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Building 4, Huaqiang Ecology and Technology Park, Guangming District, Shenzhen, Guangdong, China

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Sterile Gaskets



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Medical & Life Science

Sterile Gaskets

Cleanroom-Manufactured Gaskets for Pharmaceutical & Biotech Processing Equipment

THOR-SOFT produces sterile-compatible gaskets specifically engineered for pharmaceutical manufacturing equipment, bioreactors, and cleanroom environments. Our gaskets are manufactured under ISO Class 8 conditions, undergo rigorous particulate testing, and meet all cGMP documentation requirements for validated processes.

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24 Sterile Gaskets



TECHNICAL SPECIFICATIONS

Product Details & Parameters

Material USP Class VI LSR / PFA-encapsulated silicone Cleanliness Particle count < 0.5 particles/cm² (>0.5µm)
Surface Finish Ra < 0.4 µm (polish available) Sizes Standard tri-clamp, sanitary flange, or custom
Packaging Double-bagged, cleanroom-packed, with COA MOQ 50 pieces per SKU
Certification ISO 13485, FDA 21 CFR 177.2600, cGMP compliant Lead Time 14–22 working days



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WHY CHOOSE THOR-SOFT

Sterile Gaskets Advantages

ISO Class 8 Clean Room
Controlled environment production
Low Extractables
Validated for pharma processes
Full Documentation
COA, C of C, validation support
Sanitary Standards
ASME BPE, 3-A, DIN compatible



★★★★★
Trusted by 500+ Global Clients
“Sterile Gaskets from THOR-SOFT consistently exceeds our quality expectations. Fast response, competitive pricing, and zero-defect delivery.”
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PRODUCT SHOWCASE

Sterile Gaskets Gallery

🖼
Showcase Image 1
Close-up View
Premium Quality Close-Up
Detailed view of finished sterile gaskets
📷
Showcase Image 2
Application Scene
In-Use Application Shot
Real-world sterile gaskets deployment
🏠
Manufacturing
Process Photo
Factory Production Line
Our manufacturing facility producing sterile gaskets



APPLICATIONS

Where Sterile Gaskets Are Used

Bioreactor seals
pharmaceutical vessel gaskets
filter housing gaskets
sanitary valve seats
chromatography column seals
lyophilizer gaskets
filling machine seals
clean-in-place (CIP) systems



OUR MANUFACTURING

THOR-SOFT Production Process

1
Design Review
DFM analysis & optimization
2
Mold Making
Precision CNC tooling
3
Production
Injection/compression molding
4
QC Testing
Dimensional & visual inspection



FAQ

Frequently Asked Questions about {p[‘name’]}

What is the minimum order quantity (MOQ)?
We accept low-volume prototype orders starting from as few as 10-100 pieces for evaluation purposes. Standard production MOQ varies by product complexity — typically between 200-2,000 pieces.
Can you customize the material hardness and color?
Yes! We offer full customization of material hardness (Shore A 10-90), color (unlimited Pantone matching), and special additives like conductive fillers, radiopaque agents, or antimicrobial treatments.
How long does it take to receive my first samples?
For existing molds: 5-7 working days. For new tooling projects: 15-25 days (includes mold fabrication). Rush prototyping service available at additional cost.
Do you provide test reports and certifications?
Absolutely. Every shipment includes a Certificate of Analysis (COA) and Certificate of Conformance (COC). We can also arrange third-party testing (SGS, Intertek) and provide full material certification dossiers.



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Shenzhen,光明区,华强生态科技园4栋