Selecting the right cleanroom design-build partner can be challenging. Every detail matters from the initial concept to post-installation support, and the wrong choice can lead to compliance risks, costly delays, and project overruns.
A strong partner does more than build walls and install filters. They bring a deep understanding of your industry’s standards, offer transparent communication throughout the project, and design solutions that perform reliably long after installation.
7 Questions To Ask Your Potential Cleanroom Design-Build Partner
Before you choose a partner, ask these seven key questions to ensure you get the expertise, transparency, and long-term support your cleanroom project deserves.
1. What Is Their Experience With Cleanroom Design-Build Projects Like Yours?
Experience matters — especially when designing and building controlled environments that meet strict regulatory standards. Every cleanroom project presents its own challenges, and your partner’s background will determine how effectively they can anticipate and solve them.
When evaluating potential partners, start by asking:
➤ What industries do you have experience in?
Each sector comes with unique contamination control, layout, and certification requirements, for example:
- Pharmaceuticals: Must meet USP 797/800, FDA, and cGMP standards for sterile compounding and drug manufacturing.
- Medical Devices: Require ISO Class 7–8 environments, process segregation, and traceability for product safety.
- Aerospace & Defense: Demand advanced particulate control, ESD-safe environments, and strict documentation.
- Electronics & Microelectronics: Ultra-low particulate levels and static control are needed to protect sensitive components.
- Research & Laboratories: Often require flexible configurations for evolving experiments and processes.
➤ What certifications and standards are they familiar with?
Look for experience designing and building with:
- ISO 14644-1 classifications (defining particle count levels)
- GMP / cGMP (Good Manufacturing Practices)
- USP 797 / 800 (pharmaceutical compounding)
- FDA and NIH guidelines, when applicable
Why This Matters:
Choosing a partner without the right experience can lead to:
- Costly design revisions mid-project
- Extended certification timelines
- Inadequate environmental control for your processes
📄 Explore the Angstrom Product Catalog to explore features that make each cleanroom project unique, including lighting, laminar flow hoods, air showers, HEPA filtration systems, and more.
2. Do They Handle Both Design and Construction In-House?
A top-notch cleanroom design-build partner manages every stage of your project under one roof — from concept drawings to final certification. This integrated approach keeps communication clear, reduces costly revisions, and ensures your cleanroom performs exactly as planned.
When evaluating potential partners, ask how much of their process is handled internally versus outsourced to third parties.
Working with a single, in-house team provides key advantages:
- Seamless Communication: Designers, engineers, and installers collaborate directly, reducing misalignment and misunderstandings.
- Faster Timelines: Overlapping phases (such as design and procurement) help accelerate project delivery without cutting corners.
- Cost Control: Fewer change orders and better coordination minimize budget surprises.
- Consistent Quality: The same team oversees design intent, material selection, and installation quality.
- Single Point of Accountability: One contact manages every stage, giving you confidence and clarity from start to finish.
The Risk of Outsourcing Key Phases:
Some “builders” subcontract major components like design, engineering, or installation. This can lead to:
- Gaps in accountability between multiple vendors
- Longer lead times and communication delays
- Mismatched materials or equipment specifications
- Increased risk of noncompliance or performance issues
At Angstrom Technology, we manage the entire cleanroom lifecycle — engineering, design, construction, validation, and beyond.
Our in-house teams collaborate closely from initial concept to post-installation support, ensuring your cleanroom is delivered on time, on budget, and ready for certification.
3. How Do They Ensure Regulatory Compliance and Quality Control?
Cleanroom compliance should be a part of every decision from the start. The best cleanroom design-build partner should consider regulatory standards, validate every system during installation, and provide documentation to prove compliance.
When evaluating potential partners, ask how they incorporate compliance and quality control throughout the entire project lifecycle.
Key Standards Your Partner Should Understand:
A mix of global and industry-specific regulations governs every cleanroom. Your partner should be fluent in the following:
- ISO: Defines air cleanliness classifications and testing requirements for airborne particles.
- GMP / cGMP: Ensures facilities follow consistent processes for quality and safety in manufacturing environments.
- USP: Establishes environmental and procedural standards for pharmaceutical compounding and hazardous drug handling.
- FDA Guidelines: Apply to facilities regulated for medical, research, or biomanufacturing purposes.
What to Ask Potential Partners:
To ensure your cleanroom meets every applicable standard, ask:
- Do you design and test to specific ISO and GMP classifications?
- How often do you conduct validation and certification testing?
- Can you provide sample documentation or third-party testing results?
- How do you ensure long-term compliance after installation?
A qualified cleanroom builder should be able to walk you through their testing protocols, certification procedures, and quality assurance processes in detail — not just make general promises of compliance.
4. How Collaborative and Transparent Is Their Design Process?
When evaluating a potential partner, look for one that offers a straightforward, step-by-step process with open communication and visibility from concept through certification. You should never be left wondering what stage your project is in or what comes next.
What to Look for in a Collaborative Design-Build Process:
- Discovery-Focused: Your partner should begin by learning about your processes, contamination control requirements, and regulatory obligations.
- Transparent Planning: Expect detailed project timelines, clear communication channels, and a shared understanding of milestones.
- Cross-Functional Input: Engineers, designers, and field teams should work together (not in silos) to ensure your design aligns with real-world installation needs.
- Continuous Access: You should have direct contact with your project manager and visibility into every phase of progress.
Angstrom’s Four-Phase Customer Engagement Process:
At Angstrom Technology, we follow a structured process designed to keep clients informed and involved at every step:
- Introduction & Discovery—We take the time to understand your goals, operational flow, and regulatory requirements to develop the right cleanroom solution.
- Planning & Execution – Our experienced design engineers collaborate with sales and field operations teams to create layouts tailored to your space, standards, and budget.
- Construction & Certification – Our field team conducts a site visit before work begins to identify potential challenges early on. You’ll have direct access to your project manager, engineers, and installation crew throughout construction.
- Training & Service – Once your cleanroom is certified, we provide employee training on proper use, maintenance, and certification best practices to ensure long-term performance.
5. What Type of Cleanroom and Wall System Is Right for Your Application?
Not all cleanrooms are built the same; your industry, product type, and regulatory requirements will determine which type of cleanroom is right for you.
When evaluating potential partners, ask whether they can tailor the design to your unique application — not just sell you a one-size-fits-all system.
Angstrom’s Four Cleanroom Wall Systems
As a trusted cleanroom builder, Angstrom Technology designs and constructs modular systems that meet a wide range of environmental and performance needs:
| Cleanroom Type: | Key Features: | Best For: |
| Softwall Cleanrooms | Flexible, affordable, and easy to expand or relocate. | Temporary or adaptable spaces where mobility and cost-efficiency matter. |
| Hardwall Cleanrooms | Durable, rigid panels with full modular customization. | Long-term, high-performance environments requiring ISO Class 5–8 control. |
| Rigidwall Cleanrooms | Sleek, transparent walls for visibility and aesthetics. | Labs and manufacturing areas where visibility and cleanliness are priorities. |
| Seamless Wall Solutions | Continuous, joint-free surfaces for easy cleaning and sterilization. | Sterile and high-containment facilities that must comply with USP 797/800. |
Why It Matters:
The right cleanroom wall system can:
- Improve long-term performance and durability
- Support future expansion or reconfiguration
- Simplify cleaning and maintenance routines
- Ensure compliance with ISO, GMP, and USP standards
Your cleanroom design-build partner should explain each option and help you determine which system best meets your budget, standards, and long-term goals.
6. What Support Do They Offer After Installation?
Your cleanroom’s performance doesn’t end when construction does. Ongoing maintenance is essential to keeping your controlled environment compliant, efficient, and safe.
A reliable cleanroom design-build partner should offer comprehensive post-installation services that protect your investment for years to come.
When evaluating potential partners, ask what type of support and service agreements they provide after installation, and how they ensure your cleanroom continues to meet standards over time.
Key Areas of Post-Installation Support to Ask About:
- Routine Maintenance: Regular inspections and filter replacements to maintain air quality and pressure control.
- Performance Monitoring: Continuous environmental data tracking for temperature, humidity, and particulate levels.
- Repairs & Upgrades: Rapid service for any system failures or efficiency improvements.
- Training & Documentation: Guidance for your team on cleaning procedures, equipment maintenance, and certification protocols.
Why Future Flexibility Matters:
Your operational needs may evolve, and your cleanroom should grow with them.
When choosing a partner, look for one that can:
- Expand or reconfigure your cleanroom as production increases
- Integrate new technologies or systems into existing layouts
- Minimize downtime during maintenance or expansion work
This flexibility ensures your cleanroom continues to serve your business as it grows.
Angstrom’s Lifecycle Partnership Approach:
At Angstrom Technology, our relationship with clients extends far beyond installation. We provide a complete range of lifecycle services, including:
- Scheduled maintenance and validation programs
- Filter and equipment replacements
- On-site service and emergency response
- Cleanroom expansion and modernization
- Staff training for ongoing compliance
By offering continued partnership, we ensure your cleanroom remains efficient, compliant, and adaptable — ready to meet current and future demands.
7. Can They Provide References or Case Studies?
When choosing a cleanroom design-build partner, a reputable company should be able to provide client references, success stories, or detailed case studies that demonstrate their expertise, reliability, and ability to deliver high-performing cleanrooms across industries.
As you evaluate potential partners, ask to see examples of recent work that reflect your specific application or regulatory needs. The best partners will be transparent about their experience and eager to share how they’ve helped clients overcome complex challenges.
Why References and Case Studies Are Important:
- Validate Experience: Real-world projects prove your partner can handle similar scale, complexity, and regulatory requirements.
- Show Proven Results: Case studies reveal measurable outcomes, such as faster installation times, higher performance ratings, or successful validations.
- Demonstrate Transparency: Partners who readily share references show confidence in their quality and client satisfaction.
Explore Angstrom’s Cleanroom Case Studies:
At Angstrom Technology, we’re proud to showcase a diverse portfolio of completed cleanrooms across industries and applications, including:
| Industry / Application: | Project Example: |
| Battery Manufacturing | Li-Ion Battery Dry Room |
| Pharmaceuticals | National Compounding Pharmacy Cleanroom |
| Biopharma | Cleanroom for Manufacturing Mixer Bags, Flow Kits, and Tubing Assembly |
| Medical Devices & Plastics | Medical Molding and Packaging Cleanroom |
| Research & Development | Biopharmaceutical R&D Cleanroom |
| Electric Vehicle Production | EV Battery Production Cleanroom |
| Cell & Gene Therapy | BioCube Cell & Gene Therapy Cleanroom Suite |
| Advanced Manufacturing | Broad Institute Robotic Enclosure |
Each project reflects Angstrom’s commitment to precision engineering, regulatory compliance, and long-term performance.
A Word from an Angstrom Client:
“Angstrom’s team was with us from design through certification — anticipating challenges before they became issues. The result was a cleanroom that met every spec, stayed on schedule, and passed inspection the first time.” — Director of Manufacturing
Partner with Angstrom Technology — The Cleanroom Experts You Can Trust
At Angstrom Technology, we combine decades of experience with full-service capabilities. Our collaborative approach ensures your cleanroom meets today’s standards and remains compliant, efficient, and adaptable for years to come.
Whether you’re developing a new facility or expanding an existing one, our team is ready to help you design and build a space that achieves your operational, safety, and compliance goals.
Ready to start your cleanroom project?
Contact Angstrom Technology to discuss your vision with our expert team today!
