How automation makes for quicker, cheaper and safer API production
This five part series details the phases of an API contract manufacturing project at Fermion. In the fourth part we look at how Fermion production utilizes automation to ensure cost-efficient supply and workplace safety. Read Part 1, Part 2, Part 3.
So your new, innovative API has been cleared for production. But how is the product actually made? And how does Fermion ensure cost-efficient and timely API supply for its contracting clients?
Process Manager Veli Matti Pihlaja from Fermion’s main site in Hanko and Process Operator Janne Lahtinen from Oulu pilot plant share key insights about automated production and workplace safety.
Automation for speed, safety and high-quality production
Fermion has already utilized full automation in its API production for years. A holistic automation system with, for instance, electronic recipes and batch records, drives down costs and ensures a secure supply while eliminating quality deviations. Through the automation system, all processes can be visualized for all employees on every level of the organization.
“Automation helps us wipe out human error: a machine will complete each task exactly the same way, in the same time and with the same quality every single time. It can also monitor the quality of the process with great accuracy,” Pihlaja explains.
The Hanko plant, where Fermion produces high volume batches of over 200 kilos, is set to open a new production unit in 2018, which will feature the latest, state-of-the-art automation technology, including automated high potency API manufacturing facilities.
“We’re setting up a bar code system for weighing ingredients, which helps us automatically ensure that the right amount of the right ingredients go into the process at the right time,” Pihlaja says. “It’s cheaper as well, as we used to need two people to double check that things are running smoothly.”
The automated process secures timely and compliant supply for clients, as less batches are rejected for mistakes or deviations. With automation, everything can be done paperlessly, which allows for documentation to be sent to clients electronically.
Workplace safety enhanced through isolated processes
Besides automation, another trend in API manufacturing in the recent decade has been isolated processes, where a barrier seals the operation room from the actual manufacturing process. This is done both to protect the the products from cross contamination and to ensure workplace safety for the plant’s employees.
In Fermion’s Oulu pilot plant most process phases are isolated. This is especially important as the plant produces high-potency APIs: coming into contact with the chemicals could be extremely hazardous for workers.
“In an isolated process, we load the ingredients into the reactors through glove-boxes, which eliminates the risk of being exposed to the chemicals,” Lahtinen explains.
As the level of automation increases, safety is further improved as an automated process is more accurately controlled.
“The staff is in a good position here as Fermion has the means to invest in new, safer and more efficient technology. Isolated manufacturing processes give us better protection, especially when loading materials into the reactors. We’ve also recently installed new ventilation equipment, which helps effectively remove exhaust gases”, Lahtinen says.
Next up: Part 5: Quality throughout the API contract manufacturing project