Compliance Without Guesswork

‍How Laminar Supports FDA, FSMA, and BPE Requirements With Inline Spectroscopy

In regulated manufacturing, compliance means proving you did the right things every time, under real production conditions. That proof becomes difficult when your most critical moments happen inside a closed pipe where no one can observe them directly.

Consider what's actually at stake during fluid processing: clean-in-place endpoints, product changeovers, rinse completeness, chemical concentration, and potential cross-contact events. Small deviations in any of these areas can escalate into batch-level risks that affect food product quality and safety.  

Most plants still rely on timers, spot checks, and occasional lab tests, which means operators are often assuming the line is clean or the transition is complete rather than knowing with certainty.

Laminar exists to replace those assumptions with evidence.

Compliance Without Guesswork

Our inline spectral sensors continuously measure the UV/VIS/NIR fingerprint of whatever liquid is flowing through your piping, and our purpose-built ML models turn that real-time data into decisions your team can validate. When you're ready, those decisions can be automated through your PLC/SCADA system for closed-loop process control.

Below is how that approach connects directly to three compliance frameworks that food business operators and manufacturers care about:  

• FDA requirements for food manufacturing facilities

• FSMA compliance

• ASME BPE certification

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Keep reading for insights on how Laminar meets your compliance requirements.

‍Learn more about how Laminar works

FDA Requirements for Food Manufacturing Facilities: Moving from Assumptions to Verified Clean

FDA-regulated manufacturers across food and beverage, pharma-adjacent, and related industries operate under strict requirements for controlled processes, hygienic design, and defensible documentation.  

What Federal Regulations Require for Food Facility Sanitation

Under 21 CFR Part 117, the FDA's CGMP requirements explicitly address sanitary operations and cleaning/sanitizing practices designed to prevent contamination and allergen cross-contact in every food facility.

In practice, FDA expectations often converge on a few recurring questions.  

• Did you run the right cleaning cycle, and was it effective?  

• Did the line truly transition from product to rinse to chemical to rinse and back as intended?  

• If something drifted, how fast did you detect it and correct it?  

• Can you show objective evidence beyond a recipe timer that your process met spec?

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What Laminar Does Differently for FDA Compliance

Laminar makes the pipe itself measurable on a continuous basis.  

Our sensors collect UV/VIS/NIR spectra directly in your piping, creating distinct liquid signatures in real time with no grab samples required.  

During a training period that typically runs two to three weeks, we passively collect data from the spectral sensors and your PLC to build supervised models specific to your process and your food product characteristics.

Laminar ML models deploy first in evaluation mode, showing recommendations without triggering control, so your experts can validate performance before enabling closed-loop optimization. This approach aligns with FDA guidance for industry on process validation and verification.

Why Continuous Measurement Matters for Regulatory Compliance

When compliance teams audit a process, they look for repeatability, control, and documented evidence.  

Continuous inline measurement helps you replace timer-based assumptions with real-time confirmation of transitions and endpoints. You catch deviations immediately rather than discovering them after the fact in a lab result, and you build a stronger batch record that reflects what actually happened in the pipe.

This is where compliance transforms from a cost center into an operational advantage, delivering reduced rework, fewer audit surprises, and documentation trails that satisfy regulatory information requirements.

Food Safety Modernization Act Compliance: Prevention Through Real-Time Sanitation Data

The Food Safety Modernization Act shifted the U.S. food safety system toward prevention. The FDA describes this federal regulation as a transformation from reacting to foodborne illness toward preventing it before contamination occurs.  

Risk-based controls and sanitation verification sit at the center of the FSMA framework, requiring manufacturers to identify hazards, control them, and document that control under the Preventive Controls requirements anchored in 21 CFR Part 117.

Where Food Facilities Struggle with FSMA

FSMA compliance becomes operationally difficult when food facilities face frequent product changeovers, allergen complexity, high-care or sensitive quality environments, and legacy CIP recipes built around conservative time buffers designed for worst-case scenarios.

In those situations, manufacturers face a painful tradeoff.  

They can run longer cycles to stay safe, consuming excess water, chemicals, energy, and production time. Or they can run tighter cycles and accept uncertainty about whether they can prove they consistently hit endpoints. Neither approach serves the prevention focus that the Food Safety Modernization Act demands.

Learn more about Laminar Clean-in-Place Optimization

How Laminar Supports FSMA-Aligned Quality and Safety Outcomes

Laminar is built around real-time monitoring of product, rinse, and chemical transitions, which maps directly to the sanitation and cross-contact concerns that FSMA compliance elevates for every food business.

On the production floor, this translates to live process validation based on actual conditions rather than estimates. Laminar continuously validates fluid transitions and can trigger PLC actions to prevent CIP overwash and eliminate CIP underwash, helping teams control sanitation outcomes with spectral evidence rather than time-based buffers.

Instead of guessing when a rinse is complete, you use spectral confirmation of what's actually in the line. Because the measurement runs continuously, you can catch off-spec behavior quickly and respond before it escalates into a quality event requiring investigation.

Learn more about Clean-in-Place for Food & Beverage

Achieving Risk Prevention and Efficiency Together

The Modernization Act requires risk management without demanding resource waste. When you can measure risk-relevant transitions in real time, you can often tighten processes while improving your compliance defensibility simultaneously.  

Laminar deployments consistently achieve outcomes like 15% faster CIP cycles and 10–20% reductions in water, chemical, and energy use while maintaining or improving sanitation standards. Quality assurance teams gain precise batch records and greater visibility into their production schedule as well.

ASME BPE Standard: Verifying Fluid Processing Equipment Performance in Production

For pharmaceutical, biotech, and high-hygiene manufacturing environments, fluid processing equipment faces evaluation based on cleanability, materials, documentation, and hygienic design principles. These general requirements define what quality and safety mean for sensitive production environments.

General Requirements for Bioprocessing Equipment Certification

The ASME standard for bioprocessing equipment certification establishes adherence requirements for equipment used in bioprocessing, pharmaceutical, and personal-care industries where hygienic performance is critical.  

The bioprocessing equipment BPE standard has become the benchmark for facilities that cannot compromise on contamination control.

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How Laminar Fits Into BPE-Driven Environments

Laminar sensors are designed specifically for demanding fluid processing equipment applications like CIP optimization and product changeovers.  

Our sensors are non-contact, carry both 3-A and BPE sanitary certification, and deploy as an easy retrofit into standard sanitary process lines without major modifications.

We built our technology with pharma and biotech relevance as a priority. Laminar sensors support hygienic and cGMP-aligned practices in the most demanding bioprocessing equipment environments where regulatory scrutiny is highest.

Why the ASME BPE Standard Matters Beyond Certification

BPE-aligned design focuses on minimizing places where contamination can hide and making systems easier to clean, validate, and operate consistently over time. Selecting bioprocessing equipment that meets the ASME standard addresses hardware quality from the start.

Laminar's contribution ensures that once you've designed for hygienic operation, you can verify that performance continuously throughout production. You confirm that cleaning steps execute as intended, validate transitions and endpoints through spectral measurement rather than time alone, and generate process records that meet regulatory information requirements for audits and inspections.

The ASME BPE standard gets your equipment right. Laminar helps keep your process right on every shift.

Bringing It Together: Compliance Verification for Food Business Operations  

The common thread across FDA requirements for food manufacturing facilities, FSMA prevention mandates, and BPE hygienic standards comes down to one core need: demonstrable process control at the exact moment it matters.

Laminar's sense-tune-control approach addresses that need directly. Install our inline sensors in your fluid processing equipment, create liquid fingerprints in real time, validate model recommendations with your process experts, and automate with confidence once validation is complete.

Our customers across food and beverage, pharma, and CPG industries are achieving 15% or greater reductions in CIP cycle times, 20% faster changeovers, and 10–20% decreases in water, chemical, and energy consumption.

If you want to explore where continuous inline verification could tighten your CIP and changeover cycles without compromising your quality and safety standards, try our free CIP Savings Finder to estimate the opportunity for your food facility.