A goal of any pharmaceutical manufacturer is the pursuit of the most efficient equipment available. This equipment can increase output, reduce downtime, cut costs, and increase overall productivity while also adhering to strict cGMP requirements. The acquisition of this type of efficient equipment is the main purpose of the expansion at Piramal Pharma Solutions, Lexington, Kentucky.
Our last blog post details the new manufacturing suite as well as the new utilities put in place in anticipation of the new isolator unit acquired from Steriline. The manufacturing plant was shut down for two weeks in December to allow for the new Steriline to be installed.
What does this mean for new and existing clients?
After the Steriline is tested and qualified, the liquid filling capabilities of the Lexington manufacturing plant will be much more efficient. Maximizing the efficiency of production in the sterile pharmaceutical environment means less processing times, greater capacity, less chance of operator error, and less cost to the client.
What is the current process?
Currently, the filling process is a discontinuous procedure. The Lexington facility has perfected the process, but it requires several movements of the product through docking with different isolators. Docking and transferring the product from one part of the process to another increases product processing times and allows for a chance of human or equipment error. Weight checks are performed on vials by removing them from the line. These vials are then considered waste and cannot be released with the rest of the manufactured batch. While this process works great for small batches, larger batches take a substantial amount of time to fill.
What makes the Steriline isolator system so great?
The Steriline will change the discontinuous process and make it one continuous flow throughout the liquid filling procedure. The system will move the vials through initial vial washing and drying, filling, capping, depyrogenation, and an external vial washer. This continuous flow of the product will greatly reduce processing times and require less manipulation from the manufacturing operators. It also will not need the separate line clearances required when docking and transferring product from one isolator to the next.
What are the capabilities of the Steriline?
The Steriline is top of the line in isolator technology. It has the capabilities with two filling needles to fill 100 vials a minute in an efficient, automated process. It is able to work with vial sizes from 2 mL all the way up to 100 mL. It can perform 100% weight checks on all vials that move through the system so there is no loss for removing them from the line. Also, the depyrogenation process is shorter because the vials continuously moving through the line and does not require separate docking. The Steriline has the capability of meeting wave length requirements and time sensitivity requirements.
Piramal Pharma Solutions is dedicated to helping clients in the growing pharmaceutical industry by maximizing efficiency and quality of the products they trust in us to manufacture. The Steriline is just one of many ways we are expanding our technological capabilities to provide a great experience to our clients in an efficient and effective way.