SpeedAir 3050 Mass Extraction Pharmaceutical Container Closure Integrity Test (CCIT) Glass ampoules

SpeedAir 3050 Mass Extraction Pharmaceutical Container Closure Integrity Test (CCIT) Covers a wide range of containers Your added value High sensitivity for reliable results Versatile for a wide range of applications The SpeedAir 3050 offers a CCIT solution for a wide range of nonporous pharmaceutical containers. Flexible or rigid, liquid or solid – the SpeedAir 3050 can test a wide range of products. Typically requiring only 30 – 45 seconds, the SpeedAir 3050 quickly and efficiently delivers results you can trust. Saving time and money The SpeedAir 3050 is a global non-destructive test (NDT)...

USP2) <1207> recognized test method Fast cycle times compared to competitive air technologies High sensitivity for reliable and repeatable results The SpeedAir 3050 is the most sensitive air-based technology for liquid products. Results are repeatable and reliable -eliminating risks associated with false negatives and positives. Compliant with USP <1207> and FDA 21 CFR Part 11 The SpeedAir 3050 utilizes USP <1207> recognized and deterministic Mass Extraction technology and FDA 21 CFR Part 11 compliant software. Applications ■ Ampoules ■ Autoinjectors ■ Bottles ■ Cartridges ■ Flexible bags (IV...

SpeedAir 3050 Equivalence between defect size & air leak rate Sensor design Mass Extraction leak testers use an accelerated laminar flow design to measure flow directly. The design is unlike other flow meters that use principles of heat transfer or mechanical movement. As a result, these sensors have less impact from environmental pressure and/or temperature changes; providing fast, highly sensitive and repeatable measurements. Air leak testing with Mass Extraction at vacuum (molecular flow) conditions Leak Vacuum reservoir Vacuum reservoir 2 Fill 1 Standby – Vacuum Reservoir: P0 – IMFS: no flow...

Equivalence between defect size and air leak rate Traditionally, tightness in the pharmaceutical industry is expressed as an equivalent hole diameter in μm. However, the leak path (length) should be stated when defining the tightness criterion. ■ For large diameters, the leak can be generally considered as an orifice with leak path of negligible length as defined in USP <1207.1> section 3.9. This corresponds to “Chocked Flow” regime. In “Laminar Flow” regime, the viscosity of the gas (depending on the gas temperature) determines gas-to-gas variations of media transfer through the leak. In “Molecular...

SpeedAir 3050 Technical data, accessories, order number matrix Dimensions SpeedAir 3050 UUT Port Pilot air connection 1/4" or 6 mm push-to-connect Dimensions in mm Technical data SpeedAir 3050 CFR 21 Part 11 Compliant software SpeedAir 3050 Test method Power Flow sensor Sensitivity Operating conditions: Temperature (min./max.) Humidity (min./max.) Test Pressure range Pneumatic supply: Quality Pressure (min./max.) Nitrogen supply Pressure (min./max.) Operating system User interface LeakRx Software Stored test recipes Network connection Interfaces Discrete inputs Analog inputs Discrete outputs...

2 microgram per minute, Full Scale B 10 microgram per minute, Full Scale E 50 microgram per minute, Full Scale G 100 microgram per minute, Full Scale H External press sensor c Further accessories can be found on our website at www.pfeiffer-vacuum.com PFEIFFERS VACUUM

Errors excepted. All data subject to change without prior notice. PL 0029 PEN (October 2023/PoD) We give our best for you every day – worldwide! Are you looking for an optimal vacuum solution? Please contact us: Pfeiffer Vacuum GmbH Germany T +49 6441 802-0