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Sartocheck® 5 Plus Filter Tester

The Sartorius® Sartocheck® 5 Plus perfectly meets today’s key industry requirements for filter integrity testing in demanding GMP environments. By combining a unique approach to Quality Risk Management, with optimal data integrity, intuitive usability and minimized risk factors for Health, Safety and Environment (HSE), it sets a new standard for filter integrity testing devices.

Overview

The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.


The Sartocheck® 5 Plus can perform the following filter integrity tests:


  • Bubble Point Test
  • Diffusion Test / Forward flow Test
  • Combined Diffusion and Bubble Point Test
  • Water Intrusion Test (WIT)
  • Pressure Drop Test / Leak Test

Quality Risk Management


The regulatory focus on QRM (cf. ICHQ9 and the new Annex 1 written by EMA in cooperation with the US-FDA, WHO and PICs) also applies to filter integrity testing, as a fundamental element of sterility assurance. The Sartocheck® 5 Plus Filter Tester uses program specific parameters allowing the automatic identification of testing anomalies before or during the test. This prevents time-consuming, costly deviations, potential drug recalls and 483 warning letters.


Main Features:


Quality Risk Management


  • Automatic detection of incorrect test setups
  • Automatic detection of abnormal test conditions
  • Self-test at booting and before each test

Data Integrity


  • Custom Linux-based Operating System
  • Four eyes principle with electronic signature
  • C10- Internal Double Data Backup
  • Encrypted Data
  • Time Zone synchronization - NTP
  • Audit Trail with time stamped events
  • User Matrix to generate individual user roles
  • Mandatory fields for Operator entries
  • Data entry by Barcode Scanner
  • Long-life printouts and sticker function from optional printer

Usability


  • Intuitive iF-Design rewarded Human Machine Interface (HMI)
  • 1"" bright touchscreen with a +-88° viewing angle
  • Large digital keypad - no need for a pen – compatible with glove use
  • 10 system languages
  • LDAP - Log on with network user credentials
  • Automatic test time for faster testing
  • Data transfer

Health, Safety and Environment


  • Splash-proof (IP64)
  • Explosion proof (ATEX IECEx & FM certified
  • Safe testing and re-testing of alcohol wetted filters
  • Continuous and clear visualization of pressure status
  • Resistant to all current cleaning agents
  • H2O2-vapor resistant (VHP)
  • PFA tubes (FDA 21 CFR 177 and USP Class VI compliant)
  • Prepared for automated cleaning of all pneumatics with up to 0.5 M NaOH

Optional accessory kit for backflow protection Compliance


  • 21 CFR part 11
  • GAMP 5
  • Ex proof (ATEX | IECEx | FM)
  • CE
  • FCC

Supplies


  • Sartocheck® 5 Plus Filter Tester
  • Inlet and outlet tubes
  • Country specific power cable
  • Instruction manual
  • QRM documentation - FMEA
  • Network cable 2m
  • USB- Cable for the optional printer
  • T20 screw driver
Learn more

Specifications

Applications
Field
Biopharma
Connections (Data)
Data Interface
USB
RJ45
Dimensions
Dimensions (W×D×H)
348 × 379 × 286 mm
Features
Diffusion
Without ext. ref. tank: Cartridge systems up to net volume of 14 l; with ext. ref. tank: Cartridge systems up to 150 l
Languages
English, German, French, Spanish, Italian, Mandarin (simplified), Portuguese (Brazilian), Japanese, Korean, Russian
Measuring Accuracy - Absolute Deviation Pressure Measurement
± 7.2 mbar
Measuring Accuracy - Relative Deviation Pressure Measurement
± 0.1% full scale
General Specifications
Additional Product Specifications
Measuring accuracy - bubble point: 250-6,550 mbar acc. +/-50 mbar
Measuring accuracy - diffusion: 0.01-24.000 mL/min acc. +/-5%
Measuring accuracy - Water intrusion: 0.005-600.000 mL/min acc. +/-5%
Measuring Ranges - Net volume: 10 mL - 150 L acc. +/- 4%
Minimum Inlet Pressure
4,000 mbar
Net Volume Measurement
4 %
Pressure Drop
All filter systems up to net volume of 150 L
Water Intrusion
0.005 - 300.000 ml/min
Operating Conditions
Maximum Operating Pressure
8 bar (116 psi)
Operating Conditions - Temperature
0 °C – 40 °C (32 – 104 °F)
Operating Pressure
min. 4 bar g or test p + 0.5 bar g (whichever highest); max 8 bar g
Relative Humidity
10% – 80%
Physicochemical Information
Bubble Point
250 – 6,550 mbar acc. +/- 50 mbar
Pressure Measuring Range
50 – 6,600 mbar
Power Requirements
Input Wattage
74 W
Power Requirements
100 – 240 V AC at 50 | 60 Hz
Product Information
Primary Product Type
Systems
System Type
Integrity Testing Systems
Weights
Packing Weight
2.2 kg
Weight
16.8 kg

Contact

Nova Natura UAB

Kaštonų g. 56, Giraitės k, LT-54310,
Kaunas, Lithuania

nova@novabio.lt
Phone: +370 (620) 70159

Reg No 305063819

Nova Natura OÜ

Valukoja 8, 11415,
Tallinn, Estonia

nova@novabio.ee
Phone: +372 5656 0050

Reg No 14758203

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