Overview
A global healthcare leader operating in more than 100 countries needed process modifications and enhancements in two of their vaccine filling lines. The company is a leader in the production and distribution of vaccines – and as the world saw in 2020, there are few businesses as important, or where absolute precision in manufacturing is more critical.
The company contracted with Avanceon based on a prior relationship: members of its Engineering Management team had seen the benefits our work while with another organization. Relying on their trust and recommendation, the company first engaged with us on several small projects. Impressed with the results, they hired Avanceon to handle the upgrade.
The Challenge
Two of the company’s vaccine production lines needed a number of process modifications and new operational features. Chief among these was integration of a portable in-line filtration system, as well as the integration of the CIP/SIP (cleaning in place/sterilizing in place) sub-systems to be used when required as part of the main processes. The installation of the changes and additions needed to occur in a fixed and rigid shutdown window with the new system resuming production without a hitch.
Analysis
As Avanceon analyzed the system and processes involved, it quickly became clear that a simple upgrade was not feasible. There were serious issues involving the system code itself, and the analysis also revealed the production lines were experiencing intermittent handshaking difficulties with some allied hardware. As the client had limited access to the hardware systems’ code, neither they nor Avanceon would be able to correct the problem. In addition, the company had experienced sporadic production snags – a situation that was clearly not tolerable. Such issues made it difficult to improve, validate, and support the existing code.
The Avanceon Solution
Based on the analysis, both Avanceon and the client agreed that the scope of the project would benefit by expanding to consider some strategic opportunities. The client had originally proposed upgrading just one line in the time window, but Avanceon pointed out that it would be more efficient to upgrade both lines at the same time with the same team. The client agreed. Also, the analysis process made it clear that the best approach to the client’s needs was not to upgrade the existing programming, but rather, to create a “green field project” and, quite literally, start over. Avanceon proposed taking on the responsibility of completely rewriting the code from scratch, including creating new and detailed functional and design specs and complete documentation. The rewrites would need to include both the PLC code and the HMI code for the dispense and CIP/SIP processes for each line. Such an approach would provide more accurate, reliable, and sustainable code with no change in hardware.
Avanceon explained its rationale and the associated benefits of the project approach, and the client accepted the proposal. Avanceon worked closely with the client staff to identify how they wanted the finished process to work; the goal was to avoid reverse-engineering existing code that was admittedly flawed and create a new system that more accurately met their functional and operational goals. In addition, the new solution would solve the handshaking issue by eliminating multiple PLC processors.
The analysis also revealed that the client did not have the staff necessary to validate the rewritten process, so Avanceon took on a second project: writing the validation protocols and carrying out the validation on the production lines.
The Team
Avanceon assigned a Project Lead and put together a team of seven people to carry out the project, and they worked in tandem on different portions of the software and hardware solution. The team began preparing user requirement specifications in March with all the other specifications and validation documents followed. After some revisions to the specs, coding began in August. Installation and validation began in mid-November under an Avanceon Project Engineer.
Result
Avanceon has delivered all specifications, code and validation documents inside of the startup window and provided post go live support as necessary to tweak final system performance as necessary. All required modifications and process additions (as well as some last minute system enhancement requests) were completed on schedule and to the needs of the business. The customer now leverages an industry-standard Batch Phase Management system to define and execute the batch-controlled processes on the lines, thereby eliminating the custom code that was so cumbersome to support.
Avanceon’s relationship with the client continues to expand through the development and delivery of system and operational training, 24×7 support and planning phases for the next set of line upgrades.