Medical Syringe Plunger Seal

Medical Syringe Plunger Seal
Details:
Origin: Xiamen, China
Compliance & Testing Capability: FDA-compliant materials; ISO 13485 project support; ISO 10993 & USP Class VI testing available upon request
Materials: Medical-grade Butyl Rubber (IIR), Bromobutyl (BIIR), Chlorobutyl (CIIR), Silicone, TPE (custom available)
Hardness: 30–70 Shore A
Operating Temperature: -40°C to +200°C
Size: Custom medical syringe pistons and rubber stopper plugs
Colors: Natural, gray, black, or custom colors available
Daily Output: Up to 5 million pcs
Applications: Disposable syringes, prefilled syringes, medical injection devices
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Description
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Product Description

 

Medical Syringe Plunger Seal is a precision-engineered pharmaceutical component designed specifically for disposable syringes, prefilled drug delivery systems, and advanced medical injection devices. Manufactured from pharmaceutical-grade elastomers including medical silicone and specialized rubber compounds, it delivers exceptional drug compatibility, consistent injection force characteristics, and absolute leakage prevention for critical medication delivery applications.

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Unlike standard industrial seals, Best Seal Medical Syringe Plunger Seals feature advanced multi-rib sealing geometry that ensures superior medication containment throughout storage and administration, while precision molding technology guarantees ±0.02mm dimensional accuracy for consistent, reliable performance across millions of injection cycles.

 

🏥 Clinical Excellence Advantage:
Multi-rib sealing design + pharmaceutical-grade materials + ISO Class 7 cleanroom manufacturing = Zero contamination risk, perfect for sterile drug delivery including vaccines, biologics, and insulin formulations.

 

Technical Parameters

Property Unit Value
Origin - Xiamen, China
Material - Medical-Grade Silicone (VMQ), Butyl Rubber (IIR), Bromobutyl (BIIR), Chlorobutyl (CIIR), TPE
Hardness Range Shore A 30 – 80 (Application-specific)
Operating Temperature °C -40 to +200
Dimensional Tolerance mm ± 0.02
Compatible Syringe Sizes - Custom (1ml–60ml standard configurations)
Colors - Natural (translucent), gray, black, or custom
Testing Available - ISO 10993 & USP Class VI upon project request

 

Material Options

Pharmaceutical-Grade Elastomer Materials:

Material Key Properties Best Applications
VMQ (Medical Silicone) Superior biocompatibility, extreme temperature stability General-purpose syringes, prefilled systems, wide pH range
IIR (Butyl Rubber) Exceptional gas barrier properties, low moisture permeability Oxygen-sensitive drugs, vaccines, extended shelf-life products
BIIR (Bromobutyl) Enhanced chemical resistance, improved curing Aggressive pharmaceutical formulations, chemotherapy agents
CIIR (Chlorobutyl) Excellent drug compatibility, low extractables Lyophilized drugs, sensitive biologics, high-value therapeutics
TPE (Medical Grade) Customizable hardness, thermoplastic processing Specialty applications, unique performance requirements

 

Surface Treatment Options:

Surface Treatment Benefits Applications
PTFE (Teflon) Coating Ultra-low friction coefficient, exceptional chemical inertness Prefilled syringes, high-precision dosing, viscous formulations
Silicone Oil Lubrication Smooth injection feel, biocompatible lubricant Biologic delivery, patient self-injection devices, insulin pens
Baked Silicone Coating Permanent lubrication, no migration, autoclave stable Sterilized prefilled systems, long-term storage
Uncoated (Natural) Zero additive contamination risk Preservative-free medications, sensitive formulations

 

💊 Material Selection Guide:
Silicone (VMQ): Best for broad chemical compatibility and temperature extremes
Butyl (IIR/BIIR/CIIR): Essential for oxygen-sensitive medications, vaccines
Our pharmaceutical engineering team provides FREE consultation for optimal material selection.

 

Key Features & Advantages

  • ❶ Ultra-Precision Manufacturing: ±0.02mm tolerance ensures perfect barrel fit and eliminates micro-leakage pathways
  • ❷ Multi-Rib Sealing Design: Dual or triple sealing ribs create redundant sealing zones, preventing medication migration
  • ❸ Pharmaceutical-Grade Surface: Ra ≤0.4μm finish minimizes friction while preventing particulate generation
  • ❹ Optimized Injection Force: 8–15N consistent glide force provides 35% improvement in patient comfort
  • ❺ Regulatory Documentation: ISO 10993 & USP Class VI biocompatibility testing upon project request
  • ❻ Chemical Compatibility: Extensive testing with pharmaceutical excipients and active ingredients
  • ❼ Extractables Control: Low-extractable formulations minimize drug interaction risks

 

Main Applications

  • Disposable Medical Syringes: 1ml–60ml standard syringes, insulin syringes, tuberculin syringes, specialty injection systems
  • Prefilled Syringe Systems: Vaccines (COVID-19, influenza, pediatric), biologics, emergency medications (epinephrine, naloxone)
  • Advanced Drug Delivery Devices: Auto-injectors, safety syringes, pen injector cartridges, wearable injection devices
  • Hospital & Clinical Settings: Operating room procedures, emergency medicine, patient-controlled analgesia, chemotherapy
  • Laboratory Equipment: High-precision liquid handling, analytical sample preparation, biotechnology research
  • Veterinary Medicine: Animal vaccination programs, livestock medication delivery, companion animal therapeutics
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Packaging & Shipping

📦 Packaging Options:

Type Details
Standard Packaging

Cleanroom-sealed PE bags with double-bag protection

Inner cartons with protective layers

Export-quality palletization for bulk shipments

Custom Packaging (Upon Request)

Individual heat-sealed pouches

Thermoformed protective trays

Vacuum-sealed aluminum foil barrier pouches

Customized labels with batch tracking

Sterilized Options Gamma-sterilized (25–50 kGy) or EtO sterilized ready-to-use packaging available

🚚 Shipping Information

Item Details
MOQ 1 pcs
Lead Time In stock: 3-5 days | Standard: 2–3 weeks | Custom mold: 4–6 weeks | Sterilized: Add 2–3 weeks
Port Xiamen, China
Shipping Methods Express (DHL, FedEx, UPS), Air Freight, Sea Freight
Trade Terms FOB / CIF / DDP / EXW available
Sample Policy Free samples available (customer pays freight) | Fast quotation within 24 hours

Comprehensive OEM & ODM services available to meet your specific requirements.

 

Customer Reviews

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Factory Strength & Quality Assurance

Xiamen Best Seal Imp. & Exp. Co., Ltd. has over 20 years of experience manufacturing precision medical-grade elastomer components. We specialize in high-precision syringe plunger seals and custom pharmaceutical sealing solutions for the global healthcare industry.

Quality Certifications: ISO 9001:2015, RoHS, REACH, FDA-compliant materials

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Frequently Asked Questions

Q: What syringe sizes are compatible with your plunger seals?

A: We manufacture precision plunger seals for all standard syringe formats from 1ml to 60ml, with custom sizes available for specialty applications. Send your technical drawings for a precise quotation within 24 hours.

Q: Which material should I choose for my drug formulation?

A: Material selection depends on your drug formulation:
Silicone (VMQ): Best for broad chemical compatibility and temperature extremes
Butyl Rubber (IIR): Ideal for oxygen-sensitive drugs and extended shelf-life
Bromobutyl/Chlorobutyl: For aggressive formulations and biologics
Our pharmaceutical engineering team provides FREE consultation for optimal selection.

Q: Do you provide regulatory documentation for pharmaceutical submissions?

A: Yes. ISO 10993 and USP Class VI biocompatibility testing reports are available upon project request to support your regulatory submissions (FDA, EMA, etc.). Drug Master File (DMF) support is also available.

Q: Can you supply pre-sterilized plunger seals ready for aseptic filling?

A: Yes. We offer gamma-sterilized (25–50 kGy) plunger seals in cleanroom packaging, ready for aseptic filling lines. EtO sterilization available for radiation-sensitive materials. Lead time: add 2–3 weeks to standard production.

Q: What is the minimum order quantity?

A: There is no MOQ. We support orders from 1 piece, including sampling, R&D testing, validation studies, and mass production. Pricing depends on specifications and requirements.

Q: Do you offer custom formulation development services?

A: Yes. Our R&D team specializes in custom elastomer formulations for specific drug compatibility, unique hardness requirements, specialized color matching, or distinctive performance characteristics. Proprietary formulations available.

Q: How do you ensure consistent quality across production batches?

A: Quality consistency maintained through statistical process control, 100% automated optical inspection, dimensional verification on every batch, material certification, complete traceability systems, and rigorous validation protocols. Every batch includes a certificate of analysis.

 

📞 Contact Us Today

Xiamen Best Seal Imp. & Exp. Co., Ltd.

📍 Address: Unit 522-525, Gaodian Road 6#, Huli District, Xiamen, China

☎️ Tel: +86-592-5782315

📱 Mobile/WhatsApp: +86 189 5015 9396

📧 Email: yunying2@bestsealhk.com

Free Sample Kit  •  24-Hour Quotation  •  Custom Solutions  •  OEM/ODM Services

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