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companiesDesigning and Manufacturing

Leading-edge Filtration Products Since 1978.

Active Pharmaceutical IngredientsBioburden ReductionBiopharmaceuticals

BiotechnologyChromatography Sample Preparation

Clarification and PrefiltrationDialysis

Drug ScreeningEndotoxin Removal

General Medical Genomics

High Performance Liquid ChromatographyLaboratory Quality Control

Lab Water PurificationOphthalmics

Plasma FractionationProteomics

Single Use SystemsSterilizing Filtration

Tangential Flow FiltrationTank Venting/Process Gas

Vaccine ProductionViral Clearance www.strainrite.com | Toll Free 800-487-3136

Rev. Jul. 2016

Service Locations

Strainrite Mid-West481 N. Saginaw StreetPontiac, MI 48342Tel: (248) 334-2173Fax: (248) 334-2788

Strainrite West12410 Clark AvenueSanta Fe Springs, CA 90670Tel: (562) 941-1203Fax: (562) 941-1202

Strainrite Corporate Headquarters65 First Flight DriveAuburn, ME 04210Tel: (207) 376-1600Fax: (207) 777-3177

At Strainrite, we are dedicated to the best in Science and Service.

Strainrite offers vessels that are ISO9001:2008 certified and are hydrostatically tested in accordance with industry accepted standards. We also offer special quality assurance tests which include X-ray, Magnetic Particle, Liquid Penetrant, Ultra-sonic and Brinell hardness testing.

Our consultative selling approach focuses on custom solutions to filtration problems. We commit the time and resources to tailor our products to our clients’ unique requirements.

By working with us, our clients realize: • Innovative solutions• Operational cost savings• Improved process efficiency• Enhanced finished product quality• Reduced waste costs

At Strainrite, we believe in Science and Service.

All Clarity™ and Madd MAXX™ cartridges are manufactured in our facility. Our Quality Management System is certified to be ISO 9001:2008 compliant. Our state-of-the-art equipment and highly skilled technicians are able to maintain the highest levels of product reliability and repeatability, from receipt of raw materials to shipment of finished filters.

A few controls that are in-place include:• All cartridges are manufactured in

a Class 10000 clean room• Raw material performance verification• Bubble point and air diffusion testing• Bacteria challenge verifications of

performance• Extractable verification and determination• Ultra-pure water rinsing with resistivity

verification of effectiveness• Finished validated products are integrity

tested by air diffusion

Science and Service:The Strainrite Way

MADD MAXX

Vessels & Housing

Filter Bags

Highest Standard Sanitary Housing

Experts in High Quality

Filtration

We manufacture a variety of standard design vessels that offer the aesthetics and operational durability of stainless steel at affordable prices, ensuring optimal cleanability in critical areas.

For special system requirements, our engineers will custom design a system to meet your needs. Strainrite vessels are fabricated

from the highest quality materials and conform to strict quality standards.

• Electropolished finish• Fitted for code 7 &

code 6 cartridges.• Stainless steel legs.• Sterilization using hot

water or in-line steam.

OfferingFiltration for Every Function

• For Particle Control: Removal of foreign particles, as well as undissolved solids from product ingredients.

• For Clarification: removing smaller particles suspended in the liquid and causing a haze.

• Often performed with depth filters• Overall purpose: to protect critical downstream

membrane filters.

• Process Gas: Pumped in when normal atmosphere cannot come into contact with ingredients, final product, or container.

• Tank Vent: Process gas ‘blanket’ is forced or pumped out

• Usually hydrophobic membrane filters with 0.20 μm pore size.

• For Reduction, not Removal: Designed to remove most, not all, microorganisms.

• Choice of filter dictated by type of organism (usually dependent on environment in and around facility)

• Usually membrane filters with pore sizes from 0.45 μm to 0.80 μm.

• Overall purpose: to prevent premature fouling of sterilizing filters downstream due to an excess of particles/bacteria.

• Endotoxins: Negatively charged, large-molecule cell debris which originate in the outer membrane of some bacteria and which elicit strong immune responses. Also known as lipopolysaccharides or LPS.

• Endotoxin limits are regulated by United States Pharmacopeia (USP) and by the Association for the Advancement of Medical Instrumentation (AAMI).

• Water treatment applications often require processes that use large-particle media.

• Carbon filters contain carbon powder, which may release particles. Water Softener and Deionization tanks contain resin beads that break down into the stream.

• Depth filters are used to “trap” these special particles and prevent downstream contamination.

• For Final Filtration: Designed to remove whatever bacteria remain in product.

• Integrity tested: Before and after use to ensure filter was installed properly and has not been damaged

• Almost always membrane filters with pore sizes to 0.20 μm.

• Include Validation Guides: Required by FDA. Provides product specifications and results of pre-qualifying tests conducted.

Strainrite’s Clarity Depth (2.5” diameter) Clarity Extra Depth (2.7” diameter) and Clarity Continuous Pleated (2.68” diameter) series offer quality depth filtration in an array of filter media:

Absolute-Rated PolypropyleneNominally-Rated PolypropyleneAbsolute-Rated Dual-Density PolypropyleneAbsolute-Rated MicroglassMicro-Fiber Glass

Strainrite offers the highest quality tank vent and process gas filtration with hydrophobic, sterilizing PTFE membrane vent filters, Vent-Rite (single-layer PTFE), and Vent-MAXX (double-layer PTFE)

Strainrite’s Clarity Membrane (2.5” diameter) and Clarity Max Membrane (2.7” diameter)series offer quality depth filtration in your choice of filter media:

Strainrite offers the highest quality in endotoxin filtration with an absolute-rated, hydrophilic and integrity-tested charged nylon pleated membrane filter, the Endo MAXX CN.

Strainrite offers quality depth trap filtration in an absolute-rated high-solids-loading, polypropylene pleated depth medium with the Pur-Pleat Select (2.5” diameter), thePoly-MAXX Select (2.7” diameter) and the

HSLP (Continuous Pleated -2.68” diameter).

Strainrite’s sterile-grade Clarity Mem-Pleat SG (2.5” diameter) and Pur-MAXX E-SG (2.7” diameter) filters offer quality depth filtration in a dual-layer pleated polyethersulfone sterile membrane element.

1- Prefiltration 4- Tank Vent & Process Gas Filtration

2- Bioburden Reduction 5- Endotoxin Removal

6- Trap Filtration3 - Sterilization

• Polyethersulfone• Polysulfone• Nylon• Charged Nylon• PTFE

• Cellulose• Micro-Glass Depth

over Membrane• Polypropylene Depth

over Membrane

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FILTRATION OF ACTIVE PHARMACEUTICAL INGREDIENTS

HIGH PURITY WATER FILTRATION

BIOPHARMACEUTICAL FILTRATION