Zeta Plus™ BC Series Filter Capsule with LA Series Media as single-use capsules designed for pharmaceutical manufacturing applications requiring the most stringent levels of organic and inorganic extractables and system cross-contamination controls.
- Designed to have the lowest organic and inorganic extractable levels in the 3M depth filter portfolio
- Stringent product extractable specifications enabled by both pre-extracting of both cellulose fiber and filter aid
- Reduced potential of 1,3 beta-glucan interference in product endotoxin testing based on the use of aggressively extracted cellulose fibers
- Filtration performance optimized to a broad range of fluid challenges
- Full range of scalable single-use capsules enables predictable performance at every stage of drug development from early stage discovery to commercial production
The Zeta Plus™ BC Series Filter Capsule with LA Series Media comprises a mixture of high surface area inorganic particles, cellulose, and a positively charged crosslinking polymer.
These filters have a reduced potential of yielding false positives in drug product endotoxin testing resulting from 1,3 beta-glucan interference in LAL (Endotoxin) assays. They are designed for the lowest organic and inorganic extractable levels of the 3M depth filter portfolio by aggressively extracting both the inorganic particles and cellulose fibers. The combination of filtration efficiency and throughput results from the balance between porosity and depth, and the relatively low level anion exchange capacity: removing some negatively charged soluble and sub‐micron particles via anion exchange, and larger particles by mechanical sieving. The BC25 laboratory capsule is ideal for optimizing the filtration performance for each drug process by effectively screening the breadth of available single and dual layer media options. A scalable range of single-use capsules enables predictable performance at every stage of drug development from early stage discovery to commercial production.
Pharmaceutical Grade Product.
The Zeta Plus™ LA Series Filter products are specifically designed for use in the manufacture of biopharmaceutical, vaccine, blood fractionation and small molecule API drug substances. The effluent characteristics of the Zeta Plus LA Series Filter media and capsules has been tested following a number of protocols contained in the United States Pharmacopeia (USP) compendia.
The 3M Purification Inc. Quality Management System is approved by an accredited registering body to the ISO 9001:2008 and ISO 13485:2003 Quality Management Systems. The manufacturing process, quality controls and regulatory oriented compliance reports are documented in a Drug Master File on record with the FDA.
Filtration Performance
Zeta Plus LA Series filter media comprises a mixture of high surface area inorganic particles, high surface area cellulose and a crosslinking polymer resin. The polymer resin has a positive charge as a result of a balance of secondary, tertiary and quaternary amines resulting in a relatively low anion exchange capacity. As such, Zeta Plus™ LA Series filters are a good choice in applications where the pharmaceutical product is negatively charged and product recovery may be of concern. By controlling the choice of raw materials and the formulation, a variety of filtration grades are produced that each have a balance of fine particle removal and throughput capacity.
Single-use Capsules
Ease of use, operating costs and development time may all be improved by using 3M's single-use capsules. Specifically, single‐use capsules may reduce batch-to-batch change over time, minimize the time required to develop and manage complex validated equipment cleaning protocols and reduce the large cleaning fluid volume demands of a production operation.
The Zeta Plus™ LA Series filters are available for use in the 3M™ Encapsulated System, which enables a completely single‐use solution to process from 0.5 L to 2500+ L of liquid. The BC25 laboratory capsule with 25 cm²; filter media is ideal for media grade screening using small liquid volumes. The scale‐up capsules with 170; 340 and 1020 cm².
