Sealing tester for infusion bottles

In the production and quality control of large volume injections (infusion), the sealing integrity of the packaging system is the lifeline to prevent microbial and particle contamination and maintain the sterile state of the drug solution. Any small leak can lead to catastrophic drug safety incidents. Jinan Xio Electromechanical has launched professional testing equipment that strictly complies with regulatory standards to address this high-level quality risk——LTSealing tester for infusion bottlesThis instrument is based on the widely recognized principle of negative pressure method and is specifically designed forinfusion bottleThe bottle mouth rubber stopper aluminum cap combination system for glass and plastic bottles provides an objective and reliable sealing verification scheme, which runs through the entire life cycle quality control from packaging component evaluation, production line verification to finished product release.

1、 Core features of the product

This instrument integrates high-definition observation, stable vacuum, and intelligent control, designed specifically for high demand environments in the pharmaceutical industry

• Professional testing methods that comply with pharmaceutical packaging materials and drug GMPStrictly based onYBB 00112002-2015Test Method for Sealing of Pharmaceutical Packaging MaterialsGB/T 15171Using negative pressure method (bubble method/vacuum decay method) based on core standards. By applying and maintaining the set vacuum conditions, scientifically determine the performance of the infusion bottle packaging systemSealing integrityIt can be directly used for product release decision-making.

• High definition and durable dedicated observation room: AdoptingUltra thick vacuum organic glassCustomized vacuum chamber, with transparency and long-term anti-aging performance, ensures that during the whole test process, the infusion bottle samples immersed in water (especially the bottle mouth area) may produceContinuous bubbleConduct clear and intuitive observation to prevent misjudgment of results caused by yellowing or cracking of the observation window.

• High stability vacuum generation and automatic controlThe core adopts branded vacuum generators and high-precision pressure sensors, which can quickly establish and maintain for a long timeStable maintenanceThe preset vacuum degree (adjustable from 0 to -90KPa). system implementationAutomatic vacuum maintenance and blowback unloadingThe testing process is fully automated, eliminating manual fluctuations and ensuring the consistency and reproducibility of the test results.

• Intelligent operation and data traceabilityEquipped with a 7-inch HMI human-machine interface touch screen, digital real-time display of vacuum pressure and time. Five sets of independent test parameters can be pre-set and stored for quick retrieval of infusion bottle products of different specifications. All test results (pressure curves, judgment conclusions) are automatically counted and stored to meet GMP requirements for inspection recordstraceableThe requirements.

• Flexible non-standard customization capabilityThe standard vacuum chamber size is Φ 270mm × 210mm (H). For infusion bottles with different capacities (such as 100ml, 250ml, 500ml) or special shapes for customers,Support non-standard customization of various types of vacuum chambersAnd a dedicated bottle holder to ensure that any specification sample can be effectively tested.

2、 Testing principle

This device operates based on the principle of negative pressure method (water bubble method/vacuum decay method). During testing, immerse the sealed infusion bottle sample (usually a finished or simulated bottle) in water inside the vacuum chamber. After starting the test, the instrument automatically draws the vacuum chamber to the standard negative pressure value and maintains the set holding time. There are two complementary judgment mechanisms in this process: 1Qualitative determination (bubble method)If there is a leak in the bottle mouth rubber stopper aluminum cap combination system, air will escape from the leak point and form a continuous and clearly visible stream of bubbles in the water, thus directly locating the leak point. twoQuantitative determination (vacuum decay method)For higher standard quality control or validation, the system precisely monitors the pressure changes inside the vacuum chamber during the holding phase. If the pressure recovery rate exceeds the preset sensitivity threshold, even if no visible bubbles are generated, it can be determined that there is a micro leak, and this method has higher sensitivity.

3、 Technical parameters

4、 Execution standards

The design and testing capabilities of this instrument fully cover the core standard system of drug packaging sealing testing:

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

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

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

5、 Application Fields

This tester is a tool for verifying the sealing integrity of infusion products and their packaging industry:

• Large capacity injection (infusion) production enterprises: Used forGlass infusion bottle、Plastic infusion bottleFactory sealing sampling, batch release, and validation and revalidation of packaging processes (such as capping processes) for finished products.

• Pharmaceutical packaging material manufacturerProvide sealing performance compliance test data for rubber stoppers, aluminum caps, and infusion bottle manufacturers after component matching.

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

• Hospital preparation room and research institutionsUsed for the research and quality evaluation of self-made infusion products or new packaging systems.

6、 Detailed explanation of testing process

Standardized operations are the foundation for obtaining reliable and comparable results:

1. Sample preparationImmerse the sealed infusion bottle sample to be tested (which can be filled with water to increase detection sensitivity) in water inside the vacuum chamber, ensuring that the bottle mouth area is below the water surface.

2. Parameter SettingsCall the preset program or manually set it on the touch screen, and enter the recommended vacuum degree (e.g. -80kPa) and holding time (e.g. 120 seconds) according to relevant standards (such as YBB standards).

3. execute testsClose the vacuum chamber cover and start the fully automatic test. The instrument completes vacuum pumping, pressure holding, observation/monitoring, and automatic pressure relief in sequence.

4. Result determination：

• Bubble methodDuring the pressure holding period, closely observe whether there are continuous bubbles generated around the mouth of the infusion bottle. If there is, it is judged as unqualified sealing.

• Vacuum attenuation methodAfter the test is completed, the instrument automatically displays the pressure attenuation value during the holding period, compares it with the preset acceptance standard, and automatically determines whether it is qualified or not.

5. Record and ReportAll test parameters, process curves, and judgment results are automatically saved and can be queried and printed at any time, forming complete electronic or paper quality records.

7、 The Importance of Quality Control

For large volume injection solutions directly administered intravenously, the packaging and sealing integrity are in accordance with the Chinese PharmacopoeiaDrug GMPandISO 15378The key quality attributes that are required to be controlled by regulations such as primary packaging materials for drugs. Sealing failure is the main cause of reduced sterile assurance level (SAL), product scrapping, and even clinical infection risk. adoptLTSealing tester for infusion bottlesConducting scientific verification is the core link for enterprises to fulfill their main responsibility for product safety, establish a reliable quality assurance system, successfully pass regulatory audits, and avoid product recalls. It transforms the crucial qualitative requirement of "sealing" into measurable, monitored, and traceable quantitative scientific data.

8、 Customized service advantages

Jinan Xio Electromechanical has a deep understanding of the diversity of products and needs in pharmaceutical enterprises, and provides customized solutions for this core equipment:

• Customization of non-standard vacuum chambers and sample racksDesign and manufacture customized vacuum chamber systems with enlarged, deepened, or multi-layer rotating sample racks for large capacity infusion bottles (such as 1000ml or more), bagged infusion, or batch testing needs.

• Verification support and program customizationCustomize and develop specialized testing programs based on customer specific product specifications, internal control quality standards, or process validation plans (such as challenging testing under different vacuum thresholds), and provide relevant informationTest method validationSupport services.