Probe with fouled window - for demonstration

Window cleanliness after retraction and scraping by first seal

Window cleanliness after retraction and window wash operation

 

 

 

 


Demonstration of CIP – probe alone:

  1. Clean probe, window wash and CIP cycles
    • Swab test (A) inside wash chamber of probe housing
  2. Contamination of probe – measurement position
    • Paste of aspirin and phenacitin used
    • Probe cycled through window wash and calibrate 10 times
    • Fully retracted and CIP’ed – 5 minutes
    • Swab test (B)
  3. Contamination of probe and wash cell – CIP position
    • Paste of aspirin and phenacitin used
    • Probe cycled between measurement and CIP position 10 times
    • Fully retracted and CIP’ed – 5 minutes
    • Swab test (C + D)

Demonstration of CIP – Fluid Bed Dryer (MP 4/5) and probe:

  • High Shear Granulation PMA 300
    • Lactose, aspirin, phenacitin and PVP in liquid used (65/15/15/5)
    • Integrated transfer to MP 4/5
  • Fluid Bed Drying MP 4/5
    • Product dried for 30 minutes – probe in measurement position
    • Probe window wash cycle run once
  • CIP of Fluid Bed Dryer
    • Main chamber and filters cleaned with probe in read position
    • Probe taken to CIP position and cleaned + dried during final FBD cleaning
    • Probe taken to measurement position and FBD dried
    • Swab test (E) inside wash chamber of probe housing

Cleaning results Aspirin Phenacitin Situation
Acceptance level 0,500mg 0,500mg 1/1000 of therapeutic dose
A 0,003mg 0,008mg Before active use in wask cell
B 0,020mg 0,036mg Probe contaminated swab in wash cell
C 0,015mg 0,000mg Contamination + swab in wash cell
D 0,013mg 0,000mg Contamination + swab in wash cell
E 0,011mg 0,011mg After drying swab in wash cell

Initial active analysis using J&M spectrometer confirms visual Riboflavin tests - LHP fully CIP able.



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