3M DELI User Manual

Zeta Plus™ DELI and DELP
Zeta Plus™ DELI and DELP series comprise a family of depth filter media which incorpo­rates lipid-specific adsorbents for sel ective reduction of lipids, surfactants and biological hydrophobes from human blood plasma, serum-based products, recombinant proteins and other biological fluids. These media types provide a range of lipid reduction capacity and functionality.
Applications
During protein purification processes, lipid contamination can cause an assortment of pro­cessing problems. Lipids can foul and plug expensive chromatography columns and mem­brane filters. Prior reduction of lipids via depth filtration promotes column and membrane performance and extends their useful life. Lipid contamination can also cause solution instability of intermediate and final protein products leading to a problematic lipoprotein haze. Zeta Plus DELI and DELP series products can replace bulk silica operations which are labor-intensive, messy and difficult to prepare.
Series Filter Media
Zeta Plus DELI and DELP series filter media may be used to separate lipids within the following lipid classes: mono-, di-, and triglycerides, fatty acids, cholesterol, phospholip­ids, and lipoproteins. Enhanced reduction of lipid contaminants from protein solutions is therefore highly desirable, leading to improved processing economies (extended column and membrane life), improved product purity, and enhanced final protein product stability for longer product shelf life.
Features & Benefi ts
Two different media formulations available for varying degrees of lipid reduction.
Effi cient reduction of undesirable lipids, lipoprotein haze, and microbial and
particulate contaminants.
Depth fi lter media with hydrophobe and lipid specifi c adsorbents.
Provides effective protection and extended life for chromatography columns and
reusable membranes.
Variety of cartridge sizes, disposable capsules and fi lter sheets.
Highly scaleable.
Flexible options for all fl ow and batch volume requirements.
Totally-enclosed, sanitary-design systems and cartridge housings.
Easily cleanable, no external contamination, offers rapid assembly and take down.
Tested and optimized for pharmaceutical and biological service.
Safe for critical pharmaceutical, bioprocessing and biological applications.
Components meet USP Class VI Biological Safety Tests and requirements of CFR 21.
Applications
Lipid reduction from human blood plasma proteins such as albumin, coagulation factors, fi brinogen, and immunoglobulins
Provide protection, enhanced performance and extended life for chromatographic columns and ultrafi lters
Reduction of residual lipids from serum, fermenta­tion broths and cell culture fl uids
Reduction of detergents and surfactants from biologicals
Separation of hydrophobic bioprocess contaminants from aqueous solutions
Filter
)
DELI
DELP
M
17.9
0
9
0
5
0
Media
Protected
Flow Channels
Gasket
Retainer
Internal
Separator
Cell
Weldments
Various
Gasket Materials
Edge
Edge
Seal
Tab s
Cell
Separator
Zeta Plus ™ Products: The Benchmark for Pharmaceutical & Biological Depth Filtration
Filters using Zeta Plus™ DELI and DELP series media are part of the Zeta Plus family of depth filtration pr oducts, which provide highly efficient, cost-effective clarification of turbid, difficult-to-filter biological fluids and pharmaceutical products. Zeta Plus cellulose-based depth filtration media are designed to retain contaminants by both size exclusion and adsorption. It is composed of high surface area filter aids embedded in a cellulose fiber matrix.
Zeta Plus DELI and DELP filter media incorporate added silica adsorbents, which are the active components for lipid reduction. During the manufacturing process, mol ecules carrying a positive charge are chemically bonded to the matrix components, forming a permanent, interconnected, rigid filter sheet with positive ly -charged electrokinetic capture sites. The resulting porous depth filter structure is a tortuous network of adsorptive flow channels capable of retaining bacteria, endotoxin, cell debris and su bmicron con taminants to a level which mechanical screening alone cannot achieve. Zeta Plus depth filters provide high-efficiency submicron filtration, often surpassing the performance of pleated prefilters and competitive depth filters.
Zeta Plus Delipid Media Choices
T w o different types of delipid filter media are available to suit varying application require­ments. The chart below serves as a guideline for selecting the appropriate delipid media type:
Type Lipid Reduction Capacity
DELI Intermediate No No DELP High Yes Yes
*
Limulus
Amoebocyte Lysate
Optimized for Low Aluminum
Extractable Levels
Optimized for Sensitive
LAL* Test Procedures
All DELI and DELP fi lter media are available in totally­disposable BC fi lter capsules for lab-scale, process development or small-volume fi ltration. Shown are BC25 and BC1000/2000 capsule units with DELI fi l t e r m e d i a .
2
Media Selection
3M differentiates its DELI and DELP media offerings by varying the materials of con­struction used in their manufacture. Choice of silica type confers upon the media either a medium or a high capacity for lipids based upon the specific surface area (m²/g) of the silica incorporated into the filter matrix. Choice of cellulose type affects the level o f apparent endoto xin or Limulus Amoebocyte Lysate-R eacti v e Material (LAL-RM) extractables .
LAL Reactive Material
Trace levels of cellulosi c impurities (ß-glucans ) from several of the more useful types of cellulose interfere with some (but not all) FDA-approv ed LAL reagent systems designed to test for USP Bacterial Endotoxins. DELP media has been purposely formulated to allevi­ate this sort of interference.
Table 1: LAL Reactive Material (EU/ml
Rinse Volume l/m
EU/ml including LAL-R
35.
3.8
0.50
.25 0.01
.25 0.01
.02
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