Industries

Pharmaceuticals

Bulk Synthesis
The challenges to a new bulk synthesis seem to be growing exponentially. Among these are:

• Increasingly strict environmental regulations on solvent emissions, air and water discharge

• Handling the more potent compounds, meeting obligations to personnel and regulators
  

• Meeting cleaning validation concerns
  

• Automation of the processes in a validated environment
  

• Optimized flexibility in a multipurpose facility
  

Parenteral Products
Parenterals are where the pedal hits the metal. High value products, safe for consumers being prepared. Sterility is the buzz word. But pyrogens have to be controlled as well. Flows have to be matched. And then there is the lyophilization option. One door two: sterile transfer. Finally there is the knowledge of the processing equipment -sizing, matching, operation costs, reliability.

Solid Dosage
Solid dosage is the preferred way to deliver product to the customer. But, in contrast to most other manufacturing processes, solid dosage involves a significant movement of solids. This need leads to two types of facilities - (1) two stories with hoists or elevators or, (2) a 5 to 6 story building with unitary down flow of product.

Product and intermediates can be handled in intermediate bulk containers (IBCs). Interesting options are developing for use of IBCs:

• Available in a variety of forms so that blending can take place in an IBC
  

• Docking systems to allow safe transfer of Highly Potent Compounds
  

• Automated transfer (AGV) movement
  

• Monitoring of location and contents (as well as clean/dirty status)
  

• Automated cleaning

At the packaging level, both blister packs and bottle fill can be acommodated.

Representative Clients

• Bristol-Myers Squibb

• Targeted Genetics
  

• Alza