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Clean Room Manufacturing for Medical, FDA, and Electronic Components
Cannon Gasket supports FDA 21 CFR 177.2600, USP Class VI, platinum-cure silicone, and Kapton programs. Full documentation and lot traceability. Send your cleanliness class, material, and packaging callout. We reply with pricing, sample parts, and lead time.
Quick facts about Clean Room
- A clean room is a controlled box. Airborne particulates, temperature, and humidity stay within set limits so sensitive product is not contaminated on the bench.
- Medical-device assembly, pharmaceutical packaging, semiconductor gaskets, diagnostic components, and aerospace critical seals all need clean-room manufacturing.
- Our ISO 7 / Class 10,000 clean room handles die-cutting, inspection, kitting, and packaging of contamination-sensitive parts.
Request a quote for clean room manufacturing.
Controlled EnvironmentPrecision without
Precision without
contamination.
Cannon Gasket offers clean environment stamping for medical, FDA, electronic, and scientific applications where a controlled level of particulate is required. The room runs HEPA filtration, room pressure and airflow monitors, and constant temperature and humidity controls, and meets ISO 7 (Class 10,000) when required. We die-cut, assemble, inspect, and package under ISO 9001 quality controls with full traceability documentation.
Medical Device Components
Gaskets, seals, and diaphragms for medical devices manufactured under controlled conditions with full documentation.
FDA-Compliant Materials
We stock FDA-compliant elastomers including silicone, EPDM, and specialty compounds suitable for food contact and medical applications.
Electronics & Semiconductor
Clean room die cutting for EMI/RFI shielding gaskets, display seals, and precision components where particulate contamination is unacceptable.
Scientific & Laboratory
Sealing components for analytical instruments, research equipment, and laboratory devices requiring contamination-free manufacturing.
Custom Packaging
Clean room packaged components in sealed bags, blister packs, or custom packaging to maintain cleanliness through your incoming inspection.
Documentation & Traceability
Lot traceability, material certifications, and certificates of conformance provided with every clean room production run.
Industries
Who uses our clean room.
We run ISO 7 clean-room die-cutting, inspection, and packaging for customers whose products cannot tolerate particulate, oil, or silicone contamination from a standard shop environment.
Medical Devices
Surgical and medical-device gaskets are cut, packaged, and shipped from our ISO 7 clean room with full lot traceability.
FDA & Food Contact
21 CFR 177.2600 silicone, Buna-N, and EPDM gaskets for food, beverage, and dairy fluid-path equipment are fabricated without cross-contamination from industrial elastomers.
Pharmaceutical
Drug-delivery pumps, bioprocess equipment, and sterile fill-finish lines specify USP Class VI and animal-derivative-free elastomers processed inside a controlled environment.
Semiconductor
Wafer-fab chemical-delivery, vacuum-chamber door seals, and end-effector pads need particulate-free, outgassing-controlled gaskets produced and packaged inside the clean room.
Electronics
High-reliability electronics, aerospace avionics, medical imaging, and defense, often require gaskets handled outside normal shop floors to avoid dust or silicone contamination.
Scientific Instruments
Mass spectrometers, chromatography systems, and high-vacuum instrumentation use elastomer and PTFE seals that must be clean and outgas-controlled from the moment they are cut.
Laboratory Equipment
Automated diagnostic platforms, liquid-handling robots, and life-science analyzers specify clean-room-processed seals to protect sample integrity across extended assay runs.
Optical Systems
Laser systems, telescope cells, and precision optical assemblies require gaskets handled under particle-controlled conditions to prevent optical-surface contamination during integration.
Frequently Asked Questions
Common questions about clean-room manufacturing.
Are you ISO 9001 certified?
Yes, ISO 9001:2015 certified. Documented quality management covers incoming material verification, in-process inspection, calibrated measurement, final inspection, non-conformance handling, corrective action, and full lot traceability. AS9100-ready for aerospace, with MIL-spec and FDA 21 CFR 177.2600 / USP Class VI grades available on request.
What class clean room do you operate?
ISO 7 / Class 10,000 clean room. HEPA filtration, room pressure monitoring, airflow monitoring, and controlled temperature and humidity. Used for medical device, FDA, pharmaceutical, semiconductor, and aerospace critical-seal programs.
Do you have a clean room?
Yes. ISO 7 (Class 10,000) clean room in Fontana for die-cutting, inspection, kitting, and packaging of contamination-sensitive parts. Lot traceability and documented quality controls applied throughout.
Do you provide lot traceability?
Yes. Every production run is tied to a work order, material lot, operator, and inspection record. Full genealogy from raw stock to finished part is retrievable on request, and is standard on aerospace and medical programs.
How big is Cannon Gasket?
Mid-sized independent manufacturer. Large enough to run high-volume OEM programs (JIT / VMI / Kanban), small enough that the engineer you talk to is the same one who reviews your drawing and approves your first article.
How do I reach an engineer?
Call 909.355.1547 during business hours (Mon-Fri 7am-4pm PT), email sales@cannongasket.com, or submit an RFQ at /request-more-information/. We respond within one business day.
How long has Cannon Gasket been in business?
Since 1971. Family-owned, in-house tooling department, production and engineering under one roof at our Fontana, California facility.
What documentation ships with clean-room parts?
Certificate of Conformance, material lot traceability, clean-room processing record, and packaging certification. Sealed clean-room bags, double-bagged for airlock transfer, or customer-specified packaging on request.
What inspection documentation do you provide?
First Article Inspection Reports (FAIR), Certificates of Conformance, Material Certifications, PPAP documentation on request, and RoHS / REACH compliance statements. Dimensional inspection uses calibrated instruments with NIST-traceable cal records.
When do I need clean-room fabrication?
Medical devices that contact human tissue, pharmaceutical fluid paths, semiconductor wafer-fab tools, aerospace critical seals, and any application where particulate contamination or silicone cross-contamination would compromise the finished product.
Where are you located?
7784 Edison Ave, Fontana, CA 92336. Production, engineering, and tooling are all in the same building. Shipping nationwide and to OEM customers globally.
How fast do you return a quote?
Most RFQs come back within one business day. Simple profile updates to an existing tool quote same-day. Send a drawing, DXF, or competing part number and our engineering team reviews material, tolerance, and volume before pricing.
What is the minimum order quantity?
Minimums depend on the part and material. We cut prototype and first-article quantities for engineering evaluation, then scale up to production volumes from the same tooling. For high-volume programs we run JIT, VMI, and Kanban replenishment out of Fontana, California.
What should I send with an RFQ?
Ideal: a drawing or DXF, material spec (or compound family), estimated annual volume, and any regulatory callouts (FDA, USP Class VI, AS9100, MIL-spec). If you only have a sample or a part number from a competing supplier, send that and we will reverse-engineer the spec before quoting.
What are typical lead times?
Prototype and first-article parts usually ship in 5-10 business days. Production runs from existing tooling are 2-3 weeks depending on volume and material lead time. Rush and expedite options available on a case-by-case basis.
Need clean room manufacturing?
Tell us about your application and we'll discuss how our clean room capabilities can support your requirements.
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