No two CIP systems for manufacturing pharmaceutical/biotech products are alike. Equipment manufacturers have to be flexible enough to accommodate the unique needs of the customer but also follow a disciplined plan to ensure that they build a quality system within the project’s time frame.
A major biotechnology manufacturer recently reaped the benefits of the meticulous project procedures followed by sanitation equipment specialist Sani-Matic, when it awarded the Madison, Wisconsin-based company a contract to build CIP skids for a new manufacturing facility.
A Request for Quotation (RFQ) flipped the switch on the bidding process. The document laid out the technical specifications of the proposed systems, manufacturing standards, commercial requirements and the terms and conditions of the project. The construction management firm hired by the customer to oversee the project prepared the RFQ based on the specifications submitted from the engineering firm and the customer’s process team. The construction manager (CM) developed the RFQ package which included project specifications, proposal forms, drawings, general conditions and contract documents. The RFQ package was sent to Sani-Matic and other equipment manufacturers for bids.
Sani-Matic generated a list of questions and clarifications to ensure that the bid was based on accurate information. The company’s list included assumptions and exceptions regarding the data provided and unresolved issues that needed to be addressed before a bid could be finalized. A formal bid is considered complete if it includes the following:
• Description of products being quoted
• List of assumptions
• List of exceptions to RFQ
• List of unresolved issues
• Delivery (confirmed at time of order)
• Terms & conditions
• Payment terms
Sani-Matic offered several supporting documents to help the customer fully comprehend the features and benefits of the CIP systems. A Theory of Operation Document (TOD) established the intended functionality of the equipment. Since the customer’s systems involved complex design parameters, a Process Flow Diagram (PFD) and a Process Instrumentation Diagram (P&ID) identified conditions that may affect the performance of the system and defined system parameters.
Once all of the bids were received, the CM forwarded them to the engineering firm and the customer’s process team for technical evaluation. Bids that passed that round went back to the CM who then discussed them with the customer.
Typically, three bids are selected for final consideration. The CM then contacts finalists for any additional clarification. The engineering firm and customer conduct another technical review based on their responses. Price was one of the factors the customer considered to determine which CIP system manufacturer to choose. Although Sani-Matic was competitively priced, the customer’s lead engineer on the project said it was the company’s design expertise and flexibility that got the job.
“Sani-Matic won the contract over a few other competitively priced companies because they seemed very interested in making sure we received exactly what we wanted with as much or as little automation and functionality as we desired. They had top notch engineers working on their project.”
Once Sani-Matic was chosen, a contract review was conducted. The signed document was compared to the latest quotation to ensure that the customer and Sani-Matic agreed on all aspects of the project, including all of the specification exceptions and changes in scope that may have occurred. For example, the dimensions and capacities of the tanks had to be changed because of the lack of floor space and process design changes in the plant. Sani-Matic generated a change order for the customer to review and approve. They worked with the CM to resolve changes quickly to keep the project on schedule. The goal was to ensure that Sani-Matic, the CM, the engineering firm and the customer were on the same page.
A project kick off meeting officially transferred responsibility from sales to the project coordinator and engineering. The agenda addressed the list of issues from the quotation process and the sold project plan. The project coordinator was responsible for follow up if new unresolved issues came out of this meeting. The engineers who attended this meeting also were involved in the quote review process to maintain continuity.
“Many times you see companies that when the engineering team comes on, they aren’t very familiar with the initial part of the project,” the project manager for the CM noted. “We didn’t have any problems with Sani-Matic in this regard.”
Representatives from all disciplines of Sani-Matic’s engineering department met to review the project and establish project milestones and quality check points. Representatives from operations also were included so that operational requirements and manufacturing schedules could be discussed. Sani-Matic’s carefully managed manufacturing project was disciplined by a number of quality check points detailed on a Gantt chart with all project milestones and due dates. Quality check points included:
• A design checklist for all engineering disciplines to follow and promote continuity of design theories, standard practices and to minimize errors.
• A risk analysis review that examines the equipment design and the automation program for operator safety concerns.
• A design review to ensure compliance with specifications and to reduce design errors throughout the drawing process.
• A strict approval process for drawings, bills of materials, function design specs, software specs and factory acceptance tests.
Checklists and other procedures were followed during the final drawing reviews to reduce design errors, improve inventory accuracy and management, and reduce total job costs. Throughout the project, Sani-Matic’s project coordinator briefed all departments involved as well as the CM and the customer to ensure that they had a current understanding of the project scope and schedule.
All drawings were reviewed and Sani-Matic addressed any comments, keeping a sense of urgency about revisions and making sure that nothing fell through the cracks during the design phase. Once the drawings were finalized and approved, the project coordinator communicated the scope of the project with the appropriate representatives from engineering and manufacturing prior to beginning the manufacturing process.
Engineering was involved throughout the manufacturing process, performing quality checks at critical points to ensure compliance with design details. Any deviations or concerns were brought to the attention of the manufacturing supervisor for resolution.
The manufacturing department utilized checklists and other procedures to identify critical control points to capture quality related issues. Certain process steps, pre-determined and outlined on the project schedule, were monitored for compliance with key quality measures.
According to the CM’s project coordinator, Sani-Matic’s response throughout the whole process was very good. “One point of contact is a very good thing because you don’t want two or three different people involved. One person managed all of the internal teams and communicated with us and the customer.”
The customer’s lead engineer echoed this opinion. “The project manager was a wonderful communicator and a very quick responder to issues that needed to be resolved in order to keep the project on schedule.”When two of eight total skids had been completed, Sani-Matic conducted operational testing to validate new or modified products or processes. This is a routine quality step for Sani-Matic’s pharmaceutical skids prior to final inspection, testing and shipment.
A team that included representatives from sales, estimating, mechanical/electrical design and technical service performed the final inspection. The goals were to reveal any poor fit or finish of fabrications, deviations from intended design or functionality, access difficulties for maintenance, and uncover safety concerns so that they could be resolved before the customer came on site for final testing.
All of the testing went smoothly, the CM’s project manager noted. “The customer put together a punch list of everything that had to be fixed before the skid could be shipped out. Sani-Matic addressed these issues very quickly. The first two skids set the expectations from the customer and any items that they pointed out in the first two skids didn’t show up on any of the rest of the skids. This procedure was very efficient for Sani-Matic and the customer.”
Currently all eight skids are on site at the customer’s new manufacturing facility waiting for start up in 2-3 months. Sani-Matic will be on site monitoring the skids’ performance and addressing any issues that arise during manufacturing.
This project was full of firsts for Sani-Matic and the customer. Sani-Matic had never built skids like the ones they customized for the customer. The customer had never worked with Sani-Matic before this project. Time will tell how the skids will perform in real-world processing but the customer’s lead project engineer is confident things will go smoothly.
“I would definitely recommend Sani-Matic. We have switched from one vendor to the next on each of our projects and have not been satisfied with any of them. I was pleasantly surprised with Sani-Matic. I found them to be very flexible, urgent when required and an overall pleasure to work with, which is often not the case on a project of this scale.”