Stationary Leak Tester Pharmaceutical

The Stationary Leak Tester Pharmaceutical (SLTP) by Oxipack is a non-destructive, deterministic leak detection system tailored to the strict quality and compliance demands of the pharmaceutical industry. Using the ASTM F2338 vacuum decay method, it draws a controlled vacuum around the package with two flexible membranes, allowing for highly sensitive detection of both micro and macro leaks, without stressing the seals or compromising the packaging.

What sets the SLTP apart is its full compliance with 21 CFR Part 11, supporting secure operator login, role-based access, audit trails, and electronic signatures, ensuring data integrity and traceability in GMP environments. Results are quantitative, repeatable, and operator-independent, eliminating subjectivity and enabling straightforward validation. Its compact measuring chamber reflects Oxipack’s core philosophy: smaller test volume means greater sensitivity, allowing detection of microleaks down to 0.9 cm³/min.

The system is equipped with a touchscreen HMI, optionally paired with an external keyboard, and delivers clear pass/fail feedback to guide operators quickly and confidently.

Built for integration, the SLTP offers USB and Ethernet connectivity, making it ideal for QC labs, packaging validation, and production line checks. Its non-invasive method ensures reliable performance with minimal disruption; providing compliant, consistent, and efficient leak testing for critical pharmaceutical packaging.

• Dimensions and Weight: 630 x 705 x 333 mm (L x W x H), 40 KG 
• Materials: Stainless steel, Anodized aluminium, Polycarbonate, Rubber 
• Power Supply: 100 - 230V 50/60HZ 
• Air Supply: > 5.5 - < 8 bar 
• Air Consumption: 150 Nl/min 
• Compliance and IP Rating: CE, IP20, 21 CFR Part 11 (Software) 
• Size Measuring Chamber: 350 x 500 x 116 mm (L x W x H) 
• Leak Detection Method: ASTM F2338 
• Minimum Leakage: > 0.9 cm3/min 
• Maximum Testing Capacity: 2P/M 
• Connections: USB/Ethernet export, 24VDC logic (free programmable) 
• Packaging Type and Size: MAP up to 350 x 500 x 116 mm (L x W x H) 

*Compliance with 21 CFR Part 11:

• Electronic Records: Ensures secure and reliable storage of all test data, preventing unauthorized access or modifications. 
• Audit Trail: All user actions and data entries are recorded with timestamped logs, supporting full traceability. 
• Electronic Signatures: Supports digital signature functionality to verify and approve tests electronically. 
• Access Control: Multi-level user authentication with role-based permissions to ensure that only authorized personnel can operate the SLT or modify critical settings.