ISO 13485 & CE Certified Single-Use IV Administration Sets, Burette Lines, Extension Tubing & Vascular Access Devices for Global Healthcare Buyers.
Angiplast Private Limited has specialized in manufacturing high-precision single-use Infusion Therapy devices since 1994. Engineered inside our Class 10,000 (ISO Class 7) cleanroom facility in Ahmedabad, India, our infusion range adheres strictly to ISO 8536-4, ISO 10555, and European CE standards.
Whether you require standard IV infusion sets, DEHP-free oncology administration lines, needle-free safety extension sets, or pediatric burette systems, Angiplast delivers complete regulatory compliance, reliable flow rates, and customizable CDMO/OEM contract manufacturing options for hospital suppliers and pharmaceutical partners worldwide.
Engineered for smooth gravity-fed administration of fluid solutions. Features an ergonomic spike, clear flexible drip chamber, and high-precision roller clamp for exact flow regulation.
Designed for accurate volumetric infusion of small medication doses in pediatric and neonatal care. Features a 100ml / 150ml cylindrical graduated burette with automatic shut-off float valve.
Integrated with needle-free positive/neutral displacement valves to safeguard clinical staff against needle-stick injuries and prevent catheter-related bloodstream infections (CRBSI).
Formulated with Polyurethane (PUR) or Polyolefin lining to prevent plasticizer leaching and drug absorption during administration of sensitive pharmaceuticals and taxanes like Paclitaxel.
Co-extruded amber-tinted tubing and chamber shielding light-sensitive medications (vitamin infusions, oncology agents, parenteral nutrition) from UV degradation during administration.
Equipped with an integrated mechanical flow regulator dial for accurate dose control ranging from 5 ml/h to 250 ml/h, eliminating the need for expensive infusion pumps in standard wards.
Intravenous catheter with atraumatic needle bevel, color-coded casing (14G–26G), and wings for secure skin fixation. Available with safety self-activating needle-shielding mechanisms.
Lipid-resistant 3-way stopcocks rated up to 4.5 bar pressure, paired with high-pressure microbore and standard extension lines for multi-way intravenous drug administration.
Flexible color-coded wings with ultra-sharp Japanese stainless steel needle and kink-resistant tubing for comfortable short-term venipuncture and pediatric infusions.
Our OEM production processes are strictly monitored to meet international pharmacopoeia guidelines and medical device directives. Every batch undergoes 100% physical, chemical, and biological verification prior to shipment.
| Performance Parameter | Standard Specification | Quality Assurance Protocol |
|---|---|---|
| Cleanroom Environment | Class 10,000 / ISO Class 7 | Continuous airborne particle counts & bioburden monitoring |
| Sterilization Method | Ethylene Oxide (ETO) Gas | EN ISO 11135 validated cycle; Residual EO < 10 ppm |
| Fluid Path Integrity | ISO 8536-4 / ISO 10555-5 | 100% hydrostatic and pneumatic leak testing up to 4.5 bar |
| Biocompatibility | ISO 10993 Compliant | Cytotoxicity, systemic toxicity, pyrogenicity & hemocompatibility verified |
| Flow Rate Calibration | 20 drops/ml = 1±0.1ml; 60 drops/ml = 1±0.1ml | Gravimetric flow rate automated verification |
| Regulatory Approvals | CE Marking, ISO 13485:2016 | Full Technical File (MDR 2017/745 ready) & FSC available |
Angiplast serves as an end-to-end CDMO partner for multinational pharmaceutical companies, national health ministries, and private-label hospital brands. We transform your custom drawings or technical requirements into finished, market-ready sterile medical disposables.
In-house toolmakers and precision injection moulding machines capable of developing custom spikes, chamber caps, stopcocks, and specialized connectors.
Medical-grade paper pouch sealing, customized primary blister packaging, barcoded cartons, and multi-lingual Instructions for Use (IFU).
Complete regulatory support including CE Technical Dossiers, ISO certificates, Free Sale Certificates (FSC), and stability study reports for registration.
Our ETO-sterilized single-use infusion sets carry a validated 5-year shelf life when stored in original sealed packaging under cool, dry conditions (temperature between 5°C and 40°C) away from direct sunlight.
Standard catalogue items typically ship with an MOQ of 10,000 to 20,000 units depending on the SKU. Customized private-label packaging or custom OEM tubing configurations generally require one full production lot run.
Yes. All of our infusion therapy lines can be produced using 100% latex-free injection sites and DEHP-free / PVC-free medical grade polymers to meet rigid national hospital tender specifications.
We supply complete regulatory dossiers including ISO 13485 certificates, CE certificates of conformity, Certificate of Analysis (COA) per batch, Sterilisation Validation reports, and apostilled Free Sale Certificates (FSC).
Connect directly with our international export managers. Share your SKU specifications, target tender requirements, or OEM design drawings for immediate pricing and sample dispatch.
