Alpha Beta Valve & RTP Integrity Test Solution
Physical integrity verification for Rapid Transfer Port (RTP) alpha/beta valve systems used in isolator and RABS material transfer, reducing reliance on visual inspection alone. lpha/beta (RTP) valve systems allow materials to move into isolators without breaking containment, but their integrity depends on precise mechanical seating and seal condition that visual inspection cannot fully verify. A worn seal or misaligned docking ring can introduce a contamination path during transfer operations that may not be evident until a downstream sterility failure occurs.
Regulatory Basis
EU GMP Annex 1 (2022) addresses RTP and rapid transfer device integrity as part of the broader isolator contamination control strategy, expecting documented verification rather than reliance on visual checks alone. ISO 14644-7 covers separative enclosures including isolators and their transfer device design principles.
Our Solutions
Our RTP integrity test solution verifies alpha/beta valve seal condition using pressure decay method, without requiring disassembly of the transfer port. The system is compatible with all mainstream RTP standard diameters including 105mm, 190mm, 270mm, 350mm, perfectly matching RTP ports from global well-known brands such as Getinge, Sartorius and Extract Technology, and produces a documented pass/fail record for each transfer cycle. As the manufacturer, we offer 21 CFR Part 11 compliant electronic audit trails, customizable test pressure & threshold parameters for diverse working conditions, portable lightweight design applicable to Class A/B cleanrooms, dual positive/negative pressure testing modes, lifelong spare parts supply and global on-site IQ/OQ validation & after-sales technical support, delivering obvious cost-performance advantages compared with imported counterparts.
