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You want capacity and cost back without sacrificing quality

Your team is under pressure to add throughput, hit launch dates, and hold the line on cost. For non-sterile builds, the fastest lever is environmental right-sizing. A controlled white room preserves the discipline that influences yield and product performance. It removes classification overhead that slows changeovers and inflates unit cost. If the device does not require sterile manufacture at this stage, a white room lets you bank savings and free cleanroom hours for work that requires them.

medical white room for kitting and assembly

What a white room means for your day-to-day

You still operate within ISO 13485. You still train and certify operators to current work instructions. You still maintain complete device history records and lot traceability. The difference is everything that steals minutes and dollars without improving outcomes for non-sterile work: complex gowning, staged material transfers, heavier environmental monitoring, longer room turnovers, and higher energy use. In a white room, you reduce those burdens. Operators spend more time adding value, schedulers spend less time managing room gates, and your lines run closer to planned cycle time.

Quality will ask the right questions. Here’s how to answer them

Your Quality partners need to see risk alignment, not shortcuts. Choosing a white room is a risk-based decision that the product, its intended use, and your controls do not require a classified cleanroom. You can show that:

Your facility is registered with the U.S. Food and Drug Administration (FDA).
Your quality management system is certified to ISO 13485:2016 across environments.
Your risk file documents why particulate control and housekeeping are adequate for the device.
Your validation plan includes installation, operational, and performance qualification in the white room with acceptance criteria tied to device performance.
Supplier controls, incoming inspection, and corrective and preventive actions are unchanged.

These are the same expectations you already meet. You’re right-sizing the environment without lowering quality standards.

Where a white room fits in your portfolio

You may have products in a cleanroom due to habit or proximity to sterile work, not a documented need. Strong candidates for a white room include:

Non-sterile accessories or disposables that will be sterilized downstream after final packaging.
Electromechanical subassemblies that never require sterility but benefit from controlled handling.
Diagnostic disposables where particulate control matters, but formal classification does not change clinical value.
Kitting operations that combine sterile-barrier packaged items with non-sterile components into a finished non-sterile kit.

If you recognize your products here, you have an opportunity. The move can shorten changeovers, reduce idle time, and lighten material flow without changing your product specification.

Your cost and time impact, explained simply

A typical 15 to 25 percent reduction in fully loaded cost and lead time comes from visible and hidden overhead you stop carrying for non-sterile work. You reduce gowning time per operator per shift. You shorten room turnovers between items. You simplify material transfers that used to route through airlocks or staging. You reduce monitoring and filter replacement tied to tight classification requirements. Energy use decreases. Together, those minutes and dollars add up, especially in high-mix, small-lot environments where you feel every changeover.

Two notes matter. First, the savings range is a typical outcome, not a promise. Your results depend on lot size, bill of materials complexity, inspection sampling, and your current baseline. Second, the benefit compounds because freeing cleanroom time relieves another bottleneck. Your sterile work moves more smoothly when it no longer competes with non-sterile items for the same space.

A decision framework you can run this week

Make progress with a quick, documented assessment led by Operations and Quality.

Confirm intended use and sterilization plan

Note whether sterility is required during assembly. If sterilization occurs later, capture the method and downstream provider. For non-sterile builds, proceed to the next steps.

Identify critical control points

List steps where contamination could affect safety or performance. Many of those controls are procedural, inspection-based, or tied to equipment qualification. Flag any that require classification.

Assess materials and interfaces

Review your bill of materials for materials sensitive to particulate or electrostatic discharge. A white room typically handles these needs well. If the material is tolerant and sealed shortly after assembly, classification adds cost without measurable protection.

Run a process failure modes and effects analysis

Score severity, occurrence, and detection. Document whether the environment reduces occurrence or improves detection. If the impact is limited or zero, you likely have a white room fit.

Validate the process in the chosen environment

Create installation, operational, and performance qualification specific to the white room controls. Define objective acceptance criteria. If the pilot meets them, lock it in.

Assembly and kitting: what changes and what does not

What does not change for you:

ISO 13485 documentation control and device history record completeness.
Operator training, certification, and periodic competency verification.
Lot traceability, label control, and device identification discipline.
Equipment qualification and maintenance records.
Corrective and preventive action handling and internal audit cadence.

What changes for the better:

Gowning complexity drops, so lines start and restart faster.
Environmental monitoring is right-sized for non-sterile work.
Changeovers shrink, so your schedule flexes more easily.
Material movement simplifies, reducing touches and waiting.
Energy and consumable costs decrease, improving unit economics.

In assembly, you’ll see balanced workstations and steadier cycle time. In kitting, you’ll see smoother pick and pack cycles and fewer pauses at room gates.

A quick illustration you can use internally

Imagine a non-sterile diagnostic accessory assembled from five components, labeled, and packed for downstream sterilization. In your cleanroom, average cycle time is 65 seconds with 5 percent scrap, and you lose changeover time twice per shift to adjacent sterile production. In a white room pilot with identical work instructions, inspections, and label controls, you validate a 60second cycle time and 4 percent scrap. That delta yields more units per shift and lower cost without changing the specification or the quality management system. Use a pilot like this to align your team.

Common objections you’ll hear, and how to address them

“Regulators expect a cleanroom.” Regulators expect risk alignment and evidence. For non-sterile devices and subassemblies, a validated white room process within ISO 13485 and an FDA-registered facility is appropriate when your risk file supports it.

“Particulate and bioburden will increase.” Your white room has defined housekeeping, material controls, and in-process inspections. You confirm outcomes during operational and performance qualification. Let the data answer this.

“Our cleanroom plan is set. Moving will disrupt production.” Start with one product in parallel. A limited pilot gives you data fast. Once validated, moving the right products relieves cleanroom pressure and improves the whole plan.

“Quality will not sign off.” Bring Quality in at the risk analysis stage. Agree on acceptance criteria up front. When the pilot meets the criteria, you have the basis for approval.

White room vs cleanroom at a glance

Category	White room (controlled, non-sterile)	Cleanroom (classified)
Primary fit	Non-sterile devices and subassemblies	Sterile-sensitive processes
Quality management system rigor	ISO 13485 controls identical	ISO 13485 controls identical
Facility status	FDA-registered facility	FDA-registered facility
Environmental controls	Particulate and housekeeping discipline	Classified HVAC and monitoring
Gowning and turnover	Faster and lower overhead	Slower and higher overhead
Changeover time	Shorter	Longer
Material transfers	Simplified	Staged and gated
Energy and consumables	Lower	Higher
Throughput impact	Higher for high-mix small-lot	Constrained by classification
Cost and lead time	Typically 15–25 percent lower	Higher for non-sterile builds
Best use cases	Assembly and kitting without sterility need	Sterile assembly and packaging

White Room Fit Checklist

Use this to screen candidates before you invest engineering time.

The build does not require sterile manufacture at this stage.
Sterilization, if needed, occurs downstream after final packaging.
Process failure modes and effects analysis shows classification has limited impact on risk reduction.
Particulate control and housekeeping meet acceptance criteria without classification.
Materials are tolerant of controlled non-sterile handling.
In-process inspections and functional tests are the primary quality controls.
Kitting combines sterile-barrier packs with non-sterile items into a non-sterile kit.
Prior device history records show stable yields and low defect rates on similar work.
Faster changeovers would help you smooth scheduling and reduce overtime.
Supply chain benefits from fewer room gates and simpler transfers.

KPIs you can track to prove the case

Your committee will be influenced by evidence. Plan to track:

Cycle time, changeover time, and schedule adherence.
First pass yield, scrap rate, and defects per million opportunities.
Operator utilization and value-add time.
Environmental monitoring results required for the white room.
Energy consumption per unit, gowning and consumable spend.
On-time delivery and backlog trend after migration.

Your migration playbook, step by step

Select a pilot product

Choose a stable, non-sterile product with a clean device history record and manageable bill of materials complexity. Confirm demand for a short pilot run that gives statistically meaningful data.

Run a gap assessment

Compare current work instructions and controls to the proposed white room controls. Document rationale for any differences and update the risk file.

Validate the process

Complete installation, operational, and performance qualification in the white room. Perform a repeatability and reproducibility study where measurement methods could be environment sensitive. Define acceptance limits with Quality.

Train and certify

Refresh operator training for the revised material flow and housekeeping routines. Update training records. Treat audit readiness as the goal.

Execute a limited production pilot

Collect cycle time, scrap, rework, inspection outcomes, and downtime causes. Compare to cleanroom baselines. Share early results with your team.

Review, decide, and release

If the pilot meets acceptance criteria and improves cost and time, issue the change and move to sustained production. Plan a postrelease audit to confirm stability.

Scale out

Apply the same method to adjacent products with similar profiles. Protect your cleanroom for work that requires it and continue to bank savings.

What to look for in a partner, and what you can expect from MDI

You need a partner that will not ask you to trade quality for speed or cost. Look for:

ISO 13485:2016 certification that covers white room and general assembly environments.
An FDA-registered facility with mature document control at the point of use.
Clear go/nogo criteria for white room fit versus cleanroom requirement.
Strong line design skills for highmix, smalllot work.
Transparent metrics for yield, changeover times, and corrective and preventive action closure.
Sterilization coordination with approved providers when you need it downstream.

MDI operates under ISO 13485:2016 in an FDA-registered facility. For non-sterile assembly and kitting, we validate lines in controlled white rooms that right-size environmental controls without changing your quality management system rigor. When sterilization is in scope later, we coordinate with approved providers and manage labeling and chain of custody to your specifications. The result is a shorter path to stable production for the products that do not benefit from cleanroom classification.

What you will see on a site tour

When you walk the floor, you’ll see controlled white rooms designed for smalllot, highmix builds. You’ll watch operators accessing the latest work instructions at the workstation. You’ll see pick locations and kitting cells that keep material flow simple. You’ll review cycle time and changeover metrics, and you’ll follow the path from incoming inspection to finished goods release. You’ll also see how we keep white room work separate from classified operations and how we decide together which products belong where.

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Conclusion

If your device or subassembly does not require sterile manufacture, a controlled white room gives you the same quality outcomes at lower cost and shorter lead time. You keep ISO 13485 rigor in an FDA-registered facility, and you remove overhead that does not add value for non-sterile work. That’s why leading OEMs are shifting select products out of cleanrooms. You can do the same, prove it with a pilot, and put capacity and dollars back into your plan.

FAQ

Will regulators accept white room assembly for my device?

Yes, when your risk file supports it. Regulators expect documented controls aligned to risk and intended use. For non-sterile devices and subassemblies, a validated white room process inside an ISO 13485 quality management system at an FDAregistered facility is appropriate.

How much cost and lead time can I save?

For qualifying products, you can typically reduce fully loaded cost and lead time by about 15 to 25 percent compared to cleanroom builds. Your result depends on bill of materials complexity, lot sizes, and inspection plans. Validate with a limited production pilot.

Which products should I evaluate first?

Start with non-sterile assemblies, diagnostic accessories, electromechanical subassemblies, and kitting where sterile barriers are applied downstream. These usually benefit most from right-sizing.

Does my quality management system change if I move into a white room?

No. ISO 13485 documentation, training, validation, and traceability remain the same. You adjust environmental and housekeeping controls to fit non-sterile work.

Can you coordinate sterilization if I need it later?

Yes. Sterilization is coordinated with approved providers. The build remains non-sterile. Labeling, chain of custody, and timing are managed to your specifications.

How do I start without risking my schedule?

Select one product, agree on acceptance criteria, run installation, operational, and performance qualification in the white room, then execute a short pilot. Compare cycle time, yield, and defects to your cleanroom baseline. If the data meets the criteria, release and scale.

Why Leading OEMs Are Choosing White Room Over Cleanroom for Certain Devices