We are adding a fully automated, 100% isolator-based, and flexible filling line! The new line will be operational by end of Q2 2022.
We have added a new lyophilizer that will begin operations in Q2 2022. The new lyo can now process up to 35,000 10R vials. This is a 10 fold increase in our current capacity.
We have installed an isolator to perform sterility testing for all production runs. Sterility testing will be offered by end of Q1 2022.
We will be incorporating electronic batch records via MasterControl into our production runs beginning 2022. This will reduce the risk of operator error, encourage a “right the first time” operation, and enhance the quality and documentation for all production runs.
We are implementing a LIMS system for all analytical data. Currently, BSM uses a LIMS system by Novatek for stability data, but this will soon be extended for in-process and release testing and micro testing. This will improve GDP compliance, reduce the risk of operator error, and decrease timelines within quality control.
We are constantly striving to better ourselves as a company to best serve your needs. We expect this year’s expansion projects will offer the greatest growth and improvement in our capabilities.
Want to learn more about our capabilities? Take a tour of our facility? Or discuss an upcoming project?
Reach out to us today!
Wednesday, May 7 | 1PM EST