Helium leak detection down to ≥0.01 µm, specially designed for validating sterile packaging
Deterministic
Quantifiable and repeatable results according to USP standard
Versatile
Turnkey solution with customized test chambers, adaptable to vials, syringes, bottles and other non-porous packages
Technical data
Test methods - Vacuum and sniffing leak detection
Quantitative measurement range fine leak helium - 1 · 10⁻³ mbar · l/s
Minimum detectable helium leakage (sniffing test) - >1 · 10⁻⁵ mbar · l/s
CDA supply - required for operation
CDA quality - 1.3.1 according to ISO 8573-1
CDA pressure (bar rel.) - 4.5 - 10 bar rel.
CDA pressure (psig) - 65 - 145 psig
Helium supply - required for operation
Helium pressure (bar rel.) - 4.5 - 10 bar rel.
Helium pressure (psig) - 65 - 145 psig
Nitrogen supply - required for operation
Nitrogen pressure (bar rel.) - 4.5 - 10 bar rel.
Nitrogen pressure (psig) - 65 - 145 psig
Power supply - 90 - 250 V AC
Typical power consumption - 3750 W
Operating temperature - 15 - 25 °C
Humidity - 30 - 80 %
User interface - 10" multi-touch full HD color screen
Software - 21 CFR part 11 compliance, PDF GMP test and calibration reports, authentication local or domain (LDAP)
Operating system - Windows 10
Network connection - 1x LAN (RJ45)
Interfaces - 2x USB 3.0 (ext.), 1x HDMI
Sound pressure level - <53 dB(A)
Weight approx. - 140 kg
Dimensions (L x W x H) (mm) - 913 x 558 x 1197 mm
Dimensions (L x W x H) (inch) - 913 x 558 x 1197 inch
Accessories
Helium spray gun
Sniffer probe
Exhaust filter