Case Study

Hygiene Assurance For Pharma Clean Room

Blood Plasma

Strictest Hygiene Achieved And Changeovers Simplified

Prothya Biosolutions (formerly Plasma Industries Belgium) processes approximately 1.2 million litres of human blood plasma per year, breaking down the individual proteins for use in therapeutic and clinical analysis products via ‘fractionation’.

This is a complex process that must maintain the strictest hygiene. Installing a BFM® connector between a hopper and processing vessel fixed issues they had experienced with a clamped connector, improving changeovers and also dramatically reducing the risk of clean-room and product contamination.

The Challenge

The clean-room environment at Prothya Biosolutions requires the strictest hygiene.

The traditional clamped connection between a filter aid hopper and the manhole hat at the top of the processing vessel was very difficult for staff to mount/dismount, due to a slight variation in diameter of the tri-clamp connection.

A gasket glued to the bottom of the hopper as part of this connection was frequently loosened and would fall into the vessel below.

This posed a real risk of costly product contamination and caused powder leakage into the clean-room environment.

The BFM® Solution

BFM® spigots were installed at the connecting points of the filter aid hopper and the manhole hat of the processing vessel. A Seeflex 020E connector is now fitted between the two pieces of equipment.

The exact fit and resulting 100% seal means there is no longer any difficulty in installing the connector, and no risk of any product leakage into the clean-room. This has improved production downtime, and the one-piece snap-fit connector also removes the risk of dropping any clamp components into the processing vessel.

When not in use, the man-hole cover is sealed with a BFM® cap to ensure no contamination.

Benefits Achieved

By removing the difficult clamping system, the BFM® fitting allows much faster changeovers - in seconds - eliminating costly downtime.

The custom BFM® top and bottom spigots mean the connector can now be easily snap-fitted into the correct position by one operator.

The 100% seal has eliminated risk of clean-room contamination, and simple snap-in connection means no chance of dropping components into product.

What the client said about BFM®

“The BFM® has given us a huge improvement in handling our changeovers - it’s so much easier for us to physically replace a connector and we know it’s always fitted correctly in the right position. It’s also given us so much more confidence in terms of maintaining our strict clean-room hygiene. There’s no risk of product leakage or dropping of clamp components into the processing vessels during changeovers. Brilliant!”

- Kristof Greens
Project Engineer, Prothya Biosolutions (formerly Plasma Industries Belgium)

Case Study provided courtesy of BFM® Distributor Vlint (Benelux)

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