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What container closure integrity testing (CCIT) methods does Milestone Pharma offer?
Milestone Pharma offers a comprehensive range of container closure integrity testing (CCIT) methods to evaluate the integrity of pharmaceutical packaging systems, including vials, prefilled syringes, and other sterile containers.
Our capabilities include:
Deterministic Methods
Helium Mass Spectrometry Leak Testing
High-Voltage Leak Detection (HVLD)
Vacuum Decay Testing
Pressure Decay Testing
Laser-Based Headspace Analysis
Probabilistic Methods
Microbial Challenge Testing
Dye Ingress Testing
Bubble Emission Testing
Tracer Liquid Testing
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What types of large molecules and complex modalities can you characterize?
We support a broad range of modalities, including peptides, oligonucleotides, proteins, monoclonal and bispecific antibodies, vaccines, viral particles, VLPs, and antibody-drug conjugates. For complex formats, we can integrate DAR analysis, conjugation-site mapping, glycosylation profiling, impurity analysis, and particle characterization.
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Can your characterization package support comparability studies and global regulatory submissions?
Yes. Our integrated analytical packages are designed to support CMC development, process change evaluation, biosimilar comparability, formulation screening, stability studies, and submission-ready documentation for global regulatory filings.
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Can Milestone Pharma customize nitrosamine impurities or NDSRI reference standards that are not currently in stock?
Yes. We support custom synthesis, purification, and structural confirmation of nitrosamine impurities and NDSRIs. Customers may provide the target structure, CAS number, related API, required quantity, purity, and intended application so that we can evaluate feasibility and provide a quotation.
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What documentation and characterization data are provided with customized impurities or reference standards?
Each impurity or reference standard can be supplied with a Certificate of Analysis (CoA) and full characterization data, such as HPLC purity, ¹H-NMR, IR, MS/HRMS, and other supporting data based on project requirements.
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How do you ensure analytical methods meet global regulatory expectations?
Analytical methods should be developed and validated according to phase-appropriate requirements and relevant guidelines, such as ICH, USP, EP, NMPA, FDA, and EMA expectations. A compliant workflow should include risk-based method design, approved protocols, controlled documentation, data integrity practices, and scientifically justified acceptance criteria.
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What is the difference between method feasibility, method validation, and method verification?
Method feasibility is usually performed before validation to assess whether a method is suitable for its intended purpose. Method validation confirms that a non-compendial or developed method meets predefined performance criteria. Method verification use to confirm that the method performs acceptably for a specific API, product, or matrix.
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