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Disposable Processing Market Increasing interest and need from Biotech and Pharmaceutical filling operations Main benefits of disposable Product Path Eliminates chance of cross contamination from product path Eliminates cleaning & sterilization process for product path parts No cleaning & sterilization process development No validation of cleaning & sterilization Reduces operator exposure to potent products Reduces capital investment Reduces clean utilities usage Reduces batch turn-around time Ideal for cytotoxic product filling Saves time & money 2
Disposable Filling Systems Reduce Costs No cleaning No utilities Reduced investment Pre-validated Reduced Risk No possibility of cross contamination Reduced risk of biological contamination Reduced liability 3
Bosch Disposables Plan Bosch to offer 100% disposable pre-sterilized filling systems for both clinical and high speed production applications including: Rolling Diaphragm Pump systems Peristaltic systems Individual Needles Systems are custom designed to fit each customers needs 4
Disposable Filling Systems Rolling Diaphragm Pump System (Patent Pending) Fits existing and new Bosch & TL filling equipment Complete product path systems assembled, sterilized and validated Individual disposable needles Replaces needles used on standard pump systems Individually bagged and sterilized Peristaltic Systems Complete product path systems for use on peristaltic pump machines 5
Pre-Validated, Assembled, Sterilized Pre-Assembled Complete dosing system Pumps Needles Manifold Connectors Double Bagged 8 Marketing 3/5/2008 Interphex 2008 2008 Robert Bosch LLC and affiliates. All rights reserved.
Pre-Validated, Assembled, Sterilized Pre-Sterilized Gamma irradiated 25-40 K/Gry Gamma Certificate attached Ready to use 9 Marketing 3/5/2008 Interphex 2008 2008 Robert Bosch LLC and affiliates. All rights reserved.
6 Head system on FLC Vial Filling Line Manifold Pumps Needles 10
Configurations for any machine type 8 Head for FLC 4 Head for MRF 2 Head for FXS 8 Head for FSM 11
Advantages of Disposable Rolling Diaphragm Pump Only Single use positive displacement pump Very accurate dosing Minimal product loss Totally enclosed product chamber Scalable from clinical to large production Pre-assembled and ready to use Not sensitive to product characteristics 12 Marketing 3/5/2008 Interphex 2008 2008 Robert Bosch LLC and affiliates. All rights reserved.
Disposable Rolling Diaphragm Pump Same functionality and accuracy as legacy Stainless Steel 6cc pump Mounts in existing TL & Bosch machines in place of stainless steel Rolling Diaphragm Pumps Tested accurate to 400,000 cycles (same as 24 hrs for 7 days) 13 Marketing 3/5/2008 Interphex 2008 2008 Robert Bosch LLC and affiliates. All rights reserved.
Disposable Rolling Diaphragm Pump Description Platinum cured silicone diaphragm separates fluid chamber from piston Diaphragm rolls inside itself between piston and body Fluid valving done by pinching supply & discharge tubing Vacuum on backside of diaphragm maintains shape and dosing accuracy 15 Marketing 3/5/2008 Interphex 2008 2008 Robert Bosch LLC and affiliates. All rights reserved.
Disposable Needles Guaranteed straight needle for every fill Pre-cleaned 16
Disposable Needle Desciption Stainless steel hypodermic tubing core Over-molded with medical grade polycarbonate Current sizes; 1.6mm ID, 2.1mm ID, 3.0mm ID. Mounts in existing TL & Bosch machines in place of Stainless Steel needle 17
Validation includes USP/NF Class VI for pump & needle Sterility of assembly Shelf life of sterile assembly Extractables and toxicity Particulate load of sterile assembly Materials 18
Prevas, The Complete Package 19