Vacuum Decay

Test Principle of Vacuum Decay Leak Testing

This Vacuum Decay Leak Testing method detects package leaks by measuring the rise in pressure (vacuum loss) in an enclosed evacuated test chamber containing the test package. Vacuum loss results from leakage of test package headspace gases and/or volatilization of test package liquid contents located in or near the leak. The method requires a test chamber to contain the test package and a leak detection system designed with one or more pressure transducers.

This method is especially suitable for pharmaceutical packaging because it is:

• Non-destructive
• Quantitative and objective
• Suitable for routine quality control
• Compatible with deterministic CCIT validation
• Useful for detecting micro leaks in rigid and selected flexible packages

Vacuum Decay Leak Test Equipments in Our Lab

PTI VeriPac 355, PTI VeriPac 455, Zholion MC-V12 vacuum decay leak tester, Zholion RC-V12 auto vacuum leak detector, Zholion MC-DUO Dual System Packaging Leak Detector

Vacuum Decay for Pharmaceutical CCIT

In pharmaceutical production, package leaks may lead to microbial ingress, oxygen ingress, moisture exchange, product loss, or sterility failure. Vacuum Decay Leak Testing provides a reliable way to evaluate container closure integrity without destroying the sample.

Zholion Vacuum Decay Leak Detector solutions are designed to support:

• CCIT method development
• Routine batch release testing
• System suitability testing
• Package integrity validation
• Stability study support
• Transportation and shipping impact evaluation
• Regulatory audit documentation

By using validated Pharmaceutical Vacuum Decay Testing, manufacturers can improve package quality control and reduce the risk of undetected leakage.

Regulatory Requirements

USP<1207>

USP <1207> requires that deterministic test methods shall be prioritized over probabilistic methods and shall be validated to demonstrate detection capability relative to the product’s Maximum Allowable Leakage Limit.

Deterministic test methods (including vacuum decay, high-voltage leak detection, laser-based headspace analysis, and pressure decay) shall be used to provide quantitative, objective, and reproducible results for container closure integrity verification.

Deterministic methods are required to be validated to demonstrate the ability to reliably detect leaks at or below the product‘s MALL.

Vacuum decay is an FDA-recognized consensus standard for package integrity testing. USP <1207> refers to ASTM F2338 as the reference standard for vacuum decay technology.

Compliance with USP <1207> requires adopting validated, deterministic leak detection methods that offer high sensitivity and reproducibility. Among the available technologies, vacuum decay testing is recognized for its non-destructive nature and ability to detect microleaks reliably.

ASTM F2338

ASTM F2338 is the technical method standard for vacuum decay leak detection, referenced by USP <1207> and recognized by the FDA as a Consensus Standard.

Leak detection is based solely on measuring the rise in pressure (vacuum loss) inside an enclosed evacuated test chamber containing the test package.

Vacuum loss results from headspace gas leakage and/or volatilization of liquid contents in or near the leak.

Test results are qualitative (Accept/Reject). Sensitivity is package- and product-specific, requiring development and validation for each product-package system.

Standard detection limits for rigid nonporous packages is 5 μm diameter hole defects (gas or liquid leakage).

EU GMP Annex 1

EU GMP Annex 1 requires mandatory container closure integrity validation for all sterile products and expects deterministic CCIT methods to be implemented for fused containers, with methods referencing USP <1207> and ASTM F2338 as compliant standards.

CCIT is mandatory for sterile products—no exceptions.

For fused containers (glass ampoules, BFS), manufacturers shall implement deterministic methods for verifying container integrity. Visual inspection alone is not acceptable as a container closure integrity test method.

Probabilistic methods (dye ingress, bubble testing) are no longer acceptable for sterile product lines.

EU GMP Annex 1 now fully aligns with USP <1207> and ASTM F2338-24. Methods like vacuum decay, which directly measure pressure changes in sealed containers, are fully recognised as compliant.

Container closure integrity validation shall take into consideration any transportation or shipping requirements that may negatively impact the integrity of the container (e.g., vibration, temperature/humidity excursions).

YY/T 0681.18-2020

China‘s NMPA has published YY/T 0681.18-2020, a medical device industry standard that adopts the vacuum decay method as a validated physical integrity testing method.

Vacuum decay method (YY/T 0681.18-2020) released by NMPA on 31 March 2020.

Physical integrity test methods (e.g., pressure/vacuum decay) may be used for packaging system seal integrity testing, with method validation required.

Stability study data of not less than six months shall generally be provided to support the method.

Key Advantages of Zholion Vacuum Decay Testing

• Non-destructive CCIT method: Suitable for package integrity testing without damaging samples.
• High sensitivity for micro leaks: Helps detect small defects that may affect sterility or product quality.
• Objective test results: Provides measurable pressure change data for accept/reject decisions.
• Supports USP <1207> compliance: Designed for deterministic container closure integrity testing.
• Custom test chambers available: Adaptable to different container sizes, shapes, and packaging formats.
• Suitable for routine QC: Can be used for batch testing, system checks, and validation support.
• Multiple equipment options: Zholion offers manual, automatic, and dual-system vacuum decay leak detection solutions.

Applicable Package Types

Zholion Vacuum Decay Leak Testing solutions can be applied to many pharmaceutical and medical packaging formats, including:

• Vials
• Ampoules
• Prefilled syringes
• Cartridges
• BFS containers
• IV bags
• Eye drop bottles
• Nasal spray bottles
• Plastic bottles
• Medical device sterile packaging
• Other sealed pharmaceutical containers

Different package structures, materials, headspace conditions, and fill volumes may require customized chambers, test fixtures, and method parameters.

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