Cleaning Validation Articles

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

The latest components in sterile filtration technology are not made to last. In fact, pharmaceutical manufacturers are throwing them out after every batch filtered. Tossed out with them, however, are the expense and time of cleaning, cleaning validation, and maintenance as well as the concerns of crosscontamination associated with multipurpose production lines.

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Validation of cleaning processes has long played a critical role in pharmaceutical manufacturing. FDA requires that firms provide written documentation detailing the cleaning processes used for various pieces of equipment as well as how the cleaning processes are validated. Validation requires the development of a cleaning verification method with the typical detection limits of either
10 ppm or biological activity levels of 1/1000 of the normal therapeutic dose. Two methods of sampling the surface of equipment after cleaning are direct-surface and rinse sampling. The advantages of the direct-surface method are that it can reach hard-to-clean areas and it allows insoluble residues to be sampled. However, rinse sampling can evaluate a larger surface area as well as areas that are not accessible with a swab.

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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). Since the issuance of the US Food and Drug Administration’s “Guide to Inspection of Validation of Cleaning Process” in July 1993 (3), cleaning validations have received increasing attention.Validation is required not only for manufacturing sites, but also for the sampling– filling suite in research and development.

Robin Fredric, QA-Validation Department, Novopharm Ltd, Canada. Email: leoroby@yahoo.com

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