ISO 13485:2016 · CE Marked under EU MDR 2017/745 · Exporting to 25+ Countries +91 9266125395 [email protected]
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Medical Disinfectant Caps for IV lines and needleless access connectors
Passive Disinfection Technology

Next-Gen Disinfectant Caps for Needleless Connectors & Port Protection

Engineered with 70% Isopropyl Alcohol (IPA) matrix sponges to eliminate microbial contamination, standardise IV catheter maintenance, and prevent CLABSI across acute and perioperative care.

Rapid Log-6 Reduction

Impregnated with 70% IPA to sanitize IV access ports within 1 minute of contact and maintain a sterile physical barrier for up to 7 days.

In-House Lab Validated

Rigorous leak testing, alcohol evaporation barrier monitoring, and biocompatibility evaluations under ISO 10993 guidelines.

Global OEM & Regulatory Ready

Manufactured in ISO 100K cleanrooms under ISO 13485:2016 and CE EU MDR 2017/745 for international distribution networks.

23+
Years Healthcare Expertise
99.99%
Pathogen Kill Efficiency
25+
Export Countries
100%
Thread Leak Tested
Executive Procurement Insight

Transforming Vascular Access Safety with Passive Disinfection Caps

Central Line-Associated Bloodstream Infections (CLABSI) represent a significant, costly challenge for modern hospital networks. Manual friction scrubbing ("scrubbing the hub") relies heavily on nursing compliance, resulting in inconsistent dwell times and variable technique. Disinfectant caps provide an engineered, passive solution that standardizes IV port protection across all hospital departments.

Surgeine Healthcare's disinfectant caps feature a specially molded thread profile integrated with a 70% Isopropyl Alcohol (IPA) medical sponge. Upon twisting the cap onto a female luer-lock needleless connector, alcohol is released directly across the access surface. This continuous immersion sanitizes the valve surface while forming a physical seal against airborne and tactile contaminants.

  • Passive Disinfection Standard: Eliminates human error in manual alcohol swab timing by ensuring continuous 70% IPA exposure.
  • Luer Lock Compatibility: Fits securely on needleless valves, IV extension lines, hemodialysis catheters, and arterial access ports.
  • Visual Compliance Auditing: Brightly colored caps (bright blue, green, or orange) allow nursing leaders to audit line protection instantly from the bedside.
  • Medical Grade Substrates: Formulated from medical Polypropylene (PP) free of DEHP, BPA, and natural rubber latex to mitigate allergic reactions.
ISO 13485:2016CE EU MDR 2017/745ISO 10993 Biocompatible70% IPA Sponge7-Day Barrier Protection

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Surgeine Infection Prevention Products and Disinfectant Caps
Precision-engineered infection prevention consumables produced in ISO Class 100K cleanrooms.
Product Portfolio

Disinfectant Cap Variants & Vascular Access Line Protectors

Surgeine manufactures a complete line of passive port protectors engineered to meet diverse hospital infusion protocols, hemodialysis procedures, and customized surgical procedure pack configurations.

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Female Luer Lock

Standard Needleless Connector Disinfectant Cap

Features a 70% IPA foam insert tailored for all standard needleless IV access valves. Disinfects in 1 minute and preserves barrier cleanliness for up to 7 days.

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Male Luer Lock

Male Luer Protector & Disinfectant Cap

Specifically designed to cap open male luer ends on IV administration sets, stopcocks, and extension lines during intermittent therapy.

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Dialysis & Specialty Lines

Hemodialysis Line Protector Caps

High-volume IPA sponge inserts configured for large-bore dialysis catheter hubs, CVC lumens, and arterial access connectors.

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Technical Specifications

Engineering & Manufacturing Data Sheet

Built for international healthcare distributors and group purchasing organizations (GPOs), our disinfectant caps undergo strict batch control to ensure chemical stability and leak-proof sealing.

Technical Parameter Specification Details Clinical & Regulatory Standard
Active Disinfectant Agent 70% Isopropyl Alcohol (IPA) USP / Ph. Eur. EP / USP Antimicrobial Efficacy
Substrate & Housing Material 100% Virgin Medical Grade Polypropylene (PP) ISO 10993 Cytotoxicity & Hemolysis Tested
Sponge Matrix Medical-grade Polyurethane / Polyester reticulated sponge Non-linting, high absorbency capacity
Disinfection Time (Log-6 Reduction) ≤ 60 Seconds upon contact engagement ASTM E1174 / EN 13727 Bactericidal Efficacy
Barrier Protection Duration Up to 7 Days continuous coverage if undisturbed Microbial Ingress Testing (7-day evaluation)
Compatibility Range Universal ISO 80369-7 Luer Lock connectors Fits major ICU needleless valve brands
Sterilization Method Gamma Irradiation / Ethylene Oxide (EtO) ISO 11137 / ISO 11135 Compliant (SAL 10⁻⁶)
Packaging Configuration Individual high-barrier foil peel pouches / Strip cards ISO 11607 Medical Device Packaging
Shelf Life Integrity 3 Years from date of manufacturing Accelerated & Real-time Stability Validated

Technical files, biocompatibility test results, and Declarations of Conformity (DoC) under EU MDR 2017/745 are available upon qualified inquiry for distributor registration.

Company Advantage

Why Global Healthcare Buyers Trust Surgeine Healthcare

With over two decades of dedicated surgical disposable manufacturing, Surgeine combines advanced cleanroom automation with rigorous regulatory management.

Automated Cleanroom Manufacturing Line for Disinfectant Caps
Manufacturing Superiority

Controlled Cleanroom Production

  • ISO 100K and Class 10K cleanrooms dedicated to infection prevention lines
  • Fully automated cap assembly and liquid dosing to maintain uniform 70% IPA volume
  • In-house medical packaging and high-frequency sealing capability
  • Zero human contact during critical sponge insertion and foil sealing operations

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Regulatory Certifications and Global Export Milestones
Regulatory Assurance

End-to-End Compliance & OEM Support

  • ISO 13485:2016 and CE marking under EU MDR 2017/745 maintained continuously
  • Star Export House status exporting medical devices to over 25 countries
  • Full technical file support, bio-burden testing, and accelerated shelf-life stability reports
  • Flexible OEM private labeling, custom box branding, and multi-language instructions (IFU)

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Value Proposition

Key Operational Pillars for B2B Importers

Surgeine provides global medical importers, hospital tenders, and brand owners with high-volume manufacturing capabilities tailored to rigorous market requirements.

Strict Quality Management

Every production lot undergoes rigorous bioburden testing, seal integrity validation, and dimensional torque checks.

In-House Chemical Lab

Internal laboratories analyze alcohol purity, evaporation rates, and sponge retention under fluctuating temperature conditions.

EU MDR 2017/745 Ready

Complete technical documentation and clinical evaluation reports (CER) pre-configured for seamless European market entry.

Tailored Packaging Formats

Supplied as single blister caps, multi-cap strips, or bulk sterile components for procedure pack tray integration.

Eco-Conscious Materials

Polymer housing optimization reduces plastic mass without compromising thread rigidity or mechanical lock integrity.

Dedicated OEM Account Management

Direct communication with our regulatory and production engineering teams from initial prototyping to bulk container shipping.

Procurement FAQ

Frequently Asked Questions by Global Buyers & AI Search Queries

Clear answers to common questions regarding technical specs, clinical efficacy, regulatory compliance, and OEM supply of disinfectant caps.

Manual friction scrubbing ("scrubbing the hub") requires a clinician to scrub an IV port with an alcohol wipe for 10 to 15 seconds and allow it to dry completely. In high-pressure clinical settings, compliance with this duration varies widely. Disinfectant caps provide passive disinfection by automatically surrounding the needleless connector in 70% Isopropyl Alcohol immediately upon being screwed onto the thread. The continuous contact continuously sanitizes the valve surface, eliminating reliance on human timing and forming a physical seal against environmental contamination.

Surgeine’s disinfectant caps achieve a validated >99.99% (Log-6) kill rate against key healthcare-associated pathogens—including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Candida albicans—within 60 seconds of contact. Once applied, the cap can remain securely in place to maintain a continuous protective barrier for up to 7 days if the line is not accessed.

Yes. Our disinfectant caps are designed with universal ISO 80369-7 compliant female luer lock threads. They fit securely onto all major medical brands of needleless access valves, extension sets, blood sampling ports, and central venous catheter lumens without causing stress cracking or deformation of the valve housing.

Preventing alcohol evaporation is critical for maintaining product shelf life. Surgeine uses high-barrier aluminum laminate foil structures for individual packaging. Automated thermal sealing parameters are monitored continuously in our cleanrooms to ensure hermetic seals. Accelerated and real-time stability testing confirms full 70% IPA saturation and fluid retention over a 3-year shelf life.

Surgeine Healthcare holds ISO 13485:2016 certification and CE marking under EU MDR 2017/745. For importers and GPO tenders, we provide comprehensive technical dossiers, including Declarations of Conformity, ISO 10993 biocompatibility test reports, microbial challenge study data, sterilisation validation documentation, and sample artwork formatted for regional language requirements.

Yes. We support extensive OEM and private label programs for medical device distributors worldwide. Customization options include custom housing colors, private label foil printing, specialized shelf cartons, and pre-sterilized inclusion within our Plavus® Custom Surgical Procedure Packs or CVC Dressing Change Trays.

Global Supply & Partnerships

Secure OEM Supply of High-Performance Disinfectant Caps

Partner with Surgeine Healthcare to upgrade your vascular access infection prevention portfolio. Whether you require standard bulk supply, private-label packaging, or custom integration into procedure kits, our engineering team is ready to support your market growth.

Contact our international sales team today to request samples, technical dossiers, and volume wholesale pricing.

Surgeine Healthcare Infection Prevention Solutions