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BEA Technologies MAGNEXFLO® system for clarifying gels and high viscosity products
BEA Technologies (BEA) offers MAGNEXFLO® high capacity automatic filtration technology for clarification of particularly demanding or viscous substances in the chemicals and pharmaceutical industries.
The filtration and clarification processes of pharmaceutical products have acquired an ever-greater importance, requiring innovative equipment to face the main challenges dictated by the complexity of sterile processes and the demands of new products to be purified.
Purification of gels
The purification of gels for pharmaceutical use and liquids with viscosity higher than that of aqueous solutions represents a problem in drug production systems and in filling glass containers where low flow speeds associated with sterile filtration of more viscous products has slowed production processes., especially when depyrogenating and sterilizing filtration are required.
These issues demand a purpose-designed equipment, as BEA’s MAGNEXFLO high capacity automatic filtration technology.
The purification of gels for use in the pharmaceutical, cosmetic and medical sectors is a challenge, especially if it is necessary to guarantee very low final endotoxin content. The gels are highly biocompatible and serve to coat the active ingredients, to allow a controlled release and increase the assimilable quantity of a specific drug. Recently endotoxin-free purified gels have also become important in stabilizing vaccines and other sensitive formulations, to reduce risks of secondary reactions for improved patient safety.
In order to facilitate the production of gels with a high level of purity and minimized endotoxins, BEA Technologies developed the MAGNEXFLO automatic filtration system, which has returned consistent proven results in the clarification of gels with high initial turbidity index.
The MAGNEXFLO plant is equipped with MAGNEX high surface filtering elements to recover permeability and an automatic clean in place (CIP) washing system for autonomous regeneration with reduced energy costs. These features make the system more economical and efficient than traditionally used filters in the treatment of gels.
By adding a double final stage consisting of POSINYL filter elements, equipped with a positively charged membrane, significant reduction of final endotoxin residue is also achieved.
Filtering viscous products
Tests at BEA Technologies has shown that using a filtration stage with nanofibers before the final stage can improve the operating service life of the final filter membrane. The matrix of superimposed nanofibers allows for very high porosity grade, facilitating the passage of the most viscous fluids and avoiding rapid increases in differential pressure. In addition, any particles and aggregates that form in the viscous fluid are easily retained by the nanofibers in order to preserve the pores of the final membrane for the retention of the bacteria and microorganisms.
To improve the flow characteristics of the more viscous fluids it is necessary to increase filtering surface and porosity to maintain high filtration rate and facilitate fluid distribution through the pores of the membrane. Coupling a first nanofiber filtration stage with high surface sterilizing membrane provides much faster batch filtration before storage or packaging.
Where there is a risk of the presence of residual endotoxins in the viscous solution, the addition of a positively charged sterilizing membrane final filtering stage is recommended to absorb any residual endotoxins before packaging.
Typical high viscosity solution
A typical solution for clarifying a high viscosity get combines the flowing elements:
- Primary filtration stage using NANOTRAK and NOVATRAK filter elements with a matrix of overlapping nanofibers in a layered structure that is highly porous and capable of increasing the flow rate and retention of particles and aggregates.
- Secondary sterilizing filters with BIOKLARIS membrane in PES or STERINYL in 0.2 micron NYLON 66 fully validated for retention of diminuta (ATCC 19146) with a bacterial load of 10 log 7 cfu per cm2 of membrane.
- Additional use of POSINYL filter with positive charge NYLON 66 membrane is recommended for any endotoxins retention.
The MAGNEXFLO filter system was designed by BEA Technologies for pharmaceutical, biotech, fine chemicals and cosmetics applications requiring treatment and processing of gelatinous and viscous products. The system is modular, customizable and can be completely automated to minimize operating costs.
The system is available in different versions:
- fully automated (PC controlled) with intuitive operating interface
- semi-automated for low-cost implementation,
- manual for smaller and less expensive installations.
All MAGNEXFLO models can be equipped with a series of optional features that include an automatic rinsing system in many configurations, a section for final microbiological stabilization of the product, automatic dosing pumps for adding stabilizing additives and chemical cleaners, and an isobaric version for operation at 6.0 bar for products that require to be pressurized.
The range includes five models whose basic performance specifications compare as follows: