USP <1207> has shifted routine industry practice toward deterministic, physical CCIT methods over probabilistic dye- or microbial-ingress testing, but implementing a compliant deterministic program requires more than buying an instrument - it requires method development matched to each specific container-closure system, defined maximum allowable leakage limits (MALL), and validated correlation to product quality risk.
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High Quality
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Advanced Equipment
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Professional Team
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
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Custom Service
Integrated factory strength to support all kinds of tape customization,with paper base,cloth base,glue,coating all raw material production capacity
Regulatory Basis
USP <1207> has shifted routine industry practice toward deterministic, physical CCIT methods over probabilistic dye- or microbial-ingress testing, but implementing a compliant deterministic program requires more than buying an instrument - it requires method development matched to each specific container-closure system, defined maximum allowable leakage limits (MALL), and validated correlation to product quality risk.
Our Solutions
Our deterministic CCIT program centers on vacuum decay and Pressure decay method two core quantitative test methods, with method development support to establish maximum allowable leakage limits for your specific container-closure system, per USP <1207.1> guidance. The platform is designed for small-batch R&D formulation screening, pilot trial testing and high-volume routine production release testing, and validation documentation packages are provided to support <1207.2> qualification. As the manufacturer we offer customized method verification protocols, full GMP-compliant IQ/OQ/PQ validation files, on-site CSV computerized system validation service, free firmware upgrades for USP standard iteration, remote technical troubleshooting and long-term annual calibration contracts.
Our Products
Packaging Leak Tester MFT-900
Packaging Leak Tester MFT-600
Packaging Leak Tester MFT-1000
Our Services
USP <1207> Compliant CCIT Test Method Development & Analytical Validation Services
1. Research and determination of Maximum Allowable Leakage (MAL / MALL) for package leakage
2. Test method development, parameter optimization and analytical method validation in accordance with ICH Q2 guidelines
3. System Suitability Testing (SST), calibration of positive control drilled samples, and delivery of full validation reports
4. Documentation rectification and support for audits by FDA, EMA and NMPA
FAQ
Q1: What is the difference between USP <1207>, <1207.1>, and <1207.2>?
A1: <1207> introduces CCIT concepts and method categories, <1207.1> covers criteria for selecting a deterministic method, and <1207.2> covers method validation and qualification approaches.
Q2: What is a maximum allowable leakage limit (MALL) and who sets it?
A2: MALL is the largest leak size a container-closure system can have while still protecting sterility and product quality; it is typically established by the manufacturer through risk assessment and correlation studies specific to their product and container.
Q3: Is vacuum decay suitable for all container types?
A3: Vacuum decay works well for many rigid containers but may need adaptation or an alternative method for certain flexible or complex geometries - method selection should follow <1207.1> criteria.
Q4: How does deterministic CCIT support faster batch release?
A4: Because it produces an immediate, objective physical measurement rather than requiring incubation (as with microbial ingress testing), deterministic CCIT can shorten the testing timeline within a release cycle.