BSM Facility

BSM Facility

Designed

To
For
With
 You

Scale

We realize many companies will not take on a smaller batch size. We've designed our facility to support you from pre-clinical, through commercialization.

Flexibility

Plans change when you are developing a new drug product. We've invested in the top equipment to realize your changing needs without compromising on quality.

Quality

All filling activity occurs within isolated chambers to deliver you a product with the highest sterility assurance possible.

100 ,000
Square Feet

Our facility expands 120,000 square feet in our one site. We currently occupy half of this space as we continue to expand.

30 ,000
units maximum

We can fill as small as 100 units up to 50,000 units. We are here to help push your drug product from pre-clinical and clinical to commercialization

Semi-Automated Isolator Filling Line

Semi-automated Isolator Filling Line

Isolator Outside View

Our semi-automated Fedegari filling line (pictured) has a direct to enter depyrogenation oven for bulk glassware and direct to enter lyophilizer.

Flexible Filler Located in Semi-Automated Line

Flexible Filler

Our semi-automated filling line is equipped with a state-of-the-art flexible filler (pictured) capable of filling 40,000 unit lots of vials, cartridges, or syringes.

Manual Isolator Filling Line

Manual Isolator

Our manual GermFree filling line (pictured) is capable of filling up to 5,000 unit lots.

Flexible Filler Located in Manual Filling Line

Flexible Filler

Our manual filling line is equipped with a flexible filler (pictured) capable of filling vials, cartridges, and syringes.

Facility and Capability Details

Sterile Filling

  • Clean Air Technologies Cleanroom
  • 2 Isolator Filling Lines
  • Fedegari Depyrogenation Oven
  • Fedegari FOAF6 Autoclave
  • IMA/BOC Edwards Lyophilizer
  • 2 Formulation Rooms
  • Formulation Isolator
  • Penntech Vial Washer
  • Steris/Finn Aqua WFI Sytem

QC Analytical

  • Equipment (TOC Analyzer, UPLC (2), HPLC (3), FTIR, Conductivity Meter, Osmometer, Karl Fischer Titrator, UV/Vis, LPC, Viscometer, Analytical Balances (3), Extrusion, Plate Reader)
  • Raw Material Identification
  • In-Process and Final Product Testing

Process Engineering

  • Develop Material Specifications and SOPs with client approval
  • Formulation Process Development (Scale-up, viscous materials, biological "sensitive" products, tangential flow filtration, suspensions, non-aqueous, lyophilization)
  • Optimize Filtration (filter integrity testing, flux studies, selection and sizing of filter membrane, bacterial challenge)
  • Develop/Create Master Batch Record with client approval

QC Microbial

  • Environmental Monitoring
  • In House Water System Testing (WFI, RODI) - Bioburden, TOC, LAL, and conductivity
  • Bioburden Testing
  • Endotoxin Testing (Gel clot and chromogenic)
  • Growth Promotion Testing