2023 - Cleaning Validation Simplified

2023

Worst-Case Product Selection Criteria – Part 4

This is the fourth of several Cleaning Memos dealing with the selection of a worst-case product in a grouping approach for cleaning validation. In August we considered use of the pharmacopeia solubility categories, and also presented what may be a more useful system based on how “solubility bands” are defined. In September we considered issues […]

Nov

2023

Worst-Case Product Selection Criteria – Part 3

This is the third of several Cleaning Memos dealing with selection of a worst-case product in a grouping approach for cleaning validation. In August we considered use of the pharmacopeia solubility categories, and also presented what may be a more useful system based on how “solubility bands” are defined. In September we considered issues in […]

Oct

2023

Worst-Case Product Selection Criteria – Part 2

This is the second of several Cleaning Memos dealing with selection of a worst-case product in a grouping approach for cleaning validation. Last month we considered use of the pharmacopeia solubility categories, and also presented what may be a more useful system based on how “solubility bands” are defined. Many companies may use evaluation systems […]

Sep

2023

Worst-Case Product Selection Criteria – Part 1

This is the first of several Cleaning Memos dealing with selection of a worst-case product in a grouping approach for cleaning validation. I have taught for many years that solubility of the active (API or drug substance) alone is not the best parameter for determining the worst-case product in drug product cleaning validation. So over […]

Aug

2023

Considerations for CAPA Investigations

Last month we considered the elements of CAPA. This month we will be more “philosophical” and consider two things relevant to a CAPA investigation. Each item discussed is part of making sure we have identified the correct root cause. One is related to the investigation and corrective action proposed, and the second is related to […]

Jul

2023

Using CAPA for Cleaning Processes

CAPA (Corrective and Preventive Actions) is usually divided into three elements. If we have identified a problem with a cleaning process (which could be a process deviation or an analytical non-conformance), the parts of CAPA are: We will explore these different (but related) elements using examples to illustrate how they differ and how they can […]

Jun

2023

Recovery Studies for Sieve/Screen Sampling

Last month we covered some possible sampling methods that could be used for sieves/screens. This month is a follow-on Cleaning Memo that discusses sampling recovery studies for sieves/screens. Of course, if my suggestion made last month that sieves/screens be dedicated to one product (or at least to one active) were followed, then it would not […]

May

2023

Sampling Sieves/Screens

The issue of sampling sieves/screens (also called metal meshes) for cleaning validation protocols is a challenging one. For example, those sieves/screens may be used to sift dry powder for particle size control. Small particles may get trapped in the interstices of the crossing wires, and maybe difficult to clean. Those locations may also be difficult […]

Apr

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 […]

Memo Year: 2023

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

Worst-Case Product Selection Criteria – Part 4

Worst-Case Product Selection Criteria – Part 3

Worst-Case Product Selection Criteria – Part 2

Worst-Case Product Selection Criteria – Part 1

Considerations for CAPA Investigations

Using CAPA for Cleaning Processes

Recovery Studies for Sieve/Screen Sampling

Sampling Sieves/Screens

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

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