Pharmaceutical product connection assembly PUPSIT

Product Overview
The PUPSIT assembly (Pre-Use Post-Sterilization Integrity Testing) is a dedicated assembly used to verify the integrity of sterile filters after sterilization and before product contact. It provides connections to sterile filters, sterile tubing and integrity test instruments, enabling a controlled integrity check to confirm no compromise occurred during sterilization. The assembly is intended for use in regulated biopharmaceutical environments where pre-use verification of filter performance is required to support aseptic processing and product sterility.

Applications

• Sterile drug product manufacturing
• Biopharmaceutical processing
• Aseptic fill-finish operations
• Critical process filtration

Certifications

• FDA 21 CFR 177.2600
• USP CLASS VI
• ISO 10993
• USP 85
• USP 788
• USP 661
• USP 381
• TSE/BSE FREE
• Tested as per ISO 11737-1
• European Pharmacopoeia 3.1.5 & 3.1.9
• BPOG Extractable Studies

Characteristics / Technical specifications

• Permits pre-use post-sterilization integrity testing of sterile filters via standard test instruments
• Includes standardized connections for filters and sterile tubing to maintain aseptic path
• Reduces risk of using compromised filters by enabling verification after sterilization
• Suitable for integration in aseptic fill-finish and other critical filtration workflows
• Supports documentation and regulatory compliance in sterile manufacturing environments