Haya: The Saudi Journal of Life Sciences (SJLS)
Volume-1 | Issue-01 | 1-17
Original Research Article
Statistical Process Control in the Evaluation of Microbiological Surface Cleanliness Quality and Spotting the Defects in Clean Area of Pharmaceutical Manufacturing Facility
Mostafa Essam Eissa, Ahmed Mohamed Mahmoud, Ahmed Saber Nouby
Published : Jan. 30, 2016
Abstract
Regular environmental monitoring (EM) system is indispensable routine activity in assessing the
microbiological quality of the manufacturing environment surfaces for the production of medicinal products. However,
the release of the full potential of such regular activity will not be achieved nor the elucidation for points of defects and
improvements cannot be appropriately investigated unless systematic analysis of the results can be ensured and
performed periodically. In the current study, statistical process control (SPC) and six sigma tools were used in the study
of the quality of microbiological surface cleanliness in clean rooms in pharmaceutical manufacturing plant during ten
months period on weekly basis using contact plates. Initial evaluation of data distribution showed that ten out of 11
partitions of the manufacturing area followed distributions other than the Gaussian ones which required logarithmic
transformation to approach normalization for further statistical analysis. When control charts were constructed for
transformed data, material followed by personnel airlocks showed the greatest risk of microbial excursions then the
corridor with the overall risk of failure 99.5% suggesting that there was a state of significant imbalance between cleaning
program and its frequency with the work type and load in these sections. The present work provided insight for the area
of defects that could not be observed using conventional data trending and provided focus on defined sections that could
impact the overall microbiological quality. This analysis provided a promising mean for designing quantitative risk
assessment for microbiological quality control in pharmaceutical, human consumables manufacturing and other
healthcare industries.