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CLEANROOM INSURANCE THAT KEEPS CONTAMINATION RISK UNDER CONTROL
Why Cleanroom / Ultra-Clean Facility Insurance Matters
In contamination-critical industries, “almost clean” is not clean enough. Cleanrooms and ultra-clean facilities underpin high-value production and patient safety across sectors such as semiconductor manufacturing, pharmaceuticals, medical devices, biotech, aerospace composites, optics, advanced batteries, food ingredients, precision engineering and laboratory research.
A single incident — an HVAC fault, filter failure, power blip, cleaning protocol breach, gowning error, or airborne particle spike — can invalidate batches, destroy work-in-progress, and trigger expensive revalidation. Many businesses discover too late that standard property policies focus on physical damage and may not respond to contamination, process rejection, quality holds, or recall-related losses unless specifically endorsed.
Insure24 arranges specialist insurance that reflects how cleanrooms really operate: controlled environments, strict SOPs, validation, audit trails, and an uncompromising requirement for stability. We help you structure cover around your cleanroom classification, product criticality, and the true cost of downtime.
Cleanroom Insurance – What Can Be Covered?
Cleanroom risk is broader than “property + interruption”. The right programme can blend property, engineering, liability and specialist extensions to address contamination, rework, rejected batches and contractual consequences. Cover is always subject to policy terms, conditions, definitions, limits and exclusions — we’ll guide you through what’s realistic in the market for your specific operations.
- Property & contents – cleanroom build, fit-out, partitions, airlocks, ceiling grids, floors and controlled storage
- HVAC, AHU and environmental control equipment – engineering breakdown options where available
- Critical services – power, compressed air, process gases, vacuum systems, chilled water and monitoring systems
- Equipment breakdown – sudden and unforeseen failure of key plant impacting controlled environments
- Business interruption – loss of gross profit / revenue during restoration, including increased cost of working
- Stock / work in progress – high-value WIP, sterile components, wafers, reagents, compounds and controlled inventory
- Public & products liability – third-party injury / property damage arising from your operations or products
- Product recall / remediation – where appropriate for your product class and supply chain requirements
- Cyber & operational technology (OT) – if cleanroom controls and monitoring are digitally connected
- Environmental / pollution liability – chemical releases, waste handling, effluent and regulatory investigations
Common Cleanroom & Ultra-Clean Facility Risk Events
Cleanrooms fail in predictable ways. Insurance works best when it’s built around your actual failure modes, controls and recovery steps — not generic assumptions. Below are the common scenarios we see across semiconductor, pharma, labs and advanced manufacturing.
- HEPA/ULPA filter failure, bypass or incorrect installation leading to particle excursions
- HVAC / AHU malfunction causing temperature, humidity or pressure instability
- Power disturbances – outages, brownouts, surges impacting sensitive controls and airflow balance
- Process gas or compressed air quality issues (moisture/oil/particulates) contaminating production
- Water system issues – bacterial risk, endotoxin contamination, or chilled water failure
- Gowning and protocol breaches – human error remains a top contamination contributor
- Cleaning chemical error – wrong dilution, residues, or incompatible materials affecting surfaces
- Construction / maintenance work introducing dust, fibres and volatile compounds
- Monitoring and sensor drift – undetected excursions that only show up at final QC
- Cross-contamination between suites / zones due to airflow or traffic mismanagement
- Fire suppression discharge – accidental release affecting sterile areas and sensitive equipment
- Supply chain contamination – incoming materials packaging, pallets, or components introducing particulates
The Real Cost of Cleanroom Incidents
In cleanroom environments, losses are rarely limited to “fix the thing that broke”. The majority of cost is typically driven by rejected output, revalidation, requalification, wasted labour, expedited freight, contract penalties, reputational impact and long-tail disruption. That is why cleanroom insurance needs to be designed around the full loss chain.
Direct loss drivers
Direct losses typically start with damage to HVAC, monitoring systems, pressure control, filtration, or critical utilities. These can be expensive, but the bigger financial exposure comes when output is compromised.
- Replacement or repair of HVAC/AHU components, dampers, fans, coils, sensors and control systems
- Remediation cleaning – deep cleans, surface treatments, wipe-downs, fogging, and disposal of contaminated consumables
- Engineering intervention – rebalancing airflow, pressure differentials and verifying set points
- Waste disposal – contaminated chemicals, wipes, PPE, packaging or materials requiring specialist handling
Quality and output impact
Cleanroom incidents often lead to an extended “quality hold” while you prove the facility is back within specification. In regulated environments, a minor excursion can trigger extensive investigation, deviation reporting and repeat testing. In semiconductor or precision manufacturing, contamination may only be detected downstream after additional processing steps have already added value.
- Work-in-progress (WIP) scrap – wafers, sterile components, micro-optics, precision assemblies
- Batch rejection – finished product written off due to sterility/particulate/non-conformance
- Rework – additional processing, repolish, recoat, re-etch or reclean cycles to salvage output
- Retesting and extra QA – repeated validation runs, stability tests, sample pulls and documentation time
Downtime and interruption
Business interruption in cleanroom operations can be unusually severe because restart is rarely instant. Even after the physical fault is repaired, the facility may require environmental stabilisation, qualification and a controlled restart sequence. If your output feeds high-reliability supply chains (automotive, aerospace, medical), customers may have limited tolerance for missed deliveries.
- Lost gross profit / revenue while the suite is offline
- Increased cost of working – overtime, extra shifts, outsourcing, expedited freight, temporary equipment hire
- Contractual penalties – liquidated damages, service credits, warranty claims and missed KPI charges
- Supplier disruption – downstream customers halting their own production and seeking recovery
Third-party and regulatory exposure
Depending on your sector, contamination can trigger regulatory attention and third-party claims. Medical device manufacturers, sterile product producers and labs handling sensitive materials can face investigations, product withdrawal, or recall expectations. Even where recall is voluntary, it can be commercially necessary to protect brand and contracts.
- Regulatory investigations and defence costs (where insurable and appropriate)
- Third-party product liability – injury or damage allegedly caused by defective contaminated output
- Professional indemnity exposures (for labs/testing services) if results are impacted
- Product recall / remediation – notification, retrieval, disposal, replacement and reputational support
The right programme balances practicality (what insurers will actually write) with the realities of how contamination events produce loss. Our approach is to build the cover around your process, your controls, and your recovery plan — so you are not relying on assumptions after an incident.
Designing Insurance for Cleanrooms: What Underwriters Need
Cleanroom and ultra-clean facility risks are highly technical. Underwriters tend to price and accept risk based on stability, monitoring, maintenance discipline and your ability to isolate and recover quickly. The more clearly you can evidence control, the better your terms, pricing and scope are likely to be.
Information that helps you secure better cover
When we approach the market for cleanroom insurance, we help you present the risk in a way that matches how underwriters assess exposure: not just “we have a cleanroom”, but how it’s classified, monitored, maintained, and validated.
Facility & classification
- ISO class / GMP grade, zoning, and pressure cascades
- Room sizes, air changes per hour, and filtration configuration
- Segregation for different products/processes (to reduce cross-contamination)
- Controlled storage, gowning rooms, airlocks and material transfer points
- Validation status and change control procedures
Monitoring & risk controls
- Environmental monitoring – particles, viable counts, temp/humidity, differential pressure
- Alarm thresholds, escalation, out-of-hours response and documented corrective actions
- Preventive maintenance schedules for HVAC/AHU, sensors, dampers and controls
- Power protection – UPS for critical systems, surge protection, generator test regime
- Training & SOP compliance – gowning, cleaning, movement control and audit results
Critical utilities and dependencies
- Compressed air quality management (oil-free, dryers, filtration and monitoring)
- Process gases and chemical storage – leak detection, bunding, shut-offs and ventilation
- Chilled water / cooling capacity and redundancy
- Building management system reliability and cybersecurity posture
- Service contracts, spares strategy and repair lead times
Business interruption planning
- Restart and requalification plan – what must be proven before production resumes
- Alternative production routes / outsourcing options
- Customer delivery requirements and penalty structures
- Peak production windows and WIP concentrations
- Contingent BI dependencies on key suppliers and service providers
If you’re unsure what “good” looks like from an insurance perspective, we’ll walk you through a practical underwriting pack. That means less back-and-forth, faster quotes, and a stronger chance of securing the right extensions (where the market will support them).
Cleanroom Insurance for Different Industries
“Cleanroom” can mean very different things depending on what you make and how customers validate you. We tailor cover to match your exposure: high-value output, patient safety, contractual delivery, or precision yield.
Semiconductor & Microelectronics
- Contamination and particle excursions impacting wafer yield and downstream processes
- Critical equipment and utilities (vacuum, gases, chilled water) driving sudden downtime
- High WIP concentrations and long production cycles increasing loss severity
- Customer chargebacks, warranty exposures and high-reliability claims
- Cyber/OT risk for connected monitoring and process controls
Pharmaceutical, Biotech & GMP Suites
- Sterility assurance and documented environmental monitoring expectations
- Deviation management, batch holds, and extensive revalidation after excursions
- Cold chain dependencies and controlled storage exposures
- Regulatory investigation support considerations (where applicable/insurable)
- Product liability and product recall / withdrawal exposures
Medical Devices & Sterile Manufacturing
- Sterile pack integrity, particulate control, and validation-driven production
- Customer and regulator expectations around traceability and corrective actions
- Recall and remediation scenarios where field action is required
- Third-party claims exposures if contaminated devices cause injury
- Contractual delivery risks and dependency on critical sterile lines
Laboratories, R&D and Controlled Testing
- Sample contamination and integrity risks impacting results and client projects
- Professional indemnity exposures for testing, certification, and reporting
- Specialist equipment protection (incubators, isolators, microscopy, precision instruments)
- Cyber risk for sensitive data, research IP, and lab information systems
- Business interruption due to suite shutdown and requalification timelines
Why Choose Insure24 for Cleanroom Insurance?
- Contamination-aware underwriting packs – we present your controls clearly to insurers
- Access to specialist markets for advanced manufacturing, life sciences and labs
- Programme design – property, engineering, BI, liability and extensions aligned to your loss chain
- Claims support – practical help in documenting loss and navigating coverage questions
- Risk management perspective – improvements that can reduce premium and improve terms
How to Get Cleanroom / Ultra-Clean Facility Insurance
- 1. Tell us what you do – sector, product criticality, and what happens if contamination occurs
- 2. Share the basics – ISO/GMP classification, suite size, utilities, monitoring and maintenance
- 3. We approach the market – specialist insurers aligned to your industry and risk profile
- 4. Review options – cover scope, limits, deductibles and key policy definitions
- 5. Bind cover – and keep documentation ready for customers and audits
A pressure cascade fault triggered a contamination hold. Insure24 helped us structure cover that reflected requalification time and protected our cash flow.
Operations Manager, Ultra-Clean Manufacturing FacilityPROTECT YOUR CLEANROOM OPERATION
- Repair and replacement of critical environmental control plant
- Loss of gross profit / revenue while your suite is shut down or requalified
- Stock and work-in-progress exposure in contamination-sensitive processes
- Your legal defence costs and third-party damages (where you’re legally liable)
- Support for incident documentation to help move a claim forward efficiently
Compliance & Audit Expectations
Cleanroom operations are often assessed against strict standards. Insurance cannot replace compliance, but it can protect your business when an incident still occurs.
- ISO cleanroom classification and documented monitoring
- GMP expectations (where applicable) including deviation and CAPA processes
- Customer audit requirements and quality agreements
- Environmental and chemical handling obligations
- Cyber/OT controls where monitoring and BMS systems are connected
FREQUENTLY ASKED QUESTIONS
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What is cleanroom / ultra-clean facility insurance?
Cleanroom insurance is specialist commercial cover designed for ISO-classified and contamination-critical environments. It can include property, equipment breakdown, business interruption, stock/WIP, liability and sector-specific extensions aligned to contamination events, requalification time and quality-driven losses (subject to policy terms and definitions).
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Does insurance cover contamination without physical damage?
Standard property insurance often focuses on physical damage, so contamination-only scenarios may not be covered unless there are specific extensions and suitable triggers. We help you understand what the market can offer and how to structure cover realistically around your cleanroom’s failure modes.
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What does business interruption look like for cleanrooms?
Cleanroom interruption often includes time to stabilise conditions, complete deep cleaning, recalibrate environmental controls and complete requalification or validation before production restarts. BI cover can include loss of gross profit/revenue and increased cost of working, with indemnity periods set to match realistic restart timelines.
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Do I need products liability if I operate a cleanroom?
If you manufacture, assemble, sterilise, package or supply products, products liability is commonly required. Contamination can create defect allegations, warranty issues and (in some sectors) recall exposures. We’ll align liability limits with your contracts, customers and worst-case scenarios.
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What information do I need to get a cleanroom insurance quote?
Typically: your industry and products, ISO class/GMP grade, suite layout and zoning, HVAC and filtration details, monitoring/alarm processes, preventive maintenance, critical utilities, stock/WIP values, revenue and desired BI limits, plus any claims history. If you have recent audits, validation summaries or maintenance logs, those help.
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How can I reduce cleanroom insurance premiums?
Premium reductions typically come from stronger evidence of control: documented preventive maintenance, robust monitoring with escalation, redundancy for critical utilities, clear change control, staff training records, and an incident response plan. We can also review deductibles, limits and BI indemnity periods to balance cost and protection.