Sepha - Leak Testing Get latest price

Read more...

To contact MPI Australia about Sepha Leak Testing use Get a quote.

Applications

• Pharmaceutical blister pack integrity testing

• Container Closure Integrity Testing (CCIT) for vials, ampoules & syringes

• Flexible packaging leak detection (pouches, sachets, bags, stick packs)

• Parenteral product packaging verification

• Blow-Fill-Seal (BFS) container testing

• Drug stability studies & R&D validation

• Routine Quality Assurance (QA) testing

• Medical device packaging integrity

Key Features

• Non-destructive, deterministic leak detection

• Detects leaks as small as 1–10 microns (model dependent)

• Compliant with ASTM F2338-24, ASTM F3169-16 (2024), and USP 1207

• FDA 21 CFR Part 11 compliant data handling

• Tool-free or quick tooling changeover options

• Objective pass/fail results (no operator bias)

• Fast test cycles (from 10–60 seconds depending on method)

• USB, Ethernet, OPC & Active Directory connectivity

• Compact lab-scale and production-scale options available

Specifications (Model Dependent)

• Leak Detection Sensitivity:

  • Down to 1µm (Multi-Q HD – parenteral applications)

  • Down to 5µm (Vacuum Decay / VisionScan 3D)

  • Down to 10µm (Force Decay systems)

• Test Methods Available:

  • Vacuum Decay

  • Pressure Decay

  • Force Decay

  • Vacuum Deflection (Blister Testing)

  • Flexible Membrane Testing

• Test Cycle Time: From 10 seconds

• Power: 110/230V Single Phase

• Compressed Air: Minimum 200L/min at 0.6 MPa (ISO8573-1:2010 Class 2)

Why Choose Sepha?

• Eliminates destructive dye testing

• Reduces production waste and product loss

• Enables tested packs to return to the production line

• Improves early leak detection and reduces recalls

• Provides objective, repeatable, audit-ready results

• Supports regulatory compliance for pharmaceutical manufacturers

• Fast return on investment

Sepha’s technology is trusted globally by leading pharmaceutical and medical device manufacturers to ensure packaging integrity and patient safety.

Targeted Segments

• Pharmaceutical manufacturers

• Parenteral & sterile injectable producers

• Medical device manufacturers

• Contract Manufacturing Organisations (CMOs)

• Quality Control Laboratories

• R&D and Stability Testing Labs

• Packaging companies & converters

Read less...

To contact MPI Australia about Sepha Leak Testing use Get a quote.