Carbon Measurement Methods for Cleaning Validation (Peer Reviewed) - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Carbon Measurement Methods for Cleaning Validation (Peer Reviewed)
The authors compare direct combustion with rinse and swab sampling methods.

Pharmaceutical Technology
Volume 36, Issue 8, pp. 52-55


Table V: Summary of measurement results.
The measurement methods used here and their respective recovery rates are summarized in Table V. When using the rinse- and swab-sampling methods, some of the water-insoluble substances had high recovery rates while others had low recovery rates. It is thought that this may be due to differences in the affinity with which the substances adhere to the stainless steel pot. Accordingly, it is possible that residue evaluation using these methods would be difficult for substances with low recovery rates.

In contrast, high recovery rates were obtained for all the 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, especially when multiple compounds are being manufactured in the same vat, if the compounds are unknown, or if there is a possibility the known compounds will decompose into other compounds.

Robert Clifford*, PhD, is industrial business unit manager at Shimadzu Scientific Instruments, 7102 Riverwood Drive, Columbia, MD 21046, tel. 800.447.1227,
. Minako Tanaka is a scientist at Shimadzu Applications Development Center, Kyoto, Japan,

*To whom all correspondence should be addressed.

Submitted: Nov. 17, 2011. Accepted: March 12, 2012.


1. R. Baffi et al., J. Parenter. Sci. Technol. 45 (1), 7–12 (1991).

2. K.M. Jenkins et al., PDA J. Pharm. Sci. Technol. 50 (1), 6–15 (1996).

3. M.A. Strege et al., BioPharm Intl. 9 (4), 42(1996).

4. A.J. Holmes et al., PDA J. Pharm. Sci. Technol. 51 (4), 149–152 (1997).


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here