The complete guide to turnkey cleanroom installation

The worlds of research, services, and manufacturing across industries like the life sciences, electronics, and automotives have become overwhelmingly complex today. Fortunately, infrastructure development in these industries has also evolved to keep up with this complexity.

Specifically, in industries that require controlled environments, turnkey cleanrooms have become the go-to solution. Be it biopharma research, semiconductor manufacturing, data centres, or any other industrial application that requires stringent environmental control, turnkey cleanroom solutions have been a boon like no other.

So, what exactly is a turnkey cleanroom? How is it different from its non-turnkey counterparts? How does turnkey cleanroom cost compare to its alternatives? And how can you go about installing one for your project?

This two-part blog series is just the primer you need to understand all things turnkey cleanroom. From understanding what turnkey cleanroom manufacturers offer to the process of installing one for your project, come along for a look at the entire process.

What are turnkey cleanrooms? What is turnkey cleanroom installation?

Turnkey cleanroom installation is a comprehensive solution for your controlled environment needs. Handled entirely by a single provider, this end-to-end service encompasses everything from design and engineering to procurement, installation, validation, and everything in between. Walls, flooring, equipment, HVAC systems, fabrication, assembly, staff training, ongoing maintenance… think anything related to your cleanroom and your turnkey cleanroom manufacturer should be able to take care of it for you.

Turnkey cleanroom manufacturers take full responsibility and single-point accountability for the entire project lifecycle. For you, as a client, turnkey cleanroom solutions offer a hands-off approach of sorts, giving you the time and energy to focus on your core operations while leaving the nitty-gritties of your cleanroom to the experts.

Hire a turnkey cleanroom manufacturer, and once they’ve understood your plans, budgets and other needs and constraints, you can expect them to deliver a ready-to-use controlled environment for whatever your industry may be. From a project management, budget management and compliance perspective, opting for a turnkey cleanroom is often one of the best decisions you can make.

Non-turnkey or turnkey cleanroom solutions? Making the right choice

Whether a non-turnkey solution is better for you than a turnkey solution depends on your budget, project complexity, and internal capacity.

Opting for a non-turnkey cleanroom solution means that you have to manage multiple vendors and contracts, each of whom is responsible for different aspects of the overall cleanroom construction process. Think separate contractors for HVAC systems, electrical work, architectural design, cleanroom panels, validation, annual maintenance, etc.

The benefits of this? Greater control, more customisation, and more flexibility in how you approach cleanroom design and construction. You can choose the systems and components that are best suited to your unique project needs and budget. You can mix and match offerings from different vendors to tailor your cleanroom to your exact specifications. You could, potentially, also have greater control over costs by negotiating individual contracts.

The downsides of a non-turnkey solution? You have to do it all. Expect a potentially overwhelming amount of hands-on management and project coordination. That’s a significant investment of time, effort, and expertise. If one vendor causes a delay or makes an error, that may have a ripple effect on the work of other contractors, disrupting your entire schedule and budget. Most importantly, you’ll have to have an internal team of technical experts who can ensure your cleanroom is integrated right and functions perfectly.

So, while non-turnkey cleanrooms may have some benefits, on the whole, the ordeal is most often not worth the effort, time, resources, and risk involved.

Turnkey cleanroom solutions, on the other hand, allow you to entrust the entire cleanroom setup process to a single provider. From design to engineering, fabrication to installation, commissioning to validation, turnkey cleanroom manufacturers offer a comprehensive approach that benefits you with convenience and efficiency.

So, the choice is yours. But it depends on many, many factors. Project budget, timeline, scope, complexity, and the internal resources you have available for coordination and management.

Why do most industry players prefer turnkey cleanroom solutions?

We won’t lie: most businesses that require cleanrooms today prefer turnkey solutions because of the multiple benefits they offer. Turnkey cleanrooms not only minimise your involvement as a client, but they also speed up and streamline deployment through integrated management. This is more than just a sense of ease around your project; partnering up with a turnkey cleanroom provider shows tangible benefits in terms of cost, time, and compliance.

Streamlined project management. Turnkey cleanroom solutions offer you a single point of contact for project management, making communication and coordination far easier than it would have otherwise been. This means a lower administrative burden on your internal teams, lower internal costs, and fewer risks of miscommunication and misalignment.

Expertise and accountability. Turnkey cleanroom manufacturers are specially equipped with knowledge and experience of all things cleanroom related. Design, construction, equipment, validation, compliance, maintenance, and more. This expertise, combined with the accountability that comes from a dedicated partner, makes it easier for you to meet stringent industry standards and regulatory requirements. You can rest assured that your turnkey cleanroom manufacturer is shouldering the responsibility of your project’s successful completion.

Efficiencies of cost and time. Since turnkey cleanroom manufacturers work on multiple projects and deal in all the diverse elements that go into making a cleanroom, they are often able to leverage economies of scale and make the most of established SOPs to speed up procurement, optimise costs, and accelerate the overall turnkey cleanroom installation process. Compared to you singlehandedly managing multiple contractors and vendors, partnering up with a turnkey cleanroom manufacturer can result in significant time and cost savings.

Risk management. Assigning consolidated responsibility for your entire cleanroom project with a single provider can help you mitigate risks by minimising miscommunication, errors, delays, and other contingencies that may come in the way of the successful installation and operation of your cleanroom.

So, there you have it: a quick insight into what turnkey cleanrooms are about. But if you want to deploy one for your project, you need to be familiar with a few more concepts and stages involved. That’s exactly what we’re going to explore in the next part of this blog post: the stages involved in turnkey cleanroom planning and installation, plus all the cleanroom elements you should be familiar with to ensure your controlled space, turnkey or not, meets rigorous compliance standards and industry demands.

Cleanrooms have diverse applications across industries. For fast-moving consumer goods, cleanrooms are necessary for manufacturing powders, consumables, and for hygienic packaging. In the biopharmaceutical industry, cleanrooms are indispensable in aseptic processing, compounding, drug formulation, and other sterile processes. They offer a space for dust-free production of semiconductors and electronics. They are useful for EV battery assembly and electronics integration in the automotive industry. They are necessary for biotech manufacturing. And in the world of diagnostics, healthcare services, and research and development, they offer critical controlled environments for sterile protocols.

For all these industries and applications, turnkey cleanroom solutions are a gift.

But for each of these industries and applications, the right turnkey cleanroom solution will be unique, tailored to each use case’s specific context and requirements.

When you go the turnkey route, you’re outsourcing a large part of the coordination and communication to an external turnkey cleanroom manufacturer. This means that you won’t be handling every small aspect of fabrication and installation, but there is still a lot you will have to do, or at least oversee. So, it’s best that before you jump into the process, you have an idea of the stages involved in the entire project.

The key stages of a turnkey cleanroom project

Here is an overview of the main steps typically involved in getting a turnkey cleanroom project started and seeing it through to completion. Depending on your project specifics and the approach of your turnkey cleanroom manufacturer, there may be some changes – alterations or additions – to these stages, but on the whole, they represent the typical journey from the conception stage all the way to operations.

Stage 1: Discovery, consultation, and design. This stage involves sitting down with your turnkey cleanroom manufacturer to define your objectives, processes, and design layouts. This will help your turnkey partner understand your needs, workflow requirements, required ISO standards, HVAC (heating, ventilation, and air conditioning), and MEP (mechanical, electric, and plumbing) systems.

This step is critical as it sets the stage for the entire rest of the process. It is imperative that you assess and communicate your needs accurately and clearly so as to avoid any mismatch in your expectations and the cleanroom project that is delivered to you.

Stage 2: Engineering and layout planning. After you lay down your general requirements and expectations, you and your turnkey partner can get down to the technicalities. This covers engineering and layout planning, including structural plans, utility routing, airflow schematics, and HVAC load calculations.

Stage 3: Manufacturing, prefabrication, and procurement. Since your turnkey cleanroom manufacturer is single-handedly responsible for executing the entire project, they will also take charge of manufacturing, procuring or fabricating the components required for cleanroom assembly. This includes panels, doors, air handling units, air filters, electric gear, and anything else required to get your cleanroom up and running.

Stage 4: Site preparation and cleanroom installation. Once the modular components of your cleanroom are manufactured, your cleanroom partner will prepare your project site and install the physical structures of the space, your HVAC systems, vinyl or epoxy flooring, lighting, and accessories like pass boxes. If you’re opting for a modular or prefabricated cleanroom, this stage will typically take less time and labour than it would for a stick-built cleanroom.

Step 5: Commissioning, validation, and documentation. This stage is critical from a safety and regulatory perspective. It will involve testing your systems – temperature, humidity, pressure, airflow, etc. – and validating their performance against standards like GMP and ISO 14644. This stage also encompasses IQ, OQ, and PQ (installation qualification, operation qualification, and performance qualification), designed as quality assurance protocols for each phase of the facility setup and manufacturing processes.

Step 6: Ongoing maintenance and support. Once commissioning and validation are completed, your turnkey cleanroom is ready for operations. But the job of your turnkey cleanroom manufacturer doesn’t end there. The right cleanroom partner will help you with staff training, O&M manuals, ongoing maintenance, cleanroom consumables and the like. They will be involved, in some form or the other, through the entire lifecycle of your turnkey cleanroom project.

These stages are key to the success of your turnkey cleanroom solution. In addition to understanding these steps, it also helps to be familiar with all the different elements of cleanroom design, HVAC, and MEP to able to effectively monitor and operate your turnkey cleanroom.

The key elements of turnkey cleanroom design

Here are some of the technical elements of turnkey cleanroom design that are imperative for you to understand.

Unidirectional flow. Unidirectional or linear flow is the basis of a well-engineered cleanroom layout. It ensures that clean and unclean zones of your cleanroom never overlap by determining the pathways taken by raw materials, personnel, waste, and final products. This layout flow design helps you prevent cross-contamination, aligning with the expectations of GMP and ISO standards.

Zoning. Each cleanroom is divided into different zones. Each of these zones must align with the requirements of its specified class i.e. ISO Class 5 to 8 or Grade A to D. The most important element in maintaining the integrity of each of these zones is maintaining appropriate pressure differentials. Cleaner zones must have positive pressure so that contaminated air from other zones doesn’t infiltrate these critical areas. Additionally, you will have to rely on controlled gradients to ensure the safe movement of personnel and materials.

HVAC. At the heart of your cleanroom operations, your HVAC system is necessary for maintaining the right air cleanliness levels, humidity, temperature, and pressure differentials in your facility. It is the foundation that supports your controlled environment as a good HVAC system allows you to control diverse environmental parameters.

High-quality HVAC systems use HEPA (High-Efficiency Particulate Air) or ULPA (Ultra-Low Penetration Air) filters to achieve the required cleanliness levels. They offer laminar or turbulent airflow patterns, as required for your process. For instance, aseptic zones need a smooth laminar flow from ceiling to floor, while less critical areas use turbulent flow to ensure efficient air mixing.

Temperature and pressure control. Maintaining the integrity of your cleanroom system requires you to monitor environmental parameters in real time, log data consistently, and maintain optimal conditions using automated systems. Advanced building management systems (BMS) or SCADA platforms are ideal for this.

Sustainability. Prioritising sustainability is important not only from an environmental perspective but also from a financial perspective. When it comes to your turnkey cleanroom solution, sustainability means energy-efficient air handling units (AHU)s, variable frequency drives (VFDs) to optimise energy consumption, and heat recovery systems to prevent energy loss.

MEP. Your mechanical, electrical, and plumbing (MEP) systems must follow some basic standards and requirements. Your mechanical systems must be GMP-compliant, made using electropolished piping and a high-grade construction material like SS316L. These systems must run through service corridors or other technical spaces to ensure easy maintenance and expansion when needed.

Your electrical systems must be compliant with IEC, IS, or NFPA standards, with dedicated circuits for emergency backup, HVAC and process equipment.

Your cleanroom’s plumbing and drainage systems must be engineered for three main factors: resistance to corrosion, hygienic flow, and ease of sterilisation. You must also have effluent management systems, specialised drains, air gaps, and the like to handle waste and contaminated air safely.

A final word.

At the end of the day, turnkey cleanroom installation is a massive undertaking, best left to the experts. From layout design and engineering to automation, integration, fire protection, MEP, compliance, sustainability, and more, there’s just so much to do and consequently, so much scope for error.

To ensure safe, efficient, and compliant cleanrooms for your operations, it’s best to partner up with a turnkey cleanroom manufacturer who can take the load of cleanroom installation off your back so that you can focus on other, more strategic parts of your business.

We, at PodTech™, offer turnkey cleanroom solutions for your controlled environment needs across industries. Reach out to our expert team today to get talking on how we can solve for you.