IV and Fluid Filtration Products for OEM Health Care Devices
Pall Corporation For fifty years, Pall Corporation has provided the global medical manufacturing industry with the widest selection of customized membranes and devices. Because we manufacture our own membranes, we can control the OEM manufacturing process every step of the way from raw materials to final medical filtration device assembly. As a result you can be assured of total product quality. Whether you re filtering intravenous solutions, protecting equipment from contamination, or providing bacteria-retentive air for breathing circuits, Pall Medical has membranes for your most demanding and critical applications. By combining our strengths with yours, we can design and produce a cost-effective product, manufactured to the highest quality standards, that meets your specific needs.
Support Total OEM Support Global Sales Structure As an OEM supplier, customer satisfaction is at the core of our success. To meet customer needs, we have organized our global sales force to make representatives available to you locally. Whether located in Asia, Europe, or the Americas, a Pall Medical sales representative can meet with you within a matter of hours. Additionally, we have an experienced inside sales staff ready to help place, track and expedite your orders. It is our goal to be a resource for your organization. Our experienced staff can help develop filtration and separation solutions to address your unique application needs. Backed by a wealth of engineering and product development support, we look forward to working with you on your next project. Manufacturing Capability Poised to meet a variety of needs, Pall Medical is equipped to produce a wide variety of filtration devices. Our manufacturing team has a proven record in satisfying customer demands and solving filtration problems. Our people, from engineers to line operators, are focused on improvement always seeking to further our capability to address changing needs. Our manufacturing processes employ many advanced technologies, and we can offer devices of excellent quality matched to specific requirements and designed for easy integration into customer applications. The wide and varied use of our products speaks to the manufacturing flexibility we possess and to our responsiveness in providing solutions. Supply Chain Management Pall Medical subscribes to the principles of Lean Manufacturing. By incorporating these fundamentals, we look through the entire supply process, from our raw component suppliers to our end customers, with the determination to identify and eliminate non-value added activities and reduce costs. Areas within the supply chain where we focus our energy are quality at the source and continuous supply replenishment. In the area of quality Pall Medical has a vision of delivering quality to our customers within the expectations of six-sigma. In order to succeed, we must drive the same expectation to our component suppliers. We accomplish this through supply agreements that include defined quality requirements, working with our suppliers quality departments to explain our needs, and monitoring our raw component designs to aggressively look for ways to improve consistency in the manufacturing of our component parts. To ensure timeliness of delivery, we implement continuous supply programs, such as visual Kanban pull systems. These continuous supply systems utilize standard shipping quantities (where applicable). With the establishment of continuous supply programs we have been very successful in reducing our supplier lead-times, with resulting benefits to our end customers. By allowing Pall Medical to work with you as we do our suppliers, we believe we can help you achieve your business objectives. In concert with you and our suppliers, we can create a supply chain that cannot be broken. 888.676.7255 www.pall.com 1
Total OEM Support Product Development Pall Medical Research and Development delivers complete product development, customization, and technical support service to our OEM customers. Our team of highly trained and experienced engineers is available to assist in specification development, design and development of innovative filtration solutions, and product testing/validation support. We can serve as an adjunct to the customer s own R&D group, providing assistance and education regarding filtration technology, applications and devices. Utilizing the Pall Medical R&D group, our customers get both the focus of a small team specialized in medical filtration applications, as well as access to the full technical resources of Pall Corporation, with the broadest range of filtration technologies in the world. Quality Systems Pall Medical in Ann Arbor, Michigan is the primary location for the OEM Medical manufacturing group. The quality system on the Ann Arbor campus has been registered to ISO9001 and EN46001/ISO13485, allowing us to apply the CE mark to direct sale medical devices, or to assist in the customer s CE mark registration. Additionally, the manufacturing facilities are FDA registered for the manufacturing and distribution of medical devices. Regardless of the product, all practices meet current medical device good manufacturing practices now more commonly known as FDA Quality System Regulation, 21CFR Part 820. 2 888.676.7255 www.pall.com
Support Pall Scientific and Laboratory Services Pall s Scientific and Laboratory Services (SLS) The Scientific and Laboratory Services (SLS) Department is a cornerstone of Pall s service to our customers. Pall s unique SLS Department consists of some 400 Ph.D. scientists, engineers, and technicians. SLS personnel are supported by more than 20 well-equipped laboratories in North and South America, Europe, and Asia. To access the expert assistance of our Scientific and Laboratory Services Department (SLS), simply call your local Pall representative. SLS support and service is available to you on request. Regardless of location, Pall SLS personnel are ready to give you up-to-the-minute information, provide workable answers to your technical questions about Pall membranes, and work directly with you to optimize the integration of Pall membranes into your product. Our worldwide SLS staff will work closely with you, on-site and in our SLS Laboratories, to solve your most challenging problems. Pall SLS personnel will help you to achieve the best economics and performance from your Pall products, and will assist you in meeting relevant government requirements. Our SLS staff includes professionals with advanced degrees in chemistry, biology, microbiology, physics, engineering, and related fields. Many SLS personnel are recognized as international experts in their respective fields. SLS staff generally have years of field experience in fluid clarification and membrane-related separations processes. The three principal SLS Laboratories are located in Portsmouth, England; Port Washington, New York; and Tsukuba, Japan. All three have ISO9001 certified quality systems. Regional SLS Laboratories are strategically positioned to provide rapid response to our customers technical needs throughout the world. Pall SLS Laboratories utilize advanced equipment and sophisticated analytical methods to evaluate all aspects of membrane and device performance. Laboratory capabilities include: Biochemical diagnostic testing Chemical compatibility testing Contamination analysis Gas and liquid chromatography Hematology Light and electron microscopy Microbial and endotoxin challenge testing Particle counting DNA and protein detection 888.676.7255 www.pall.com 3
Filtration Adds Safety and Value Added Patient Protection Filtration devices integrated into IV sets provide additional patient safety and give medical providers peace of mind knowing their IV lines will remain worry-free. Air Elimination Air introduced during priming or set-up of the IV line can eventually make its way to the patient. An air embolism is a great health hazard, and potentially fatal. Most IV filters have vents for air elimination. During priming, the major membrane on the IV filter is wetted and thus incapable of passing air. Any air traveling into the IV filter is then forced to escape through the hydrophobic vent. Particle Retention Manufacturing by-products Particles, such as glass fragments and pieces of plastic, have been found in commercially-prepared IV bags. Additionally, when an ampoule is broken to administer medication, glass particles can be withdrawn into the syringe along with the drug product and administered to the patient. An in-line filter will prevent particles, introduced up-stream, from reaching the patient. Drug precipitates There are certain drugs that may precipitate out of solution under certain conditions, and include paclitaxel, ganciclovir, and mannitol, among others. The precipitated drugs can cause vein irritation, phlebitis, and lead to infection in some cases. Lipid micelles Lipid droplets form micelles in solution. These micelles can aggregate, creating very large lipid globules that can exceed five micron in size. These aggregates can become trapped in pulmonary capillaries, acting as a nidus for infection and potentially hazardous immune reactions. Bacterial/Fungal Retention If a parenteral solution becomes contaminated with bacteria or fungi, an IV filter will reduce the potential for these organisms from reaching the patient. The filter provides a barrier against microorganisms introduced during the parenteral manufacturing process either through minute holes in the system or by touch contamination. Endotoxin retention (positively-charged membranes only) A 0.2 µm filter will trap bacteria during administration, but over an extended period of time, the bacteria break down and generate endotoxins. These by-product endotoxins can cause fever and other infection-like reactions that, in immuno-compromised patients, can lead to serious complications. Bacteria associated endotoxins easily slip through a 0.2 µm filter, but because they are negatively charged, a filter with a net positive charge will electrostatically attract and retain them as they are generated. Added Value IV sets incorporating filtration provide extra value to healthcare providers, and expand business opportunities for healthcare suppliers. The premium performance offered by a filtered set can prevent many costly healthcare procedures by preventing contamination. When examining the potential cost liability of not filtering, budget-conscious health systems recognize filtered IV sets as a wise investment. 4 888.676.7255 www.pall.com
Performance Membrane Performance Advantages Only Pall offers patented Supor membrane in specially-engineered devices designed to meet the diverse and critical requirement of IV therapy. Built on decades of experience in membrane formulation and manufacturing, Supor membrane was the first polyethersulfone membrane specifically designed for medical filtration and contamination protection. Superior Performance Proven low drug binding Specially formulated for critical fluid applications, Supor membrane s low protein-binding characteristics provide minimal adsorption and superior bacterial retention. Certified biologically safe Supor membrane complies with United States Pharmacopoeia (USP25/NF20) Biological Reactivity Tests, In Vivo <88>, and ISO 10993 standard for externally communicating, circulating blood, extended-use devices. Supor membrane s advanced formulation contains no external wetting agents or surfactants that might introduce unwanted extractables downstream of the filter. Fast flow rates, long life The highly porous membrane structure provides excellent filtration efficiency, outstanding flow rates, and high throughputs. The inherently hydrophilic membrane allows multiple-repriming capability. Proven Drug Compatibility Pall has undertaken extensive studies to evaluate Supor membrane adsorption characteristics with a variety of commonly infused and/or injected drugs. The following is a list of drugs Pall has studied, all of which are compatible with IV filter devices containing Supor membrane. Generic Name Acetazolamide sodium Albumin Ampicillin sodium Bupivacaine hydrochloride Cefoxitin Cimetidine hydrochloride Cisplatin Dexamethasone sodium phosphate Dobutamine hydrochloride Dopamine hydrochloride Doxorubicin hydrochloride Ephedrine hemisulfate Etoposide 5-Fluorouracil Insulin Lidocaine hydrochloride Mannitol Methotrexate sodium Methyldopate hydrochloride Metronidazole Morphine sulfate Nitroglycerin Paclitaxel (Taxol ) Penicillin G potassium Procaine hydrochloride Sodium citrate Sodium nitroprusside Sulfamethoxazole Trimethoprim Vidarabine Vinblastine sulfate Vincristine sulfate Ceftriaxone soldium Foscarnet sodium Ganciclovir sodium Nafcillin Piperacillin Tobramycin Versatile Supor membrane is available in a wide selection of pore sizes to meet the filtration requirements of applications ranging from antibiotic therapy to pain management. 888.676.7255 www.pall.com 5
Endotoxin Concentration (EU/mL) 75 60 45 30 15 0 0 24 48 72 96 Bacteria Associated Endotoxin Retention Superior protection against endotoxins Supor IV filter devices were separately tested for bacteria associated endotoxin retention at differing challenge concentrations. At clinically significant endotoxin concentrations, 0.2 µm positively-charged IV filters were retentive. At gross-contamination concentrations, the Pall IV filters outperform the leading competitor. Time (hours) Pall 0.2 um (+) charged IV filter Leading competitive IV filter Unfiltered positive control Flow Rate (ml/min) 15 12 9 6 TPN Flow Decay Outstanding flow rates, limited flow decay over 96 hours Twelve liters of a standard TPN solution were administered through gamma-sterilized devices for 96 hours. Maximal flow rates (ml/min) were measured initially and every 24 hours to determine flow decay. Flow rates for Pall IV filter devices at 96 hours were 22% greater than the leading competitor s initial flow rates. 0 0 24 48 72 96 Time (hours) Pall 0.2 um IV filter Leading competitive IV filter Air Elimination Patient protection against air embolism regardless of position Primed Pall IV filter devices eliminate air at constant rates regardless of filter position. Air bubbles will not obstruct flow at any time; thus, no need to worry about patients rolling over and changing the position of the filter. 6 888.676.7255 www.pall.com
Performance Challenge Concentration (cfu/cm 2 ) 10 7 100% 100% 100% 100% Bacterial Retention 96-hour Brevundimonas diminuta Retention Gamma-irradiated 0.2um Pall IV filter devices were challenged with Brevundimonas diminuta according to a modified ASTM F838-83 methodology for 96 hours. The filters retained the challenged organism for the entire 96-hour period. 24 48 72 Time (hours) 96 ASTM guideline requirement Pall SuporGARD IV filter performance Solution Head Height (inches) Time (seconds) 0.2 % water 18 2.8 0.2 % water 30 2.5 0.9 % saline 18 3.0 0.9 % saline 30 2.6 Initiation Time Fast and easy priming The time required to prime each filter device (expel the air within the housing) and begin flow with differing solutions and head heights were recorded. Pall IV filter devices consistently allow nurses to quickly prime IV lines and move to the next patient. Total Organism (cfu) Challenge Total Initial Collection Recovered from: Concentration Challenge (cfu) Time (hrs) Admixture Effluent 3.4 x 10 2 cfu/ml 8.84 x 10 5 0 8.8 x 10 5 0 16 3.7 x 10 6 0 24 5.2 x 10 7 0 4.15 x 10 4 cfu/ml 1.108 x 10 8 0 1.1 x 10 8 0 16 2.9 x 10 8 0 24 1.2 x 10 9 0 Candida albicans Retention Retention of Candida albicans for 24 hours Pall 1.2 µm Supor IV filter devices were separately challenged with two differing concentrations of c.albicans, a commonly occurring fungal contaminant of lipid-containing total nutrient admixtures (TNA). Both the gross-contamination and touch-contamination challenges were retained for 24 hours. Flow Rate (ml/min) 30 25 20 15 Initial Flow Rates Consistent flow rates for reliable and precise delivery of solutions 0.2 µm filtered water, at a 36-inch head height, was allowed to flow through Pall 0.2 µm IV filter devices. Flow rates were measured for one minute. The average flow rate for Pall devices was 29.4 ml/minute with a standard deviation of less than 1 ml/min. 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Devices 888.676.7255 www.pall.com 7
1.51 in Micro IV Filter Low priming volume and superior air elimination ensure accurate drug delivery critical for home and alternate-site infusion therapy..80 in Alternate-site infusion therapy Chemotherapy Insulin infusion Antibiotic therapy Lipid/TPN infusion Neonatal infusion therapy Product Features: Hydrophobic vent evacuates entrained air, removing potentially harmful air contamination introduced during priming and set-up Variety of connector socket sizes available to facilitate easy and reliable assembly with microbore tubing Single-plane tubing connectors reduce tubing set assembly cost Highly porous membrane structure provides filtration efficiency, high throughputs and flow rates Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride Provides a barrier to microorganisms and particulate introduced during parenteral manufacturing and set-up 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions 38 X 20 mm (1.51 X 0.8 in) Effective Filtration Area 1.65 cm 2 Inlet/Outlet Connections Inside Diameter: 2 mm (0.080 in) 2.3 mm (0.090 in) 2.4 mm (3/32 in) 2.5 mm (0.094 in) 2.7 mm (0.110 in) Materials of Construction Filter Media: Supor (polyethersulfone) membrane Housing: Modified acrylic Vent: 0.02 µm supported PTFE Maximum Operating Pressure 5.2 bar (75 psi) Maximum Operating Temperature 55 C (131 F) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) 0.8 µm: 0.7 bar (10 psi) 1.2 µm: 0.3 bar (5 psi) 5 µm: 0.1 bar (2 psi) Minimum Water Flow Rate 0.2 µm: 2 ml/min at 91 cm (36 in) head pressure 0.8 µm: 12 ml/min at 91 cm (36 in) head pressure 1.2 µm: 30 ml/min at 91 cm (36 in) head pressure 5 µm: 30 ml/min at 91 cm (36 in) head pressure Pore Size 0.2, 0.8, 1.2, 5 µm Priming Volume < 0.4 ml Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: Micro IV Filter 69224421 0.2 µm Supor membrane, clear housing, 2 mm (0.080 in) 69024421 0.2 µm Supor membrane, clear housing, 2.3 mm (0.090 in) 69324421 0.2 µm Supor membrane, clear housing, 2.7 mm (0.110 in) 69054421 0.8 µm Supor membrane, clear housing, 2.3 mm (0.090 in) 69124421 1.2 µm Supor membrane, clear housing, 2.3 mm (0.090 in) 69454421 0.2 µm Supor membrane, clear housing, 2.4 mm (3/32 in) 69444421 5 µm Supor membrane, clear housing, 2.7 mm (0.106 in) 69134421 +0.2 µm Charged Supor membrane, clear housing, 2.3 mm (0.090 in) 8 888.676.7255 www.pall.com
IV Filters Pediatric Filter 2.18 in Our air-eliminating filter protects against air emboli in adult, pediatric, and neonate patients. 1.31 in Neonate and pediatric IV therapy Chemotherapy Antibiotic therapy Nutrient admixture Product Features: Patented vent design allows filter to be taped down in any position Easy priming and accurate drug delivery even at low drug delivery rates Rotating hub Male slip Capping available Small, compact design makes it ideal for alternate site and ambulatory care applications Supor membrane s low protein binding characteristics provide minimal adsorption and contain no external wetting agents or surfactants which might introduce unwanted extractables downstream of the filter Housing designed for comfortable, secure placement in even the most difficult body areas, such as the scalp Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions 56 X 34 mm (2.187 X 1.312 in) Effective Filtration Area 4.5 cm 2 Inlet/Outlet Connections FLL/MLL, (Male luer inner diameter accepts microbore tubing) MSL Materials of Construction Filter Media: Supor (polyethersulfone) membrane Housing: Modified acrylic Vent: 0.02 µm supported PTFE Maximum Operating Pressure 3.1 bar (45 psi) Maximum Operating Temperature 55 C (131 F) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) 1.2 µm: 0.3 bar (5 psi) Minimum Water Flow Rate 0.2 µm: 10 ml/min at 91 cm (36 in) head pressure 1.2 µm: 90 ml/min at 91 cm (36 in) head pressure Pore Size 0.2, 1.2 µm Custom products available Priming Volume 0.7 ml Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: Pediatric Filter 6074422 0.2 µm Supor membrane, clear housing, non-sterile, DLL 6074423 0.2 µm Supor membrane, clear housing, non-sterile, male slip luer 6104423 1.2 µm Supor membrane, clear/blue housing, non-sterile, DLL 6104424 1.2 µm Supor membrane, clear/blue housing, non-sterile, male slip luer 888.676.7255 www.pall.com 9
IV-5 Filter 2.83 in This versatile IV filter provides patented design features maximizing patient comfort and safety. 1.26 in Aqueous IV solutions TPN and lipid solutions Drug therapy Apheresis solutions Any process requiring the removal of entrapped air from liquid solutions Product Features: 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods The 1.2 µm Supor version, for use with lipid-containing solutions, provides documented Candida albicans retention Dual-vent design ensures air elimination and quick priming in any position Standard or microbore connectors accommodate a variety of tubing configurations Custom pad printing option allows for product distinction and company brand identification Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions Length: 72 mm (2.8 in) Width: 36 mm (1.2 in) Effective Filtration Area 10 cm 2 Inlet/Outlet Connections Standard Connectors: Outside Diameter: 3.42 mm (0.135 in) Inside Diameter: 1.45 mm (.057 in) Microbore Connectors: Outside Diameter: 4.32 mm (0.170 in) Inside Diameter: 2.29 mm (0.090 in) Materials of Construction Filter Media: Supor membrane Housing: Clear modified acrylic Vent: 0.02 µm supported PTFE Maximum Operating Pressure 3.1 bar (45 psi) Minimum Water Bubble Point 0.2: 3.1 bar (45 psi) 0.8 µm: 0.2 bar (10 psi) 1.2 µm: 0.3 bar (5 psi) Minimum Water Flow Rate 0.2 µm: 20 ml/min at 91 cm (36 in) head pressure 0.8 µm: 50 ml/min at 91 cm (36 in) head pressure 1.2 µm: 100 ml/min at 91 cm (36 in) head pressure Pore Size 0.2, 0.8, 1.2, 5 µm Priming Volume 2.4 ml Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: IV-5 Filter 7024400 0.2 µm Supor membrane, SIV connectors 7024412 1.2 µm Supor membrane, SIV connectors, clear/blue housing 7044400 1.2 µm Supor membrane, SIV connectors 7034400 +0.2 µm Charged Supor membrane, SIV connectors, clear/green housing 7023300 0.2 µm Supor membrane, MIV connectors 7043301 0.8 µm Supor membrane, MIV connectors 7043300 1.2 µm Supor membrane, MIV connectors 7033300 +0.2 µm Charged Supor membrane, MIV connectors 10 888.676.7255 www.pall.com
IV Filters IV-3 Filter 2.6 in The original self-priming filter requires no manipulation to provide position insensitive air removal and fluid delivery. 1.3 in IV solutions TPN and lipid solutions Drug therapy Apheresis solutions Product Features: 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Maximizes delivery of critical drugs with proven low drug binding Supor membrane Contains no exogenous surfactants, protecting patient from delivery of unwanted extractables Colored housings and pad printing available for ease of final product identification Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions 33 x 66 mm (1.3 X 2.6 in) Effective Filtration Area 10 cm 2 Inlet/Outlet Connections Standard Connectors: Outer Diameter: 3.43 mm (0.135 in) Inner Diameter: 1.40 mm (0.055 in) Materials of Construction Filter Media: Supor membrane Housing: Modified acrylic Vent: 0.02 µm supported PTFE Maximum Operating Pressure 3.1 bar (45 psi) Maximum Operating Temperature 55 C (131 F) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) 0.8 µm: 0.7 bar (10 psi) 1.2 µm: 0.3 bar (5 psi) Minimum Water Flow Rate 0.2 µm: 20 ml/min at 91 cm (36 in) head pressure 0.8 µm: 50 ml/min at 91 cm (36 in) head pressure 1.2 µm: 100 ml/min at 91 cm (36 in) head pressure Pore Size 0.2, 0.8, 1.2 µm Customized products available Priming Volume 2.4 ml Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: IV-3 Filter 6494420 0.2 µm Supor membrane, clear housing, SIV connectors 6584420 0.8 µm Supor membrane, clear housing, SIV connectors 6974420 +0.2 µm Charged Supor membrane, clear/green housing, SIV connectors 6564420 1.2 µm Supor membrane, clear/blue housing, SIV connectors 6102042 Clip Clip for IV-3 filters 888.676.7255 www.pall.com 11
IV Filters 2.7 in IV-6 Filter Apheresis solutions Drug therapy Saline filtration 1.6 in Product Features: This new IV option offers a larger media surface area for higher flow rates. Maximizes delivery of drugs with low protein binding Supor Membrane Removes air, particulate, and microbial contamination in-line Colored housings available Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Choice of media and pore sizes Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions (68.6 X 40.9 mm) (2.7 X 1.6 in) Effective Filtration Area 18 cm 2 Inlet/Outlet Connection Outer Diameter: 3.56 mm (.140 in) + 2.3º Taper Inner Diameter: 2.11 mm (.083 in) Materials of Construction Filter Media: Supor membrane Housing: Modified acrylic Vent: 0.02 µm supported PTFE Maximum Operating Pressure 2.1 bar (30 psi) Maximum Operating Temperature 37.8 C (100 F) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) Minimum Water Flow Rate 0.2 µm: 150 ml/min at.54 bar (7.8 psi) Pore Size 0.2 µm Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: IV-6 Filter Product No. Description 7224402 Supor Membrane, clear/blue housing, non-sterile 12 888.676.7255 www.pall.com
Fluid Filters 1.86 in Epidural Filter Proven drug compatibility in an easy to use device for filtration of injectable solutions. 1.22 in Glass ampoule drug injections Epidural or intraocular injectables TPN solution additives Extemporaneous morphine, radiopharmaceutical, allergenic extracts or ophthalmic solutions Product Features: Flat housing design with double luer locks allows for easy and secure attachment Supor membrane s low protein binding characteristics provide minimal adsorption, and contains no external wetting agents or surfactants to introduce unwanted extractables Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions 47 X 31 mm (1.86 X 1.22 in) Effective Filtration Area 4.3 cm 2 Inlet/Outlet Connections FLL/MLL, (Male luer inner diameter accepts microbore tubing) Materials of Construction Filter Media: Supor (polyethersulfone) membrane Housing: Modified acrylic Support: Polyester Maximum Operating Pressure 5.2 bar (75 psi) Maximum Operating Temperature 55 C (131 F) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) 1.2 µm: 0.3 bar (5 psi) Minimum Water Flow Rate 0.2 µm: 200 ml/min at 3.1 bar (45 psi) Pore Size 0.2, 1.2 µm Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: Epidural Filter 6004910 0.2 µm Supor membrane, clear housing, FLL/MLL, non-sterile 6004911 1.2 µm Supor membrane, clear housing, FLL/MLL, non-sterile 888.676.7255 www.pall.com 13
Female Slip Luer ISO 594 AcroCap Filter Air elimination and large volume solution filtration available with hose barb connectors. 1.47 in IV solutions Apheresis Pharmaceutical solutions Female Slip Luer ISO 594 2.71 in Product Features: More filtration area for extended fluid delivery requirements Removes air, particulate, and microbial contamination in-line Colored housings available Materials of construction contain no natural rubber latex, or latex derivatives, PVC, or hydroxyvinyl chloride 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Non-vented housing available Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions 68.8 X 40.9 X 34.5 mm (2.71 X 1.61 X 1.47 in) Effective Filtration Area 15 cm 2 Inlet/Outlet Connection 6.4 mm (1/4 in) HB ID conforms to ISO 594 FSL Materials of Construction Filter Media: Supor membrane Housing: Modified acrylic Vent: 0.02 µm supported PTFE Vent Support: Non-woven polyester Maximum Operating Pressure 2.04 bar (30 psi) Maximum Operating Temperature 55 C (131 F) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) 0.45 µm: 2 bar (30 psi) Minimum Water Flow Rate 0.2 µm: 220 ml/min at 1 bar (15 psi) 0.45 µm: 500 ml/min at 1 bar (15 psi) Pore Size 0.2, 0.45 µm Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Ordering Information: AcroCap Filter 6004480 0.2 µm Supor membrane, clear/blue housing, non-sterile 6004482 0.45 µm Supor membrane, clear/blue housing, non-sterile 14 888.676.7255 www.pall.com
Fluid Filters.87 in 1.10 in 25 mm Filter Widest selection of housings and media for small volume applications. Pharmacy admixture Small volume sterilization Low volume pain control Low volume injectables Product Features: Superior flow rates and throughput offer faster filtration times and more filtration per device Mix and match over a dozen ISO594 and standard connector styles Custom-printed blister packaging available Variety of colored housings Biologically safe all materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Selection of 510(k) cleared and CE marked products reduces your time to market 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Specifications: Dimensions Vary with connector choice Please call for detailed information Effective Filtration Area 2.8 cm 2 Inlet/Outlet Connections Female Luer Lock (FLL) Female Luer Slip (FLS) Male Luer Lock (MLL) Male Luer Slip (MLS) Male Luer Funnel (MLF) Hose Barb (HB) Materials of Construction Filter Media: Supor (polyethersulfone), Versapor (acrylic copolymer), HT Tuffryn (polysulfone), or polyester screen Housing: Modified acrylic Maximum Operating Pressure 5.2 bar (75 psi) Maximum Operating Temperature 55 C (131 F) Minimum Water Bubble Point Supor Membrane 0.2 µm: 3.1 bar (45 psi) 0.45 µm: 2 bar (30 psi) 0.8 µm: 0.83 bar (12 psi) 1.2 µm: 0.34 bar (5 psi) 5 µm: 0.2 bar (3 psi) Versapor Media 1.2 µm: 0.34 bar (5 psi) 5 µm: 0.034 bar (0.5 psi) HT Tuffryn Media 0.2 µm: 2.2 bar (32 psi) 0.45 µm: 1.2 bar (18 psi) Minimum Water Flow Rate Supor Membrane 0.2 µm: 180 ml/min at 3.1 bar (45 psi) 0.45 µm: 300 ml/min at 3.1 bar (45 psi) 0.8 µm: 700 ml/min at 3.1 bar (45 psi) 1.2 µm: 1000 ml/min at 3.1 bar (45 psi) 5 µm: 1500 ml/min at 3.1 bar (45 psi) Versapor Media 5 µm: 970 ml/min at 3.1 bar (45 psi) HT Tuffryn Media 0.2 µm: 110 ml/min at 3.1 bar (45 psi) 0.45 µm: 250 ml/min at 3.1 bar (45 psi) Pore Size 0.1-105 µm Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility Criteria depend on media, products sold sterile are gamma irradiated Ordering Information: 25 mm Filter 6624192 0.2 µm Supor membrane, clear/clear, FLL/MLL 6034612 0.2 µm Supor membrane, clear/blue, FLL/MLS 6764192 0.2 µm Supor membrane, clear/blue, FLL/MLL, sterile 6544184 0.45 µm Supor membrane, clear/clear, FLL/MLL, sterile 6664192 0.8 µm Supor membrane, clear/green, FLL/MLL 6224187 0.8/0.2 µm Supor membrane, green/blue, FLL/MLL, sterile 6674192 1.2 µm Supor membrane, clear/blue, FLL/MLL 6684192 5 µm Supor membrane, green/green, FLL/MLL 6104192 0.2 µm HT Tuffryn membrane, clear/blue, FLL/MLL 6144192 0.2 µm HT Tuffryn membrane, clear/blue, FLL/MLL, sterile 6224184 0.45 µm HT Tuffryn membrane, clear/clear, FLL/MLS, sterile 6224190 1.2 µm Versapor membrane, ecru/ecru, FLL/MLS, sterile 6224199 5 µm Versapor membrane, clear/green, FLL/MLS, sterile 6224185 17 µm Polyester screen, clear/clear, FLL/MLS 888.676.7255 www.pall.com 15
32 mm Filter 1.37 in Features nearly double the effective filtration area of competitive devices..88 in TPN solution additives Extemporaneous preparations Glass ampoule drugs Antibiotics Chemotherapy preparations Product Features: Biocompatible Supor membrane combines low protein binding and low extractables for high purity preparations Female luer lock inlet and male luer lock or male luer slip outlet connectors available May be customized with a variety of colored housings and printed blister packaging 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Specifications: Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Dimensions 34.8 X 22.1 mm (1.37 X 0.88 in) Effective Filtration Area 5.3 cm 2 Inlet/Outlet Connections FLL inlet; MLL or MLS outlet Luers conform to ISO 594 Materials of Construction Filter Media: Supor (polyethersulfone) membrane Housing: Modified acrylic Maximum Operating Pressure 5.2 bar (75 psi) Minimum Water Bubble Point 0.2 µm: 3.1 bar (45 psi) 1.2 µm: 0.3 bar (5 psi) 5 µm: 0.2 bar (3 psi) Minimum Water Flow Rate 0.2 µm: 490 ml/min at 3.1 bar (45 psi) 1.2 µm: 1700 ml/min at 3.1 bar (45 psi) 5 µm: 1750 ml/min at 3.1 bar (45 psi) Pore Size 0.2, 1.2, 5 µm Pyrogenicity < 0.25 EU/mL using the LAL test method Sterilization Compatibility EtO, gamma irradiation (tested to 50 kgy) Individually packaged gamma sterilized products are available Ordering Information: 32 mm Filter 6084187 0.2 µm Supor membrane, blue/blue housing, FLL/MLL 6094187 1.2 µm Supor membrane, clear/blue housing, FLL/MLL 6104187 5 µm Supor membrane, green/green housing, FLL/MLL 16 888.676.7255 www.pall.com
Fluid Filters Small and Mid-Volume Filters Multiple housing and connector styles to fit your particular application requirements. Clarification or sterilization of up to 3 liters of pharmaceutical solutions Crystalloid cardioplegia solutions Prefiltration Product Features: Mix and match standard connectors to adapt our 13, 37 and 50 mm filters to any application 50 mm devices available in acrylic or polypropylene housings with custom printing option 37 mm devices available in polypropylene, also with custom printing option Specifications: Materials of Construction Filter Media: Supor (polyethersulfone), Versapor (acrylic copolymer), HT Tuffryn (polysulfone), Nylon Polyester Screen Media Housings: 13 mm: Polypropylene 37 mm: Polypropylene 50 mm: Polypropylene or modified acrylic Pore Sizes 0.1-105 µm Effective Filtration Area 13 mm: 0.8 cm 2 37 mm: 7.2 cm 2 50 mm: 20 cm 2 Pyrogenicity <0.25 EU/mL using the LAL method Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Sterilization Products can be EtO sterilized or gamma irradiated. Ordering Information: Small and Mid-Volume Filters 6004270 0.2 µm 13 mm with Nylon membrane, FLL/ML 6804483 0.2 µm 13 mm with Supor membrane, FLL/ML 6804485 0.45 µm 13 mm with Supor membrane, FLL/ML 6104272 0.45 µm 50 mm with Versapor membrane, 1/8" NPT 6154270 105 µm 50 mm with Polyester Screen, 1/4" hose barb 6204270 0.6/0.2 um 50 mm with HT Tuffryn membrane, 1/4"-1/2" stepped hose barb 888.676.7255 www.pall.com 17
Fluid Filters 500, 1000, and 1500 Filters Fast filtration and high throughputs with Supor membrane. Surgical hand washing Preparation of food and beverage for high-risk patients Personal hygiene and care of immuno-compromised patients Pre-bypass extracorporeal circuits Large volume fluid sterilization, pharmaceutical admixtures Product Features: Higher throughputs and faster flow rates than similar-sized competitive devices 100% integrity tested to assure sterile filtrate Save money by increasing throughput with available built-in prefilter Low extractables no adhesives used in manufacturing Adaptable, fits any system, available in a variety of inlet and outlet configurations Custom labeling promotes your product and company Specifications: Bacterial Filtration Efficiency 0.2 µm Supor membrane is retentive of B. diminuta and meets USP 25/NF20 requirements for a sterilizing grade filter per ASTM F838-83 test methods Biological Safety Materials of construction pass USP Biological Reactivity Tests, In Vivo <88> Effective Filtration Area 500: 500 cm 2 1000: 1000 cm 2 1500: 1500 cm 2 Inlet/Outlet Connections 9.5 to 12.7 mm (3/8 to 1/2 in) THB; 6.4 to 12.7 mm (1/4 to 1/2 in) THB; 12.7 mm (1/2 in) HB; 6.4 mm (1/4 in) MNPT; 6 mm Quick Disconnect SF Materials of Construction Filter Media: Supor membrane, Housing, Vent Plug and Filter Support: Polypropylene Maximum Operating Pressure 4.1 bar (60 psi) at ambient temperature Maximum Operating Temperature 60 C (140 F) at 30 psid Minimum Water Bubble Point 3.1 bar (45 psi) Minimum Water Flow Rate 500: 1.1 Lpm/0.1 bar (0.2 Gpm/psid) 1000: 1.7 Lpm/0.1 bar (0.3 Gpm/psid) 1500: 2.2 Lpm/0.1 bar (0.4 Gpm/psid) Pore Size 0.8 µm prefilter membrane/ 0.2 µm membrane Pyrogenicity < 0.25 EU/mL using the LAL test method Sealing Materials Thermal bonding Sterilization Compatibility Autoclave, EtO, gamma irradiation to 50 kgy Ordering Information: 500, 1000, and 1500 Filters 12063 0.8/0.2 µm 500 with Supor-200 membrane, 9.5 to 12.7 mm (3/8 to 1/2 in) HB The 500, 1000, and 1500 Filters have a large number of possible configurations. Please contact our customer service department for additional configurations and part numbers. 18 888.676.7255 www.pall.com
Accessories Duckbill Check Valve/Large and Small Tubing Connectors Features and Benefits: ABS housing material bonds easily to tubing RF (radio frequency) welded housing locks valve into proper position Closes at 34.47 mbar (0.5 psi) Low pressure valve Functions on tubing ID 3.75 to 4.31 mm (0.148 to 0.170 in), 2.79 to 3.22 mm (0.110 to 0.127 in) Applications: Low pressure one-way valve in primary IV administration sets Materials of Construction: Valve: Latex free/latex Housing: Modified acrylic Self-Leveling Drip Chamber Features and Benefits: Primes without manipulation Self-venting Housing conforms to ISO 1135-4 requirements Vent Ports conform to ISO 594-1, 594-2 requirements Applications: In-line IV or blood sets Materials of Construction: Materials of construction in the fluid pathway pass USP Biological Reactivity Tests In Vivo <88> Housing: Acrylic Tethered Cap: Polyethylene Vent Media: Fluoropolymer Vent Support Media: Cellulose, polyethylene, PVC, polyvinyl acetate Transfer Bag, 600 ml/homopolymer Features and Benefits: Center tubing port is adaptable to multi-bag system Two spike entry ports allows double bag entry Suitable for EtO, gamma (to 50 kgy) and autoclave sterilization Applications: PVC blood collection bag systems Materials of Construction: PVC Hand Blood Pump Features and Benefits: Flexible PVC barrel is easy to squeeze Double ball check valves prevent drawing blood back during pump refill phase Clear material makes it easy to see contents Flexible PVC endcaps bond easily to PVC tubing Total length from port end to port end is 165.1 mm (6.5 in), tubing length is 114.3 mm (4.5 in), tubing ID is 24.13 mm (0.950 in), wall is 12.7 mm (0.050 in) Applications: Blood administration sets Materials of Construction: Flexible PVC Ordering Information: Specialty Products Product No. Description 993-52 Duckbill Check Valve/Large Tubing Connectors 993-53 Duckbill Check Valve/Large Tubing Connectors, Synthetic valve 995-69 Duckbill Check Valve/Small Tubing Connectors 995-71 Duckbill Check Valve/Small Tubing Connectors, Synthetic valve Product No. Description 996-23M Hand Blood Pump 100-0165 Self-Leveling Drip Chamber for red blood cells 100-0166 Self-Leveling Drip Chamber for platelets 985-45 Transfer Bag, 600 ml/homopolymer 888.676.7255 www.pall.com 19
Membranes PES Membrane Low protein binding, filtration membrane. Supor membrane is a low protein binding polyethersulfone (PES) membrane used in filtration. Major Advantages Excellent flow rates Lot-to-lot and within-lot consistency Low extractables Passes USP Biological Reactivity Tests, In Vivo <88> Applications Medical Applications Bacteria and particulate removal Syringe filtration Sterilization: Gamma and EtO. Biosafety: Complies with USP Biological Reactivity Tests, In Vivo <88> Charged PES Membrane Supor HP-200 membrane is a positively charged hydrophilic polyethersulfone membrane. The positive charge is created by adding quaternary ammonium groups to the membrane surface. Applications Prefiltration Final filtration Water filtration Sterilization: Autoclave, gamma irradiation, or EtO. Biosafety: Passes USP Biological Reactivity Tests, In Vivo <88> Versapor Membrane Filtration Membrane with a Strong, Non-Woven Nylon Support for Ease of Handling and Processing. Biosafety: Passes USP Biological Reactivity Tests, In Vivo <88> Versapor membrane is an acrylic co-polymer on a non-woven nylon support available in different thickness ranges. Major Advantages Non-fiber shedding Passes USP class VI test Gamma or EtO compatible Durable Applications General filtration Vacuum filters Particulate removal 20 888.676.7255 www.pall.com
Filtration Concepts IV Filters Basic Filtration Concepts Filtration is a science of growing information, distinctive terminology, and proprietary knowledge. These Basic Filtration Concepts have been compiled so that we at Pall Medical can establish a common ground with you, our customer, on the basic language of filtration. As always, if you have questions about any of these concepts, or how they apply to your specific applications, please contact our Customer Service Department. We will explain some of the fundamental aspects of filtration technology and how they relate to each other and to your application. Then, we will guide you through the logic of selecting the proper filter media. Filter media have many different properties which affect the performance of the filter in certain applications. When selecting the proper filter media for your application, consider the following important properties. Depth Filtration vs. Membrane Filtration Depth filtration describes a process that entraps contaminants both within the matrix and on the surface of the filter media. Chemical Compatibility Chemical compatibility is defined as the ability of a filter material to resist select chemicals so that the pore structure is not adversely affected by chemical exposure, and the filter material does not shed particles or fibers, and add extractables. To select the proper filter material, you must determine the compatibility of the filter medium with the fluid. Temperature, concentration, applied pressure, and length of exposure time affect compatibility. The materials used in the manufacture of filtration products are carefully chosen for their resistance to a wide range of chemical solutions. Still, understanding the compatibility between the fluid to be filtered and the filter medium is essential. Hydrophilic vs. Hydrophobic Hydrophilic media possess an affinity for water. (Example: Pall s Supor membrane.) Gases move somewhat freely through a dry, hydrophilic membrane. Hydrophilic media can be wetted with virtually any liquid, and are preferred for aqueous solutions. Once wetted, hydrophilic media do not allow the free passage of gases until the applied pressure exceeds the bubble point and the liquid is expelled from the pores of the membrane. Depth filters have the ability to retain large quantities of particulate matter and provide high throughputs in gas applications. They offer high contaminant capacity and work well as pre-filters in certain applications. When used to filter liquids, depth filters are usually given a nominal pore size retention rating, not an absolute rating. Membrane filtration describes a process that traps contaminants larger than the pore size on the top surface of the membrane. Wetted membrane prior to bubble point Hydrophobic media lack an affinity for, or repel, water. A hydrophobic medium will not wet in water but will wet in low surface tension liquids, such as organic solvents. Once a hydrophobic medium has been wetted out by an organic solvent, aqueous solutions also will pass through. Hydrophobic media are best suited for gas filtration and venting, or filtering organic solvents. (Example: Pall s Emflon PTFE.) The size of the pores determines the size of particles that will be retained by the filter. This allows for an absolute pore size rating of membranes. Bacteria and particle retention claims can be made based on the pore size of the membrane and these claims can be integrity tested. Membrane filters are manufactured from a plastic film and contain no fibers that can break loose. They are often used in critical applications, such as removing microorganisms from a fluid. Water or aqueous solutions can also pass through a hydrophobic membrane once the water breakthrough pressure is reached. Pore Size The filter material pore size is determined by the diameter of the particle that it can be expected to retain with a defined, high degree of efficiency. Pore sizes are usually stated in micrometers (µm). Pore size ratings refer to the size of a specific particle or organism retained by the filter media to a specific degree of efficiency. Ratings can be stated as either nominal or absolute. 888.676.7255 www.pall.com 21
Basic Filtration Concepts, continued A nominal pore size rating describes the ability of the medium to retain the majority of particulates (60%- 98%) at the rated pore size and larger. Processing conditions such as operating pressure and concentration of contaminant have a significant effect on the reten tion efficiency of the membrane. Note: Rating parameters vary widely among manufacturers. (Example: depth media, such as Pall s Glass Fiber media.) An absolute pore size rating specifies the pore size at which a challenge organism of a particular size will be retained with 100% efficiency under strictly defined test conditions. Among the condi tions that must be specified are: test organism (or particle size), challenge pressure, concentration, and detection method used to identify the contaminant. (Example: most membrane filters, such as Pall s Supor membrane.) Below are typical challenge organisms for specific membrane pore sizes: Absolute-rated Filter Media (Pore Size) Challenge Organism 0.1 µm Acholeplasma laidlawii 0.2 µm Brevundimonas diminuta 0.45 µm Serratia marcescens 0.8 µm Lactobacillus species 1 µm Candida albicans Extractables Extractables are contaminants that elute from the filter media which may adversely affect effluent quality. These contaminants may include wetting agents in the filter media, manufacturing debris, sterilization residuals (ethylene oxide), or adhesives. The type and amount of extractables will vary with the type of liquid being filtered. Extractables can affect filtration in almost every application: in HPLC analysis, they can add extraneous peaks, in cell culture, they can cause cytotoxicity (kill cells), in microbiological analysis, they can inhibit growth and affect recovery of microorganisms, in environmental analysis, they can appear as additional contaminants. Extractable components that can end up as contaminants may be minimized with sufficient preflushing. Binding Binding is the property of substances to have an affinity for filter media. Binding can be a desirable characteristic, as in the case of nucleic acid or protein binding on certain microporous transfer membranes, or an undesirable characteristic, as in the case of protein binding during filtration of proteinaceous solutions, some times leading to a loss of active ingredients during filtration. (Examples: Pall s HT Tuffryn, Supor, Omega, and GH Polypro membranes are extremely low protein binding.) Thermal Stability Thermal stability is the ability of the filter media to maintain integrity and functionality at elevated temperatures. Stability is measured by determining the maximum operating temperature under specified conditions. Thermal stability is important when considering sterilization, such as autoclaving. Certain filtration media are not autoclavable due to insufficient thermal stability. Keep in mind that there is a relationship between chemical com patibility and thermal stability; many types of filter media may be compatible with a chemical at room temperature, but at elevated temperatures, they are not compatible. Flow Rate and Throughput Flow rate and throughput are two important related measures of filter media performance. This performance is affected by many different variables. The most important variables are described below: Viscosity determines a liquid s resistance to flow. The higher the viscosity of a liquid, the lower the flow rate and the higher the differential pressure required to achieve a given flow rate. Porosity is the measure of all of the open spaces (pores) in the mem brane. Generally, membranes are 50% to 90% open space. Flow rate is directly proportional to the porosity of the membrane (more pores = higher flow rate). Filter Area (device size): Filter media are available in a wide range of sizes with different Effective Filtration Areas (EFA). EFA is the filter area that is available for filtration the larger the filter area, the faster the flow rate at a given pressure differential and the larger the expected filter throughput volume prior to clogging for a given solution. Measuring a Filter Media s Performance Pall uses various tests to rate the performance of its media. Biological Safety Tests: Series of United States Pharmacopoeia (USP) tests conducted on filter construction materials that come in contact with test solutions that simulate most body fluids. Extracts of filter construction materials are tested to establish whether there are potential leachables present. Testing is performed to determine whether leachables are capable of inducing measurable degrees of systemic toxicity, localized skin irritation, sensitization reaction, or other biological responses. Tests such as the USP Biological Reactivity Tests ensure there will be no adverse reactions to test solutions exposed to filter construction materials at an elevated temperature of 121 C. Pyrogenicity: Property of a substance that, when injected into the body, causes a rise in body temperature. Filtration materials that come in contact with injectable fluids must meet pyrogenicity stan dards and are therefore classified as non-pyrogenic. Pyrogenicity can be determined by such standard tests as the Limulus Amoebocyte Lysate (LAL) test. 22 888.676.7255 www.pall.com
Filtration Concepts Filter Hydrophobic Filter Bubble Point Bubble Point: Measure of the air pressure required to force liquid from the largest wetted pore of a membrane. Serves as an in dica tion of pore size and a barrier to particulates. The bubble point is dependent on the liquid used to wet the membrane; for a given pore size, the bubble point will be higher in a liquid with a higher surface tension (such as water) than in a liquid with a lower surface tension (such as isopropyl alcohol). The bubble point rating is determined when the largest pore yields a bubble; the larger the pore, the less pressure required to form the bubble. Expressed in units of pounds/square inch (psi) or bar for mem branes (ASTM:F316-80). Water Breakthoug Water Breakthrough: Measure of the amount of pressure required to transmit water through the largest pore of a dry hydrophobic media. Serves as an indication of pore size for a hydrophobic membrane. The larger the pore size, the less pressure required to intrude the water. Expressed in the membrane industry in units of pounds/square inch (psi) or bar. Water Flow: Measure of the amount of water that flows through a membrane. Related to the degree of contamination, differential pressure, total porosity, and filter area (ASTM:F317-72). Expressed in the membrane industry in units of milliliters/minute/square centimeter at a defined pressure. Air Flow: Measure of the amount of air that flows Filter through a membrane. Related to the degree of contamination, differential pressure, total porosity, and filter area. Commonly expressed in the Air Flow membrane industry in liters/minute/square centimeter at a given pressure. DOP Test: Measure of the efficiency of a membrane for the removal of particulate from air, based on the retention of 0.3 µm Dioctyl phthalate (DOP) aerosol droplets, usually expressed as a percentage. A 99.97% DOP retention indicates a High Efficiency Particulate Air (HEPA) filter grade (ASTM:D2986-71). Filter Efficiency: Measure of the quantity of particulate retained as a function of the total number and size of the challenging particles and differential pressure. Usually expressed as a percentage of retention of predetermined particle size at a given challenge concentration. In the case of bacterial removal efficiency, this may be expressed as a log reduction value. As you use this catalog, you will find more helpful hints for select ing the proper filter media for your applications. If you have additional questions, or just want to talk more about your application, please contact our Technical Service Department we d like to hear from you! Technical Reports Abstracts Following are abstracts of a number of studies specific to filtration topics that Pall has on file. Contact your Pall representative, or call us at 888-676-7255 for a complete copy of the any of these reports. Compatibility of specific anesthetic agents with Pall Supor HP filter devices Simulating clinical concentrations and delivery rates of a typical intravenous infusion, three routinely used epidural anesthetic drugs were tested for potential binding to HP filter devices containing Supor polyethersulfone membrane. Drugs studied were Bupivacaine HCI, Lidocaine HCI, and Procaine HCI. Drug samples were assayed via HPLC before and after passage through filter devices. Adsorptive losses to the HP filter devices were negligible for all three drugs studied. Reducing Infusion Phlebitis in Singapore Hospitals Using Extended Life End-Line Filters Journal of Infusion Nursing, Vol. 25 No. 2, March/April 2002 Two studies were conducted to investigate the impact of the 4-day end-line filter used to treat infusion phlebitis in Singapore. In the first study, conducted in 1997, 200 patients received IV antibiotics and chemotherapy. In the first 100 patients, end-line filters were not used during the infusions. This resulted in a phlebitis rate of 31%. In the second group of 100 patients, end-line filtration was used, resulting in a phlebitis rate of 5%. In 2000, a second study was conducted, measuring the outcome of end-line filtration versus no end-line filtration use. In this case, phlebitis developed in 35% of 100 patients receiving antibiotics, as compared with 8% of 394 patients with the use of 4-day end-line filtration. These are the first such studies performed in southeast Asia that highlight identical benefits, namely the reduction of phlebitis by elimination of particulates, in two separate patient populations. End-line filtration, when used to deliver antibiotics and chemotherapy, will result in significantly fewer cases of infusion phlebitis, reduce the cost of delivering IV antibiotics and chemotherapy, increase nursing efficiency, and ultimately improve patient comfort. Intravenous in-line filtration: Choice or necessity? Ensuring patient safety through the use of in-line filtration of intravenous infusions is worthy of serious consideration for prevention of inadvertent infusion of particulate matter, air and lipid emboli, microorganisms, and endotoxin. The article is intended to provide a comprehensive literature review to underscore the potential impact of in-line filtration of intravenous solutions on cost considerations, as well as patient outcomes. Compatibility of various pharmaceutical agents with Pall Supor intravenous filter devices Simulating clinical concentrations and delivery rates of a typical intravenous infusion, a variety of routinely used pharmaceutical drugs were tested for potential binding to in-line filter devices containing Supor polyethersulfone membrane. More than 55 drugs have been assayed via HPLC, direct UV/VIS spectrophotometry, or indirect methodologies before and after passage through filter devices. Adsorptive losses to air-eliminating filter devices were negligible for all drugs studied, with the exception of insulin, which displays moderate initial adsorptive characteristics for Supor polyethersulfone membrane. 888.676.7255 www.pall.com 23
Relative Size of Particles Mol.Wt. Å µm 80 Human Hair Diameter Reverse Ultrafiltration Microfiltration General Osmosis Filtration 1,000,00 500,000 300,000 100,000 50,000 30,000 10,000 500 50 105 104 8,000 4,000 1000 800 400 100 80 40 10 60 40 20 10 8 6 4 2 1 0.8 0.6 0.4 0.2 0.1 0.08 0.06 0.04 0.02 0.01 0.008 0.006 0.004 0.002 0.001 Smallest Visible Particle Ragweed Pollen Bacillus megaterium Candida albicans Staphylococcus aureus Serratia marcescens Brevundimonas diminuta; DOP Albumin Endotoxins <PYROGEN> Unstable Lipid Micelles Tobacco Smoke Carbon Black Soluble Salts <Ions> Red Blood Cell Virus Yeasts & Fungi Mycoplasma Bacteria Pollens Emulsions (latex) Metal Ions Human Chromosome Proteins Å, ANGSTROM = 10-8 cm µm, MICROMETER (MICRON) = 10 4 Å 1 mil = 0.001 inch = 25.4 µm Differential pressure increases with reduced micron ratings; dirt holding capacity and relative flow rates decrease with reduced micron rating. 24 888.676.7255 www.pall.com
Reference Pall Medical Facilities Pall Corporation Facilities Worldwide Offices Where the World Turns for Medical Filtration and Separations Solutions You ll find Pall Medical filtration products in healthcare settings throughout the world. Our filtration devices provide our OEM customers with solutions for con tamination control, which is critical in infusion therapy, blood separation, delivery of epidural anesthetic and analgesic solutions, in the preparation of irrigation and injectable solutions, and with cytotoxic drugs. Our devices are also found in critical applications like minimally-invasive surgery, respiratory therapy, cardiovascular surgery, ophthalmic surgery, and in the delivery of microbiologically pure water. Pall Medical was formed in 1998 by joining the global resources of Pall Biomedical, Pall OEM Healthcare, and Medsep Medical Components. This partnership provides our customers with unprecedented access to filtration expertise and the widest array of filtration, system engineering, and separa tions solutions available anywhere in the world. Together, our companies form the strongest sales, technical, and manufacturing organization within our industry. All of this converges to serve you, our customer. Our experienced sales representatives offer our global OEM customers convenient, rapid access to the filtration products you need to accomplish your business objectives. For more information, please call your nearest office, or contact the Pall Medical Critical Care headquarters, at 734.913.6155 or 888.675.7255. Pall Medical (OEM) 674 South Wagner Road Ann Arbor, MI 48103-9019 USA Tel: 734-913-6124 888-676-7255 (in USA) Fax: 734-913-6353 Australia 1-3 Wandarri Crt Cheltenham Vic 3192 Tel: 61 3 9584 8100 Fax: 61 3 9584 6647 France 3, rue des Gaudines B.P. 5253 F-78715 St. Germain-en-Laye Cedex Tel: 01 30 61 39 92 Fax: 01 30 61 58 01 Germany Philipp-Reis-Straße 6 D-06103 Dreieich Tel: 6103-307-333 Fax: 6103-307-399 India Pall Pharmalab Filtration Pvt. Ltd. Sahney Kirkwood Compund I floor, 27, Kirol, Vidyavihar (West) Mumbai - 400 086, Maharastra State Tel: 91-22-5956050 Fax: 91-22-5956051 Italy Division of PALL Itala S.r.l. 20146 Milano Tel: 02-477961 Fax: 02-4122-985 or 02-47796-394 Japan Gotanda Nomura Shoken Building 1-5-1 Nishi Gotanda Shinagawa-ku 141 Tel: 3-3495-8319 Fax: 3-3495-5397 United Kingdom Europa House Havant Street Portsmouth, Hampshire PO1 3PD Tel: 023 92 302600 Fax: 023 92 302601 Pall Corporation 2200 Northern Boulevard East Hills, NY 11548 USA Tel: 516-484-5400 800-289-7255 (in USA) Fax: 516-484-6129 888.676.7255 www.pall.com 25
for more medical device options. Lots more 553,560 and counting. Our customers count on options. And us. Count on Pall to save you time and money. With so many components, it s likely we have the right membrane in the right type of device with the right connectors to meet your needs. Add in the expertise of our global support staff, technical and engineering support, and scientific laboratory services and you ll see how we can dramatically speed up your development. Bring your challenging application to Pall. We offer the largest selection of proprietary media in the world, plus state-of-the-art manufacturing facilities that will deliver a solution to you that s expeditious and cost-effective. When it comes to medical device filtration, count on Pall. You ll be in very good company. Start with the one filtration company that does it all. Call Pall. 888-676-7255 Copyright 2003, Pall Corporation. Pall and are trademarks of Pall Corporation. Indicates a Pall trademark registered in the USA. is a service mark of Pall Corporation. Unless otherwise noted, all trademarks belong to Pall Corporation. 1/03 33278