10 Key Questions When Choosing a Modular Cleanroom Design Partner (Part 1)

16:08 - 15/08/2025 251

In the development of advanced pharmaceutical therapies, the design, construction, and installation of cleanrooms play a critical role in ensuring a controlled, hygienic, and safe environment.

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Understanding the difference between cleanroom certification and cleanroom validation.

☰ Table of Contents

10 Key Questions When Choosing a Modular Cleanroom Design Partner (Part 1)
1. Can the partner meet the project’s specific requirements?
2. Does the supplier have the capability to deliver the project?
3. How flexible is the supplier?
4. What strategies does the supplier use to accelerate the project schedule?
5. How does the supplier ensure quality?
Part 1 summary

10 Key Questions When Choosing a Modular Cleanroom Design Partner (Part 1)

In the development of advanced pharmaceutical therapies, the design, development, and installation of cleanrooms play a critical role in ensuring a controlled, hygienic, and safe environment. The right partner not only helps deliver compliant clean equipment and facilities, but can also shorten the time needed to bring therapies to patients. Therefore, evaluating a supplier’s capability, expertise, and delivery strategy is essential. [web:32]

The first part of the “10 questions to ask” series covers the five key topics below to help you determine whether a supplier can meet your project needs:

1. Can the partner meet the project’s specific requirements?

The supplier should have hands-on experience with similar projects in scale, application type, and location.
They should provide references, project examples, and the ability to support a factory visit, enabling clear discussions around user requirements, scope of work, materials, and execution approach.

2. Does the supplier have the capability to deliver the project?

Because cleanroom projects require significant investment, you should closely review financial stability and execution capability to ensure schedules and commitments can be met. [web:32]

3. How flexible is the supplier?

Cleanroom design should be flexible enough to adapt to changes during design, manufacturing, and installation.
Prefabricated modular solutions (prefabrication) make it easier to accommodate changes such as process updates, schedule shifts, or late-arriving equipment—helping minimize downtime. [web:32]
At the same time, the ability to customize to requirements helps protect schedule and cost, while ensuring the cleanroom can adapt to organization-specific needs (e.g., pharmaceuticals, biotechnology).

4. What strategies does the supplier use to accelerate the project schedule?

Prefabricated cleanroom solutions assembled during on-site installation help reduce construction time and accelerate commissioning compared with traditional construction methods.
Standardized modular designs allow teams to start execution without redesign, accelerating both delivery and qualification/testing (aesclean.com). [web:32]

5. How does the supplier ensure quality?

Cleanroom components—especially operational components—should be manufactured using high-quality materials.
Modular solutions help deliver a cleanroom environment that is stable, repeatable, and consistently high quality for manufacturing. [web:32]
A supplier with an integrated commissioning plan can help verify quality and document the full process from installation through operational testing—while also reducing future validation time (aesclean.com). [web:32]

Addressing investor questions – Finding the right partner – Long-term growth

Choosing a modular cleanroom supplier requires careful evaluation across key criteria: practical experience, financial capability, flexibility, delivery speed, and quality assurance. The next section (Part 2) will continue with the remaining five questions to help you make a more confident partnership decision.