2022

The new year is here!
This a year of

Expansion Growth  New Capabilities Improvement

2021

A year in review

99
increase in employee head count
99
square feet of cleanroom space added
99
increase in lab space
99
increase in warehouse space

What's there to look forward to?

New Filling line

We are adding a fully automated, 100% isolator-based, and flexible filling line! The new line will be operational by end of Q2 2022.

New Lyophilizer

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.

Sterility Testing

We have installed an isolator to perform sterility testing for all production runs. Sterility testing will be offered by end of Q1 2022.

electronic Batch Records

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.

Berkshire Sterile Manufacturing staff at work

LIMS System

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 have so much to look forward to...

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!

Upcoming Webinar:

Wednesday, September 7th | 1PM EST

Aseptic Filling Techniques for Viscous Drug Products