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Analysis of Industrial Detergents for the Cleaning of a Soft Capsule Production Line in a Pharmaceutical Plant

  • Andrés Betancourt,
  • Patricio Quitiaquez,
  • William Quitiaquez,
  • Erika Pilataxi

摘要

In the present study, the results obtained after cleaning a production line of anti-inflammatory soft gels were statistically analyzed. Four cleaning agents were selected, water samples were taken from the last rinse of 5 critical points (points of higher difficulty for cleaning) and were subject to measurements of hydrogen potential (pH), conductivity, and total organic carbon (TOC). The data obtained were processes by multivariate analysis of variance (MANOVA). The value for Pillai’s trace model for the detergent variable in degrees of freedom (gl) was 9.120 gl; F = 2.381, Sig. = 0.016, while, for the control points variable, the Pillai’s trace was 12.120 gl; F = 1.814, Sig. = 0.053. the treatments were different to verify if the means, the Bonferroni statistical test was performed as a Post Hoc analysis for detergents 2–4; in this test the 95 % confidence interval [–1068.50; –203.36] was obtain, and for detergents 3–4 a Sig.=0.012, 95 % CI [–946.90; –81.76]. The analysis showed that the means of each detergent were significantly different for the TOC variable. According to the results obtained by the SPSS software for the statistical analysis MANOVA, it has determined that detergents 2 and 3 comply with all the required parameters in terms of conductivity. Duncan’s homogeneous subsets statistical test was performed for the TOC variable.