CCP1: Micro-filtration
(1) Actual flow rate will be recorded in GMP01-07 Micro-filtration Monitoring Form.
(2) Operating pressure will be defined, recorded and controlled as per HACCP Plan.
CCP2: UV Sterilization
(3) Water flow rate: actual data will be recorded.
(4) Actual UV dose will be recorded. UV lamps have CE markings and their strength is self-evident according to supplier. Actual temperature will be recorded to indicate compliance with CL.. GMP01-08 UV Sterilization Monitoring Form will be used.
CCP3: Bottle Rinsing
(5) 2,900 rpm is the operating speed of the water pump according to specifications. Speed of water jet will be recorded in GMP01-09 Bottle Rinsing Monitoring Form.