In the pharmaceutical and cosmetics industry, the packaging sealing of semi-solid preparations such as ointments and creams directly affects the stability of the products during their shelf life. Once the packaging leaks, it will cause oxidation, contamination, water loss, or microbial invasion of the contents, leading to drug failure or safety risks. Jinan Xio Electromechanical has launched a professional solution to address the complex characteristics of multi material composite, welding and sealing processes for medicinal ointment tubesLTSealing strength tester for medicinal ointment tubesThis instrument strictly follows the standards for drug packaging material sealing testing, and provides a scientific and intuitive sealing performance verification solution for aluminum tubes, plastic composite tubes, etc. by simulating negative pressure environments. It is the core testing tool to ensure packaging integrity and product quality.

1、 Core features of the product

• Professional methods that comply with pharmaceutical packaging standards: Strictly followYBB 00112002-2015Test Method for Sealing of Pharmaceutical Packaging MaterialsGB/T 15171Standards such as "Test Method for Sealing Performance of Flexible Packaging Components". Using the principle of negative pressure method, by observing bubbles or monitoring vacuum decay, accurately determine the position of the ointment tube body, tube shoulder, and sealing tailSealing strengthThe testing method results are reliable.

• Highly transparent and durable dedicated observation system: AdoptingUltra thick vacuum organic glass定制真空室，透明度highIt is also anti-aging, and will not yellowing or cracking after long-term use, so as to ensure that the paste tube samples immersed in water (especially the bubbles generated by slight leakage) can achieveClear and intuitive observation.

• High stability vacuum generation and intelligent controlThe core adopts a branded vacuum generator and high-precision pressure sensor, which can quickly achieve and maintain the set vacuum degree (adjustable from 0 to -90KPa) for a long time. The system hasAutomatic vacuum maintenance and blowback unloadingThe function and testing process are fully automated, eliminating human error and ensuring good repeatability.

• Intelligent operation and data managementEquipped with a 7-inch HMI human-machine interface touch screen, digital real-time display of vacuum pressure and timing. Five independent test parameters can be pre-set and stored for quick access to products of different specifications. Automatic statistics and storage of experimental results, supporting quality traceability and batch analysis.

• Powerful non-standard customization capabilityThe standard vacuum chamber size is Φ 270mm × 210mm (H). For ointment tube samples of different lengths, diameters, or special shapes for customers,Support non-standard customization of various types of vacuum chambersAnd a dedicated sample fixing bracket to ensure the feasibility and accuracy of the testing.

2、 Testing principle

This device operates based on the principle of negative pressure method (water bubble method/vacuum decay method). During testing, immerse the tube of the medicinal ointment to be tested (usually an empty tube or containing a substitute) in water inside the vacuum chamber. After starting the test, the instrument automatically draws the vacuum chamber to the preset negative pressure value and maintains it for the set time. During this process: 1Qualitative determination (bubble method)If there is a leak at the welding seam, shoulder joint, or sealing tail of the ointment tube, air will escape from the leak point and form a continuous stream of bubbles in the water, thus quickly and intuitively locating the leak point. twoQuantitative determination (vacuum decay method)For higher quality control requirements, the system can precisely monitor the pressure changes inside the vacuum chamber during the holding phase. If the rate of pressure rise exceeds the preset sensitivity threshold, even if no visible bubbles are generated, it can be determined that there is a microscopic leak with higher sensitivity.

3、 Technical parameters

4、 Execution standards

The design and testing capabilities of this instrument fully comply with the core standards for sealing testing of drugs, medical devices, and packaging materials at home and abroad:

• National Core Standards for Pharmaceutical Packaging Materials：YBB 00112002-2015Test Method for Sealing of Pharmaceutical Packaging Materials

• National General Packaging Standards：GB/T 15171-1994Test Method for Sealing Performance of Flexible Packaging Components

• International Standard for Common Testing Methods：ASTM D3078(Bubble method)ASTM F2096-11a(Packaging leakage detection)

• International standard for medical device packaging：ISO 11607-2Packaging of Final Sterilized Medical Devices

• Other international standards：JIS Z 0238:2017(Packaging Sealing Performance Test)

5、 Application Fields

This tester is a device used for sealing integrity verification in the ointment preparation and related packaging industry

• Pharmaceutical and ointment manufacturing enterprises: Used forMedicinal aluminum tube、Composite plastic ointment tubeFactory inspection of packaging sealing, batch release, and packaging process validation (such as optimization of sealing process parameters).

• Manufacturer of pharmaceutical packaging materials (hoses)Used for quality control of our own products and providing compliance testing reports to pharmaceutical customers.

• Cosmetics and daily chemical industryUsed for testing the sealing performance of packaging such as toothpaste tubes and skincare hoses.

• Third party quality inspection agencies and drug testing institutesAs a legal requirementSealing test of drug packagingEquipment used for product registration inspection, market supervision spot checks, and quality arbitration.

• R&D and Quality Inspection LaboratoryUsed for research and performance comparison testing of new packaging materials and new sealing processes.

6、 Detailed explanation of testing process

1. Sample preparationImmerse the sample of the ointment tube to be tested (usually a finished tube) in water in a vacuum chamber to ensure it is covered by water.

2. Parameter SettingsSelect the preset program or manual settings on the touch screen, and enter the required vacuum degree (e.g. -80kPa) and holding time (e.g. 60 seconds) for the test standard (e.g. YBB standard).

3. Start testingClose the vacuum chamber cover and start the fully automatic testing program. The instrument will automatically complete the entire process of vacuum pumping, pressure holding, observation/monitoring, and pressure relief blowback.

4. Result determination：

• Bubble methodDuring the pressure holding period, directly observe whether there are continuous bubbles generated on the surface of the ointment tube (with a focus on the tube tail, tube shoulder, and weld seam). If there are continuous bubbles, it is judged as a leak.

• Vacuum attenuation methodAfter the test is completed, the instrument automatically displays or records the pressure change value during the holding phase, and compares it with the set threshold to automatically determine whether it is qualified or not.

5. Record and ReportThe test results (pressure curve, judgment conclusion, timestamp) are automatically saved and traceable or printed out, forming a complete quality record.

7、 The Importance of Quality Control

For semi-solid preparations such as ointments, the sealing integrity of their packaging is key to ensuring product chemical stability, preventing microbial contamination, and maintaining the activity of active ingredients. Poor sealing can lead to the deterioration, drying, clumping, or contamination of the paste, which not only affects the therapeutic effect but may also cause safety issues such as skin irritation. passLTSealing strength tester for medicinal ointment tubesConducting strict packaging verification is to meet the requirementsGMPThe Chinese Pharmacopoeia requires drug packaging and is a necessary step in reducing market complaints and recall risks. It transforms the key quality attribute of "sealing" into a measurable and controllable scientific indicator.

8、 Customized service advantages

Jinan Xio Electromechanical understands the differences in product specifications and testing requirements among different customers, and provides professional customized solutions for this core equipment:

• Customization of non-standard vacuum chambers and sample racksDesign and manufacture customized vacuum chambers with enlarged, lengthened, or multi-layer separators for the efficiency requirements of ultra long ointment tubes, irregular tubes, or multiple small tubes that need to be tested simultaneously.

• Test programs and standard extensionsCustomize and develop specialized testing processes and data analysis models based on customer enterprise internal control standards, specific product quality agreements, or R&D requirements (such as graded stress testing).