Barrier Isolation Technology Consulting for Aseptic Processing

• Sterility testing with isolation technology.
• Filling operations with isolator technology.
• Cleaning & biodecontamination of isolators.
• Validation.
• Aseptic containment techniques for processing hazardous API’s.

Examples of Services Provided:  “A well-designed positive pressure isolator, supported by adequate procedures for its maintenance, monitoring, and control, offers tangible advantages over traditional aseptic processing, including fewer opportunities for microbial contamination during processing”¹.  Regulators are now strongly recommending the implementation of isolation technology for all new facility construction and expansion projects.  Very high profile regulators such as Rick Friedman and Thomas Arista have embraced the technology as a form of sterility risk mitigation.   Isolator technology options include gloveless isolators using robotic technology, filling isolators using prewashed/depyrogenated components in nests or trays, isolators that have “L-flanges” with various replaceable modules, isolators using rapid VPHP cycles for fast turnaround of decontamination cycles and many other methodologies that require focused technical expertise.

• User requirements specifications, request for quotation, and equipment specification.
• Isolator equipment manufacturer selection.
• Glove management policies and procedures.
• Expert knowledge of various isolator and strong relationships with numerous equipment manufacturers.
• IQ/OQ/PQ of equipment, facilities and utility systems associated with barrier isolation.
• Qualification strategies such as media fill programs.
• Consultation on the latest presterilized component technologies which will eliminate expensive and utility intense equipment such as vial washers, depyrogenation tunnels, autoclaves and component preparation areas.

 

¹  Guidance for Industry.  Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice.  Appendix 1.