Global Compliance & Rigorous Quality Control Standards
At Angiplast Pvt. Ltd., quality assurance forms the core of our manufacturing philosophy. Operating in full alignment with international medical device directives, our quality management system ensures that every disposable medical device meets stringent criteria for safety, biocompatibility, and operational performance.
Documented Quality Surveillance Across All Manufacturing Stages
Our integrated Quality Assurance system covers a systematic, fully documented, and comprehensive series of physical, chemical, microbiological, and visual inspections at every stage of production. From raw material intake to final pouch sealing and sterilisation release, every batch is held to strict quality metrics.
- Raw Material Control: Comprehensive chemical and physical verification of medical-grade polymers prior to moulding.
- In-Process Monitoring: Continuous dimensional and operational checks during extrusion, injection moulding, and assembly.
- Cleanroom Assembly: Controlled manufacturing in Class 10,000 (ISO Class 7) environments to ensure minimal bioburden.
- Batch Traceability: Complete lot tracking from resin batch to final sealed pouch for simplified tender audits and product registration.
Certified Regulatory Approvals
Our manufacturing plant operates under Good Manufacturing Practices (GMP) and holds ISO 13485:2016 certification audited by Presafe (DNV GL & NEMKO). Our product portfolio carries CE marking for distribution across the European Economic Area, and selected medical device families hold US FDA 510(k) clearances.
ISO 13485 & International Compliance Certificates
We maintain fully audited technical dossiers, stability test summaries, biocompatibility reports, and Free Sale Certificates (FSC) to assist international buyers and distributors with rapid country registration and hospital tender clearance.
ISO 13485:2016
Certified Quality Management System for Medical Devices
CE Marking Certification
European Medical Device Directive Compliance (EEC)
US FDA 510(k) Cleared
Cleared Device Lines for Global Procurement
GMP Compliance
Good Manufacturing Practice & Cleanroom Validation
State-of-the-Art Quality Control Laboratory
Angiplast operates a modern, fully equipped testing laboratory managed by experienced microbiologists, polymer engineers, and quality assurance specialists. Every production lot undergoes multi-stage testing before final release.
Microbiological & Sterility Testing
Routine bioburden monitoring, bacterial endotoxin testing (LAL test), and sterility testing to guarantee zero microbial contamination in finished sterile packs.
Physical & Dimensional Inspection
Optical comparator profiling, wall thickness measurement, tensile strength testing, solvent bond joint testing, and pressure leak verification.
Chemical & Toxicity Analysis
Evaluation of raw resin purity, heavy metal presence, extractables/leachables testing, and ETO sterilizer gas residual (EO & ECH) analysis.
Key Infrastructure & Technical Capabilities
Controlled Injection Moulding
Precision moulding area equipped with modern electric and hydraulic presses operated by trained technical teams.
High-Frequency RF Welding & Printing
Automated RF welding for bag production, precise graduations, and clear silk-screen medical printing.
Class 10,000 Cleanroom (ISO Class 7)
Hygienic, positive-pressure cleanrooms with HEPA filtration for component assembly and primary packaging.
Captive ETO Sterilisation Plant
In-house ethylene oxide sterilisation chambers featuring automated cycles and micro-biological validation controls.
Sterile Medical Disposables Manufactured to Global Standards
All single-use medical devices produced across our nine core product lines strictly adhere to our ISO 13485 quality system and CE technical documentation standards.
Infusion Therapy
IV infusion sets, measured volume burette sets, microbore extension lines, and needle-free infusion valves built for accurate flow and pressure resistance.
Transfusion Therapy
Blood administration sets, blood collection accessories, and inline blood filter systems engineered to protect against haemolysis.
Dialysis Disposables
Haemodialysis blood tubing sets, AV fistula needles, and transducer protectors manufactured with uniform priming volume.
Gastroenterology
Ryle's tubes, infant feeding tubes, enteral feeding bags, and stomach tubes with smooth atraumatic distal tips and clear visual depth marks.
Urology Devices
Foley balloon catheters, urine collection bags, urinemeter drain systems, and male incontinence accessories tested for leak-tight performance.
Anaesthesia & Respiratory
Oxygen masks, nebulizer masks, venturi masks, nasal oxygen cannulas, and ventilator breathing circuits compliant with breathing resistance specs.
Surgical Disposables
Closed wound drainage systems, thoracic drainage catheters, and suction tubing assemblies designed for sterile operating theatre workflows.
General Disposables
Essential hospital consumables, cord clamps, mucus extractors, and rectal catheters prepared for hospital supply chains.
Medical Components
Injection-moulded drip chambers, roller clamps, luer lock spikes, safety valves, and connector components for device assembly partners.
Require Quality Compliance Documentation or Tender Technical Packs?
Our regulatory team provides ISO 13485 certificates, CE declarations of conformity, US FDA submission files, and technical product specifications for international procurement requirements.
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