INSIGHTS ON PHARMACEUTICAL PRODUCTION

PHARMACEUTICAL PRODUCTION SOLUTIONS

  • Ensure Compliance. Safeguard Sterility. Drive Manufacturing Excellence.

  • Unused Turn-Key Modular Systems (TKMS) Tangential Flow Filtration (TFF) system. This TFF unit is designed to remove ethanol from the process stream (via diafiltration, where a buffer exchange occurs to a required number of diavolumes). The system consists of: - UF Filter: Repligen model KROSFLOW MAX X06-E100-05-N for solvent removal and buffer exchange, CIP and SIP rated, 12,000 fiber count, 128,000 square-centimeter surface area (12.8 square-meters). - Filter cartridge & housing: Allegheny Bradford Corp. Model OC-1-01-QT49394-2 Air and Clean Steam Filter, 316L SS construction, design pressure FV to 150 psig, design temperature -20 to 350F (SIP temp approx. 121C). - Feed Pump: Waukesha Cherry-Burrell model 220-U2 positive displacement pump (100 lpm min/ 600 lpm max) - GEMU, Steriflow , and PBM valves - Optek UV Analyzers (not Ex rated) - Instrumentation: Bronkhorst, Endress & Hauser, and others - Sample holder: Millipore model AT51/5-3E0 - Aflex Hose - 316L stainless steel product contact parts - Stainless steel skid frame - Built to comply with "ATEX Zone 2 II 3G Ex" standards - FAT performed still on original shipped skid from OEM.

  • PCI offers flexible and globally compliant commercial scale manufacturing and packaging of multiple dosage forms including tablets, capsules, creams, gels, ointments and oral liquids for both highly potent and non-potent drug products.

  • Used Cytiva XDR-500 bioreactor system, model XDR-500. Includes (2) Rosemount Analytical model 1056 dual channel intelligent transmitters and (4) peristaltic pump heads, serial# 29294331, built 2018.

  • Used Glatt CPS 3 Fluid Bed Dryer, model CPS 3 Lab System, Roto-granulator chamber, made in 2011, S/N 11565.