Memos - Page 2 of 15 - Cleaning Validation Simplified

2023

What’s the “Worst-case” Product for a Protocol?

Sometimes I hear clients (or potential clients) get confused about what is the “worst-case” product for a protocol. This Cleaning Memo will clarify the question, and provide several answers depending on the context. Use IIn a grouping approach for cleaning of drug products, it is generally the most “difficult to clean” drug product that is […]

Mar

2023

Both Swab and Rinse Sampling in One Protocol Run?

Last month we reviewed and expanded on some issues in setting limits for rinse samples. This month we’ll cover issues related to performing both swab and rinse sampling in the same protocol run. In doing so, considerations relating both to a separate sampling rinse (SSR) and to a grab sample of the final cleaning procedure […]

Feb

2023

Clarifying Rinse Sample Limit Calculations

Most of us are fairly comfortable with setting limits for swab samples. However, I still see some confusion in setting limits for rinse samples. This Cleaning Memo clarifies what is involved in rinse sampling and how limits could be appropriately set. It also includes examples of how not to set rinse limits (or at least […]

Jan

2023

Options for Extending the Maximum DHT

Last month we discussed options for validating the maximum Dirty Hold Time (DHT). We’ll start this year off by covering options for extending the maximum DHT for an already validated (shorter) maximum DHT. That is, we will assume that in the past a maximum DHT has been validated. Now, we want to extend that maximum […]

Dec

2022

Options for Validating the Maximum DHT

Last month we discussed options for shortening the DHT to simplify (and perhaps improve) execution of the cleaning procedure. This month we will focus on options for actually validating the maximum DHT. In this current discussion, it is assumed that the desired maximum time has already been selected (see considerations for selection of a maximum […]

Nov

2022

Shortening the DHT to Improve the Cleaning SOP

More and more I am thinking that that companies can improve their cleaning validation program by making improvements not necessarily in the cleaning validation activities, but rather in the cleaning process (cleaning procedure) design and execution. When you stop and look at your overall program, is it better to have a well-designed cleaning procedure or […]

Oct

2022

Alert and Action Levels

This Cleaning Memo is indirectly related to those of the prior three months in that it deals with assessing the “health” of a cleaning validation program. However, the focus here is on individual data values in routine monitoring, and specifically those higher than normal results which may call for more attention to be paid to […]

Sep

2022

Trending of Cleaning Validation Data

This Cleaning Memo is a continuation of the discussions in the July 2022 and August 2022 Cleaning Memos dealing with data evaluation to determine the “health” of a cleaning validation program. Please review those before you continue with this month’s Cleaning Memo. The focus here will be on trending data over time to provide a […]

Aug

2022

Using Histograms for Cleaning Validation Data

This Cleaning Memo is a continuation of the discussion in the July 2022 Cleaning Memo. Please review that before you continue with this Month’s Cleaning Memo. In this continuation we will cover the issue of histograms to provide a one-time picture of the health of cleaning validation data. It is assumed that the data generated […]

Jul

2022

Process Capability Index for Cleaning Validation

This Cleaning Memo, entitled “Process Capability Index for Cleaning Validation”, discusses what a process capability index is, how it is typically utilized, and how it has been promoted for cleaning validation. It includes a discussion of the limitations and value of process capability index considerations for cleaning validation in the pharmaceutical world. Process capability is […]

Jun

2022

Simplified Shortcut Designations for Protocol Data

In the past I had designed a simplified designation for referring to the values for cleaning validation limits in different situations. This system (including L0, L1, L2, L3, L4a, L4b and L4c) was originally formulated around 2004 and then updated and refined in a Cleaning Memo of September 2012. Not surprisingly (!!!) I like the […]

May

2022

Multiple Product Groups on the Same Equipment

In the ideal word we would prefer to treat all products manufactured in a given equipment train as part of just one group. But since we don’t live in an ideal world, there are some situations where we have to make tradeoffs. One situation involves the manufacture of traditional products and highly hazardous product on […]

Apr

2022

Sampling Recovery Studies at the LOQ?

I sometimes run across situations where a company either wants (or is asked) to perform a sampling recovery study at the LOQ (Limit of Quantitation) of the analytical method. The reasons for doing so may be things like “the LOQ value is closer to the actual values I would measure in a cleaning validation protocol.” […]

Mar

2022

Dealing with Campaigns – Part 3

In the last two months, we covered definitions and clarifications in dealing with issues related to cleaning validation for campaigns and then how to select the maximum campaign length. In this Cleaning Memo we will cover how to validate for that maximum campaign length. I will assume that we plan to make sure that the […]

Feb

2022

Dealing with Campaigns – Part 2

Last month we covered definitions and clarifications in dealing with issues related to cleaning processes and cleaning validation for campaigns. This month we will cover how to select the maximum campaign length. There are two basic considerations for choosing a maximum campaign length. One of the considerations is really related to process validation; that is, […]

Jan

2022

Dealing with Campaigns – Part 1

This is the first of several Cleaning Memos dealing with issues related to cleaning processes and cleaning validation for campaigns. We’ll start with some definitions and clarifications. A campaign is a series of batches of the same product manufactured consecutively (that is, one batch immediately followed by another batch). Those batches within a campaign may […]

Dec

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), there are issues that […]

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 of the 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 […]

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 […]

Memos by Destin

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

What’s the “Worst-case” Product for a Protocol?

Both Swab and Rinse Sampling in One Protocol Run?

Clarifying Rinse Sample Limit Calculations

Options for Extending the Maximum DHT

Options for Validating the Maximum DHT

Shortening the DHT to Improve the Cleaning SOP

Alert and Action Levels

Trending of Cleaning Validation Data

Using Histograms for Cleaning Validation Data

Process Capability Index for Cleaning Validation

Simplified Shortcut Designations for Protocol Data

Multiple Product Groups on the Same Equipment

Sampling Recovery Studies at the LOQ?

Dealing with Campaigns – Part 3

Dealing with Campaigns – Part 2

Dealing with Campaigns – Part 1

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

Take me to the memos

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Memos by Destin

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

What’s the “Worst-case” Product for a Protocol?

Both Swab and Rinse Sampling in One Protocol Run?

Clarifying Rinse Sample Limit Calculations

Options for Extending the Maximum DHT

Options for Validating the Maximum DHT

Shortening the DHT to Improve the Cleaning SOP

Alert and Action Levels￼

Trending of Cleaning Validation Data￼

Using Histograms for Cleaning Validation Data￼

Process Capability Index for Cleaning Validation

Simplified Shortcut Designations for Protocol Data

Multiple Product Groups on the Same Equipment

Sampling Recovery Studies at the LOQ?

Dealing with Campaigns – Part 3

Dealing with Campaigns – Part 2

Dealing with Campaigns – Part 1

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

Take me to the memos

Alert and Action Levels

Trending of Cleaning Validation Data

Using Histograms for Cleaning Validation Data