Memo Year: 2020

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

All the articles are copyright protected and may be only used for research, compliance and scientific purpose. Any other use such as commercial distribution, is illegal and unethical.

Visual Residue Limits – Part 2

In this second of a two-part series, we will look at using Visual Residue Limits (VRLs) as part of routine monitoring to establish that a quantitative residue limit is being met. If you haven’t read (and understood) last month’s Cleaning Memo, please do so before considering this one. Before I start, here is a little […]

Visual Residue Limits – Part 1

For this two-part series, we will look at how to establish visual residue limits in this first part. In Part 2 we will look at the recent (2018) EMA Q&A that deals with using a visually clean criterion in routine monitoring to establish that a quantitative residue limit is being met. Before I start, here […]

Two More Nails in the Coffin?

I have for years taught (or preached) that performing quantitative swab recovery studies at multiple spiked levels is a waste of effort and resources. Furthermore, I have also maintained that, other things being equal, the percentage recovery of spiked material will decrease as the spiked level increases. If this is true, then one spiked level […]

Avoiding “Visually Dirty” Observations

A frequent question I get is “What is the most common FDA (or another regulatory body) finding in an inspection?” Well, I certainly haven’t seen them all, and don’t have any clear data. However, based on my experience one of the most frequent observations I see is that in an inspection some item of equipment […]

Causing Cleaning Validation Problems by Analogy

Last month we discussed how analogies can be useful when we are faced with a new cleaning validation issue. This month we will look at how analogies can do just the opposite – lead us down a rabbit hole that just may seem to be a solution, but in reality just complicates life. A key […]

Solving Cleaning Validation Problems by Analogy

I have been very interested in recent popular discussions of “models”. No, I don’t mean fashion models; I mean models in scientific thinking. We in the cleaning validation community have a certain model of what happens in a cleaning process that could lead to cross-contamination of the next manufactured product. That model usually envisions that […]

Another “Worst Case” Product Grouping Idea

I frequently teach that the solubility of the active, when used alone, is not the most appropriate way to select the “hardest to clean” product in a product grouping approach. Note that I sometimes refer to the “hardest to clean” as the most “difficult to clean”; so for purposes of this Cleaning Memo consider them […]

Words (Again??)

I wrote several Cleaning Memos last year about the importance of using terminology more carefully. While it may seem to be more of a problem now (perhaps because of the widespread dissemination of information on the internet), it is not something new in the arena of cleaning validation. In this Cleaning Memo I will focus […]

Protocol Limits for Yeasts/Molds?

Meeting protocol requirements for bioburden is generally not a significant problem provided the final rinse is with hot Purified Water (PW) or hot Water for Injection (WFI). It is not likely that such a water final rinse would contribute to bioburden, and it is likely that the hot temperature would significantly reduce any vegetative microorganisms […]

Routine Monitoring for Highly Hazardous Products

This is a continuation of a discussion of products with highly hazardous actives, and deals with the question of routine monitoring for highly hazardous products. Hopefully (if you follow my Cleaning Memos) you know that I generally define a “highly hazardous product” as a drug product with an active that has a significant toxicity concern […]

Highly Hazardous Products in Shared Facilities

This is a continuation of a discussion on products with highly hazardous actives, and deals with the question of manufacturing highly hazardous products in the same equipment or in the same facility as products that are not highly hazardous. The obvious answer to that question is “Yes”, that certainly can be done from a regulatory […]

EMA vs. ISPE on Cleaning Limits?

You might be mystified at this title. What is Mr. LeBlanc getting at? Well, what I will discuss this month is the difference (or conflict?) between the EMA and ISPE on setting limits for cleaning validation. For the EMA “position”, I will refer both to the 2014 “Guideline on setting health based exposure limits for […]

Take me to the memos

from the year: