Pharmaceutical Technology Europe - August 2012 - (Page 9)

Carbon Measurement Methods for Cleaning Validation: Comparing Direct Combustion with Rinse and Swab Sampling Methods For cleaning validation using a TOC analyser, the following types of sampling methods are available: rinse sampling, swab sampling with aqueous extraction, and swab sampling with direct combustion. These methods were compared using a total organic carbon analyser to measure residual pharmaceutical products and their constituent substances. Residue samples were prepared by applying various types of products and their constituents to stainless steel pots. Compounds with varying levels of water solubility (i.e., soluble, insoluble and very insoluble) were evaluated to determine how each method performed. The watersoluble substances were dissolved in water and the water-insoluble substances were dissolved in ethanol or acetone. Rinse-sampling method. In rinse sampling, the final rinse water from the cleaning of a productionequipment unit is used as the TOC measurement sample. This method is suitable for systems that cannot easily be disassembled, such as CIP equipment and narrow tubing. Sampling is considered to be difficult if the residues are not soluble in water. Swab-sampling with waterextraction method. Swab sampling with water extraction consists of wiping the inside surface of the production apparatus with a fibrous swab material, extracting the adhering material with water and conducting TOC measurement of the extract solution. Since the residue is physically wiped off from a fixed area of the surface, sampling efficiency is high. Residues that are insoluble in water, however, are difficult to extract with water. Swab-sampling with directcombustion method. Swab sampling with direct combustion consists of wiping the inside surface of the production apparatus with a piece of quartz filter-paper swab material, and then conducting measurement using a direct-combustion carbonmeasurement system. substances when using the swab sampling with direct-combustion method, regardless of whether the substances were water soluble or water insoluble. Therefore, this method is considered to be the most versatile measurement method for conducting cleaning validation. The full technical article is available at: PharmTech.com/CleaningValidation Conclusion When using the rinse- and swabsampling methods, some of the water-insoluble substances had high recovery rates while others had low recovery rates. In contrast, high recovery rates were obtained for all the Robert Clifford is industrial business unit manager at Shimadzu Scientific Instruments. Minako Tanaka is a scientist at Shimadzu Applications Development Center. 2 Enhancing Bioavailability 10 German Pricing 5 Nanoparticle Engineering 11 Blogs 7 News and Twitter Trends 13 Top Technologies 9 Peer Reviewed Research 14 Staff http://www.PharmTech.com/CleaningValidation

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - August 2012

Pharmaceutical Technology Europe - August 2012
Bioavailability Enhancement: When to use Hot-Melt Extrusion Versus Spray Drying
Tackling Solubility Issues with Nanoparticle Engineering
News Bites and Trends on Twitter
Peer-Reviewed Research: Carbon Measurement Methods for Cleaning Validation
Changing German Market Depresses the Pharma Industry
Blogs: Big data; the Olympics and GSK; FDA lawsuit; and unlicensed medicines
Top Technologies: Biopharmaceutical Equipment

Pharmaceutical Technology Europe - August 2012