Packaging container air leak test equipment
FUKUDA CO., LTD.
About This Product
■What is packaging container air leak test equipment?
This is a leak testing device that performs packaging integrity testing (CCIT) by identifying the presence or absence of peeling, tears, and pinholes in packaging containers for pharmaceutical products, etc. It can be applied to a wide variety of packaging containers, including flexible packaging, bottle containers, and glass containers. The measurement method uses the sealed chamber method (pressure change leak test method 1).
Quantitative testing is performed by placing a sample in a chamber, pressurizing or depressurizing it, and measuring the change in pressure within the chamber. It can be used in a variety of situations, including manufacturing offline, manufacturing inline, CMC laboratories, quality control laboratories, and stability testing. *The container to be inspected is called a workpiece or sample. Here, we refer to specific samples as samples and use different terminology.
■Features
・Ideal for packaging container integrity testing (CCIT), ensuring the quality of the product during its shelf life, confirming barrier properties (water vapor, oxygen, microorganisms, etc.), quantifying the amount of leakage, scientifically controlling quality, quantitatively Reproducible measurement results
- Compatible with GMP/validation (IQ, OQ) and data integrity (DI). Data protected by this is output to a PC or printer. Compliant with USP<1207>, JISZ2332:2012, JP18 reference information, printer output possible (optional)
■Leakage test in accordance with Japanese Pharmacopoeia/USP<1207> Pharmaceutical packaging integrity test (CCIT)
With improvements in the quality of pharmaceuticals and the internationalization of distribution, demand for quantitative testing on packaging containers is increasing. JP18 reference information includes "Integrity evaluation/leakage test method for sterile pharmaceutical packaging," and like USP<1207>, quantification using "maximum allowable leakage limit" is now required. In JP18 and USP<1207>, positive and negative controls are prepared and evaluated as a requirement for integrity evaluation.
■ Setting scene for “maximum allowable leakage limit”
When determining the "maximum allowable leakage limit", use the MSP series and the pseudo defect FPH series.
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Product
Packaging container air leak test equipment
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Handling Company
FUKUDA CO., LTD.
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Categories
1 Models of Packaging container air leak test equipment
| Product Image | Part Number | Price (excluding tax) | Additional tank | External dimensions/mass | External input/output | Measurement method | Operating temperature/humidity range | Pneumatic source | Power supply voltage/power consumption | Pressure range | Target work size | Test pressure range | Validation | Variety setting |
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MSP-0101-WWNV |
Available upon quote | None | W380×D560×H290mm・25kg | Serial 3Port (PC/printer/barcode reader), USB 1Port, Ethernet 1Port | Tank pressurization type, tank partial pressure type sealed chamber method (pressure change leakage test method 1) | 0~40℃45~85%RH (no condensation) | Please use clean dry air with a pressure of 0.4MPa or higher that does not fluctuate. Recommended conditions: Compressed air cleanliness class 1, 3, 1 according to JISB8392-1:2012 | AC100~240V50/60Hz100VA | Compound pressure specification (equipped with APU) | W130×D180×H65mm or less | 1~200kPaabs compound pressure specification (equipped with APU) | Can be | 1~100 groups (100 types) |
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About Company Handling This Product
- Japan