CALCET  Company


Training Experience


Members of CALCET Company have experience teaching the highest college-level academic courses.  CALCET Company has trained production and engineering personnel on a variety of different operations.  Their experience in engineering and equipment validation has given them insight into the operation which they can pass on to the production operators.  The following is a representative sample of their training experience: 


3.1      AMGEN, Thousand Oaks, Seminar on Corrosion Protection/Passivation 


CALCET Company prepared a seminar titled “Prospective Maintenance for Corrosion Protection in Pharmaceutical Industry” for AMGEN.  This seminar addressed the following topics: 

•         Understanding Corrosion Damage Processes

•         Prospective Maintenance Program Goals

Þ     Material/Design Selection

Þ     Fabrication/Welding

Þ     Surface Finish and Passivation

Þ     Water/Environmental Control

Þ     Inspection/Monitoring

•         Corrosion Mechanisms

•         Corrosion Damages in Pharmaceutical Industry

•         Pitting Corrosion (Process, Shapes, Reason/Causes)

•         Metal Pitting Resistance (Stainless Steel/Protective Film, Duplex Stainless Steel, High Purity Ferritic Stainless Steel)

•         Causes of Pitting

•         Passivation (Process, Methods, Testing, Inspection)

•         Maintenance Program Economic Appraisal

 

3.2      BAYER, Building 60, Training on –35 °C Cold Storage Room

 

CALCET Company conducted a training to production, utility, and maintenance personnel with a reference source for understanding the function, the equipment, and the operation of the –35 °C Cold Storage Room located in Building 60 used for storage of intermediate products generated during the production of rFVIII.  This training addressed the following topics:

•         Storage/Retrieval System (horizontal and vertical carousels)

•         Air Conditioning System (air handling, refrigeration, and control systems)

•         Refrigeration Cycle and Refrigerants

•         Refrigeration Compressors

•         Troubleshooting

•         Maintenance and Safety Procedures


3.3      BAYER Pharmaceutical CIP Training 


CALCET Company has developed and taught a course on CIP operation and maintenance.  The training included instruction material and hands-on CIP skid operation and maintenance.  The course promoted cGMP and safety, and facilitated cycle development.  The course was designed for Production, Utility, and Maintenance personnel.  The course material described normal operation, and the appropriate response to abnormal or alarm conditions with troubleshooting tips. 


3.4      BAYER Pharmaceutical Utilities Training 


CALCET Company has developed and presented a course on Utility Operation and Maintenance.  The following systems were addressed: 

•         Purified Water System

•         WFI Generation and Distribution

•         Clean Steam Generation and Distribution

•         Plant Steam and Condensate Return

•         Cold Glycol

•         Tower Water

•         Chilled Water

•         Chemical Storage

•         Chemical Dilution

•         Process Gases (Carbon Dioxide, Oxygen, and Liquid Nitrogen)

•         Instrument Air

•         General Neutralization

•         Fermentation Neutralization


The course was designed to provide a basic understanding of the various utility systems and how they interrelate to serve the manufacturing process needs.  Various abnormal scenarios were postulated and appropriate actions described.