Cardiology Packaging Manufacturer IndiaCardiac Catheter & Implant Packaging, Cleanroom Class 8 · Vapi
Custom PETG thermoformed cardiology packaging — cardiac catheter packaging, pacemaker lead trays, cardiac valve packaging, coronary stent packaging. Cleanroom Class 8, GMP, ISO 9001:2015. Cardiology packaging manufacturer from Vapi, Gujarat.
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photoCardiology Packaging Manufacturer IndiaCardiac Catheter & Implant Packaging, Cleanroom Class 8 · Vapi
Trizen Packaging manufactures cardiology packaging from our Cleanroom Class 8, GMP-compliant, ISO 9001:2015 certified facility in Vapi, Gujarat — custom PETG thermoformed packaging for the complete cardiology and cardiac surgery device range. Cardiology packaging manufacturer from Vapi for cardiac catheterization device companies, electrophysiology device manufacturers, cardiac implant companies, and cardiac surgery instrument manufacturers across India and for export.
Cardiology medical device packaging covers both interventional cardiology devices (catheters, stents, balloons used in catheterization laboratory procedures) and cardiac implants (pacemakers, ICDs, cardiac valves) — the highest value and most life-critical category in medical device packaging. Cardiac implant packaging must protect devices worth tens of thousands of dollars through the supply chain. Cardiac catheter packaging must protect delicate balloon and stent systems from any mechanical damage that would cause device failure during a cardiac intervention procedure.
| Medical Device / Application | Packaging Format | Material | Key Requirement |
|---|---|---|---|
| Cardiac Catheter Packaging | PETG face seal blister tray — cardiac catheter in linear format | Medical-grade PETG | Catheter tip protection, curve radius maintenance, hub geometry, face seal flange |
| Coronary Stent Delivery System Packaging | PETG face seal blister — stent delivery system in linear cavity | Medical-grade PETG | Balloon protection, stent crimped-profile clearance, hub geometry |
| Pacemaker Lead Packaging | PETG thermoformed tray — pacemaker lead in coiled format | Medical-grade PETG | Lead coil geometry, connector protection, minimum bend radius, tip protection |
| Electrophysiology Catheter Packaging | PETG face seal blister — EP catheter in curve-maintained format | Medical-grade PETG | Electrode tip protection, catheter curve radius, handle mechanism clearance |
| Cardiac Valve Packaging | PETG thermoformed tray — cardiac valve in sterile solution cavity | Medical-grade PETG | Valve leaflet protection, suture cuff clearance, sterile presentation, large cavity format |
| ICD & CRT Device Lead Packaging | PETG thermoformed tray — ICD lead in coiled format | Medical-grade PETG | Lead coil minimum bend radius, connector protection, high-value device protection |
| Cardiac Surgery Kit Packaging | Multi-instrument PETG tray — cardiac surgery kit in procedural sequence | Medical-grade PETG | All instruments in procedural sequence, sterile kit presentation, face seal flange |
Cardiology Packaging — Technical Enquiry
Medical-grade PETG · Cleanroom Class 8 · GMP · ISO 9001:2015 · ISO 11607 compatible.
Cardiology PackagingSpecific Technical Requirements
Cardiology Packaging<< /span> Key Design Requirements
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01 / Cardiology control
Coronary Stent Balloon Clearance — No Packaging Contact on Balloon Profile
Balloon outer diameter confirmed from stent delivery system technical drawing. Cavity provides defined clearance zone over the balloon length — no packaging contact on balloon surface at any handling orientation.
Cardiology Packaging — Submit Device Drawing
Cleanroom Class 8 · GMP · ISO 9001:2015 · Medical-grade PETG · Validation support documentation.
Materials for Cardiology Packaging
| Material | Medical Application | Key Property |
|---|---|---|
| Medical-Grade PETG | Primary — face seal blister trays, lidded trays, all sterile barrier packaging components | EO and gamma compatible, ISO 11607 compatible, medical-grade additive specification, CoA per batch |
| Medical-Grade HIPS | Protective transit trays and secondary packaging where sterile barrier is not required | Good impact resistance, chemical resistance, cost-efficient for non-sterile-barrier applications |
| Medical-Grade PP | Non-sterile-barrier protective packaging — device presentation trays | Chemical resistance, dimensional stability, autoclave compatible grades available |
Why Medical Device Companies Choose Trizen for Cardiology Packaging
Frequently Asked QuestionsMedical device packaging
PETG thermoformed packaging for cardiac catheters, coronary stent delivery systems, pacemaker leads, electrophysiology catheters, cardiac valves, ICD and CRT device leads, and cardiac surgery kit packaging. Cleanroom Class 8, GMP, ISO 9001:2015. Cardiology packaging manufacturer from Vapi, Gujarat.
ISO 9001:2015, GMP, and Cleanroom Class 8 (ISO 14644-1 — 100,000 particles/m³). All medical packaging components produced in the Class 8 cleanroom with full GMP batch documentation per production batch.
Yes — medical-grade PETG is compatible with Ethylene Oxide (EO) sterilization and gamma radiation sterilization. EO compatibility confirmed by material CoA per production batch.
First article inspection report, dimensional inspection records per production batch, material CoA with medical-grade PETG specification per batch, batch records, ISO 9001:2015 certificate, GMP compliance documentation.
Cardiology packaging manufacturer Vapi — Cleanroom Class 8, GMP, ISO 9001:2015. Cardiology packaging manufacturer Gujarat for medical device companies. Medical packaging manufacturer from India for domestic and export medical device markets.
Trizen manufactures the thermoformed PETG packaging component — the tray or blister shell. Device loading, Tyvek/foil lidding, heat sealing, and sterilization are performed by the medical device manufacturer. Clear scope for DHF traceability.
First article: 14 to 21 business days from device technical drawing or sample — cleanroom CNC tooling at Vapi. ISO 9001:2015, GMP, and Cleanroom Class 8 documentation per production batch.
Cardiology Packaging — Cleanroom Class 8, GMP, ISO 9001:2015 · Vapi
Medical-grade PETG · ISO 11607 compatible · Validation documentation · Cleanroom Class 8 · Vapi, Gujarat