White panel
manufacturing capabilities

BioSpectra operates more than a dozen quality-system-based manufacturing suites in its 175,000+ ft2 facilities.

For more information about our manufacturing capabilities, click the topics below or scroll down.

Batch Sizes

Employing more than 30 corrosion-resistant, 316 stainless and glass reactors, BioSpectra manufactures batches ranging from 25kgs to 24,000kgs, and 10L to 20,000L. Laboratory products and developmental custom formulations are available from quality-system-based production lines. Smaller volumes are available to ensure expedient delivery of cost-effective materials.


BioSpectra's Legacy Products are typically available in 3,000kg to 24,000kg crystal batches, and 200L to 20,000L solution batches. These are available in a full selection of packaging, as determined by specific customer need.


Processing Capabilities

Providing leading cGMP recrystallizations, acidifications, acid/base reactions, custom formulations and particle manipulation, BioSpectra offers a wide range of existing technologies and processes to accommodate customers’ specific chemistry needs. Custom process capabilities are limited only by the request itself.


Batch Process vs. Continuous

BioSpectra has been manufacturing quality-system-based batches of biological buffers since 1996. In 2007, BioSpectra validated the first and only cGMP continuous process for biological buffer production. These processes provide customers with the formulation flexibility needed to choose from convenient standard batch sizes or batch specific lot sizes.


Equipment

Tanks

  • 316 S/S jacketed reactors: 20gal, 30gal, 40gal, 50gal, 250gal, 300gal, 500gal, 2000gal, 2500gal and 3000gal sizes
  • Composite process tanks/reactors: 200gal, 500gal, 2000gal, 3000gal, 6000gal sizes
  • Glass reactors: 10L, 20L, 30L sizes

Crystal Collection

  • 316 S/S batch centrifuges: 30", 40", 48"
  • Composite centrifuge: 48"
  • 316 S/S continuous centrifuges (3 KMPT units)
  • Corrosion-resistant filter funnels (many units, custom sized, product dedicated)

Dryers

  • 316 S/S fluid bed dryers: 10ft, 15ft sizes
  • Combination 316 S/S and composite fluid bed dryers: 10ft, 15ft, 20ft sizes
  • Tray drying rooms (many rooms, various sizes, dedicated trays)

Particle Manipulation

  • 316 S/S Fitz-Mill
  • 316 S/S hammer mill
  • 316 S/S 30ft3 rotary blender
  • 316 S/S air sieve

Packaging Sizes

Standard packages include:

  • Laboratory Dry: 100g, 500g, 1kg tamper-evident HDPE bottles
  • Laboratory Liquids: 100mL, 500mL, 1000mL HDPE tamper-evident bottles
  • Bulk Dry: 10kg, 25kg tamper-evident poly-pails
  • Bulk Liquids: 5L and 10L Carboys; 20L, 100L, 200L drums; 500-1200L totes

Custom packages include:

  • We are capable and willing to use any preferred packaging and/or components.

Particle Manipulation

Managing flow characteristics and dissolution requires consistent and defined crystals. BioSpectra uses the best available technology from the original rotary grinding systems, to the newest pressurized technology. Therefore, BioSpectra crystal manipulation continues to meet BioPharm processing parameters and provide an industry standard in purity and reliability.