Cleaning Validation Articles

Cleaning Validation Technologies
Technical Consulting Services
Cleaning Memo for August 2004

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Another question I commonly get is “What constitutes three consecutive runs for cleaning validation protocol purposes?” The basic approach to answering this question is to use the same principles o­ne uses for process validation. If I am validating a blending process in a certain manufacturing vessel, do the three validation runs have to be o­ne after the other, with no intervening product being processed? Or, in between the three manufacturing processes for the validation, am I allowed to blend other products? Most people would agree that the latter is appropriate for process validation.


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Destin A. LeBlanc
Cleaning Validation Technologies
Technical Consulting Services
Cleaning Memo for JULY 2004
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You are fed up, tired of it all. Your boss has been harassing you to develop "a scientifically sound, logical, and rational basis for cleaning acceptance limits." Should be simple enough, right? Yet, every time you ask someone about setting cleaning limits they look at you as if you have three, maybe four heads. Asking a consultant o­nly makes things worse, leaving you more confused when they present you with more theoretical options than you ever imagined possible (but of course offering to help you solve the problem with a team of experts!) You’ve scoured the literature, yet haven’t found anything but theoretical discussions and vague references to the "Mullen and Fourman method." Before kicking the cat or cursing your boss, let’s see what this is really all about.

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Alconox A cleaning validation involves testing for acceptable residues o­n pharmaceutical manufacturing or medical device surfaces. The validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues 3 or more times and then a rational monitoring program to maintain a validated state is put in place. If you are changing any part of your procedure or cleaner, first clean the new way, collect data and then clean the old way before using any equipment while you are in the process of validating the new procedure.


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Destin A. LeBlanc,Cleaning Validation Technologies,Technical Consulting Services Cleaning Memo for APRIL 2004 This Cleaning Memo will address the proper selection of sampling materials used if Total Organic Carbon (TOC) is the sampling method of choice. Particularly since TOC is subject to a multitude of interferences, it is necessary to make sure that the sampling materials provide a consistent TOC value due to those “interfering” materials. Those materials contribute to the TOC “blank”, and are preferably materials which provide a blank with a low, consistent TOC value.


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A swab-sampling method was developed for cleaning validation of a residual active pharmaceutical ingredient in samples collected after cleaning the sampling suite. A summary of the strategies and results of the method development is presented. The developed extraction method produced an acceptable level of recovery and precision.Cross contamination with active ingredients is a real concern. The Code of Federal Regulations (CFR) states that “Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official, or other established requirements” (1). Cleaning validation is required in the pharmaceutical field to avoid potential clinically significant synergistic interactions between pharmacologically active chemicals (2).

This Cleaning Memo will address issues in the proper selection of blanks for TOC validation samples. In this situation, the purpose of sampling is to quantitate the organic residues that may be o­n the equipment product-contact surfaces after cleaning. The post-cleaning residues are o­ne source of organic carbon o­n surfaces. Those organic residues may include the active drug, any excipients or process aids, the cleaning agent, and any degradation products. The proper use of TOC is to measure the organic carbon in the validation sample, and then express that organic carbon value as if it were all the target analyte (for example, as if it were all the drug active).


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Detergent Residue Testing using a pH Meter, pH Indicator, or Test Kit