Cleaning Validation Memos from 2010

2010

Understanding the Cleaning Process in 2010 (and Beyond)

In January 2005 I wrote a Cleaning Memo entitled “Understanding the Cleaning Process”. That Cleaning Memo was in response to the FDA report on risk-based approaches to pharmaceutical CGMPs. At the end of that Cleaning Memo, I encouraged manufacturers to “explore more fully what is occurring in a cleaning process, and then to use that […]

Nov

2010

A Critique of Cleaning Validation Issues in ISPE’s RiskMaPP

ISPE has issued the document “Risk-Based Manufacture of Pharmaceutical Products” (Volume 7 of their Baseline Guides, September 2010). As I understand it, the effort to write this guide started with concerns over regulatory bodies tending to require dedicated equipment and/or facilities for certain highly hazardous drug actives, such as potent drugs, hormones, genotoxic compounds, and […]

Oct

2010

Swab Sampling Recovery as a Function of Residue Level

I have generally taught that the percent swab sampling recovery decreases with increasing spiked level of residue, other things being equal. In other words, recovery at a level of X µg/cm2 should be higher than recovery at a level of 2X µg/cm2 . I have not said how much higher the recovery percentage at the […]

Sep

2010

More Uses for Visual Limit Determination

Last month I discussed that in a cleaning validation protocol, it is only required that one determines a Visual Limit (VL) by performing a spiking study if one is exclusively using visual examination as the acceptance criterion for defined equipment surfaces. However, there are other situations broadly under the category of cleaning validation, but not […]

Aug

2010

Visually Clean and Visual Limits

Last month I discussed the application of statistics for determining a visual limit. This month we will consider another issue related to what the PIC/S regulatory document (PIC/S PI 006-03) states about visual limits. First, let’s clarify the purpose of a visual limit (VL) determination. VL is typically expressed in units of mass per surface […]

Jul

2010

Statistics in Visual Limits

This makes two months in a row that I have discussed statistics in the context of cleaning validation, because it is that important. This Cleaning Memo is an evaluation of a recent Pharmaceutical Technology article entitled “Statistically Justifiable Visible Residue Limits”, by M. Ovais (March 2010 issue, pages 58-71). The author asserts that “current methods […]

Jun

2010

Acceptable Variability for Sampling Recovery Studies

Several months ago (January 2010), my favorite statistician, Lynn Torbeck, published an article in Pharmaceutical Technology entitled “%RSD: Friend or Foe”. The article was basically about the misuse of statistics. In it Mr. Torbeck made the statement that applying a percent relative standard deviation (%RSD) criterion to percentage recovery values in recovery studies was not […]

May

2010

Final Notes on “Stratified Sampling”

In the past two months I have covered the use of “stratified sampling”, first applying stratified sampling to segments within a given piece of equipment and then applying it to a series of equipment items in a manufacturing equipment train. This month I will address some additional questions in the use of stratified sampling. The […]

Apr

2010

More on “Stratified Sampling”

Last month I covered the basics of “stratified sampling”. While “sampling” is part of the name, stratified sampling is not primarily a way to sample (although that is part of it), so much as a way to determine whether measured residues are in compliance with a calculated total carryover limit. Last month we covered the […]

Mar

2010

Basics of “Stratified Sampling”

What I call “stratified sampling” is in part a way of sampling, but more importantly it is a way of determining compliance with the calculated acceptance limits in a protocol. Stratified sampling can be applied to both swab sampling and rinse sampling (or possibly the combination of the two); however, for simplicity I will use […]

Feb

2010

Revisiting “Cleaning Verification”

This is a follow-up to my November 2009 Cleaning Memo on “continued process verification” and “continuous process verification”. You might notice that I am putting the term “cleaning verification” in quotes. The reason is that for cleaning validation purposes, “cleaning verification” has a very specific meaning. It is not just any verification that is done. […]

Jan

2010

What’s an “Equivalent” Swab?

In my training seminars (and in the recent webinar on swab sampling), I always caution against specifying a certain swab or an “equivalent”. My concern is with the “or equivalent” part. How is “equivalency” defined or determined? It is not prudent to use a certain swab from one manufacturer, and ask another manufacturer for its […]

Memo Year: 2010

Destin LeBlanc has been publishing memos on Cleaning Validation since 2001.

Understanding the Cleaning Process in 2010 (and Beyond)

A Critique of Cleaning Validation Issues in ISPE’s RiskMaPP

Swab Sampling Recovery as a Function of Residue Level

More Uses for Visual Limit Determination

Visually Clean and Visual Limits

Statistics in Visual Limits

Acceptable Variability for Sampling Recovery Studies

Final Notes on “Stratified Sampling”

More on “Stratified Sampling”

Basics of “Stratified Sampling”

Revisiting “Cleaning Verification”

What’s an “Equivalent” Swab?

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