FDBusiness.com

Two systems for decontaminating and protecting the sterility of parenteral nutrition solutions developed and designed by Telstar were recently installed in the new B.Braun pharmaceutical facility at Alcobendas (Madrid), where they produce parenteral nutrition products for the Spanish market.

The project requirements included an isopropyl spraying booth, intended for the pre-filling process, and a double exit Pass Through box for the finished product and waste material. Additionally the equipment had to incorporate the complex process of producing small batches of personalised parenteral nutrition solutions. B.Braun produces injectable food solutions intended for a specific group of patients who require individualised recipes, which have to be produced on a small scale and under aseptic conditions. In both units, designed and developed by Telstar, the product transfer system is automatic and therefore does not require any operator intervention.

ATEX Isopropyl alcohol booth (4 chambers in total)

The first system is an isopropyl alcohol spraying booth for decontaminating the external surface of the parenteral solution bag before it enters the filling room. The booth is fitted with a double chamber, double doors and a fast intermediate automatic door, together with an automatic transfer system that works on rollers, developed under the ATEX directive. The Booth also has an automatic alcohol spraying system sourced from a storage tank located outside. In the entrance booth which includes a pass-through loading system the alcohol is sprayed to disinfect the material, this is followed by vapour extraction in the chamber and finally flushing with HEPA filtration. The equipment is fitted with a second booth that has a double chamber for automatically returning the raw material trays and maintaining the pressure cascade from the filling area, thereby avoiding cross-contamination. The Technical area is located directly on the upper portion of the unit, resulting in a compact design with significantly reduced footprint requirements.

Quadruple Safety Airlock System (SAS) boxes

The system is designed for automatically transferring parenteral solutions from the filling area to the packing area. The system maintains sterile conditions in both the filling room and the product during the transfer process. Consisting of four double ventilated chambers (8 sub-chambers in total) for removing the waste and the finished products, they are fitted with HEPA type filtered air flow systems in both the impulsion and extraction sections.

The structure is comprised of 8 external swing doors and 4 automatic roller doors inside. The Upper zone is designed for the outlet of the finished product, and the bottom zone is for removing the waste material from the filling area. Each of the 8 chambers are managed independently, with a dedicated ventilation system providing chamber flushing with HEPA filtration, on both inlet and exhaust, between each door opening. A sterile atmosphere inside the chamber and pressure cascade is guaranteed and in addition the system prevents cross-contamination between rooms with different degrees of cleanliness. This concept is reinforced with an interlock door system and pressure control managed by a PLC ensuring the protection barrier prevents contamination.