Infusion Therapy
Infusion sets, IV cannulas, measured volume sets, needle-free infusion lines, microbore extension lines, and scalp vein sets manufactured with precision flow controls.
Advanced Manufacturing Standards
Class 10,000 Cleanroom Infrastructure & Environmental Controls
Operating over 50,000 square feet of modern manufacturing floor space in Ahmedabad, Gujarat, Angiplast Private Limited maintains strict controlled environmental conditions engineered specifically for high-volume single-use medical disposable production.
Our core assembly operations take place inside an audited Class 10,000 (ISO Class 7 equivalent) Cleanroom Facility. Backed by dedicated HVAC micro-filtration systems, constant air-pressure differential controls, and routine particulate testing, our cleanroom environment guarantees minimal particulate contamination and controlled bioburden levels prior to final packaging and sterilization.
- 50,000+ sq. ft. modern manufacturing facility with Class 10,000 cleanroom setup
- Adept workforce of over 300 skilled technicians and medical polymer engineers
- Rigorous HEPA air filtration, positive pressure differential, and temperature-humidity monitoring
- Comprehensive particulate and microbiological air monitoring protocols
- Fully integrated cleanroom packaging system (Form-Fill-Seal & pouch sealing)
Class 10,000 Clean Room · ISO 13485 Certified
Integrated Production Technology
Controlled Moulding & Polymer Processing Capabilities
From medical-grade raw polymer resins to complex sub-assemblies, Angiplast operates precision equipment controlled by automated parameters to ensure zero-defect output for overseas healthcare importers and OEM partners.
01
Precision Injection Moulding
High-speed, multi-cavity injection moulding lines running in controlled environments to produce medical components like Luer connectors, spikes, roller clamps, and drip chambers.
02
Tubing Extrusion Lines
Automated extrusion machinery processing non-toxic, kink-resistant medical-grade PVC, TPU, and DEHP-free polymers with strict wall-thickness tolerances.
03
RF Sealing & Ultrasonic Welding
High-frequency Radio Frequency (RF) sealing machines for leak-proof urine bags, colostomy bags, and drainage pouches, combined with ultrasonic welding for rigid components.
04
Catheter Tipping & Hole Punching
Specialized automated tipping and thermal punching machinery producing smooth, atraumatic tips and side eyes on Foley catheters, feeding tubes, and suction lines.
05
Solvent Bonding & Jig Assembly
Ergonomic cleanroom assembly lines equipped with micro-dosing solvent bonding fixtures, ensuring robust tensile pull-strength across infusion tubing lines.
06
Automated Form-Fill-Seal Packaging
Medical-grade pouch sealing, blister packing, and form-fill-seal machinery utilizing breathable Tyvek and medical paper-film packaging materials.
In-House ETO Gas Sterilisation Plant
Quality Assurance & Safety
Captive ETO Sterilization Plant & Testing Laboratory
To eliminate dependence on third-party vendors and safeguard product turn-around times, Angiplast operates a captive Ethylene Oxide (ETO) Gas Sterilization Plant on site.
Sterilization processes follow ISO 11135 validated cycles, including pre-conditioning, gas exposure, vacuum cycles, and forced aeration to ensure residual EO gas levels remain well below international safety limits (EN ISO 10993-7).
In-House QC & Biological Laboratory
Our fully certified Quality Control Laboratory conducts complete raw material testing, in-process inspection, and finished goods testing before release:
- Sterility & Bioburden Testing: Validated bacterial endotoxin testing (LAL test), sterility assays, and microbial limit testing.
- Physical & Mechanical Testing: Tensile strength verification, leak-rate pressure testing, burst pressure, and drop-rate testing.
- Chemical & Biocompatibility Analysis: Chemical purity, UV absorption, heavy metal limits, and residual gas chromatograph analysis.
Production Portfolio
Medical Disposables Manufactured at Our Facilities
Our infrastructure supports mass production of single-use devices engineered for intensive care, dialysis, surgery, and general hospital applications.
Transfusion Therapy
Blood transfusion sets and blood administration lines fitted with 200-micron filters for hemolyzation-free blood component delivery.
Dialysis Range
Haemodialysis blood tubing lines, AV fistula needles, and transducer protectors produced under exact volumetric and non-pyrogenic standards.
Gastroenterology
Ryle's tubes, infant feeding tubes, enteral feeding bags, and stomach tubes featuring radiopaque depth lines and rounded atraumatic tips.
Urology Disposables
Foley balloon catheters, urine collection bags, urine meter drainage bags, male incontinence devices, and Nelaton catheters.
Anaesthesia & Respiratory
Oxygen masks, nebulizer masks, venturi masks, nasal oxygen cannulas, ventilator circuits, and suction catheters.
International Compliance
Certified Quality Management & Audit Systems
Our manufacturing facility and product lines are certified to meet international regulatory standards, simplifying customs clearance, medical device registration, and tender submissions for global healthcare importers.
ISO 13485:2016
Medical Device QMS
Fully audited quality management system governing design, raw material procurement, cleanroom moulding, and traceable lot release.
CE Marking
European Conformity
Products conform with European Medical Devices Directive (MDD/MDR) supported by Technical Files and EU Declaration of Conformity.
US FDA 510(k)
Cleared Device Lines
Selected medical device product ranges hold US FDA 510(k) clearances, validating bio-compatibility and performance parameters.
GMP Compliant
Good Manufacturing Practice
Facilities strictly abide by WHO-GMP guidelines, cleanroom hygiene controls, CAPA workflows, and continuous air quality testing.
Purchasing & Audit FAQ
Frequently Asked Questions About Our Facilities
Key information for international hospital procurement teams, importers, and contract manufacturing buyers.
Angiplast operates an audited Class 10,000 (ISO Class 7 equivalent) Cleanroom facility spanning over 50,000 square feet. All device assembly, component joining, leak testing, and primary packaging are conducted inside this environmental cleanroom zone under positive HVAC air pressure.
Yes, we operate an in-house Ethylene Oxide (ETO) sterilisation plant equipped with validated cycles per ISO 11135 standards. Captive sterilisation guarantees full batch traceability, rapid turnaround times, and strict control over residual gas aeration.
Yes. We welcome physical factory audits from regulatory authorities, pharmaceutical partners, and distributor quality teams. Virtual video audits and complete documentation access (Master Files, ISO certificates, CE technical dossiers) can also be arranged by contacting our export team.
Yes, contract manufacturing (CDMO / OEM) is one of our primary core businesses. We provide custom tool design, cleanroom moulding, customized extrusion, private-label artwork design, multilingual IFU printing, UDI barcoding, and custom kit assembly.
Require High-Volume Medical Disposables or OEM Production?
Get in touch with our technical sales specialists to review facility capabilities, request cleanroom audit reports, or receive product sample kits.