BEAPURE: Re-engineered filters made with “Animal – free” polymers (compliance to Halal) for critical processes in biopharma production

BEA Technologies (BEA) has developed BEAPURE as a proprietary technology to provide high quality filtration in critical production processes. The BEAPURE range of “animal-free” filters and sterilizing membrane filters is designed for high purity production processes and facilities where extractables and potential contamination are critical factors.

Benefits include , being “animal-free”, protection from extractables of “animal-origin” ( generally present in polymers used for moulding plastic parts), compliance to Halal requirements, compliance with most recently issued European, USP and FDA regulations and codes, full traceability and periodic control and testing by the BEA internal Laboratory.

Animal-free benefits

The life sciences landscape is moving at a rapid speed, putting demands on manufacturers to create innovative, safe content while maintaining compliance.

The R&D Dept. of BEA Technologies S.p.A has been focused on developing filtration technologies that can meet the ever-more demanding standards of modern pharma production while also bearing in mind the needs of small and medium-sized companies and new production bio-processes.

One response has been the BEAPURE concept that combines highly purity materials with rigorously controlled supply chain, to produce filter elements for critical biopharma applications.

“Animal-free” requirements can be ethically motivated but in practical terms are also demanded to remove all biohazards.

To be certificated as “animal-free” means that no polymeric part or component used in production can contain any trace of materials, substances or additives of animal origin. These include for example ‘tallow’ waxes that have been widely used in polymers for moulding parts.

The BEAPURE Concept

BEAPURE technology is designed to meet the six critical criteria needed to guarantee ultimate Patient Safety:

• Filters certified “Animal-free” made of pure components and parts .
• Controlled original materials in compliance with latest regulations.
• Periodic controls in BEA laboratory of extractables and leachables.
• Protection from external contamination during production.
• Easy and quick identification of materials to help operators ensure quality
• Full traceability of production through barcoding and a full data chain.

BEA Technologies can also act as a consulting supplier to enables life science clients to leverage from its extensive experience in filtration and separation to obtain the best cost-effective  clarification of products and to achieve the safety and quality prescribed for the therapy. The established expertise of BEA Technologies and implementation of the BEAPURE Concept provides added value and applied services that can support individual customer processes in obtaining highly safe products.

BEAPURE Technologies

After a long research process, the BEA Research team was able to select and test the “pure” polymers to be used for the production of “BEAPURE” line of filters. This line consists of filter elements which incorporate Nylon 66 membrane as well as a positively-charged Nylon 66 membrane, used to remove endotoxins or other very fine contaminants negatively charged from different liquid solutions.

Nylon 66-based products also meet Halal stipulations required for certification in some Muslim countries.

The “BEAPURE” line also includes filter elements made with polyethersulfone (PES) and PTFE membranes and  a series of filters containing borosilicate fibers and nanofibers for high performance filtration of viscous solutions in drug manufacturing process . PES membranes can be alternative or used in combination with positive charged Nylon 66 membrane for sterilization of liquids and removal of bacteria and very fine contaminants in drug manufacturing processes.

BEA Technologies is studying ever more efficient ways to target drug production of small batches and provide effective high protection from the effect of toxic or mutagenic or irritating drugs that pose significant challenges for the pharmaceutical industry.

BEA is now working to extend BEAPURE technologies to “Animal-free” capsules for filtration of small batches, Indicated for filtration of solvents, venting, gas pressurization of tanks and bioreactors.  These capsules will use PTFE membranes, allow easy gloved opening of vent and drain valves and include validation guides and documentation for validation on site.

BEAPURE quality control

BEA critical filters are manufactured in controlled environments to cGMP standards where all key production activities are constantly controlled by information system. Membrane filter elements are individually checked by non-destructive test methods, as well as destructive tests performed with bacterial challenge according to ASTM F838-05 guidelines.

The bacterial retention results correlated with the integrity test data are reported in the validation guide of each BEAPURE membrane filter product to define the acceptable test values.

Materials used in BEAPURE production are characterized to be BSE/TSE free, with accompanying “Animal-free” and Halal statements.

Production materials for BEAPURE filters are selected for compliance to relevant regulations with quality checked through controls across the entire supply chain. There are backed up by regular and repeated quality controls in BEA’s internal laboratory and analysis of extractables executed in external laboratories.

Accurate recording and careful check of materials guarantee full traceability and a validated quality chain from manufacturer to final user.

Resources

Click on BEA Filtration for Life Sciences for further information.