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Pharmaceutical Isolators


Overview

Springs Fab – ATG offers OEM custom containment for aseptic and toxic processes.  We have extensive experience designing and fabricating custom solutions for our pharmaceutical customers and tailoring solutions to their demanding applications.  From developing a custom OEM isolator solution for a blow-fill-seal process to developing customizable Restricted Access Barrier Systems (RABS) for various filling lines, we have the experience and expertise to solve your most complex isolation needs.  In addition, we can integrate HEPA filtered laminar airflow, hydrogen peroxide (H2O2) sterilization systems, control systems, and custom process equipment.  

Our engineers work with the OEM technical staff and operators to understand the need, define a solution, and develop a performance specification. Springs Fab – ATG offers mock-ups to verify ergonomics and process flow to improve design.  All our systems are thoroughly tested in our factory before shipment.  We offer installation or installation assistance in the field as required.

Springs Fab – ATG fabrication capabilities include experience working with various metals including all grades of stainless steel, aluminum, and other exotic metals such as Iconel and Hastelloy.  Our welders are all certified to ASME Section IX.  We provide superior metal polishing and finished expertise meeting or exceeding 32 micro-inch Ra through hand polishing techniques.

Capabilities

Services
  • ·         IQ/OQ & Documentation
  • ·         Decontamination Cycle Development
  • ·         Microbiological Qualification
  • ·         Isolator Re-Qualification (of used isolators)
  • ·         Ammonia Leak Testing
  • ·         Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • ·         Installation & Startup
Experience
  • ·         Finishes
  • ·         Pressure Controls (differential pressure transmitter & VFD controlled blower)
  • ·         Ventilation Controls (single of double HEPA filtered, safe change HEPA filters)
  • ·         Current Good Manufacturing Practice (cGMP)
  • ·         Good Automated Manufacturing Practice (GAMP 5)
  • ·         Shielded Hot Cells (radiopharmaceutical)
  • ·         Laminar Flow Transport Carts (on-board battery powered)
Accessories
  • ·         Safety Interlocks
  • ·         Manipulators (master/slave or ball-and-tong)
  • ·         CIP Spray Ball System
  • ·         Safe Change Gloveports
  • ·         UL-508A Control Cabinets (in-house, standard or explosion proof)
  • ·         Air Handling Carts
  • ·         Particle Counters
  • ·         Rapid Transfer Ports (RTP): 105mm, 190mm, 350mm
  • ·         Split Butterfly or Cone Valves



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