BSM Updates

Berkshire Sterile Manufacturing has made several improvements to its current facility in order to increase our capabilities. Found out how these process improvement affect your drug production. 

Process Updates & New Equipment

Lyophilization

We have increased the capacity of our current lyophilizer.
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Autoclave Cycle

A new shorter autoclave cycle has been validated at BSM.
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New Instruments

BSM has added several new analytical instruments to increase capability and redundancy.
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About our Process Improvements

Berkshire Sterile Manufacturing prides itself on being in the forefront of innovation and quality. We are continuously looking to improve on our current facility as well as expand our capability so we can best suit you.

What we Offer

  • Container Choice
  • 100% Isolator-Based Sterile Filling
  • Lyophilization Capability
  • Onsite Analytical Testing
  • Stability Programs

View a fill
Expansion Coming Soon!

Berkshire Sterile is currently adding a third isolator line with the ability to fill up to 90,000 units.

480 Pleasant Street, Lee, MA 01238

Please call 1-413-243-6052 or email info@berkshiresterile.com to start your next fill finish project.

Ready to start your next project?

contact us today

Lyophilization

The capacity of our lyophilizer has been increased by 50% by redesigning the tray cassettes used to hold all of our product trays.  This change will allow us to provide clients with significantly larger batches of lyophilized product.  This change will require an assessment of particular product lyophilization cycles to use the new capacity but the original cassettes and original capacity is available for those clients that do not wish to make the change to larger batches at this time.  To assist in assessing how this change impacts your product we have installed a new pirani gauge in our lyo which will allow for calculation of pirani-MKS convergence during cycles to ensure your product achieves the same level of dryness expected even with a larger load size.

Autoclave

A new autoclave cycle has been validated for general use at BSM. This new cycle has approximately 40% reduced cycle time as compared to the original cycle. This time savings has been made without compromising sterility assurance by using lethality accumulation calculations instead of strict time requirements and introducing a pre-heating phase that cuts down on drying time requirements resulting in an overall dryer end result.

Instruments

The new spectrophotometer and TOC analyzer were bought to provide BSM with redundant equipment. This ensures testing can continue uninterrupted if an instrument is placed out of service for recalibration or maintenance. BSM has also added HPLCs and UPLCs so to increase our total instrument count to 4 Waters 2695s and 3 Aquity H-Class UPLCs. This is to provide increased LC testing and method transfer throughput.