3M Separation and Purification Sciences Division 3M Zeta Plus Filters with DELI Grade Media ™ Regulatory Support File

E. 3M™ Zeta Plus™ Encapsulated System Filter Capsule and 3M™ Manifold Design

3M Separation and Purification Sciences Division is a leader in advanced filtration and purification solutions, offering a wide range of products and services for various stages of pharmaceutical and biologics manufacturing. 3M, a U.S. based multinational high technology company, has operations in more than 65 countries. Facilities that participate in the manufacturing of 3M™ Zeta Plus™ Filters with DELI, DEL1, and DEL1LP Grade Media (herein collectively 3M™ Zeta Plus™ Filters with DELI Grade Media unless designated otherwise) with products as shown below, have quality systems registered to quality...

Drug Master File Reference 3M™ Zeta Plus™ Filters with DELI Grade Media are listed in a Drug Master File (DMF) registered with the United States Food and Drug Administration (FDA). The information contained in the DMF may be utilized by regulatory reviewers to support a New Drug Application (NDA), Investigational New Drug Application (INDA), Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or supplements to any of these. Permission by 3M for review of a DMF is granted only to appropriate United States Food and Drug Administration (FDA) or similar regulatory agency...

Table 1.3M™ Zeta Plus™ 8-Inch Filter Cartridge Product Descriptions: Single Layer Media Product Description Examples: 45805ADELI, Z12MDDEL1 LP Table 2. 3M™ Zeta Plus™ 12-Inch Filter Cartridge Product Descriptions: Dual Layer Media

3M™ Zeta Plus™ 16-Inch Cartridges

All components used in the manufacture of 3M™ Zeta Plus™ Filters with DELI Grade Media products are traceable. Intermediate products are packaged and labeled throughout the manufacturing process to provide complete traceability from the raw materials to media batch to finished product. All grades of the 3M Zeta Plus Filters with DELI Grade Media are composed of the same materials of construction at varying ratios. Therefore, the test results reported herein are generally applicable to all grades and product configurations. 3M™ Zeta Plus™ Filters with DELI Grade Media are produced in the United...

A. Media 3M™ Zeta Plus™ DELI Grade Filter Media contains a mixture of natural and precipitated silica, cellulose, nonionic surfactant, and a crosslinking polymer binder resin. The polymer binding resin used in 3M™ Zeta Plus™ DELI Grade Filter Media is a polyamide epichlorohydrin (PAE) polymer that contains a mixture of secondary, tertiary, and quaternary amines. The media is produced by a wetlaid process. Media or filter sheets may be die cut to various shapes and dimensions per customer specifications. Converted filter sheets are generally used in commercially available filter presses. Each...

Figure 1c. 3M™ Zeta Plus™ Filter Cartridge and components Figure 1d. 3M™ Zeta Plus™ Filter Cartridges shown with housings Figure 1e. 3M™ Zeta Plus™ 8-Inch Plug-In Cartridge Figure 1f. 3M™ Zeta Plus™ Plug-In Filter Cartridge housing C. Capsules There are three capsule categories for the 3M™ Zeta Plus™ Encapsulated System Filter Capsules: Laboratory (BC Series), Scale-up and Production Capsules. The Laboratory capsule (BC0025, 3M™ Zeta Plus™ BC Series Filter Capsule) is constructed by compressing the single or dual layer filter media between the inlet and outlet capsule components, then overmolding...

lenticles have an outside-to-in flow path. The flow passes through the filter media and is directed to a central exit flow path along the separator. The production capsules have three single-use capsule configurations. The 0.23 m² capsule has one lenticle of single or dual layer media. The 1.6 m² capsule has seven (7) lenticles of dual layer media. The 2.5 m² capsule has eleven (11) lenticles of single layer media. The outermost lenticles of the lenticle stack have respective male and female connectors thermally attached to provide connection to adjacent capsules or manifolds. The connectors...

Scale-up Capsule Shell Top Lenticle Edge Seal Fluid Inlet Fluid Outlet Downstream Separator Media-Top Upstream Scale-up Capsule Shell Bottom Figure 3c. 3M™ Zeta Plus™ Encapsulated System Scale-up Filter Capsule cross-section Figure 4. 3M™ Zeta Plus™ Encapsulated System Filter Capsules (Production Capsules) Figure 4a. 3M™ Zeta Plus™ Encapsulated System 0.23 m² Filter Capsule Figure 4b. 3M™ Zeta Plus™ Encapsulated System 1.6 m² & 2.5 m² Filter Capsules Figure 4c. 3M™ Zeta Plus™ Encapsulated System Filter Capsule (Production Capsul

Figure 4d. 3M™ Manifolds - Top manifold Figure 4e. 3M™ Manifolds - Bottom manifold D. Materials of Construction Table 8. Materials of Constructor

Weights and Volumes shown in Tables 12-15 below were experimentally determined from samples of various representative grades and families of 3M™ Zeta Plus™ Filter Media. Please note that these values are presented for guidance only and are not specifications; actual amounts depend upon individual capsule variability, exact blow-down conditions, media type in capsule, the number of capsules in the system, the process fluid, and loading level of the capsule. 1) Dry Weight - Weight of capsule prior to use. 2) Wet, Post Blow-down Weight - Liquid retained in the system, as measured by the differential...

Table 13. Capsule Design Characteristics - 3M™ Zeta Plus™ Encapsulated System Scale-Up Filter Capsules Post blow-down wet weight is defined as the experimentally measured weight of the capsule after air/gas blow-down using water as the flush fluid. Actual amount depends upon exact blow-down conditions, media type in capsule, the number of capsules in the system, the process fluid, and loading level of the capsule. Capsule Fill Volume is defined as the volume of liquid required to fill the capsule (experimentally measured). Post blow-down hold-up volume is defined as the estimated volume of the...