom certification standards and is ready for use.
Simplified Management: One firm undertakes the entire project, which helps simplify the task.
Time Efficiency: Experienced providers can complete projects within a comparatively shorter time due to smooth procedures.
Expert Knowledge: Providers are aware of the technical and regulatory requirements of industries like pharmaceuticals.
Reduced Risk: With single-provider responsibility, the risk of errors or delays is significantly lower.
Consistency: The design, materials and construction are done by the same team, leading to improved integration between systems.
Turnkey cleanrooms are ideal for:
Large-scale pharmaceutical cleanrooms where compliance is critical.
Complex research facilities where precise airflow and contamination is required.
Organizations that have low internal resources and prefer to rely on outside expertise.
A non-turnkey clean room implies that the client hires a number of contractors or vendors. The entire project is divided into multiple parts, e.g., design, construction, HVAC, electrical systems, and so on, which are handled independently. Although this strategy is more flexible, it also requires greater efforts, coordination and technical expertise.
Complex Project Management: Managing multiple vendors is a time-consuming job that needs attention and expertise.
Longer Timelines: Delays by a single contractor can affect the entire project.
Technical Expertise Required: You may need in-house engineers or consultants to ensure that all systems are fitted together properly.
Higher Risk: Due to multiple points of accountability, there is a higher risk of miscommunication and mistakes.
Non-turnkey solutions are often best for:
Smaller cleanrooms or simpler facilities with fewer systems.
Organizations that have their own technical teams to manage vendors.
Projects that need some very specific customization for research or manufacturing needs.
Turnkey and non-turnkey cleanroom construction differ mainly in project management, responsibility, and flexibility. Understanding these differences means your cleanroom project can meet both operational needs and regulatory standards efficiently.
|
Feature |
Turnkey Cleanroom |
Non-Turnkey Cleanroom |
|
Project Management |
Single provider manages everything |
Client manages multiple vendors |
|
Customization |
Limited to the provider’s offerings |
High, the client selects each component |
|
Completion Time |
Faster due to streamlined processes |
Longer due to coordination between different vendors |
|
Cost Control |
Predictable, often fixed |
Flexible but may include hidden costs |
|
Expertise Required |
Provider handles all technical needs |
Client must have or hire expertise |
|
Risk |
Lower, one point of accountability |
Higher, multiple vendors may cause delays |
The choice between turnkey and non-turnkey cleanroom is based on the size and complexity of your project, timeline, and available resources. Turnkey cleanroom solutions fit well into organizations where hassle-free solutions are desired, where speedy solutions are needed, and where compliance is a major issue.
Constructing a cleanroom is a big project and it must be planned accordingly. Turnkey cleanrooms offer an all-inclusive and hassle-free service fully handled by one vendor, which is of great use in large or complicated projects. Non-turnkey cleanrooms are more flexible and controllable as you choose individual components and suppliers, but they are more complex and challenging to operate.
Knowing the difference between turnkey and non-turnkey can guide you to select what fits your project requirements, budget, and schedule to provide a safe and most controlled environment for your projects.
If you are looking for state-of-the-art turnkey cleanrooms for your next big pharmaceutical project, don’t miss out the turnkey solutions by Suzhou Pharma.