How to use a bag detection machine

【Introduction】  

For disposable medical soft bags—urine bags, drainage bags, infusion bags, etc.—seal integrity is the last gate in a “zero-defect” quality system. For three decades the industry relied on “manual inflation + water bath” or “manual inflation + static pressure hold” sampling. Intuitive as these methods are, they bring high labor intensity, excessive clean-room footprint, poor repeatability, secondary damage to bags, and no data traceability. Since 2010 HETRO has been running a dedicated R&D program. After six generations of prototypes the HBAT-01 medical bag leak tester was born, integrating precision pneumatics, closed-loop pressure control, and dedicated fixtures into one platform that is Fast, Accurate, Stable and Economical. This article dissects HBAT-01 from eight perspectives—working principle, core advantages, parameter setting, leak-miss risk, maintenance, ROI, and reference cases—to give soft-bag manufacturers a complete “from 0 to 1 and from 1 to N” deployment guide.

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1. Pain-Points of Traditional Testing Methods  

1.1 Manual inflation + water bath  

• One hand pinches the drain-valve, the other holds the inflation gun; the operator must keep the seal for the entire hold time. After the test liquid has to be removed, the bag deflated and the valve closed again—tedious motions.  

• If the water bath is not changed frequently microbes bloom, violating GMP clean-room limits; operators’ hands macerate, crack and develop dermatitis, driving high turnover.  

• After immersion droplets remain on the bag surface; an extra drying step is required or the subsequent sterilization-seal step is compromised.

1.2 Manual inflation + static pressure hold  

• Large racks or trolleys are needed; for 50 000 bags/day more than 200 m² of clean room is occupied.  

• Inflation pressure is set by “feel”: too high and the bag bursts, too low and leaks are missed.  

• Hold time is 12–24 h, destroying any hope of continuous flow.

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2. HBAT-01 System Architecture  

2.1 Frame & Enclosure  

• All SUS304 stainless steel + sand-blasted anodized aluminum, rounded corners for easy wipe-down.  

• Swivel castors with brakes and adjustable leveling feet for mobility and stability.

2.2 Pneumatic unit  

• Proportional servo valve + 0.01 MPa-resolution pressure sensor in closed loop.  

• Triple-buffered regulator eliminates pulsation and delivers smooth pressure curves.

2.3 Test fixtures  

• Drawer-type modular design; each drawer holds one bag; change-over <300 s.  

• Upper and lower clamp plates ensure even force distribution and eliminate lateral shear on welds.  

• Specially textured clamp faces guarantee that surface pin-holes are not masked.  

• For bags with valves the fixture includes a “valve-hover” structure preventing root cracking.

2.4 Control & Software  

• Industrial ARM + FPGA dual-core, large color HMI.  

• Results displayed as numeric values, color curves, indicator lights and audible alarms.  

• Password protection; only administrators can alter set-points.

2.5 Auxiliary functions  

• Auto vacuum to empties the bag in 3 s.  

• Optional automatic shut-off mechanism for open-drain designs.  

• Two modes: standard and precision, switchable at the touch of a button.

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3. Core Advantages in Depth  

3.1 Labor & Throughput  

• Actual cycle: insert inflation probe → auto clamp → inflate → 20 s hold → vacuum → release; operator action only 2 s/bag.  

• One machine tests four stations simultaneously; 8-hour output ≥3 200 bags.

3.2 Bag damage control  

• Fixture limits maximum expansion to 120 % of design height, preventing vertical film rupture.  

• 20 s short hold + even force; bag recovery ≥99.99 %, no creases.  

• Field data: at 0.25 MPa manual inflation damage 1%; HBAT-01 <0.01 %.

3.3 Clean-room footprint  

• After testing the bag is immediately vacuum-collapsed and can be folded into a tote; no storage needed.  

• For 50 000 bags/day the machine occupies only 20 m² versus 200 m² for static hold—a one-time saving of ~1.2 M CNY in clean-room construction.

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4. Leak-Miss Risk Control  

4.1 Physical boundary  

Gas molecules are far smaller than liquid molecules; any leak will be found if pressure is high enough and time long enough. Medical films, however, have yield limits. HBAT-01 uses multi-stage regulation plus differential-pressure algorithms to keep system error within ±0.25 kPa, ensuring micro-leaks cannot escape.

4.2 Reference-value SOP  

(1) Select 40 confirmed good bags at the end of the line.  

(2) Assign 10 bags to each of stations 1–4.  

(3) Test on HBAT-01, record the pressure at each station.  

(4) Discard highest and lowest readings; take the mean P_avg of the remaining eight.  

(5) Reference = P_avg – 3σ, giving 99.99 % pass-band.  

(6) Enter the reference into the station parameter table.

4.3 Routine calibration  

• Repeat 4.2 weekly using retained sample bags.  

• If reference drifts, the system alarms for re-calibration.  

• Calibration records must be dual-signed by operator and engineer.

4.4 False-reject management  

• At each shift-end QA re-tests all “failed” bags manually.  

• If a discrepancy is found, repeat 4.2 promptly.

4.5 Environmental interference  

• Pressure sensors are enclosed in mu-metal + copper mesh shields.  

• Distance to HF bag-making machines ≥20 m; if impossible, active degaussing coils are installed.

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5. Maintenance & Troubleshooting  

5.1 Daily checks  

• Read differential gauge; pressure must stay in range.  

• Wipe fixture surfaces to prevent weld slag from scratching bags.

5.2 Weekly maintenance  

• Re-tighten all pneumatic fittings to eliminate micro-leaks.  

• Open rear cover and inspect components for looseness or deformation.

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6. ROI Calculation (30 000 bags/day example)  

6.1 Cost comparison  

• Manual: 12 staff × 6 k CNY/month × 12 = 864 k CNY/year.  

• HBAT-01: 8 machines × 60 k CNY = 480 k CNY capex; 8 staff × 6 k × 12 = 576 k CNY/year.  

• Year-1 outlay: 192 k CNY.  

• Year-2 saving: 96 k CNY.  

• Year-3 saving: 288 k CNY.

6.2 Hidden benefits  

• 1 % drop in damage rate saves 30 000 × 1 % × 365 × 1 CNY ≈ 110 k CNY/year.  

• 150 m² clean-room space freed, construction saving 90 k CNY.  

• Customer complaints cut by 50 %, brand premium rises.

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7. Reference Cases  

Case 1 Shandong leading urine-bag maker  

• 2022: 8 HBAT-01 installed, daily output rose from 30 k to 50 k.  

• Headcount fell from 16 to 8; zero labor disputes.  

• Passed FDA on-site audit; auditor praised data integrity.

Case 2 Jiangxi medical polymer park  

• 2023: green-field plant laid out around HBAT-01 lines, 100 % air-leak testing.  

• Two-shift rotation; equipment pay-back in one year.  

• Urine-bag complaint rate remains 0 % to date.

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8. Conclusion  

HBAT-01 is more than a leak tester; it is the pivot point for medical soft-bag manufacturers to move toward lean, compliant production. By closing the loop in pressure, time and tooling, it solves the traditional conflict between efficiency, quality, cost and compliance, building a future-proof quality moat for every soft-bag factory.