• 21 production lyophilizers
• 8 aseptic filling suites
• 2 terminal sterilization facilities
• 8 packaging lines
• 2 automated inspection lines
• Dedicated cytotoxic production area

Lyophilization and Vacuum-Drying

Ben Venue has the largest capacity in the United States for contract lyophilization and vacuum-drying of sterile pharmaceuticals.

We have over sixty years of lyophilizing experience, starting with Human Blood Plasma for the Armed Forces in 1941. Since then we have successfully lyophilized chemicals, biologicals, and diagnostics.

As a result of our extensive experience, we are familiar with many of the challenges associated with lyophilization and vacuum-drying. Some of the methods we have used to solve these problems are rate-controlled freezing, excipient/solvent modification, and controlled vacuum-drying to regulate drying rate. Internal stopper-seating makes it possible to manufacture lyophilized products with various inert atmospheres or vacuum in the headspace.

Our variety of chamber sizes allows customers the flexibility to choose the largest batch size possible or to use smaller chambers to accommodate limited raw material supply.

Scheduling flexibility and scale-up are assured because cycles are not limited to any one lyophilizer. A particular product or process need not be restricted to specific equipment.

Formulation

Our specialized equipment and systems, a broad range of formulation techniques, and the accumulated experience of our personnel enable us to minimize formulation issues. Drug solubility, chemical incompatibility, photosensitivity and filterability, as well as temperature and atmospheric constraints are all addressed. For example, by using special mixing methods, the time for complete dissolution of certain compounds in aqueous systems can be markedly reduced. Reduced fill volumes have also been achieved, resulting in shortened lyophilizing and vacuum-drying cycles, more attractive final product appearance, and larger batch sizes.

Ben Venue’s experienced formulators work closely with the Product and Process Development Department to design techniques, systems and equipment. We offer:

• Various batch sizes using glass-lined, stainless steel, or plastic compounding vessels
• Formulation of aqueous and nonaqueous solutions
• Formulation of emulsions
• Aseptic formulation
• Formulation of liposomes
• Formulation of microspheres
• Compounding and holding temperatures from 1°C to 90°C
• Inert atmospheres for compounding and filling
• Protection for photosensitive products
• Batch filtration design for very small to very large volumes
• Specialized mixing systems
• Endotoxin removal
• Customized batch production records