By Bea Technologies…
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BEAPURE Animal-free filters
Bea Technologies (BEA) has developed specific filter elements targeted to guarantee the highest quality of products in most critical life science applications and for the biopharmaceutical industry. These BEAPURE animal-free filter elements incorporate high purity materials delivered by a carefully controlled supply chain.
Benefits include protection from external contamination, animal-free and Halal certification, compliance with most recently issued European, USP and FDA regulations and codes, up-graded traceability and periodic control and testing by the BEA Laboratory.
BEAPURE features and benefits
BEAPURE is one of a wide range of proprietary technologies developed by BEA to provide high quality filtration in critical production processes. This range uses animal-free sterilizing filters and membrane filters for high purity production processes and facilities where external contamination is a critical factor.
BEA critical filter systems are manufactured in controlled environments to cGMP standards with all key production activities constantly controlled by computerized systems. Membrane filter elements are individually checked by non-destructive test methods, as well as destructive tests performed 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.
BEAPURE quality control
Production materials for BEAPURE filters are selected for compliance to relevant regulations with quality validated by 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.
BEAPURE filters are produced in highly controlled environments to guarantee absolute protection from external contamination.
Accurate recording and careful marking of production materials guarantee up-graded traceability and a validated quality chain from manufacturer to final user.