Offline packaging leak detector
DHS 740
Vacuum Pressure Decay Leak Detector
DHS740 is a vacuum decay packaging container closure integrity tester with vacuum/pressure decay test mode. The method complies with USP1207, "Technical Requirements for Quality and Efficacy Consistency Evaluation of Generic Chemical Injections", and "Technical Guidelines for Sealing Research of Chemical Injection Packaging Systems".
The main unit of the tester is connected to a test chamber specially designed to hold the package to be tested. The package is placed in the test 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 to be qualified/unqualified according to the threshold value developed by the method. The minimum package leakage of 1μm can be detected. At the same time, the detection mode based on the double cycle can achieve the ability to detect micro leaks while covering the ability to detect large leaks.

Features

  • Dual sensor dual loop technology
  • Extremely high detection sensitivity 0.01 s cc m (about 1 μ m)
  • Extremely small system internal volume
  • Automatic calculation of leaks
  • All imported components and sensors

FAQ

  • What are the advantages of the fluorescence residual oxygen analyzer?

    1) High anti-electromagnetic interference capability; high detection accuracy


    2) Fast, with response time down to milliseconds


    3) The process is reversible and does not consume oxygen


    4) Use optical fiber to transmit signals, with low signal loss and long transmission distance, which can realize remote detection (the optical fiber can be up to 20M long)


    5) No need for constant maintenance


    6) Can be applied to agriculture, forestry and fishing, life pharmaceuticals, science, strong electromagnetic interference and other harsh environments.

  • What are the tips for using the seal detector?

    The seal tester is a device that uses compressed air to generate negative pressure through a vacuum element group to detect and examine the heat sealing performance and processing technology of plastic flexible packaging materials.

    This instrument provides an advanced, practical and effective testing method for the quality and reliability of plastic sealed packaging. It is easy to operate, has a unique and novel design, and is easy to observe the test results. In particular, it can quickly and effectively detect leakage from tiny pores in the seal.

    1. Installation and debugging of sealing detector:

    1 Put the plexiglass cylinder into the clip of the base.

    2 Connect a compressed air source with stable pressure to the air inlet of the tester's "compressed air" (on the right side of the rear end of the base), and connect the vacuum output (on the left side of the rear end of the base) to the quick connector on the plexiglass barrel.

    3 Inject a certain amount of clean water into the cylinder to a height above the pressure plate surface (but do not allow the water to be sucked out after adding the test sample).

    4 Cover the sealing cover of the organic glass cylinder, turn the switch on the tester to the on position, and adjust the control knob of the tester. First, determine whether the knob is locked (i.e., in the pressed state). If it is locked, you need to pull the knob up with a little force when adjusting it, then rotate it to adjust it, and observe the vacuum pressure gauge to adjust the pressure to the value you need. After adjusting to the required stable pressure, press the knob to fix the position to prevent accidental collision and misoperation, which will cause the vacuum degree in the vacuum cylinder to change and affect the test results.

    5 After completion, turn the switch on the tester to the off position, open the sealing cover and drain the clean water.


    2. Operation of the sealing tester

    1 Inject clean water into the vacuum chamber to a height higher than the bottom pressure plate surface on the cylinder head. To ensure the sealing effect, sprinkle a little water on the sealing ring.

    2. Cover the sealing cover of the vacuum chamber, turn the switch on the tester to the on position, adjust the control knob of the tester (see above for adjustment method), observe the vacuum pressure gauge, and adjust the pressure to the stable value required for the test.

    3 Turn the switch of the tester to the off position to eliminate the vacuum, open the sealing cover of the vacuum chamber and immerse the sample in water. At this time, the distance between the top surface of the sample and the water surface shall not be less than 25 mm. Note: As long as leakage of various parts of the sample can be observed during the test, 2 or more samples can be tested at one time.

    4 Cover the vacuum chamber with a sealed cover, turn the switch of the tester to the on position, and start evacuating the vacuum chamber. Note: The adjusted vacuum value is determined according to the characteristics of the sample (such as the packaging material used, sealing conditions, etc.) or the provisions of relevant product standards.

    5 The leakage of the sample during the vacuuming process and during the vacuum holding period after reaching the preset vacuum degree is determined by whether there is continuous bubble generation. Single isolated bubbles are generally not considered as sample leakage.

    6 Turn the switch on the instrument to the off position, eliminate the vacuum, open the sealing cover, take out the test sample, wipe off the water on its surface, and observe the damage results on the surface of the packaging bag.

  • What are the characteristics of airtightness leak test?

    1. One-button vacuuming and one-button pressure relief, easy to operate.

    2. The thickness of the box plate is 30MM, with high hardness, durable and never deformed.

    3. High-quality clean silicone rubber sealing strip, anti-aging, good sealing and no air leakage.

    4. Equipped with high-quality small and efficient vacuum pump, it can quickly complete the internal exhaust to reach the vacuum state.

    5. High-precision pressure sensor, accurate reading, combined with pointer-type negative pressure gauge, to meet various customer needs.

    6. High-quality imported transparent acrylic plate is CNC-molded, with good transparency, and the experimental conditions in the box can be clearly seen.

    7. The target negative pressure value can be set, and the pressure will be automatically maintained after reaching the set pressure.

    8. The pressure holding time can be set. For the same batch of products, a unified testing time can be set to fully ensure the accuracy of the test results while improving the test efficiency.

    9. A layer of water pressure plate can be set in the box, which can be filled with clean water, and the product can be placed in the water for water permeability test. One box can be used for multiple purposes and can test a large number of products at the same time.

  • What types of packaging should be noted for the sealing performance test of pharmaceuticals?

    Pharmaceutical packaging integrity is necessary to ensure that the critical quality attributes of unknown products are within the physical and chemical specifications indicated on the product label and to ensure the sterility of the product before use.

    Most packaging types, even well-fitting closure systems, will have extreme but certain gas leakage. Therefore, it is impractical to require that the packaging is absolutely leak-free. The packaging should not allow leakage to exceed the maximum allowable leakage limit of the product. When formulating the maximum allowable leakage limit of the product, the packaging structure and assembly, the packaging contents, and the range of environments that the product packaging may be exposed to during its life cycle should be considered.

    There are two main categories of product packaging quality requirements, as follows:


    1. Sterility and product formula content must be maintained, and gas headspace content is not required


    For this type of pharmaceutical packaging, the maximum allowable leakage limit is related to preventing the loss of formula ingredients and external liquid, solid matter and microbial contamination of the product, while the gas headspace content (i.e., ambient air pressure) does not need to be considered, and the minimum leakage channels that only allow limited gas exchange are irrelevant because they do not pose a substantial risk to product quality.

    This type of packaging may need to consider the potential impact of processing, storage, distribution and use during the product life cycle on the integrity of the package. For example, elastomeric seals have been found to shrink and lose elasticity during storage at low temperatures, less than -80 degrees Celsius, to the point where gas inflow into the stoppered injection vial package may occur. During warming, the package seal recovers, enclosing the gas and significantly increasing the pressure within the package. In this case, even if the product does not require a specific headspace content or pressure under optimal stability conditions, gas headspace retention is a quality concern for the product.

    2. Sterility, product formula content and gas headspace content must be maintained


    This type of pharmaceutical packaging should prevent the loss of product prescription or prevent the product from being contaminated by external liquids, solid substances or microorganisms. In addition, the packaging is to maintain the stability of the product within the limits of Ewha's quality standards and facilitate the use of the product by the end customer.

    The maximum permissible leakage limit of the product in this category can be expressed as the maximum permissible packaging headspace content or the relationship between pressure and time.


    3. Sterility must be maintained and the product must be used multiple times

    For this type of pharmaceutical packaging, once the product reaches the end customer, the seal is broken or the drug is otherwise administered, the maximum allowable leakage limit at this stage of the life cycle is defined in terms of the prevention of microbial ingress and product loss during the dosage interval and use period.

Technical Parameters

model

DHS 740

Applicable packaging

Vials, ampoules, prefilled syringes, cartridges, infusion bottles/bags, BFS, eye drops, etc.

Applicable Products

Freeze-dried, powder, solution, etc.

Purpose of testing

Prevent the risk of microbial invasion

Test Method

Pressure/vacuum decay dual mode

Test Principle

Dual sensor dual cycle differential pressure detection

Test Standards

ASTM-F2338-09 (vacuum decay); ASTM F2095 (pressure decay)

Detection sensitivity

Up to 0.01sccm (equivalent pore size about 1 μm)

Test chamber

Customized chambers are available according to user specifications, and 316 stainless steel test chambers are available

Test results

Qualitative pass/fail; quantitative mbar\Pa

software

It has permission management, audit log, and automatic data storage functions, and complies with 21CFR Part 11 requirements.

System Verification

IQ/OQ/PQ, method development and method validation

Optional

Standard Leak / Micro Flow Meter

language

Chinese/English

Power supply/power

100-240V AC/50W

Gas source

Vacuum: 1mbar Pressure: 6bar

Environmental requirements

Operating temperature

+10℃~+45℃

Storage temperature

0℃~+60℃

Host size (L*W*H)

420*420*380mm

Host weight

25kg /55 lbs

Noise Level

< 53db

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