Ampoules Bottles

ONE SUPPLIER

Bottles

Ampoules

ONE LINE

rommelag ag rommelag Kunststoff-Maschinen rommelag USA, Inc. rommelag Trading (Shanghai) Co., Ltd. ® P.O. Box Vertriebsgesellschaft mbH 27905 Meadow Drive, Suite 9 Room 1501 Xinyin Building CH-5033 Buchs P.O. Box 16 11 P.O. Box 2530 No. 888 Yishan Road www.rommelag.com Switzerland D-71306 Waiblingen/Germany Evergreen CO 80437, USA 200233 Shanghai, P.R. China ® Phone: +41 62 834 55 55 Phone: +49 7151 958 11-0 Phone: +1.303. 674.8333 Phone: +86 21 6432 0166 Fax: +41 62 834 55 00 Fax: +49 7151 155 26 Fax: +1.303.670.2666 Fax: +86 21 6432 0266

E-Mail: [email protected] E-Mail: [email protected] E-Mail: [email protected] E-Mail: [email protected] 05/2011 HVLD_EN Technical data

HVLD 923 HVLD 924 HVLD 926 fully - automatic fully - automatic fully - automatic for small individual for ampoule blocks for bottles containers As a supplier of BFS technology it is becoming increasingly important to support the customers with ancillary equipment. Dimensions and Weight

This is particularly true for the downstream equipment. While the upstream requirements 1 test station 1 test station 2 test stations 2 test stations are represented by a number of reputed suppliers, some specific equipment to follow the Width 2.300 mm 3.000 mm 3.000 mm 2.250 mm BFS process is not widely available. Length 4.000 mm 3.000 mm 3.000 mm 2.700 mm Height 2.500 mm 2.300 mm 2.300 mm 2.800 mm Weight 1.500 kg 1.500 kg 2.000 kg 2.500 kg

The application The process Ozone absorption system optional optional optional

Integrity testing of pharmaceutical packages The rommelag® HVLD high voltage leak Ampoule rotation unit optional optional — has always been an important part of the detector operates based on the high manufacturing process and quality control. voltage test method and the electrical Electricity conductivity of the fill product packaged in a non-conductive plastic ampoule. The system Connected load approx. 2,5 kW approx. 1,8 kW approx. 12 kW is designed for fully-automatic in-line leak approx. 4,0 kW with rotation unit testing. Consumption approx. 2,2 kW/h approx. 1,5 kW/h approx. 10 kW/h approx. 3,5 kW/h with rotation unit

Pneumatic

Operation pressure 6 bar 6 bar 6 bar Consumption 350 sl/min 150 sl/min 150 sl/min Drive electr./pneumatic operation electrical operation electr./pneumatic operation

Capacity

Current FDA guidelines require validation for Ampoule width < 15 mm 6.000 amp/h container closure integrity tests. EU GMP Ampoule width < 21 mm 4.800 amp/h guidelines stipulate «Plastic ampoules should Ampoule width < 22 mm 4.500 amp/h be subject to 100% integrity testing». Ampoule width < 24 mm 4.200 amp/h If any leak is present, the discharge current Ampoule block width < 65 mm 6.000 blc/h will flow through the pinhole into the con- Ampoule block width < 75 mm 5.000 blc/h tainer and the detection of this current will Ampoule block width < 150 mm 2.500 blc/h automatically cause the container to be Bottle width < 38 mm 5.500 b/h rejected. Bottle width < 48 mm 4.400 b/h rommelag®´s HVLD high voltage leak Bottle width < 56 mm 3.850 b/h detector represents a testing method Bottle width < 66 mm 3.300 b/h without risk of contamination of product Bottle width < 79 mm 2.750 b/h and does not require human intervention. Bottle width < 101 mm 2.200 b/h

The above are all approximate figures. ® Technical modifications reserved. www.rommelag.com Technical data