STATIONARY LEAK TESTER PHARMACEUTICAL (SLTP) – OXIPACK
Features:
- Non-destructive vacuum decay method (ASTM F2338)
- 21 CFR Part 11 compliant software for secure electronic records and signatures.*
- Can test multiple packs simultaneously
- Operator-independent results
- Integrated vacuum pump and control systems
Benefits:
- Precise & Reliable: High precision in detecting micro leaks. Consistent and reliable results.
- Adaptable & User-friendly: Adaptable for different sizes and shapes. Easy to operate.
- Efficient: Fast and efficient, suitable for high-volume testing.
Technical Specifications:
- 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.
