Cleaning Validation Memos from 2006

2006

Dealing with Deviations in the Dirty Equipment Hold Time (DEHT)

This month’s topic is how to handle situations in which the dirty equipment hold time (DEHT) is exceeded in ordinary cleaning processes after a specific DEHT is validated in a cleaning validation protocol. For clarification, the DEHT is the time from the end of manufacture to the beginning of the cleaning process. It may be […]

Nov

2006

Use of Sampling Templates

This month’s topic is the use of templates for swab sampling in cleaning validation protocol execution (as well as in recovery studies). A template is usually a sheet of inert material, such as PTFE, within a “window frame” cut out to the same size as the desired swabbed area. If the sampling area is to […]

Oct

2006

Cleaning Validation for General Room Surfaces?

I am hearing questions more frequently, particularly from pharmaceutical manufacturers in Europe, about regulators and/or auditors who are asking for cleaning validation for surfaces such as floors, walls and external surfaces of process vessels. This month’s Cleaning Memo addresses some of the issues related to such cleaning validation, and particularly addressing why, in general, it […]

Sep

2006

Clean Equipment Hold Time (CEHT) for Sterilized Equipment

A question that sometimes comes up is “How should I handle a Cleaned Equipment Hold Time (CEHT) if my next step is to perform a SIP cycle on the cleaned equipment?” Does it make sense to evaluate the CEHT in such a situation? If so, why? In trying to address the issues in such questions, […]

Aug

2006

Surface Roughness and Cleaning

This month’s Cleaning Memo relates to a paper that was just published in the PDA Journal of Pharmaceutical Science and Technology, entitled “Bacterial Adhesion to Surfaces: The Influence of Surface Roughness” (Volume 60, No. 3, pages 164-171), by Frank Reidewald. While the title refers to bacterial adhesion, there is an emphasis in a portion of […]

Jul

2006

FTIR with Fiberoptic Sampling

Last month I mentioned two new analytical techniques that have been promoted for pharmaceutical cleaning validation in the last five years. “Ion mobility” was discussed in last month’s Cleaning Memo. The other “new” technology is FTIR with a fiberoptic probe. In one sense this is just a novel combination of two technologies, “conventional” infrared analysis […]

Jun

2006

Ion Mobility Spectrometry

Two analytical techniques have been newly promoted for pharmaceutical cleaning validation over the last five or so years. They are (1) ion mobility spectrometry, and (2) FTIR with a fiberoptic probe. The latter is certainly more an example of the combination of infrared analysis with a fiberoptic probe for sampling. This Cleaning Memo, however, will […]

May

2006

Measuring Bioburden in Protocols

The question sometimes arises as to the value of establishing bioburden specifications and measuring bioburden following cleaning in validation protocols. Those involved in non-sterile manufacture sometimes object that bioburden is not significant. Those involved in aseptic processing sometimes object that bioburden is not relevant because the equipment undergoes a SIP (steam in place) cycle following […]

Apr

2006

More on Using Rinse Sampling Alone

Several months ago I discussed the option of using rinsing sampling alone for cleaning validation protocols. The purpose of this Cleaning Memo is to possibly explain why this could be a valuable option to consider, as well as why there may be objections to that approach. I believe the main reason why there appears to […]

Mar

2006

Separating CEHT Protocols from Cleaning Protocols

Last month I discussed setting bioburden limits in a CEHT (clean equipment hold time) protocol. This is ordinarily done by evaluating bioburden proliferation during storage. This involves comparison of the bioburden on equipment surfaces at the beginning of storage and at the end of storage. Since the data at the beginning of storage is essentially […]

Feb

2006

Bioburden Proliferation in CEHT Protocols

A primary concern in clean equipment hold time (CEHT) protocols is that there should be a lack of bioburden or microbial proliferation. This emphasis has a good scientific rationale. In addition, it is specifically mentioned in the FDA cleaning validation guidance (1993): “There should be some evidence that routine cleaning and storage of equipment does […]

Jan

2006

Acceptance Criteria for Dedicated Equipment

This Cleaning Memo addresses the question of what residue limits should be set for manufacture of one product in dedicated equipment. Before we get into those details, it is necessary to restate some important issues related to dedicated equipment so that it is clear that residue limit must be set for dedicated equipment, and that […]

Memo Year: 2006

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

Dealing with Deviations in the Dirty Equipment Hold Time (DEHT)

Use of Sampling Templates

Cleaning Validation for General Room Surfaces?

Clean Equipment Hold Time (CEHT) for Sterilized Equipment

Surface Roughness and Cleaning

FTIR with Fiberoptic Sampling

Ion Mobility Spectrometry

Measuring Bioburden in Protocols

More on Using Rinse Sampling Alone

Separating CEHT Protocols from Cleaning Protocols

Bioburden Proliferation in CEHT Protocols

Acceptance Criteria for Dedicated Equipment

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