Cleaning Validation Memos from 2005

2005

Selecting the Swab Sampling Area

This Cleaning Memo addresses the question of the specific surface area to swab in a cleaning validation protocol. For clarification, this will address the size of swab area, not the location of the swab area. Most companies will swab areas of 25 cm2 (4 square inches) to 100 cm2 (16 square inches), although I have […]

Nov

2005

Averaging Swab Sample Results?

In cleaning validation, limits are set for swab samples (usually based on a carryover calculation). The question is often asked, “Am I allowed to average different swab samples and compare that average to my calculated established acceptance limit?” This is usually asked in the context of having one (or more) swab samples exceed the established […]

Oct

2005

Limits for Rinse “Grab” Samples

Limits for rinse samples in finished drug manufacture have always been a problem area for pharmaceutical cleaning validation. How does one justify limits on a scientific basis, much like is ordinarily done for swab sampling? I have answered this in part in a May 1998 Pharmaceutical Technology magazine publication. However, I have gone one step […]

Sep

2005

More on Limits for Formulated Cleaning Agents

In last month’s Cleaning Memo, I discussed that for formulated cleaning agents (those cleaning agents containing surfactants and other functional aids), residue limits are generally set based on the toxicity of the cleaning agent. Rather than using something like 0.001 of a dose (as is used for actives), the limit of the formulated cleaning agent […]

Aug

2005

Issues in Limits for Formulated Cleaning Agents

For formulated cleaning agents (those cleaning agents containing surfactants and other functional aids, perhaps in addition to an alkali or acid), residue limits are generally set based on toxicity of the cleaning agent. Rather than using something like 0.001 of a dose (as is used for actives), the limit of the formulated cleaning agent in […]

Jul

2005

Revisiting Cleaning Validation for Medical Devices

I recently presented at an ASTM conference on cleanliness of medical device implants. An expanded paper based on that presentation will hopefully be published shortly in ASTM’s online Journal of Testing and Evaluation. The industry seems to be heading in the direction of the ASTM testing procedure being adopted. My position is slightly different. While […]

Jun

2005

Setting Limits Based on Process Capability?

As some of you might know, I am not generally a fan of setting residue limits based on process capability. Where this sometimes comes up is when a manufacturer sets limits based on standard dosing calculations (also called maximum allowable carryover calculations), but then the actual residue data measured is much below that calculated limit. […]

May

2005

Objectionable Microorganism Concept in Cleaning Validation

A special Cleaning Memo authored by Dr. Tony Cundell A common question asked of pharmaceutical microbiologists, by their counterparts in validation, is what microorganisms should be absent from the surface of pharmaceutical manufacturing equipment when monitored for microorganisms during cleaning validation? For equipment used for the manufacture of non-sterile pharmaceutical and over-thecounter drug products, we […]

Apr

2005

Cleaning Validation for Packaging Equipment: Part 2

This is a continuation of last month’s Cleaning Memo. In that Cleaning Memo, I discussed the criticality of cleaning for primary packaging equipment. That this is important is evident from the fact that the principle involved (non-uniform contamination of the next batch) is mentioned in the FDA cleaning validation guidance. This month I will focus […]

Mar

2005

Cleaning Validation for Packaging Equipment: Part 1

Sometimes I am asked about cleaning validation for packaging equipment, and the thought behind the question appears to be that this is not a critical cleaning process and therefore doesn’t require cleaning validation. While it is true that effective cleaning of some packaging equipment may be much easier to achieve, it is not necessarily true […]

Feb

2005

Dealing with Unknown Peaks

A common question in training seminars is “How do I deal with unknown peaks in HPLC analysis?” My first answer is a facetious one: “Try TOC; there are no unknown peaks in TOC!” However, TOC is not without its problems. To directly answer the question about unknown peaks in HPLC analysis, the first attempt should […]

Jan

2005

Understanding the Cleaning Process

A key issue in the FDA’s recent report on a risk-based approach to pharmaceutical CGMPs was that manufacturers should move to a better understanding of their manufacturing processes. A clear statement of this is on page 5 of that report: “Quality and productivity improvement share a common element – reduction in variability through process understanding….” […]

Memo Year: 2005

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

Selecting the Swab Sampling Area

Averaging Swab Sample Results?

Limits for Rinse “Grab” Samples

More on Limits for Formulated Cleaning Agents

Issues in Limits for Formulated Cleaning Agents

Revisiting Cleaning Validation for Medical Devices

Setting Limits Based on Process Capability?

Objectionable Microorganism Concept in Cleaning Validation

Cleaning Validation for Packaging Equipment: Part 2

Cleaning Validation for Packaging Equipment: Part 1

Dealing with Unknown Peaks

Understanding the Cleaning Process

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