Automation of GMP Validated Processes in Quality Assurance Testing

GMP regulated processes are time consuming and require accurate documentation in addition to traceable sample processing. Accordingly Zinsser Analytic designed a solution for GMP regulated tests for quality assurance.

• Precise Dilution of Diverse Sources Stock Solutions
• Reproducible and Reliable Results
• Well Defined GMP Documentation
• Customized Software Interface

1. Piercing tip to pipette through septum and gripper for 50 mL vials
2. Source rack for ten 50 mL stock solution vials
3. Rack for ten 50 mL pre-dilution vials
4. Single tube vortexer A and B
5. Spare ten 50 mL vials as replacement vials if errors appear
6. Wash station for tip
7. Destination rack for fifty 50 mL vials with dilutions
8. Precision syringe pump with 1.5 mL syringe and 4-port-valve
9. Balance with wind-shield and deionisator
10. Micro dosing pump for large volumes (> 5 mL)

For GMP regulated quality assurance laboratories a precise definition of automated process steps is crucial to assure the validation of the workflow. The dilution routine process is able to prepare various dilutions due to formulas coming from a predefined Excel file.

Dilution Process Targets: The variation coefficient for pipetting should range from ≤ 1.5% for stock solution and ≤ 0.5% for dilution solvent

With this process a throughput of 160 dilutions in an 8 h working day is achievable with a preparation time of maximum 180 seconds per dilution.