Cleaning of the Lighthouse Probe™ - in process

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.