BEA Technologies adds new pharma-grade cleanroom facilities

Milan, Italy: – Filtration specialist BEA Technologies has planned a major investment program to create new cleanroom production facilities for its innovative high quality pharma filtration solutions.

BEA is spending up to €3m on transforming a new building close to its existing headquarters site at Pero, Milan, to provide new cleanroom space to be equipped to ISO Class 5 standard, dedicated to pharma-grade products.

Focus on Qualikap

This will allow BEA to achieve a 50% increase in its production of ultra-fine filters for pharmaceutical and medical use.

Some of the new production space will be dedicated to manufacture of the recently added series of Qualikap QKP filter capsules specifically designed for filtration of small batch production.

The Qualikap QKP capsules contain a heat-sealed filter element inside a high-quality polypropylene container, with new concept non removable rotating valves with double O-ring seals incorporated in the structure, to address a long identified vulnerability on other designs.

Diverse applications

The Qualikap capsules are built to withstand repeated sterilization, and are available in a wide choice of materials, including PES, Nylon 66, PTFE, and PVDF membranes, to meet various application needs, such as filtration of alcoholic solutions, ultrapure water, vaccines, physiological solutions, and ophthalmic liquids.

Like other BEA Technologies filter capsules, Qualikap cartridges are assembled and integrity tested in GAMP-certified Clean Rooms, controlled and monitored by computerized systems, to ensure high-quality products free from contamination.

Quality tested

To ensure effective bacterial retention power, destructive Bacterial Challenge tests are performed in accordance with ASTM F838 standards.

BEA has also developed a series of procedures for checking the integrity of its filter capsules, including diffusion, bubble point, and water intrusion tests.

The latest investment is part of an overall program to transform BEA production to implement digitalized Industry 4.0 standards that has included investment in new automated pleating and manufacturing machines capable of transmitting real-time data, along with end-to-end tracking and tracing through vertical automated warehousing already installed in existing production and warehouse for final products ready for shipment.

About BEA Technologies

BEA Technologies S.p.A has been an active presence on the filtration market for the last 50 years, working successfully worldwide in various sectors, including beverage, chemicals and pharmaceutical markets.

The company manufactures a wide range of innovative and high technology products to filter both solid particles, microorganisms – bacteria and endotoxins, removing them from liquid solutions, air and gas.

The filters are produced in a certified cleanroom, in a controlled environment that is constantly monitored by computer systems to ensure that it complies with GMP (good manufacturing practice) requirements.

Internally, the company is structured in such a way as to be able to guarantee, through its commercial service and laboratory service (SLB), timely and expert consulting service and after-sales assistance. The headquarters in Pero, just outside Milan, based on three facilities which occupy a surface area of 13,000 sqm. In the plant there are two cleanrooms where the company produces all its membrane filters and filter elements for use in food and pharmaceutical applications. In 1994, BEA became one of the first filtration companies in Italy to get its quality assurance system certified in accordance with the requirements of the ISO 9001 standard, constantly renewed until now.

To find out more, visit https://www.bea-italy.com/en/

Resources

Click on BEA Technologies Life Sciences Solutions  for other information.