Bottle Leak Testing Machine Vacuum Packaging Positive and Negative Pressure Non-Destructive Sealing Instrument

• Customization: Available
• After-sales Service: Lifetime Maintenance
• Warranty: 1year
• Model NO.: HJ
• Type: Positive and Negative Pressure Sealing Instrument
• Accuracy Grade: 0.5
• Load Way: Pressurized
• Display: Digital
• Control: Computer Control
• Weight: 0-100Kg
• Power Source: AC220V
• Vacuum Degree: Excellent Vacuum as Low as 10PA
• Accuracy: 0.25 Level
• Detection Sensitivity: Minimum 0.01sccm
• Net Weight: 25kg
• Transport Package: Fumigation-Free Standard Export Wooden Box
• Trademark: Hongjin
• Origin: China
• Production Capacity: 1000 Sets/ Month

Product Description

Product Description

Scope of application:
The positive and negative pressure non-destructive sealing tester, also known as the container packaging sealing integrity tester, adopts a non-destructive testing method, using a vacuum decay or pressure decay dual method, and is professionally suitable for micro-leakage and packaging sealing integrity testing of ampoules, vials, injection bottles, freeze-dried powder injection bottles and pre-filled packaging samples.
Basic application: Suitable for micro-leakage detection of ampoules, vials, injection bottles, freeze-dried powder injection bottles and pre-filled packaging samples.

Product features:
1. Non-destructive testing methods are used to detect micro-leakage of finished product packaging. After the test, the sample is not damaged and does not affect normal use, which effectively reduces the testing cost.
2. The main machine adopts a stainless steel casing, and the test chamber is made of stainless steel 316.
3. The main machine has its own environmental temperature and humidity monitoring device, which has the compensation and calculation functions of temperature and humidity fluctuations.
4. It is used to detect tiny leaks and can also identify samples with large leaks. The system automatically determines whether it is qualified or unqualified according to the leakage situation.
5. The vacuum decay method and the pressure decay method are integrated into one, with a wider application field and stronger applicability.
6. The accuracy of the vacuum/pressure decay method can reach 0.03ccm (about 2 microns).
7. Wide range of applications, corresponding test can be selected for different samples Test chamber, users can easily replace it.
8. Pneumatic safety door for the operating station, pneumatic clamping of the test chamber.
9. Automatically print the test results after the test, without manual intervention, to ensure data accuracy and objectivity.
10. 12-inch embedded industrial control all-in-one computer, humanized operation is more convenient.
11. After the test is completed, the test results are automatically statistically analyzed, including yield statistics and sample normal distribution diagram statistics.
12. Equipped with a micro printer, USB data interface, support PC software measurement and control operation.
13. Automatically save historical test records, local query, and can be exported to EXCEL and PDF formats.
14. User hierarchical authority settings to meet GMP requirements and test record audit tracking functions.

Test standards:
The instrument complies with many national and international standards:
YY/T 0681.18-2020 : "Sterile Medical Device Packaging Test Methods Part 18: Nondestructive Testing of Package Leakage by Vacuum Decay Method", ASTM F2338-13 Standard Test Method for Package Leakage-Vacuum Decay Method, ASTM F2095 Standard Test Method for Package Leakage-Pressure Decay Method USP1207 United States Pharmacopoeia Standard, "Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections", "Technical Guide for Sealing Research of Chemical Injection Packaging Systems"

Product parameters:

index	parameter
Screen size	12-inch industrial control all-in-one computer
Test Method	Vacuum decay and pressure decay methods
Vacuum degree	Excellent vacuum as low as 10Pa
Accuracy	0.25 level
Detection aperture accuracy	1 ~ 2 μm (5 μm optional)
Test chamber	Size and type are specially customized according to the sample
Detection sensitivity	Minimum 0.01sccm (equivalent pore size about 1μm)
Test results	Qualitative: qualified/unqualified; quantitative: leakage volume, leakage rate, leakage hole diameter
Dimensions	720 mm (L)*430 mm (B)*600 mm (H)
power supply	AC 220V 50Hz
net weight	25 kg

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