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The Engineering Process

The Custom Engineered Design Process: Case Study
Restricted Access Barrier System for Aseptic Processing

One of the world’s major pharmaceutical companies decided to upgrade and improve its aseptic filling suite where, for over three decades, they had manufactured and filled a powder form antibiotic that was added to IV solutions. While the facility and the equipment received general upgrades, the existing laminar flow units remained unchanged since the facility came on line. The laminar flow equipment used to insure aseptic conditions had performed reliably since it was installed in the 1970’s, but for many reasons the company felt it was time to modernize.

In addition to a complete redesign of the room and building, The Baker Company was selected to design, fabricate, install and test a new integrated system of HEPA-filtered laminar flow modules to completely cover the process from the time vials exited a depyrogenation tunnel to the time they were capped.

The client had an extensive list of requirements but most importantly:

• The equipment had to provide a unidirectional Class 100 area directly over the packing line with an air velocity standard of 90 FPM +/- 20%
• A “universal” barrier system would be used to separate the product from the operators during filling
• The individual modules had to be adjustable to achieve consistent, uniform velocities within individual plenums and or between adjacent filters and plenums
• Barriers could not interfere with production
• All prefilters, motor blowers and HEPA filters had to be easily replaceable from within the filling suite· The individual modules had to be suspended from the ceiling of the room
• The individual modules had to follow the contour of the filling line

After extensive on-site meetings with operators, engineers, validation personnel and facilities personnel, The Baker Company developed an actual two-module working mockup to validate that all parameters were met.

Many new and unique features were developed to meet and exceed the customer’s every requirement. These included:

• An integral heavy gauge rib section that allowed modules to be “sandwiched” together for ease of installation
• Rib sections that that allowed for precise placement of barriers around the perimeter of the filling line
• A universal barrier system that can be rotated to allow access or prevent entry over critical areas
• A clean air zone outside of the critical to prevent particulate entry
• An internal set of stainless steel supply diffusers to allow one to effectively manage airflows and gain access to the HEPA filters for replacement within minutes

After acceptance of the mockup, The Baker Company was given the authorization to proceed with the manufacturing of a 40-module system which is currently in the process of being installed and validated.Overall, this project reflects Baker’s well-gained reputation as a company that can partner with clients to come up with creative, effective engineering solutions for clean air and containment.