CFR 21 Part 11 compliant IT-SystemMeets all normative requirements (GMP, FDA, ISO etc.)

CONTAINER CLOSURE INTEGRITYTESTING SYSTEM – CCIT

MEET INCREASED REQUIREMENTS

CONTAINER CLOSURE INTEGRITY TESTING SYSTEM - CCIT

The mobile Container Closure Integrity Testing System (CCIT) of 3D innotec AG is used for automated leak testing of asep-tically prefilled units by means of methy-lene water mixture, also called „blue bath liquid“, at defined pressure cycles up to maximum +/- 1 bar relative to the ambient pressure. The test pressure can be regu-lated within +/- 0.01 bar. A test sequence consists of maximum 5 cy-cles with 4 test steps each and can be speci-fied via a recipe. The pressure vessel is loa-ded with the samples to be tested, filled with blue bath liquid and put under test pressure. The blue bath liquid and the over- or under-pressure make leaks in aseptically prefilled units visible.

At the end of the test, the CCIT system au-tomatically generates a test report. Vacuum, pressure and test times are adjustable and are stored in the unit. This ensures that the same parameters are used for repeated tes-ting. Tests are therefore reproducible and documented by the printed test report.

The entire system is designed for the phar-maceutical industry and for compliance with the demanding industrial requirements, such as strict adherence to the current GMP guidelines and standards and the use of FDA-compliant building materials.

The closed system with integrated blue bath preparation, filtering and the corresponding

data recording and logging can be conveni-ently placed anywhere. The system can be easily integrated into the existing IT environ-ment and is also very low maintenance.

3D innotec AG provides a wide range of qua-lification documentation, such as DQ, IQ, OQ, FAT and SAT protocols. The control unit ensures compliance with the CFR 21 Part 11 regulation and all events are recorded and archived in an audit trail. In addition, all mea-surement sensors are delivered with corres-ponding calibration protocols.

CFR 21 PART 11 COMPLIANT IT-SYSTEM

Advantages • Mobile unit• Low maintenance operation• System availability 7 x 24 h• Data transmission of the test results optional via

Ethernet or Wireless• User administration and control of rights• Holders, baskets etc. are supplied to customers and

developed and produced according to specific requi-rements

• Step filtration before each test cycle (200 / 50 / 1µm)• High process reliability and monitoring• CFR 21 Part 11 compliant IT-System• PM-Control, PM-Quality and Audit-Trail integrated• Meets all relevant normative requirements• Customer-specific adaptations possible at any time• Requires no other media connections apart from the

mains power supply

3D innotec AG . Hofstetstrasse 8 . 9300 Wittenbach . www.3dinnotec.ch

TECHNICAL DATA AND SPECIFICATIONS

Technical DataDimensions (l x b x h) 1670 mm x 930 mm x 1500 mmEmpty weight 350 kg ElectricsPlug main cable CEE Typ 5L 16A 6h 3x400VPower consumption 1,8 kVA MechanicsTotal volume of pressure vessel 70 LitresMax. tank capacity for blue bath liquid 87 LitresMax. volume pressure vessel for 62 Litres (without displacementblue bath liquid to overflow of the test pieces) MaterialsMachine frame Aluminium profiles 40mmPanelling / pressure vessel Stainless steel 1.4404 electropolishedBlue bath tank / collecting tank Stainless steel 1.4404 PneumaticsMaximum pressure - 0,5 to +1 bar relativMax. setpoint deviation test pressure +/- 0,01 bar (incl. overshoot)Max. time to reach test pressure 2 minutesRecording interval test pressure optional (default: 5 Seconds)Display accuracy process pressure 0,01 bar

Main view Side view

3D innotec AG . Hofstetstrasse 8 . 9300 Wittenbach . www.3dinnotec.ch

CONTAINER CLOSURE INTEGRITY TESTING SYSTEM - CCIT

Wir sind ein innovatives und technologisch hochstehendes Unternehmen, welches sich auf die Bereiche Engineering, 3D-Messtech-nik und Beratungen spezialisiert hat.

Durch den Einsatz modernsten Equipments, einem grossen Netzwerk und jahrelanger Erfahrung sind wir ein Garant dafür, dass Ihre Anforderungen an uns erfüllt oder gar übertroffen werden.

Mit unserem lösungsorientierten Denk- und Handlungsansatz generieren wir einen ma-ximalen Kundennutzen und schaffen Raum für neue Ideen und Lösungsansätze. Dabei setzen wir auf Innovation, Kompetenz und Verlässlichkeit.

Ihre Zufriedenheit ist unsere Motivation.Kontaktieren Sie uns, wir freuen uns auf Ihre Herausforderung.

ÜBER 3D INNOTEC AG

3D innotec AGHofstetstrasse 8 9300 Wittenbach

+41 (0) 71 571 96 70 +41 (0) 71 571 96 79 info@3dinnotec.ch www.3dinnotec.ch