Cleaning Validation Memos from 2021

2021

Annual Confirmatory Protocols in a Grouping Approach

A validation maintenance strategy used by some companies is to perform a single run “confirmatory” protocol (also called a “verification” protocol) on a regular basis (such as annually) on a drug product that has been qualified (or validated). This confirmatory protocol is just one part of what the company might do as part of “Stage […]

Nov

2021

What to Do about Suspected Contamination

Last month, we talked about what to do if residue limits change. That was a prospective (going forward) issue. This month we’ll discuss a retrospective issue. Specifically, what could (or should) be done if a serious issue comes up and (while you believe that previously manufactured product probably is not cross-contaminated), some issues have arisen […]

Oct

2021

What to Do When Residue Limits Change

Let’s say you have previously validated a cleaning process, and that things have changed such that the limit for the active product cleaned has changed. This is generally a significant issue only if the result of the change is a lower limit. This change may have been caused by the addition of a new drug […]

Sep

2021

Status Signs for Cleaning Processes

This Cleaning Memo focuses on the signage (labels) that should be used during routine cleaning of equipment in pharmaceutical manufacturing facilities. It will cover possibilities for verbiage to be used in those temporary signs at various times during the cleaning process. The purpose of such signage is to make sure the various steps in a […]

Aug

2021

Action and Alert Levels

We will cover three issues in this Cleaning Memo. They are (a) how action and alert levels are defined, (b) how action and alert levels are used, and (c) how action and alert levels are established, all in the context of pharmaceutical process equipment cleaning validation. The first issue is one of clarifying terminology (as […]

Jul

2021

Recovery Studies for Microbial Sampling – Revisited

In the recent (2020) ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls, there is one section and a related appendix on bioburden sampling recovery methods (including methods for swab, contact plate, and rinse) that state the following: “The recovery study results should be assessed by the QC laboratory when reviewing cleaning validation and […]

Jun

2021

Risk Assessment for Indirect Product Contact Surfaces

Last month, we focused on limits for indirect product contact surfaces (IPCSs). This month, we will focus on studies that could be performed as part of a risk assessment related to cleaning validation for such surfaces. In particular, the examples I use will involve the interiors of isolators, although the principles of the studies should […]

May

2021

Residue Limits for Indirect Product Contact Surfaces

This Cleaning Memo is focused on limits for indirect product contact surfaces. It first covers my recommendations, and then specifically addresses the considerations in setting limits for isolators as recommended in a November 2017 PDA Letter (“Isolator Surfaces and Contamination Risks to Personnel”, by Richard Denk et al). I’ll start with a clarification of the […]

Apr

2021

Why a Default of 10 ppm “Solids” for Detergents?

I sometimes get the question as to why I recommend a “default” value for a detergent limit based on the solids content of the detergent. After all, shouldn’t the default value for a detergent be the same as the default value for an active (an API), which is 10 ppm? This Cleaning Memo will discuss […]

Mar

2021

An Unusual Situation for Shared Surface Area

In taking a look at the shared surface area (SSA) between two products, there are several options that are typically used for limits calculation purposes. As a reminder, the SSA is in the denominator of the typical carryover calculation; therefore, the larger the SSA between the two products, the lower the limit. There are several […]

Feb

2021

What’s a “Worst Case”?

I commonly hear companies say that they use a “worst case” approach for their cleaning validation program. My first question is usually “Which worst-case aspect are you referring to?” The term “worst case” could cover a variety of different things for cleaning validation. For example, there are worst-case aspects that may be used for setting […]

Jan

2021

Statistics in Cleaning Validation?

There is an increasing call for the use of statistics for use in cleaning validation programs. Statistics can be appropriately used to evaluate data to determine variability. Statistics conceivably could be used in the following situations related to cleaning processes: Statistics for evaluating data in the design of a cleaning process.A. Statistics for evaluating data […]

Memo Year: 2021

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

Annual Confirmatory Protocols in a Grouping Approach

What to Do about Suspected Contamination

What to Do When Residue Limits Change

Status Signs for Cleaning Processes

Action and Alert Levels

Recovery Studies for Microbial Sampling – Revisited

Risk Assessment for Indirect Product Contact Surfaces

Residue Limits for Indirect Product Contact Surfaces

Why a Default of 10 ppm “Solids” for Detergents?

An Unusual Situation for Shared Surface Area

What’s a “Worst Case”?

Statistics in Cleaning Validation?

Take me to the memos

Subscribe to Destin LeBlanc's cleaning validation memos.