CASE STUDIES

Customer:

Biopharm Pilot Scale Facility

Scope:

• Disassembly and relocation of Biopharm equipment to a new location
• Multiple bioreactors
• Water chiller, gas manifolds, clean steam generator
• Support equipment
• The work was performed in phases:
• Consultation on facility redesign and layout
• Demo/disassembly of equipment
• Relocation and installation
• Field work executed by a team of (6) field technicians on site

ABEC Impact:

• Existing piping and other material was reused where applicable.
• Scope was added by customer during project with no impact on schedule
• Project completed on-time
• 6 weeks from order receipt through completion of field testing

Customer:

Major Biopharm Manufacturer, US West Coast

Scope:

• To facilitate a product/process transfer, ABEC designed and installed various modifications to 60L, 300L and 2,000L bioreactors on-site.
• Initial mix study to determine requirements for new mixing and drive components, as well as sparger design and placement.
• Complete 3D design.
• Replaced existing top-mounted agitators, modified gas piping, and repaired upper addition ports for pipe stress and misalignment at sterile boundary TC connections.
• Replaced all fittings and lines as necessary to allow proper alignment, prevent sagging over time and eliminate forces that can result in damaged components.
• Site Support included (6) field technicians on-site for (16) days and (1) project engineer was on-site for (5) days.

ABEC Impact:

• Customer faced a very aggressive timeline. ABEC delivered in (12) weeks from order receipt through turnover.
• Included design/engineering assessment, procurement of agitation components, and design.
• Complex project using a combination of process engineering expertise, project management, and field execution.
• Overcame unexpected issues during field work by increasing the assigned personnel to maintain critical project schedule.
• Completed project on-time and to complete specification and performance.

Customer:

Major Biopharm Manufacturer, US East Coast

Scope:

• To repair existing vessel Heat Transfer Surfaces which failed as a result of stress corrosion cracking.
• The stress corrosion was a result of the following:
• Temperature differential (thermal shock) between steam sterilization cycle & introduction of chilled glycol.
• High chloride content in city water.
• Harsh CIP cleaning solutions.
• Normal wear from 25 years of production cycles.

ABEC Impact:

• With each mobilization, site support included (4) field technicians on-site for (10) days each.
• Room and equipment layout provided limited accessibility for technicians and tools. Also, tanks pass through a platform, so Heat Transfer Sections had to be carefully repaired and/or removed, and skillfully re-installed.
• With each maintenance shutdown, adherence to schedule was absolutely critical. Downtime must be minimized and the tanks must be back online immediately. In each case, ABEC was able to meet or beat the deadline and stay within the budget.
• Project completed on time and on budget.
• ABEC was awarded multiple projects by this customer to repair Heat Transfer Surface on other tanks.

Customer:

Major Biopharm Manufacturer, US East Coast

Scope:

• ABEC fabricated a new 1,250L media tank per customer specifications.
• ABEC team was mobilized to the site, to execute the demolition an existing 11,000L media tank.
• In its place, ABEC team installed new 1,250L media tank.
• Site Support included (4) field technicians on-site for (8) days.

ABEC Impact:

• Due to overall size of the 11,000L Media tank, the tank had to be cut into smaller pieces to fit through interior doorways and service elevators.
• ABEC salvaged the agitator assembly and lower piping sections from the 11,000L Media tank.
• For the installation of the 1,250L Media tank, ABEC worked with a local rigging company on site.
• For the re-installation of the piping and instrumentation, ABEC worked closely with local pipe fitters.
• For the re-installation of the load cells, ABEC worked closely with the load cell supplier. In each case, the coordination was critical to the schedule.
• With the coordinated effort, the project finished on time and on budget.

Customer:

Major Biopharm Manufacturer

Scope:

• Major SIP modifications for 10,000L Bioreactor Train.
• Redesign of clean steam supply and harvest line to (5) bioreactors and (9) addition vessels that feed the 3000L and 10,000L bioreactors.
• Major rework on the S/CIP supply manifold.
• A new Add Can Addition Line to the S/CIP supply.
• Design, created 3D model.
• On-site team of 24 personnel from vessel, piping, welding, electrical, quality, and documentation disciplines.

ABEC Impact:

• Completed this major project on-time to meet Customer's schedule.
• Performed within hard confines of scheduled Holiday shutdown.
• All documentation completed on-time to meet automation and validation requirements (i.e. certs, electrical drawings, P&ID).
• Elapsed time ARO to turnover 8 weeks (including year-end Holiday).

Customer:

Major Biopharm Manufacturer, US East Coast

Scope:

• ABEC was contracted to perform seal change-outs on site for (100L, 1,000L, 2,000L, 11,000L) systems.
• Previously, customer was requiring seal replacements every 6 months. With ABEC's skills and expertise with this equipment and type of replacement, the systems are now operating for a full 18 months between maintenance intervals.

ABEC Impact:

• Significantly reduced downtime due to lengthened seal life.
• Scheduled shutdowns are more efficient and equipment is operable in less time.
• Changeouts completed in hours with less personnel as opposed to days with other contractor.
• Project incurred less expenses.
• Reduced cost of bioreactor maintenance by 30%. Additional production batches per year.