Coating Process Improvements in Solid Dose Form Manufacturing
Zusammenfassung
Organization’s goals and objectives
use strategic scorecards that include Quality,
Economics, Speed and Culture to establish business
metrics focused on building continuous future
success and competitiveness to create value. As a
result, manufacturing facilities are encouraged to
adopt Lean Transformation to align to an
organization’s priorities and goals. Assessments of
the manufacturing processes in a single dose
manufacturing facility and interviews with key
personnel to determine potential opportunities were
performed by means of Voice of the Costumer.
Cycle Time Reduction for Color Suspension and
Clear Solution Preparation was attained with a
minor equipment modification that improved
material reconstitution minimizing mixing time, air
entrapment and foaming formation; thereby,
reducing the deaeration time. Cycle Time
Reduction for Line Flush was achieved by
increasing (2X) USP Purified Water flow rate.
Spray Gun Performance using an equivalence test
between Pan Loads, Manufacturing controls and
procedures evaluation and standardization of spray
guns assembly supported the reduction of spray gun
verification frequency. Removal of redundant
documentation where automated systems are in
place and verifications by a second person from
non critical steps according to 21 CFR Part 211
Subpart F--Production and Process Controls
reduced redundant documentation and head count.
A 62% cycle time reduction (6.91 hrs hours from
11.4 hrs) per lot as well as 1 head count reduction
($43,680) were the immediate benefits attained
from all process improvements.
Key Terms - Critical to Quality (CTQs),
Cycle Time, Voice of the Costumer (VOC), Waste,
Coating Improvement, Solid Dosage Forms.