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The information contained in this sheet may be used only for the purpose for which it is supplied by Pharmaplan,

and mus

Document Name : Document Number: Date / Version : 1 2 3 4 5 6 Medium: State Oper.press.min/max: Oper.temp.min/max: Density of oper.- cond.: Operating type:

discontinuous

JUBILANT ORGANOSYS LTD, NANJANGUD DATA SHEET - 0.2 FILTER DS -MF-02 25.09.2009 / REV 00 Operating and design data Process fluid*** 9 Rating *** 10 Volume flow: 0 / 5 *** bar g 11 Abs. filtr. efficiency * : 25 / 90 *** C 12 Dyn.visc. at.op. cond.: 500 / 1500 *** kg/m 13 Standing time: 14 Max allow temperature continuous 15 Sterelizable Grade xx xx

0.2 xx xx xx xx xx Non Sterlizable

m m/h % mPas hr Deg C

7 Design life: 8 No. Of stress cycles: 16 17 18 19 20 21 22 23 24 25 26 27 28 29 40 41 42 43 44 45 50 51 52 53 54 55 56 57 58 59 60 61 Filter Manufacturer: Filter type:

by Pharmaplan

Design and Dimensions 30 Housing Manufacturer: xx Particle filter: 31 Housing type: Vertical, cylinderical Sterile filter 32 Housing dimensions: xx mm No of filter elements: One 33 Weight: xx kg Filter pack.-partic. size: xx mm 34 Sterilisable: Filter pack.-height: xx mm 35 Incl. Diff Pr Guage: Packing volume: xx m 36 Vent 3/8" BSPT Packing density: xx kg/m 37 Drain 3/8 " BSPT Type of filter element: Hydro phobic / y 38 Pressure gauge 0 to 6 Bar 3/8 " BSPT (M) Size of filter element: xx mm with PTFE Diaphragm Total filter area: xx m 39 Valve at drain To Suit drain size Diaphragm type Design pressure: xx bar g 40 End Connc. 25 NB ASA 150 # Flanged Design temperature: xx C Diff. press. (clear): xx mbar Remarks: All process parameters to be confirmed by JOL Materials SS / PTFE xx Housing SS-316 L 46 Case & Core Membrane PTFE 47 Pressure gauge xx End cap supports SS-316 48 Ball Valves SS-316 O Rings PTFE 49 Diaphragm Valves SS-316 Remarks: NOTE: The pressure drop across the filter shouldnot be more than 1.0Kg/cm2(g) in fully clogged condition. Surfaces Inner shell: 380 grit mirror finish Outer shell: 220 grit mirror finish Remarks: Filter should have pressure safety valve, differential pressure gauge, vent and all interconnecting valves Other informations *) absolute filtration efficiency relating to = 99.9% No Sharp edges/crevices/pin holes in the equipment surface. All internal/external surfaces should be buffed smooth. All weld parts to be ground smooth External Surface finish shall be <1.2 Ra All metallic product contact surfaces should be constructed of 316L grade stainless steel and surface finish shall be <0.4 Ra Gaskets/ O-ring shall be food grade ,EPDM, Silicone or PTFE All fabrication should be as per current good manufacturing practices & Equipment to comply with cGMP Use of Asbestos is prohibited Remarks : dp v/s flow curve to be provided by vendor

Copyright

62 Note :xx - vendor to specify, *** Client to confirm xxx - vendor to confirm, ** Client to specify 63 Remarks: AFI - Approved for inquiry, AFO - Approved for Ordering 0 Rev 25.09.2009 date AVB/SR Prepared by SEM/ SKR/ PRK Checked by 5/24/2012 sheet: 1/2

AFI

AFO

JUBILANT ORGANOSYS LTD, NANJANGUD


The information contained in this sheet may be used only for the purpose for which it is supplied by NNE Pharmaplan, and must not be shown to third parties. This sheet and all copies must be returned on demand.

Document Name Date / Version

: :

DATA SHEET - 0.2 FILTER PRD-DS-MF-02 25.09.2009 / REV 00

Document Number :

This document shall also serve as URS Document for following Equipments:-

Sl. 1 2 3 4

BLOCK PILOT PLANT PILOT PLANT SEMICOMMERCIAL PLANT SEMICOMMERCIAL PLANT

LOCATION POTENT POTENT POTENT POTENT

EQUIPMENT ID MF-11102 MF-11104 MF-12202 MF-12204

Copyright

by NNE Pharmaplan