TAKEONE Aseptic Sampling System

Transcription

1 TAKEONE Aseptic Sampling System

2 What would you do if...you had more time? Break Bottlenecks The patented TAKEONE aseptic sampling system is the only system of its kind. TAKEONE is delivered fully assembled and ready-to-use. Bypass parts washing, equipment prep and assembly with the TAKEONE and break the bottlenecks to your process. Single-Use The TAKEONE was conceived to embrace the benefits of single-use technology. TAKEONE is not a hybrid of single-use and multi-use components. Dispose of the TAKEONE aseptic sampling system at the conclusion of the batch and find time previously lost to disassembly. How much time can you find? Hybrid Single Multi-Use Systems TAKEONE Aseptic Sampling System Parts Washing 6 minutes 0 minutes Equipment Prep 4 minutes 0 minutes Assembly 3 minutes 0 minutes Disassembly 3 minutes 0 minutes Devices Per Year Man Hours Used 400 hours 0 hours Man Weeks Used 10 weeks 0 weeks Contact your Sartorius Stedim sales person today for your customized time study analysis

3 ...you could make a wish? Strategic Design Not all samples are created equal and we don t treat them that way. Whether it s sterility, bioburden or endotoxin testing or routine process monitoring, your TAKEONE device is designed for your process demands. You don t have to wish for a better sampling device; TAKEONE is your better sampling device. Erase Waste Samples collected from a process are valuable product that cannot be replaced. Sartorius offers collection vessels and procedures that reduce product loss from over-sampling, saving our customers millions of dollars....you knew you wouldn t fail? 100% Leak Testing Every sampling line of every TAKEONE device is leak tested after assembly. Only a factory assembled aseptic sampling device can make this claim and it gives you assur-ance that your TAKEONE is built right and can be relied upon. QUICKSEAL Aseptic Disconnect The ingeniously intuitive QUICKSEAL aseptic disconnect has no match for its performance in the field. Use QUICKSEAL to remove the collection vessel and remove any fear of failed aseptic disconnections or tube seals.

4 Product Life Cycle No aseptic sampling system matches the simplicity or efficiency of the TAKEONE aseptic sampling system. The TAKEONE device is assembled in an ISO 7 certified cleanroom in accordance with applicable cgmp guidelines Receive Sampling Vessels Tailored to your needs: Choose from bags, bottles, syringes Needleless or septum sites Install Sample

5 Performance & Materials Spring-Loaded Actuator Never touch a needle Enhances operator safety Glass Reinforced Polyester Body Hermetically sealed cannula diaphragm 2 mm Cannula Electropolished 316 L stainless steel Silicone Septa Platinum-cured Self-sealing QUICKSEAL Aseptic tube separation Platinum-cured Silicone, C-Flex & other tubing Mount Electropolished 316 L stainless steel 2 : 9 sampling lines 1.5 : 5 sampling lines Disposal Disconnect Removal

6 Technical Specifications Mechanics Sampling Mechanism Aseptic Disconnect Connection to Tank 2mm needle pierces platinum-cured silicone septa QUICKSEAL aseptic disconnect 1.5 or 2 Sanitary Fitting Materials of Construction 2mm Needle Sanitary Fitting Septa TAKEONE body 316L Stainless Steel, electropolished 316L Stainless Steel, electropolished Platinum-cured silicone High Glass Reinforced Polyester Performance Specifications (independent of collection vessel) SIP (30 psig, 30 mins) Up to 10 cycles (including after actuation) Multiple Actuations Up to 40 actuations per sampling line Sampling Pressure 7.5 psi (0.5 C Validation & Material Tests (independent of collection vessel) USP <88> Class VI Pass USP <85> Pass, routine testing USP <788> Pass, routine testing Gamma Irradiation Validated to SAL 10-6 per ISO Leak Testing Pass, 100% testing

7 Recommended Configurations Materials of Construction EVA (S71)/PE (CX5-14), silicone or C-Flex tube, PP, PC, Platinum-cured silicone Sample Volume Maximum Pressure Outlet 50, 150, 500, 1000mL (EVA), 50, 100, 250, 500, 1000mL (PE) 7.5 psi (0.5 bar) -70 to 40 Celsius (EVA), -80 to 60 Celsius (PE) 2-option; female luer & luer activated access site TSE/BSE Free Yes BPA Free Yes Flexboy bags include graduations to assist with fluid volume control and support fully aseptic samples. Materials of Construction PETG/PC, silicone or C-Flex tube, platinum-cured silicone, PE, PP Sample Volume 30, 60, 125, 250, 500, 1000 ml Maximum Pressure Outlet 7.5 psi (0.5 bar) -40 to 40 Celsius (PETG), -135 to 135 Celsius (PC) Puncture Site (>125 ml bottles), PE Vent Filter TSE/BSE Free Compliant* BPA Free Yes Bottles from Nalgene feature accurate molded-in graduations for fluid volume control. Materials of Construction PP/PS, silicone or C-Flex tube, platinum-cured silicone, PE, PP Sample Volume 15, 50 ml Maximum Pressure Outlet 7.5 psi (0.5 bar) -40 to 40 Celsius PE Vent Filter TSE/BSE Free Compliant* BPA Free Yes Centrifuge tubes provide best fluid volume control. Select polystyrene (PS) for improved endotoxin sampling. Materials of Construction PC, platinum-cured silicone, SAN, silicone or C-Flex tube Maximum Pressure 7.5 psi (0.5 bar) -40 to 40 Celsius TSE/BSE Free Compliant* BPA Free Yes Materials of Construction PC, PE, PE, silicone or C-Flex tube Maximum Pressure 7.5 psi (0.5 bar) -40 to 130 Celsius TSE/BSE Free Compliant* BPA Free Yes * The raw materials used to make components used in construction of these assemblies are treated high tempera-tures and undergo chemical reactions which exceed by far the stringent requirements laid down in the documents CPMP/BWP/1230/98 and WHO/CPS/VPH/ and or EMEA/410/01. These processing conditions are considered sufficient to inactive TSE & BSE transmitters. BENCHMARK includes a check valve to prevent unintentional contamination. AseptiQuik is ideal for supplemental or unplanned samples and for autoclave applications.

8 Sales and Service Contacts For further contacts, visit Croatia Sartorius Croatia - Libra Elektronik d.o.o. ZAPREŠIĆ Savska 45a Zaprešić Phone Fax sartorius@sartorius.hr Bosnia and Herzegovina Sartorius Libra Elektronik d.o.o. Olimpijska Sarajevo Phone Fax sartorius@bih.net.ba