Cleaning Validation and its importance in Pharmaceutical Industry

Cleaning validation is a documented process that proves the effectiveness and consistency in cleaning a pharmaceutical production equipment1. Validations of equipment cleaning procedures are mainly used in pharmaceutical industries to prevent cross contamination and adulteration of drug products hence is critically important2. The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations. The most important benefit of conducting such a validation work is the identification and correction of potential problems previously unsuspected, which could compromise the safety, efficacy or quality of subsequent batches of drug product produced within the equipment. This paper provides a review of the current trends in cleaning validation and its related importance.

[1]  D. Murawski Ion Chromatography for the analysis of household consumer products , 1991 .

[2]  W. K. Gavlick,et al.  Use of Total Organic Carbon Analysis and Fourier-Transform Infrared Spectroscopy to Determine Residues of Cleaning Agents on Surfaces , 1997 .

[3]  P. López-Mahía,et al.  SURFACTANTS AND DETERGENTS , 2005 .

[4]  R.-C. Hwang,et al.  Process design and data analysis for cleaning validation , 1997 .

[5]  T. Schmitt HPLC ANALYSIS OF SURFACTANTS , 1998 .

[6]  R Raghavan,et al.  Low-Level (PPB) Determination of Cisplatin in Cleaning Validation (Rinse Water) Samples. I. An Atomic Absorption Spectrophotometric Method , 2000, Drug development and industrial pharmacy.

[7]  C. Vogt,et al.  Determination of surfactants by capillary electrophoresis , 1999, Electrophoresis.

[8]  H. Esser,et al.  European immigration policy: Federal Republic of Germany , 1985 .

[9]  W. K. Gavlick,et al.  Analytical strategies for cleaning agent residue determination , 1995 .

[10]  S. Lin,et al.  Comparison of analyses of surfactants in cosmetics using high-performance liquid chromatography and high-performance capillary electrophoresis , 2000 .

[11]  C. Vogt,et al.  Separation of nonionic surfactants of the polyoxyethylene type by capillary electrophoresis , 1997, Fresenius' Journal of Analytical Chemistry.

[12]  E. W. Ciurczak Validation of spectroscopic methods in pharmaceutical analyses , 1998 .

[13]  R.-C. Hwang How to establish an effective maintenance program for cleaning validation , 2000 .

[14]  Robert A. Nash,et al.  Pharmaceutical process validation , 1984 .

[15]  J Agalloco,et al.  "Points to consider" in the validation of equipment cleaning procedures. , 1992, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.

[16]  R. B. Kirsch Validation of analytical methods used in pharmaceutical cleaning assessment and validation , 1998 .

[17]  D. Pietrzyk,et al.  Separation of anionic surfactants on anion exchangers , 1995 .

[18]  J. Dugger,et al.  An Integrated Approach for Validating Cleaning Procedures in Biopharmaceutical Manufacturing Facilities , 1996 .

[19]  R. Saari-Nordhaus,et al.  Recent developments in surfactant analysis by ion chromatography , 1998 .

[20]  C. A. Davidson,et al.  Evaluation of two methods for monitoring surface cleanliness-ATP bioluminescence and traditional hygiene swabbing. , 1999, Luminescence : the journal of biological and chemical luminescence.

[21]  M. Guazzaroni,et al.  Application of total organic carbon analysis for cleaning validation in pharmaceutical manufacturing , 1998 .

[22]  Margaret L. Wells,et al.  Validation of Chromatographic Methods , 2019, Ewing’s Analytical Instrumentation Handbook, Fourth Edition.

[23]  D. Blanc Rinse sampling for cleaning validation studies , 1998 .

[24]  C. Vogt,et al.  Determination of cationic surfactants by capillary electrophoresis with indirect photometric detection , 1997 .

[25]  M. A. Kelly,et al.  Quantitative analysis of sodium dodecyl sulphate by capillary electrophoresis , 1997 .

[26]  A J Vanderwielen,et al.  Application of total organic carbon analysis to cleaning validation. , 1996, PDA journal of pharmaceutical science and technology.

[27]  Destin A. Leblanc Establishing scientifically justified acceptance criteria for cleaning validation of finished drug products , 1998 .

[28]  K. Jenkins,et al.  CLEANING VALIDATION : AN OVERALL PERSPECTIVE , 1994 .

[29]  G. L. Fourman,et al.  DETERMINING CLEANING VALIDATION ACCEPTANCE LIMITS FOR PHARMACEUTICAL MANUFACTURING OPERATIONS , 1993 .

[30]  L Westman,et al.  Methods for detecting residues of cleaning agents during cleaning validation. , 2000, PDA journal of pharmaceutical science and technology.

[31]  D. Corradini Handbook of HPLC , 1998 .

[32]  A. Weston Ion chromatography in the pharmaceutical industry , 1998 .

[33]  N. Danielson,et al.  Individual and simultaneous class separations of cationic and anionic surfactants using capillary electrophoresis with indirect photometric detection , 1995 .

[34]  Points to consider for cleaning validation. Technical Report No. 29. PDA. Parental Drug Association. , 1998, PDA journal of pharmaceutical science and technology.