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Stationary Leak Tester Pharmaceutical SLTP

Manufacturer: Oxipack

Stationary Leak Tester Pharmaceutical SLTP

Deterministic vacuum decay leak tester for pharmaceutical flexible packs, with 21 CFR Part 11 software, audit trail and e-signatures.

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Key features

  • Non-destructive vacuum decay method to ASTM F2338
  • 21 CFR Part 11 compliant software for secure electronic records and signatures
  • Tests several packs at the same time
  • Operator-independent results
  • Integrated vacuum pump and control system
  • High precision in detecting micro leaks
  • Adapts to different pack sizes and shapes
  • Fast testing, suitable for high volumes
  • Consistent, reliable results
  • Easy to operate with immediate pass/fail feedback

Technical data

Dimensions (L x W x H)
630 x 705 x 333 mm
Weight
40 kg
Materials
Stainless steel, anodised aluminium, polycarbonate, rubber
Power supply
100–230 V, 50/60 Hz
Compressed air supply
> 5.5 – < 8 bar
Air consumption
150 Nl/min
Compliance and IP rating
CE, IP20, 21 CFR Part 11 (software)
Measuring chamber size (L x W x H)
350 x 500 x 116 mm
Leak detection method
Vacuum decay, ASTM F2338
Minimum detectable leakage
> 0.9 cm³/min
Maximum testing capacity
2 P/M
Connections
USB/Ethernet data export, 24 VDC logic (freely programmable)
Packaging type and size
MAP packs up to 350 x 500 x 116 mm (L x W x H)
Suitable for
Pouches, stick packs, sachets, flow wraps, foil packaging

Description

The SLTP is a non-destructive, deterministic leak tester built for the quality and compliance requirements of the pharmaceutical industry. Using the ASTM F2338 vacuum decay method, two flexible membranes draw a controlled vacuum around the pack, so micro and macro leaks are detected without stressing the seals.

Results are quantitative, repeatable and independent of the operator, which simplifies validation. The measuring chamber is deliberately compact: a smaller test volume gives higher sensitivity, with microleaks detected down to 0.9 cm³/min. A touchscreen HMI (optionally with an external keyboard) shows clear pass/fail results. USB and Ethernet connections make it suitable for QC laboratories, packaging validation and production line checks.

21 CFR Part 11 software

  • Electronic records: test data are stored securely and protected against unauthorised access or changes.
  • Audit trail: every user action and data entry is logged with a time stamp for full traceability.
  • Electronic signatures: tests can be verified and approved digitally.
  • Access control: multi-level user login with role-based permissions, so only authorised staff can operate the machine or change critical settings.

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