Cleaning Process Design of Experiments (DOE) Study
COMPLETE SPRAY COVERAGE
New pipe work & spray ball locations in Bolz vessel based on computer imaging
INCREASED THERMAL MASS
New 6kW Air Heater (Increased thermal mass)
CONTINUITY OF AIR SUPPLY
New Air supply header
GUARANTEE HOMOGENUITY of CIP SOLUTION
New Conductivity probe
OBVIATES AIR LOCKS & PRIMING ISSUES
New detergent pumps & set-up
Project
Description
A legacy cleaning process for the removal of a
product residue containing significant amounts
of the Active Pharmaceutical Ingredients (API)
residue was identified by the engineering team
as both a potential safety hazard and a known
bottleneck in the manufacturing process
The cleaning process could take up to five (5)
working days for Cleaning in Place (CIP)
operations. The long duration of the cleaning
process was due to an inconsistent cleaning
cycle that did not completely remove the
hormonally bases oral solid dose residue from the
process equipment. Due to the inconsistent
nature of the residue removal, the process
routinely required manual intervention, including
confined space entry resulting in a breach of the
room integrity.
As the product residue represents
the highest danger at a Level-5 on the
Occupational Exposure Band (OEB), manual
cleaning was not desirable.
Scale Up Of Development
Pilot CIP Process
New designed recipe, developed at Hyde Analytical Lab introduced to production scale
Successful Riboflavin & “Edge of Failure” performed
Installation, Operation, & Performance Qualification (IQ/OQ/PQ) as well as Commissioning Validation (CV) successfully complete on schedule/budget
Automation
Services
Protocol development, execution, and summary reports.
A new recipe designed from 1st principles to clean and dry
New intelligent detergent dosing program incorporated
