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Runlab Specimen Container
Leak Test Procedures
1.Purpose:
1.1. The purpose of this document is to provide the procedures to be followed for leak testing of,
a. specimen containers(marked -95kPa Compliance)
b. centrifuge tubes(marked -95kPa Compliance)
c. transport tubes(marked -95kPa Compliance)
manufactured by ZHEJIANG RUNLAB TECHNOLOGY CO., LTD.
2.Scope
2.1 These procedures will be followed for leak testing performed on manufactured specimen containers/centrifuge tubes/transport tubes.
3.Materials:
3.1 Vacuum Test Chamber and Vacuum Pump
3.2 Torque tester
3.3 Room Temperature water
3.4 Blue, red or green liquid food color
3.5 White towels (Paper or cloth)
3.6 Isopropyl Alcohol or water
3.6.1 Ethanol may also be used as an alternative if isopropyl alcohol is not available.
4.Responsibilities:
4.1 QC inspectors/technicians for incoming or in-process inspections will perform this test.
4.2 This test may be performed by QC, Q.A., or engineering as required for new product and/or new process development.
5.Test Procedure:
5.1 Sample preparation
5.1.1 Identify each test Samples body and lid with permanent marker
5.1.2 Fill each test Samples body with Isopropyl Alcohol or water 2/3 of labeled volume and add one drop of food color.
5.2 While performing the test, record the following parameters onto the Record list:
5.2.1 Lid ID
5.2.2 Liquid fill (ml)
5.2.3 Torque used to tighten lid
5.2.4 Liquid type
5.2.5 Leakage at the start of test and after 10 min, using the scale mentioned in step 5.5
5.2.6 Vacuum (inches Hg)
5.3 Samples need to be evaluated after securing the lid to make sure the lid is on correctly and not cross-threaded. In cases where the lid is difficult to apply due to the torque tester or where the torque tester is the cause of the cross-thread/leak, Divisional QA may authorize the technician/inspector to apply all lids by hand if deemed necessary as long as this is documented in the testing PRIOR to performing the test.
5.4 Invert and place Samples on white towel and visually examine for leakage
5.4.1 At time zero
5.4.2 Minimum 10 minutes
5.5 Record leakage by Samples body cavity and lid cavity combination on a scale of three where:
5.5.1 No visible leakage
5.5.2 Liquid visible only in threads in 10 Minutes or more or drips when shake
5.5.3 Liquid runs out of the container
5.6 All Samples that DO NOT leak after inversion test will be placed LID DOWN in the vacuum test chamber, the stoppers inserted and vacuum valve opened.
5.7 Utilizing vacuum pump (with vacuum gauge attached), a 4 inch Hg +/- 1/4 (55 +/- 3 inch H2O) vacuum is pulled, the test chamber valve closed and sample subjected to vacuum for a minimum of ten minutes.
5.7.1 Pull vacuum to 95 kPa if testing needs to meet standards in 49 CFR, IATA and ICAO regulations.
5.8 Open vacuum valve, remove sample and visually examine for damage and leakage
5.9 Record the results on Test Record Form including damage, leakage and degree of leakage.
5.10 Repeat test on remaining samples
6.Test Acceptance Criteria
6.1 No samples have a leakage score > 1 when tested inverted and vacuum tested for "Suitable for Pneumatic Tube" claim.
6.2 No samples have a leakage score > 2 when tested inverted or vacuum tested for "leak resistant" claim.
Date of Issue: 2022-05-27 Version:R01
视频信息
答案文本
视频字幕
Welcome to Runlab Technology's professional leak testing procedures. This video demonstrates the comprehensive testing protocol for specimen containers, centrifuge tubes, and transport tubes, all designed to meet negative 95 kilopascal compliance standards for laboratory and medical applications.
The leak testing procedure requires specific materials and equipment. Essential items include a vacuum test chamber with pump, torque tester for proper lid application, room temperature water, liquid food coloring for leak detection, white towels for visual inspection, and isopropyl alcohol or water as test medium. Ethanol may be used as an alternative cleaning agent when isopropyl alcohol is unavailable.
Sample preparation begins with identifying each container and lid using permanent markers. Fill each sample container two-thirds full with the test liquid, either isopropyl alcohol or water, then add one drop of food coloring for leak detection. Secure the lid using the torque tester to ensure proper tightening without cross-threading. Record all parameters including lid identification, liquid volume, torque applied, liquid type, and initial leakage assessment on the test record form.
The testing process involves two critical phases. First, the inversion test where samples are placed upside down on white towels for visual leak inspection at time zero and after a minimum of ten minutes. Leakage is scored on a scale of one to three. Samples that pass the inversion test proceed to vacuum testing, where they are placed lid-down in the vacuum chamber. A vacuum of 4 inch mercury or 95 kilopascals is applied for ten minutes, then samples are examined for damage and leakage to ensure compliance with pneumatic tube and leak-resistant standards.
The acceptance criteria ensure product reliability and safety. For pneumatic tube applications, no samples may have a leakage score greater than one during inversion or vacuum testing. For leak-resistant claims, no samples may exceed a leakage score of two. All containers must successfully withstand negative 95 kilopascal vacuum pressure. This comprehensive testing protocol maintains Runlab Technology's commitment to quality and ensures laboratory safety standards are consistently met across all specimen containers, centrifuge tubes, and transport tubes.