MC-V12 Vacuum Decay Leak Detector

MC-V12 Vacuum Decay Leak Detector utilizes high-resolution absolute pressure sensor technology to detect both gross and fine leaks by monitoring vacuum level changes within a test chamber over a preset time. Its broad compatibility makes it suitable for most products and packaging types, widely used in pharmaceutical manufacturing.

The MC-V12 utilizes vacuum decay according to ASTM standard test method, the FDA, EMA, WHO, PIC/S, NMPA recognized consensus for non-destructive detection of leaks in packages by vacuum decay. The method is in line with new guidelines outlined in USP1207 preferring deterministic and objective methods that provide reliable and repeatable results.

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Test Method

Vacuum Decay

Application

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Applicable packaging types

Vials, PFS, BFS, cartridge bottles, nasal spray bottles, etc
Applicable drug types

lyophilized powder, powder, liquid

Features

01

Non-destructive, deterministic test method
02

Ideal for leaks in containers filled with dry contents and liquids
03

Delivers high levels of sensitivity, repeatability, and accuracy
04

Identifies defects down to 1-2 μm under ideal condition
05

User-friendly operation streamlines inspection and validation processes
06

Developed based on ASTM F2338 test method
07

In line with FDA 21 CFR part 11 standard

Technical Specifications

Parameter	Parameter Value
Interface	Touch Screen
Dimensions	390 × 350 × 390 mm (LxWxH)
Weight	21 kg
Power Supply	100-240 VAC, 50/60 Hz

More Information

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Frequently Asked Questions

Q:
What is the difference between probabilistic and deterministic test methods?

A:

Probabilistic and deterministic methods differ fundamentally in principle, output, and reliability.

- Probabilistic methods (e.g., microbial ingress, dye ingress) – Results are influenced by variable factors. Output is typically qualitative or semi‑quantitative, and cannot precisely locate or size leaks. They provide probability‑based, indirect evidence of integrity.

- Deterministic methods (e.g., vacuum decay, laser-based headspace analysis) – Based on physical principles, measuring quantifiable parameters to directly detect leaks. Results are objective, quantitative, and highly repeatable, enabling calibration, trend analysis, and statistical process control. They provide a higher level of assurance and reliability.
Q:
What is Container Closure Integrity (CCI)?

A:

Container Closure Integrity (CCI) refers to the ability of a packaging system to prevent product loss, microbial ingress, and entry of gases (oxygen, air, water vapor, etc.) or other substances, thereby ensuring that the drug product remains safe and meets quality standards throughout its shelf life.

For injectable packaging systems, CCI requirements fall into three categories:

1. maintain sterility and product composition without the need to preserve headspace gas;

2. maintain sterility, product composition, and headspace gas;

3. for multi-dose containers that must maintain sterility after opening – prevent microbial ingress and product leakage during use. CCI studies for injectable products should be tailored to product characteristics.

A packaging system is generally considered to have acceptable CCI when it has passed or is capable of passing a microbial challenge test. In a broader sense, CCI means the absence of any leakage that could compromise drug quality. Based on scientific research and risk assessment, the Maximum Allowable Leakage Limit (MALL) should be determined considering packaging composition and assembly, product contents, and the environment to which the product may be exposed over its lifecycle. If a package’s leakage does not exceed its MALL, the closure system is considered integral.
Q:
Which regulations and guidelines address Container Closure Integrity?

A:

Key regulatory and technical guidance documents for CCI include:

- EU GMP Annex 1 – Mandates container closure integrity verification and testing for terminally sterilized products, with differentiated requirements based on container type.

- USP <1207> – A comprehensive technical guide widely accepted as the industry standard, systematically describing test method categories, selection, validation, and lifecycle application. FDA guidance also permits physical CCI testing as an alternative to some sterility tests in stability studies.

- China NMPA – "Technical Guideline for Packaging System Integrity Study of Chemical Injectables (Trial)" – Signals increasing regulatory attention and alignment with international standards.