Flexible Pouches and Sachets: Vacuum Decay CCI

Overview

Flexible pouches and sachets are among the most format-diverse applications PTI tests, spanning single-chamber sealed sachets, multi-cavity pouches with several independent compartments, and pouches used as a secondary sterile barrier around a rigid item such as a prefilled syringe. PTI's approach is unique in that it typically deploys a flexible test chamber. This chamber design allows for more sensitive and practical leak detection.

Fill content varies— liquid and semi-solid pharmaceutical or food fills, dry fiber-based medical materials, and secondary pouches that simply contain a rigid, sealed component rather than a bulk fill. Package populations can be created based on sealing stations or sealing conditions to identify systematic quality conditions.

Sample & Container Type

• Sealed flexible pouches and sachets — foil-laminate and multi-layer film formats
• Single-chamber and multi-cavity (side-by-side or nested) configurations
• Pouches used as secondary packaging around a rigid primary container such as a syringe

Product Class & Rheology

• Liquid and semi-solid pharmaceutical and food products
• Dry solid materials such as fiber-based medical dressings
• Empty or product-filled rigid containers packaged inside a secondary pouch

General Test Method

Defect challenges are introduced as calibrated micro-holes (drilled or laser-cut, most often 15–30 microns and up) and, for secondary syringe/device pouches, as intentionally mis-sealed or channel-leak samples representing realistic sealing-process failures rather than only idealized round holes. Where a pouch serves as secondary packaging, testing also evaluates whether the pouch and the primary container should be qualified together or separately. It is critical to verify that both large and small leaks can be detected, as many test solutions fail to properly detect large leaks.

Typical Findings & Sensitivity

PTI consistently demonstrates reliable separation of defective from intact pouches in the 15–30 micron range for single- and multi-cavity liquid or solid-fill designs, with larger catastrophic defects (gross seal openings, dislodged fitments) being detectable with the right test method. Pouch CCI is highly format- and defect-type-dependent, so PTI matches chamber selection, method development, and defect-challenge strategy to the specific pouch and failure mode of concern.

Frequently Asked Questions

1. Can multi-cavity pouches be tested cavity by cavity?

Yes. Each cavity's seal population is evaluated individually, since baseline variability can differ by cavity position within the sealing tooling used in production.

2. Can a pouch containing a syringe be tested as a single unit?

Yes, the outer wrap of a device can be tested using vacuum decay if it is non-porous. For porous packaging consider airborne ultrasound.

3. What sensitivity is typical for pouches and sachets?

Reliable separation of defective from intact pouches in the 15–30 micron range is typical for single- and multi-cavity liquid or solid-fill designs.

4. How are catastrophic defects distinguished from micro-leaks?

Catastrophic defects such as gross seal openings or a dislodged fitment are confirmed using the single-sample chamber approach, since a multi-sample chamber can mask this failure mode as the pouch empties out during evacuation.

Why Clients Choose PTI for This Application

Rather than applying one generic pouch recipe regardless of format, PTI first characterizes which defect types and sizes matter most for a client's specific seal and fitment design, then builds the chamber design, sample throughput, and defect-challenge strategy around that reality.