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Are restricted access barrier systems (RABS) and isolators replacing traditional cleanrooms? All have the same aseptic requirements, but some argue that isolators and RABS increase asepsis. Many companies, especially large pharmaceuticals, are making the switch from cleanrooms to RABS or isolators. But others remain leery of these relatively new technologies. The first isolators of the early 90s fell short of expectations, leading to the development of RABS as an alternative.
To meet the growing demand for pediatric and adult vaccines, GSK is investing more than 500 million euros in a vaccine manufacturing plant to increase production in formulation, filling, freeze-drying, and packaging.
• new design in peristaltic pumps provides precise filling and fast, efficient cleanup validation
• sterile product comes into contact with only the medically graded silicone tubing and filling needle, handling fill volumes from 0.1-mL to more than 1 L
• for small- and medium-sized batches, the pumps can be part of a stand-alone filling unit or up to a system with 16 filling needles
• Filamatic Mini-Monobloc filling system accommodates pharmaceutical, diagnostic, and biotech applications, from micro doses to 60 ml at accuracies of +/-1/4%
• offers servo motor filling, stopper/tip placement, cap torque, and indexing systems in a 2x4-ft footprint
• handles glass vials, plastic or glass tubes, microtubes or precapped microtubes, at speeds to 30 cpm
• fills vials and infusion bottles at speeds to 400/min in continuous motion
• handles fill volumes from 0.2 to 500 mL
• turntable meets aseptic production requirements
• industrial PC controls machine and stores production data; controls are compatible with CFR Part 11 systems
