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E-mail
Ellasong@qiyi-china.com
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Phone
13296018069
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Address
A226, Building A, No. 58 Yindu West Road, Shanghai
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Shanghai Qiyi Instrument Equipment Co., Ltd
Vacuum decay method leak detector
NegotiableUpdate on 01/21
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Overview
DHS640 is a vacuum attenuation method packaging container sealing integrity tester with dual sensor dual cycle detection technology. The method complies with USP 1207, "Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Injection Generic Drugs", and "Technical Guidelines for Sealing Research of Chemical Injection Packaging Systems". The $r $n tester host is connected to a specially designed testing chamber to accommodate the testing packaging that needs to be tested. The packaging is placed in the experimental chamber to be evacuated and the chamber is evacuated. The leakage of the container is reflected by detecting the differential pressure pa during the pressure holding stage of the container.
Product Details
Vacuum decay method leak detectorDHS640 is a vacuum attenuation method packaging container sealing integrity tester with dual sensor dual cycle detection technology. The method complies with USP 1207, "Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Injection Generic Drugs", and "Technical Guidelines for Sealing Research of Chemical Injection Packaging Systems".
The tester host is connected to a specially designed testing chamber to accommodate the testing packaging that needs to be tested. The packaging is placed in the experimental chamber to be evacuated and the chamber is evacuated. The leakage of the container is reflected by detecting the differential pressure pa during the pressure holding stage of the container, and the product is judged as qualified/unqualified according to the threshold developed by the method.
Features:
Dual sensors
Dual cycle technology
Small system internal volume can automatically calculate leakage holes
Application fields:
Vacuum decay method leak detectorTechnical Specifications:
Applicable packaging: penicillin bottles, ampoules, pre filled syringes, cartridges, BFS, Di eye drops, etc
Applicable products: freeze-drying, powder, solution, etc
Purpose of testing: To prevent the risk of microbial invasion
Test method: Vacuum decay method (optional pressure/vacuum decay dual-mode)
Test principle: Dual sensor dual cycle differential pressure detection
Test standard: ASTM-F2338-09 (vacuum attenuation); ASTM F2095 (pressure attenuation)
Detection sensitivity: high 0.01 sccm (equivalent aperture of about 1 μ m)
Test chamber; Provide customized cavities according to user specifications, with optional 316L or organic glass materials
Test results: Qualitatively qualified/unqualified; Quantitative mbar \ \ Pa
Software: equipped with permission management, audit logs, and automatic data storage functions, in compliance with 21CFR Part 11 requirements
System validation: IQ/OQ/PQ, method development and method validation
Optional: 3Q Verification/Micro Flow Meter (Mass Flow)
Language: Chinese/English
Power supply/power: 100-240V AC/50W
Gas source: Vacuum degree below 1mbar
Working temperature:+10 ℃~+45 ℃
Storage temperature: 0 ℃~+60 ℃
Host size (L * W * H): 420 * 420 * 380mm
Host weight: 25kg/55 bs
Noise level:<53db
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