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: Vaccine Development and Manufacturing Facility Global Vaccine Manufacturer

The Challenge: The owner was designing/constructing a new multi-purpose/multi-product Vaccine facility and required the specification, development, installation, commissioning, and qualification of a Process Control System and Building Management System that would be suitable for a wide range of equipment sizes and process unit operations. The solution to this challenge required a PCS that would have a high degree of flexibility and ease of operation for Development operations and a rigorous DCS formula controlled operation for Manufacturing Operations. The development and deployment of this system was further complicated by the owner’s lack of staff to adequately man the Automation portion of the project.

The Solution: The principals’ in CHT had previously supplied this customer with innovative Automation Engineering and Process Solutions on numerous Development scale projects. CHT has also worked for this customer as Owner’s Representative for numerous other major projects. Consequently, CHT was selected as the Owner’s Representative and was contracted to manage the Automation Engineering functions for this $150 million project with responsibilities for overall performance, schedule, and budget. CHT staff joined the project team near the end of the PID development stage and worked with the customer’s to identify and document operational requirements.CHT built on this knowledge base to develop User Requirement and Functional Specifications. After selecting and bringing the System Integrator onboard, the concept of a multi-purpose easily operated process controls began to emerge from a concept into a system specification. 

Ultimately, the team developed and deployed a unique process control system that has selectable modes of operation. In the Development Mode, the scientist or operator is presented with multiple menu type graphical screens that present questions with pull down responses for the specific types of unit operations that will be conducted, the specific equipment that will be used, and all other variable process information. All information is recorded into a Part 11 compliant set of historians and presented in the End of Run Report. 

The control system code is especially complicated both because of the variety of choices for unit operations such as Media, Buffer, Fermentation, Centrifugation, Ultrafiltration, and Chromatography as well as the many different methods of operation for each type of multipurpose equipment. For example, depth filtration operations could be selected for product capture, contaminant capture, or charcoal filtration.

The Result: The customer ended up with an easy to use, highly flexible, process control system that works well in either Development or Manufacturing operational mode. All operations at either scale are conducted in full batch control by the DCS process control system. The procurement and engineering integration of the controls were completed within the initial budget. 

Almost immediately, the system proved its flexibility and value since during the later stages of commissioning several new serotypes were introduced that required significant process changes and final development during initial operations. The Development Mode operation was leveraged to a large extent to successfully and very quickly make the modifications required to operate the new processes.

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.

CASE STUDY: Capital Project Automation & Process Engineering Support Large Puerto Rico Solid Dosage Facility

The Challenge: Provide Owner’s Representative Services for Automation and Instrumentation Engineering during construction, commissioning, qualification, and initial operations for multiple projects. The facility is located in Puerto Rico and required full time local engineering presence. 

The Solution: CHT began its operations in Puerto Rico in early 2001 as a response to this request. Since that time, CHT has maintained a continuous presence on the island during which time CHT has been a key member of the engineering and construction team providing dedicated engineering on a daily basis. CHT has actively directed contractors during construction periods, written specifications for additional work scope, commissioned various projects, and provided product demonstration-run process, equipment, and automation engineering services. A representative project is described in the following paragraph.

Project R consisted of a new installation for a formulation and tablet coating operation. This project consisted of 2 independent trains for formulation and wet milling of coating solutions followed by tablet coating and drying operations. Also included were dust collection, vessel temperature control systems, and drying humidity & temperature control. CHT directed all stages of the electrical and controls installation and was fully responsible for the commissioning, startup, and demonstration batches produced in the facility. 

During product demonstration runs, CHT worked closely with the customer process development scientists and solved critical processing requirements including significant automation improvements to the vendor supplied pan drying controls and major modifications to the spray gun control server controls.

The Result: The customer has benefited from a full time presence of CHT engineers who ensure that all aspects of the Automation Engineering design, installation, and commissioning meet expectations. Most importantly, the facilities are put into working condition as part of the CHT team deliverable. At this juncture, many projects have been successfully completed and are in operation. All customer expectations have been met and CHT continues to serve this customer on a daily basis.