Cleaning Validation Memos from 2002

2002

Additional Considerations in Recovery Studies: Part 2

Last month’s Cleaning Memo covered several issues in designing sampling recovery studies. This month’s memo continues with three more considerations. Drying time: Since in most cases, swabbing of equipment surfaces will involve swabbing of dry equipment surfaces, it is a reasonable expectation that the spiked residue be allowed to dry on surfaces for a recovery […]

Nov

2002

Additional Considerations in Recovery Studies: Part 1

Last month’s Cleaning Memo suggested that swab recoveries were relatively straightforward. That is definitely true in comparison to recovery studies for rinse sampling- the swab procedure utilized in the lab recovery study is exactly the same as that used in the validation protocol, whereas the rinse sampling procedure has to be simulated in the lab. […]

Oct

2002

Recovery Studies for Rinse Sampling

A key feature of any cleaning validation protocol is having sampling methods and analytical methods that can accurately assess the levels of residues on the sampled surface. One regulatory expectation is that the sampling method be challenged in conjunction with the analytical method to determine the percentage recovery of the sampling method. Doing a sampling […]

Sep

2002

Sampling the Sampling Rinse

I have discussed in most of my cleaning validation training seminars that there are two types of rinse sampling. One type (the more conventional) involves taking a “grab” sample at the end of the process rinse. A second type is a “sampling rinse”, in which a separate, discrete rinse (following the final process rinse) is […]

Aug

2002

Selecting Swab Sampling Sites

If sampling is designed to identify potential residues on cleaned equipment surfaces that might be transferred to the next manufactured batch, then it is necessary to select swab sample sites that can appropriately provide that information. This Cleaning Memo will cover selection of sampling sites for swab sampling (next month’s will cover an equivalent subject […]

Jul

2002

Worst-case Process Conditions

Cleaning validation generally involves three PQ runs where one challenges the cleaning process under worstcase process conditions to demonstrate that within normal process variations, the cleaning process is effective. This generally involves stressing under worst-cases within normal process conditions. For example, if the cleaning process temperature were 70° ± 5°C, one would NOT conduct a […]

Jun

2002

Recovery Studies for Microbial Sampling?

Measurement of potential microbial contamination has become a more of an expectation in cleaning validation protocols for process manufacturing equipment. Sampling for bioburden on surfaces has usually involved contact plates, swabs and rinse water (with membrane filtration) analyses. A common question that arises for this microbial sampling is whether or not recovery studies (analogous to […]

May

2002

Cleaning Validation for Medical Devices

Apr

2002

Understanding and Applying “Visually Clean”

I have recently published a paper on the use of a “visually clean” standard as the sole acceptance criterion in cleaning validation protocols. That publication was based on a presentation at the December 2000 PDA meeting in Washington, D.C. and a similar presentation at the February 2001 Japan PDA meeting in Kyoto, Japan. Since that […]

Mar

2002

What’s a Contaminant?

At recent FDA Basic Drug School, I was asked the question whether allowing a specified level (such as 0.001 of a therapeutic dose of a previous active) of residue in a manufactured product was, in fact, allowing manufacturers to produce and release drug products which were “contaminated”. My answer at the time was related to […]

Feb

2002

The Use of Default Limits

References to default limits such as 10 ppm are included in both the FDA and PIC/S guidance documents (although they are not specifically called default limits in those documents). This Cleaning Memo will address what these default limits are, how they should properly used, and how they are commonly misused. Default limits are, in a […]

Jan

2002

The Use of Safety Factors in Limits Calculations

Safety factor are a commonly used part of the usual dose-based calculations for cleaning validation residue limits. In the traditional formulation, “one one-thousandth of a minimum dose of the active in the maximum dose of the next drug product”, “one one-thousandth”, or 0.001, represents the “safety” factor. This Cleaning Memo will cover the significance of […]

Memo Year: 2002

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

Additional Considerations in Recovery Studies: Part 2

Additional Considerations in Recovery Studies: Part 1

Recovery Studies for Rinse Sampling

Sampling the Sampling Rinse

Selecting Swab Sampling Sites

Worst-case Process Conditions

Recovery Studies for Microbial Sampling?

Cleaning Validation for Medical Devices

Understanding and Applying “Visually Clean”

What’s a Contaminant?

The Use of Default Limits

The Use of Safety Factors in Limits Calculations

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