Services

Today it is more challenging than ever for a BioPharm company to market a product regulated by the Food and Drug Administration (FDA) or sold in the European Union.

Our Expertise

Our knowledge and expertise will help your company navigate through the regulations to get your project completed properly and on time.

  • Bioreactors and Fermentors

  • Media and Buffer tanks

  • Filtration skids

  • Purification equipment

  • CIP skids

  • Programmable Logic Controller (PLC)

  • DeltaV

  • HMI (Human Machine Interface)

  • DCU

  • MFCS

We have an extensive library of Installation Qualification (IQ) and Operational Qualification (OQ) protocols to meet your needs. We may also assist you in drafting and executing a Process Qualification (PQ) to fulfill your particular requirements.

 
 

Installation Qualification

Input/Output (I/O) Testing
Material Verification
Drawing and Bill of Material Verification

 

Operational Qualification

Alarm and Security Testing
Boundary Condition Verification
Screen Navigation
Control Loop Testing
Temperature Mapping with Biological Indicators
Riboflavin Coverage Testing

 

Process Qualification

Cleaning Validation
Completing Multiple Successive Batches

Book a Consultation

We’ll prepare a proposal and walk you through every step of the process.