CASE STUDY:  Parenteral Facility Expansion International Pharmaceutical Company

The Challenge: This customer had recently commissioned a parenteral filling facility but had met with poor operations, confusing operator interface for DCS control, lack of scalability, poor batch controls, and major sterility issues. The poor design resulted in extended manufacturing cycles that reduced plant capacity and operability to unacceptably low levels. Although brand new, the plant needed a major overhaul to the Automation and Equipment Systems and they needed it in a hurry in order to meet scheduled production requirements. 

The Solution: CHT’s Subject Matter Expert Engineer worked with the manufacturing department to operate the facility for data gathering purposes. Information was obtained that enabled a Failure Mode Effects Analysis determining the root causes of the process and controls problems. The solution proposed by CHT and which was agreed was to make several minor but critical equipment improvements and then to operate the plant to make sufficient product inventory to permit a brief shut down. 

While this was happening, CHT led a team from all departments gaining consensus on the fundamental changes required for a successful manufacturing operation. CHT then developed Functional Specifications, participated in the selection of other team members, and managed the project through engineering and integration of the required modifications required to resolve the fundamental causes of the operability issues. Equipment and piping modifications were made and a new S88 compliant batch control system (software, existing hardware was utilized) was installed. 

The timely construction completion, quick commissioning, and immediate operation objectives were met or exceeded and the customer was able to successfully use the facility for filling the new product for an international roll out.

The Result: The highly motivated engineering and integration team worked superbly together to produce a remarkable facility in record time ultimately leading to the timely and successful product launch.

CASE STUDY: International Biopharmaceutical Company Fast Track Plant Expansion & Renovation

The Challenge: The Owner had the schedule and performance of a capital expansion and renovation project for a major new rheumatoid drug seriously at risk due to a log jam of unresolved contractor questions and issues due to a lack of onsite field engineering for automation during construction. CHT was contracted to join the team as the Owner’s Representative for Instrumentation and Automation construction and commissioning activities with the directive to get the installation back on track to meet the required project completion dates.

The Solution: CHT deployed multiple engineering resources to the site. At the time of deployment, there were more than 650 Requests for Information on the Process Control System backlogged in the site office. CHT worked with the contractors and the Construction Manager to classify and prioritize the RFI’s and to set about immediately developing answers for the highest priority items. CHT worked hand in hand with the Design Engineer and the contractors for the next 12 months providing 20 hour per day direction to their installation crews and resolving any and all issues that came up in the Automation area. CHT was frequently called upon to engineer alternative designs in response to changes in scope and or problems encountered with the initial design. This was a fast track project and there was simply no time to waste waiting for engineering to go through the normal A&E channels. 

The automation installation included more than 8000 conventional I/O with no buss technology. The massive instrument wiring and tubing runs were in many cases subject to revised field installation since the design engineers were required to issue construction documents prior to equipment or instrument selections being finalized. Working with an outstanding construction crew, the CHT engineers resolved all the issues as they came up and kept the installation moving forward on schedule. 

CHT also participated in the initial plant commissioning for the instrumentation and DCS systems successfully directing the Installation and Operational Verification of the DCS hardware, power supplies, communications networks, and instrument I/O.

The Result: The facility was completed and placed into operation in record breaking time largely due to the fast track field approach of multiple team members including CHT. The customer seized this opportunity and implemented the tech transfer to initiate manufacturing operations also in record breaking time and ultimately received licensing and was able to ship product less than 2 years from start of commissioning activities.