mdi Filters for Pharmaceutical and Biological

Transcription

1 mdi Filters for Pharmaceutical and Biological Applications mdi Filters for Biologicals are specially designed filtration devices for filtration of culture media, culture soups, serum solutions, nutrients, growth regulators and other sensitive solutions in the laboratory. These filters are validated for absolute bacterial retention, hold-up volume, and protein recovery. mdi Filters offer: Maximum product recovery High throughputs Absolute microbial retention Product Key Features Product Code Dia/ Application SY4PN 4mm Sterilization of heat labile additives such as growth hormones, vitamins, and antibiotics (<1ml) Membrane Syringe Filters SY13PN 13mm (<10ml) SY25PN 25mm (<20ml) Membrane Syringe Filters with pre-filter and high throughputs SY25PG-S SY50PG-S 25mm 50mm Sterilization/clarification of difficult to filter solutions (<5 liter) Membrane Bottle Top Vacuum Filter and high throughputs Vacufil-S 75mm (<1 liter) Membrane Capsule Filters and high throughputs DPL 1" (<10 liters) Capsule filtration system for biologicals Biologically inert materials of construction CFS - B 5-20 liter capacity 8

2 mdi Pre-sterilized Membrane Syringe Filters PRESTERILIZED PACK SYPN-S Pre-sterilized syringe filters are available in pore sizes of and 0.45µm and several diameters to suit various applications for filtration in the laboratory. Special s Available SY25PG-S This special syringe filter houses a microglassfiber pre-filter along with the membrane filter and is ideal for filtering difficult to filter solutions. SY50PG-S This 50 mm syringe filter incorporates large filtration area and microglassfiber pre-filter for larger volume filtration. These filters can be used with 50 ml syringe or a peristaltic pump to filter volumes from 500 ml to 2 liters. Specifications, 0.45µm Diameter 4mm 13mm 25mm Effective Filtration Area 0.07cm² 0.8cm² 4.15cm² Hold-Up Volume <5µl <20µl <50µl Retention Efficiency 50mm 18cm² <300µl : LRV >7 for Br. diminuta 0.45µm: LRV >7 for Sr.marcescens Special Feature Extremely low protein binding exhibited by mdi syringe filters results in very high product recovery. (Refer Fig.1) Protein Recovery (µg) BSA 99.9% 98% SYPN Competition Figure 3: Protein recovery with a BSA challenge of 150µg/30ml through 25mm syringe filters SY4PN-S Diameter 4mm Pore 0.45µm Inlet End Connections Outlet Pack 100 Qty SY13PN-S SY25PN-S SY25PG-S 13mm 25mm 25mm 0.45µm Female luer lock Male luer slip 100 Example: SY25PN-S,, 100nos SY50PG-S 50mm 0.45µm Female luer lock 1/4-3/8 Stepped hose 10 9

3 mdi Vacufil-S: Pre-Sterilized Bottle Top Vacuum Filters (with Pre-Filter) mdi Pre-Sterilized Bottle Top Vacuum Filtration units with an extra large 75mm diameter, low protein binding membrane along with a specially designed pre-filter are the best option for filtration of biologicals like sera and culture media, and other proteinaceous solutions. Vacufil filters have a hydrophobic filter in the vacuum arm to prevent passage of filtrate to the pump. These filters screw perfectly on to vacuum safe bottles with 45mm neck size. PRESTERILIZED PACK Features Extra large filter area High flow rates 100% Integrity tested No elastomers or adhesive used in sealing Non-toxic materials of construction Specifications Length Connection Hold-Up Volume Retention Efficiency, 0.45µm 75mm 45mm (Screw cap neck) <3ml : LRV>7 for Br. diminuta Materials Membrane: Housing: Acrylic Sterilization: ETO sterilized o Maximum Operating Temperature: 45 C Qty Example: Vacufil-S,, 50nos 10

4 mdi Membrane Capsule Filters mdi 1 Capsule filters are self contained, ready to use disposable filtration devices that contain a mini cartridge filter element sealed inside a polypropylene housing. The special design assures highest packing density of the membrane per unit volume resulting in a very compact capsule offering long service life. s Available DPL: Single layered Capsule Filter for clear media, buffer filtration etc. DPS: Serial filter, specially designed for filtration of difficult to filter solutions like sera, culture soups and serum solutions in culture media. These incorporate a large pore size upstream membrane layer to protect the downstream final filter. Features Compact design Large filter area High flow rates Long service life 100% Integrity tested No elastomers or adhesives used in sealing Preflushed to minimize particulate release at installation Non-toxic materials of construction End connections to suit different needs Specifications DPL DPS Length Diameter Hold-Up Volume Retention Efficiency Sterilization: 25 autoclave cycles of 30 minutes at 121 C Maximum Operating Temperature: 80 C continuous Maximum Operating Pressure: 30 C Biosafety:, 0.45µm 38mm without adapters 42mm <5ml 0.8µm+, 0.8µm+0.45µm 38mm without adapters 42mm Effective Filtration Area 260cm² 230cm² <5ml : LRV>7 for Br. diminuta 0.45µm: LRV>7 for Sr.marcescens Passes the Biological tests for Class VI plastics as described in USP Extractables with Water: Within limits specified in USP Pressure Drop (psi) Water Flow Rates Figure 4: Water flow rates Integrity Test Data (50% IPA wetted) Test Pressure DPL 1 inch D PL µm 1 i nch DPS 1 inch Max. Air Diffusion Flows 16psi 1.12Kg/cm² <1ml/min 0.45µm 12psi 0.84Kg/cm² <1ml/min PRESTERILIZED PACK Water Flow Rate (lpm) Pressure Drop (Kg/cm²) Oxidizable Matter: Passes as per USP DPL DPS 1 2 A B C End Connections 1/4" stepped hose barb 1/4" MNPT 1/2" MNPT 0.45µm D 1/2" hose barb E 1½" sanitary flange 1 1 Inlet Connection Example: DPL1AA1 For presterilized packs: DPL1AA1-S Outlet Connection For capsule filters with larger filtration area please refer our Process Filtration Product Guide. 11

5 mdi Capsule Filtration Systems for Pharmaceuticals and Biologicals ( 0.5 liters to 20 liters ) mdi Capsule Filtration System for pharmaceuticals and biologicals is a compact, clean, and faster alternative to conventional vacuum or pressure filtration systems using disc filters. It is especially useful for difficult to filter solutions such as serum and other biologicals. s Available CFSF-B: with Flexipump CFSP-B: with Pressure Vessel mdi Flexipump Components mdi Flexipump, variable speed - One peristaltic, table top pump Vertical Stand - One Silicone Tube 3/8 diameter - 3mtrs Clamps - 6nos mdi Pre-sterilized - 6nos membrane capsule filter with bell : DPL1AA1-S : : 1 DPL1AA2-S / / 2 Capsule filter - 3nos DPL1AA5-S/ / 5 Capsule filter - 2nos Components SS316 Pressure Vessel with vent - One valve and 0-100psi SS pressure gauge (Available in 5, 10 and 20 liter capacity) Vertical Stand - One Silicone Tube 3/8 diameter - 3mtrs Clamps - 6nos mdi Pre-sterilized - 6nos membrane capsule filter with bell : DPL-1AA1-S : : 1 DPL1AA2-S / / 2 Capsule filter - 3nos DPL1AA5-S/ / 5 Capsule filter - 2nos 12

6 Features Compact design Available in 5, 10, and 20 liter capacity to filter volumes ranging from 500ml to 20 liters All components in contact with the fluid are made of non-toxic, non-biodegradable materials Ready to use with minimal preparation time Advantages Higher throughput with reduced filtration time due to very large filtration area Lower hold-up volume in comparison to systems using membrane disc or mini cartridge filters, results in considerable cost savings in case of expensive solutions Reduced preparation time with ready-to-use presterilized capsule filters Occupies very little laboratory space due to its compact design A closed filtration system ensures no extraneous contamination and/or exposure to hazardous biologicals capsule filters ensure maximum recovery of high value products Capacity Qty CFSF-B CFSP-B5 CFSP-B10 CFSP-B20 with Flexipump with 5 litre pressure vessel with 10 litre pressure vessel with 20 litre pressure vessel Example: : CFSP - B20 Capacity : 20 liters Quantity : 1 13