3M Purification Life Sciences Process Technologies Markets ™ PLA LifeASSURE Series Capsules & Cartridge Filters Log reduction grade Nylon 6,6 membrane filter for pharmaceutical and biological Service New name for CUNO LifeASSURE PB capsules and cartridges Multi-zone microporous membrane design and APT (Advanced Pleat Technology) construction High cartridge flow rates for smaller filter assemblies and lower running costs Superior microorganism reduction and exceptional protection of downstream membranes LifeASSURE PLA cartridge and capsule filters Upstream Fluid Flow Downstream LifeASSURE™ PLA filter cartridges and capsules, formerly known as CUNO LifeASSURE PB, are one of 3M Purification’s advances in membrane filter technology. Encompassing two leading-edge processes, multi-zone microporous membrane manufacture and APT (Advanced Pleat Technology) construction, the LifeASSURE PLA series of filters offers unmatched protection of final membrane filters, as well as exceptionally long service life. Designed with pleated Nylon 6,6 membrane in an all- polypropylene cartridge construction, LifeASSURE PLA filters are ideally suited for a wide range of pre-filtration and clarification applications in the pharmaceutical, biological and bioprocess industries. Optimal system performance Used as a prefilter, LifeASSURE PLA filters protect and significantly extend the service life of 3M Purification‘s sterilising-grade LifeASSURE 020SP and LifeASSURE PSA final filter, as well as other membrane filters. LifeASSURE PLA Filters will: ■ increase final filter life substantially, often by 10 times or more. ■ decrease filter change-outs, greatly reducing filter costs. ■ provide superior microorganism reduction. Multi-zone microporous membrane technology LifeASSURE PLA filters incorporate 3M Purification’s multi-zone microporous membrane technology. It allows unmatched flexibility in creating a multi-zone membrane that offers the maximum in contaminant holding capacity while maintaining high retention efficiency. The SEM photograph on the left shows that the single layer LifeASSURE PLA membrane consists of an “open” zone on the upstream side of the membrane and a “tighter” zone on the downstream side. In effect, the open zone acts as a prefilter by capturing larger particles and colloids while the tighter zone provides the retention of smaller contaminants. This multi-zone structure eliminates dual-layer membrane construction to provide a larger surface area, significantly increased contaminant holding capacity and longer service life. For an in-depth technical presentation of multi-zone microporous technology, request 3M Purification. Features and Benefits Multi-zone microporous nylon membrane • Maximum membrane protection • Increased contaminant capacity • Extended service life • Lower total filtration costs APT (Advanced Pleat Technology) construction for extremely high surface area • Faster flow rates and smaller filter assemblies • Lower total filtration costs 100% Integrity tested in manufacturing • Ensures product quality Installation integrity testable by the user • Ensures proper installation and operation True membrane construction • Higher Integrity Meets USP Class VI Biological Test for Plastics and 21CFR materials of construction • Safe for product contact 2 LifeASSURE™ PLA Series APT (Advanced Pleat Technology) construction advantage LifeASSURE™ PLA cartridge filters also feature 3M Purification’s APT construction for extended service life. This design technology helps maximise the useful surface area of the filter while maintaining proper flow paths between media pleats. By employing as much as 50 % more effective surface area than competitive filters (see chart 1), the LifeASSURE PLA filter provides lower pressure drops, longer service life and lower overall filtration costs. Figure 1: Cartridge cross-section revealing the pleat configuration of the LifeASSURE™ PLA filter Superior microorganism reduction 3M Purification’s LifeASSURE PLA filters consistently exhibit a greater reduction of microorganisms than competitive filters that are constructed of polypropylene fibres or filters that are constructed with less efficient membranes. For effective prefiltration of pharmaceutical and biological products, microorganism reduction is a critical parameter resulting in economical, reliable filter systems. LifeASSURE PLA filters ensure compliance with your GMP requirements to maintain low system bioburden. In tests with Brevundimonas diminuta, (considered one of the smallest bacteria) LifeASSURE PLA020 grade filters exhibited an average log reduction value* (LRV) of 7.3 and the LifeASSURE PLA045 grade filters exhibited an average LRV of 3.5. Optimised for service life and effluent quality As the data in chart 2 demonstrates, LifeASSURE PLA cartridges are designed to provide both enhanced service life and performance. When compared to competitive products, LifeASSURE PLA filters allow the user to select equivalent effluent quality with vastly superior life or improve the effluent quality with reduced, yet competitively superior, service life. Either way, the result is the same, LifeASSURE PLA filters allow significantly more throughput than the competitive filters and provide up to double the service life. Chart 1: Surface area comparison of 10” cartridges Table 1: Comparative log reduction values Product LRV LifeASSURE™ PLA020 7.3 Cartridge A 4.5 LifeASSURE™ PLA045 3.5 Cartridge B 2.6 Cartridge C 0.41 Chart 2: Prefilter throughput comparison using a model contaminant solution LifeASSURE™ PLA 100 90 Filter Cartridge A 0.8 0.6 Filter Cartridge B 0.4 Filter Cartridge C 0.2 80 Percent Throughput (%) Surface Area (m²) 1 LifeASSURE™ PLA045 70 LifeASSURE™ PLA020 Filter cartridge A 0.2 μm nominal 60 50 Filter cartridge C 0.6 μm absolute 40 30 20 10 0 * LRV= log10 (number of organisms in/number of organisms out). 3 Chart 4: LifeASSURE™ PLA 10” cartridge water flow rates at 25 °C 200 180 PLA020 160 PLA045 The LifeASSURE™ PLA filter construction results in a higher per-cartridge flow rate at the same pressure drop when compared to competitive filters. Shown in chart 3 is the water flow versus pressure drop of commonly used 10” cartridges and minicartridges. Typical flow vs. mbar for LifeASSURE PLA filters are shown in charts 4 and 5. Chart 3: Comparative flow vs. pressure drop 120 10” Cartridges 100 12 Flow rate at 70 mbar (lpm) 80 60 40 20 0 8 6 4 2 LifeASSURE PLA020 Competitor A Cartridge 0.2 μm nominal Competitor B Cartridge 0.6 μm absolute 0 0 5 10 15 20 25 30 35 1000 900 (2. 5” ) PL A0 20 500 400 ”) (2.5 5 4 0 PLA ”) 20 (5 PLA0 5 (5”) PLA04 300 200 100 0 0 5 10 Flow Rate (lpm) LifeASSURE™ PLA020 2 Competitor A Cartridge 0.2 μm nominal 1.5 1 Competitor B Cartridge 0.6 μm absolute 0.5 0 15 Higher flow at a lower pressure drop reduces filter cost two ways – For existing applications at a given flow rate, filter cartridges with more surface area per-cartridge have a lower flux (flow per unit surface area) than those filter cartridges with less surface area. Since service life is inversely proportional to flux (lower flux = longer service life) in most applications, LifeASSURE PLA filter cartridges provide longer service life and require fewer cartridge change-outs. This greatly reduces filter costs, disposal costs, CIP/SIP, labour and downtime. Use smaller more efficient 3M Purification filter systems - For new applications where filter housing size is selected based on a desired “clean” initial pressure drop, filter cartridges that provide a higher flow rate per-cartridge at a given pressure drop will require fewer cartridges, and hence a smaller filter housing, to complete the task. This results in a substantial reduction in system costs. 800 600 3 2.5 Higher flow at a lower pressure drop reduces filter cost two ways? Chart 5: LifeASSURE™ PLA mini-cartridge and disposable capsule water flow rates at 25 °C 700 LifeASSURE™ PLA045 3.5 40 Flow Rate (lpm) Pressure Drop (mbar) 10 Capsules/Mini-cartridges 4 LifeASSURE™ PLA045 Flow rate at 70 mbar (lpm) Pressure Drop (mbar) 140 Benefits of higher per-cartridge flow rates 20 Table 2: Number of 10” filter cartridge required for a 76 l/min water flow at 70 mbar. LifeASSURE™ PLA045 7 LifeASSURE™ PLA020 14 Competitor A cartridge 0,2 μm 20 Competitor C cartridge 0,6 μm 25 Prefilter selection The table below is provided as a guide to prefilter selection, although actual process conditions may dictate the use of a more open or closed prefilter, than specified below. Prefilter selection can be aided by smaller scale pilot tests or flow decay studies using membrane discs or LifeASSURE PLA Capsules. Consult 3M Purification’s Scientific Applications and Support Services (SASS) or 3M Purification Technical Sales for more information. Grade PLA020 PLA045 Upstream Zone 0.65 μm 0.8 μm Downstream Zone Fluid Condition Prefilter for: 4 0.2 μm 0.45 μm Low particulate/ colloid content LifeASSURE™ 020SP, 020ST LifeASSURE™ PSA High particulate/ colloid content LifeASSURE™ 020SP, 020ST LifeASSURE™ PSA LifeASSURE™ PLA Series LifeASSURE PLA cartridge construction Standard cartridge LifeASSURE™ PLA filter cartridges are constructed of a single-layer, Nylon 6,6 microporous membrane pleated with polypropylene upstream and downstream support materials. The cage, core, end caps and capsule shell are made of polypropylene. All materials of construction are CFR 21 listed and have passed USP Class VI Biological Safety Test for Plastics at 121 °C. Cartridges are manufactured under an ISO certified quality system using the most advanced thermoplastic welding techniques to ensure filter integrity. LifeASSURE PLA filters are 100 % integrity tested after manufacture to ensure quality and are supplied with a Certificate of Quality. A regulatory support file (RSF) is available to assist in regulatory control and documentation. 316 stainless steel reinforcing ring Various O-ring materials End cap adapter Multi-zone microporous Media LifeASSURE PLA mini-cartridge construction 3M Purification’s 2.5“ and 5“ mini-cartridges can be installed in existing competitor housings or 3M Purification’s mini-cartridge housing. The significant LifeASSURE PLA flow advantage (chart 3) results in greater batch capacity than competitive filters, greatly reducing filter costs. Support layers LifeASSURE PLA disposable filter capsule construction Inner core and outer cage For critical small-volume applications where convenience and ease of use are desired, LifeASSURE PLA filters are available in 5“ and 2.5“ disposable capsules. LifeASSURE PLA capsules are supplied with sanitary vent and drain ports, as well as a choice of 1 ½“ sanitary flange connections or ½“ (13 mm) hose barb inlet/outlet connections. Mini-cartridge Cartridge end cap LifeASSURE PLA specifications Mini-cartridges 2.5” 5” length length Cartridges Material of construction Cage, core, end caps, capsule shell and media support layers Membrane Adapter support ring (full length cartridges only) Dimensions Filtration surface area Outside diameter Length Operating parameters Maximum operating temperature Maximum differential pressure Capsules 2.5” length polypropylene Multi-zone microporous media Inner core & outer cage multi-zone microporous Nylon 6,6 316 stainless steel N/A N/A N/A N/A 0.13 m² 0.3 m² 0.13 m² 0.3 m² 5.7 cm 5.7 cm 7.9 cm 7.9 cm 1 ½“ sanitary inlet/outlet Nominal 10”, 20”, 30” 13 cm 19.4 cm and 40” (nominal 250 7.9 cm 14 cm mm, 500 mm, 750 mm ½“ hose barb inlet/outlet and 1000 mm) 14 cm 20.3 cm Support layers 1 m² per 10” element 70 mm nominal 80 °C Forward: 5.5 bar at 25 °C 1.7 bar at 80 °C Reverse: 3.4 bar at 25 °C Steam sterilisation Autoclave sterilisation Installation integrity test methods 5” length 40 °C Inlet Multi-zone microporous media Vent valve 5.2 bar at 40 °C Do Not in situ steam 30 minutes at 126 °C Consult 3M Purification for appropriate values for the specific filter and housing in use 30 minutes at 126 °C Capsule Support layers Drain valve Outlet 5 Applications LifeASSURE™ PLA cartridges are designed for a broad range of aqueous based pharmaceutical, biological and bioprocess prefiltration and fine particle removal applications, including: • • • • • • • • • • protection of 0.2 μm final sterilising membrane filter Fermenter feed streams Parenterals (SVP, LVP) Solvent filtration Reagentsand buffers Orals and topicals Particulate and bioburden reduction Vaccines Cell culture fluids High-Purity DI water and WFI systems Safety and regulatory compliance Installation integrity test LifeASSURE PLA filter cartridges are 100% tested for integrity in manufacturing prior to shipment. Additionally, LifeASSURE PLA filter cartridges are installation integrity testable in situ by the user. The installation integrity test is a non-destructive measurement of filter‘s ability to function as intended. Conducting an installation integrity test assures the user that the filter is installed and sealed correctly in the filter housing and is ready for service. This is of particular value where LifeASSURE PLA filters are employed in intermediate process steps not requiring a sterilising grade final membrane filter. For installation integrity test procedures and values, please consult 3M Purification. Final Filters LifeASSURE™ 020SP and LifeASSURE™ PSA Filters – employed as the final filter in critical applications, LifeASSURE 020SP and LifeASSURE PSA series filter cartridges and capsules are constructed with a charge-modified nylon membrane and polypropylene components. LifeASSURE 020SP and LifeASSURE PSA sterilising-grade filters are qualified for complete retention (>107 CFU’s/cm²) of B. diminuta following ASTM methodology. LifeASSURE 020SP and LifeASSURE PSA filters are supported with a 3M Purification Validation Guide. 6 LifeASSURE™ PLA Series Validation support services 3M Purification offers specialised support to the pharmaceutical and biotechnology industry through our Scientific Application Support Service (SASS) Group. SASS routinely provides end-users with: ■ Validation and regulatory support ■ Extractable and compatibility analysis ■ Filter system optimisation studies For more information regarding 3M Purification’s Validation Support Services, please contact 3M Purification Technical Services. Filter housings A specialised range of filter housings are available to meet the needs of the pharmaceutical, biological and bioprocess. They provide easy access for filter changeout and the greatest assurance that LifeASSURE PLA filter cartridges are sealed securely, thus eliminating the possibility of fluid bypass. All housings are constructed using 316L stainless steel to help maximise corrosion resistance. Internal surfaces of the filter housings are polished at least 0.8 μm Ra to limit microbial adhesion and provide easy cleaning. Alternative materials such as Hastelloy® (C-22®) and low ferrite are also available to order. For further information on our housing capabilities, please contact your local 3M Purification representative. Housing IW Specifications Design code Housing material (in contact) Surface finish Closure Number of cartridges Standard gasket material Cartridge height Connection sizes Vent connections Max. operating pressure Max. operating temperature PED 97/23/CE ATEX 94/9/CE 01 IWN / 03 IWN / 05 IWN / 08 IWN 12 IWN 18 IWN / 24 IWN AD Merkblätter 95 316L (1.4404) stainless steel mechanical polish < 0.8 micron Ra clamped bolted bolted 1-3-5-8 12 18 -24 silicone (others on request) 1, 2, 3 and 4 high 3 and 4 high • threaded Male DIN 11851 • DIN 2633 flanges • triclover 3M Purification’s offering of IW sanitary style filter housings accommodate from 1 to 24 LifeASSURE™ PLA filter cartridges in 10” through 40” lengths • MACON ½” TC 10 bar g 9 bar g 8 bar g 150 °C Category I (18 IWN) Category II (24 IWN) Category I II-2-G/D-T5 Table 1 is intended as a guide. Grade selection and performance should be confirmed with small-scale pilot trial. Housing model Cartridge capacity Housing style Equivalent cartridge lengths Materials of construction Pressure and temperature Mini-housing For 2.5” mini-cartridges For 5” mini-cartridges sanitary type in-line 2,5” (63 mm) 5” (125 mm) electropolished 316L stainless steel 10 bar at 149 °C 10 bar at 149 °C 3M Purification’s mini-cartridge filter housings provide the user with low product hold-up volume for critical small scale applications. 7 LifeASSURE™ PLA Series LifeASSURE™ PLA cartridges - Ordering guide Cartridge grade PLA020 – 0.2 μm Configuration Length (inch) B – APT configuration PLA045 – 0.45 μm End modification Gasket/O-ring material 01 – 10” B – 226 O-ring & spear (Code 7) A – silicone (MVQ)** 02 – 20” C – 222 O-ring & spear (Code 8) B – fluorocarbon (FPM)** 03 – 30” D – Double open end (10” Length) C – EPR (EPDM)** 04 – 40” E – Double open end (9 ¾” Length) D – nitrile (NBR)** F – 222 O-ring & flat cap (Code 3) H – clear silicone* J – 226 O-ring & flat cap * O-Ring only ** ISO Designation LifeASSURE™ PLA mini-cartridges - Ordering guide Cartridge grade PLA020 – 0.2 μm Configuration M – mini-cartridge PLA045 – 0.45 μm Length (inch) 01 – 2.5” End modification A – standard Packaging option 6 – 6 cartridges 02 – 5” LifeASSURE™ PLA capsules - Ordering guide Cartridge grade PLA020 – 0.2 μm Configuration C – capsule PLA045 – 0.45 μm Length (inch) End modification 01 – 2.5” A – sanitary flange 02 – 5” B – hose barb Packaging option 1 – 1 capsule NOTE: LifeASSURE PLA is new name for CUNO LifeASSURE PB. Important Notice The information described in this literature is accurate to the best of our knowledge. A variety of factors, however, can affect the performance of the Product(s) in a particular application, some of which are uniquely within your knowledge and control. INFORMATION IS SUPPLIED UPON THE CONDITION THAT THE PERSONS RECEIVING THE SAME WILL MAKE THEIR OWN DETERMINATION AS TO ITS SUITABILITY FOR THEIR USE. IN NO EVENT WILL 3M PURIFICATION BE RESPONSIBLE FOR DAMAGES OF ANY NATURE WHATSOEVER RESULTING FROM THE USE OF OR RELIANCE UPON INFORMATION. It is your responsibility to determine if additional testing or information is required and if this product is fit for a particular purpose and suitable in your specific application. 3M PURIFICATION MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE HEREUNDER WITH RESPECT TO INFORMATION OR THE PRODUCT TO WHICH INFORMATION REFERS. Limitation of Liability 3M Purification will not be liable for any loss or damage arising from the use of the Product(s), whether direct, indirect, special, incidental, or consequential, regardless of the legal theory asserted, including warranty, contract, negligence or strict liability. Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. 3M United Kingdom plc 3M Purification 3M Centre, Cain Road Bracknell, RG12 8HT United Kingdom Tel.: 0845 602 5237 Fax: +44 (0)1344 858559 E-mail: purifi[email protected] 3M is a registered trademark of the 3M Company. LifeASSURE is a registered trademark of the 3M Company used under license. Hastelloy® C-22® are trademarks owend by the Haynes International Inc. company. For more contact addresses visit our website www.3M.eu/filtration or www.3Mpurification.com/international. Data may be subject to change without further notice. © 3M 2011. All rights reserved. v.3 - DOC10077 LITCTLAPLA1.EU - 1211