Cleaning Validation Memos from 2014

2014

Is Pre-cleaning Allowed?

Occasionally when I review regulatory documents, something jumps out at me that I had not fully thought about before. In a review of the FDA’s Human Drug CGMP Note of the second quarter 2001, I noticed the following FDA question and FDA answer: Question: “Must a firm quantify the amount of residue on equipment surfaces […]

Nov

2014

White Rings in Buffer Tanks

It isn’t often that I hear a cleaning validation presentation or read a cleaning validation article and say “Wow, I really learned something new.” However, that was the case in a recent presentation by Jenna Carlson of Genentech at an IVT conference in San Diego. The title of the presentation was “Cleaning and Passivation Program […]

Oct

2014

Cleaning Validation Limits for Lyophilizers – Part 3

This is the third part of a three-part Cleaning Memo series on lyophilizers (freeze driers). So far, we have covered some general issues, and then focused separately with more detail on vial lyophilization and then tray lyophilization. This month we will cover the regulatory basis for doing cleaning validation of lyophilizers. If (has been discussed […]

Sep

2014

Cleaning Validation Limits for Lyophilizers – Part 2

This is the second part of a three part Cleaning Memo series on lyophilizers (freeze dryers). Last month, we discussed some general issues, but focused on vial lyophilization. This month the focus will be on lyophilization of bulk materials, which typically are on (or in) trays. Many of the same issues related to transfer of […]

Aug

2014

Cleaning Validation Limits for Lyophilizers – Part 1

This is another topic that I have presented on numerous times (the first time was at a technical conference in Zurich in 2000), but which has never evolved into a formal Cleaning Memo. The internal surfaces of lyophilizers (freeze dryers) are what I generally call “indirect-product-contact surfaces”. For clarification, I generally divide surfaces into three […]

Jul

2014

Dealing With Preferential Transfer of Residues

Often in dealing with a specific issue for someone, I will think that I have previously written a Cleaning Memo on that subject, and I can just refer the person to that publication. Sometimes, however, I am surprised in that while I have presented numerous times on that topic, I don’t have a Cleaning Memo […]

Jun

2014

Issues in Equipment Grouping

Equipment grouping (also called matrixing, a family approach, or bracketing) is an option companies are considering more and more as part of a risk-based approach to cleaning validation. In a grouping approach, what is done is to consider certain equipment as equivalent for cleaning validation purposes. This Cleaning Memo will cover two issues: first, how […]

May

2014

Addendum Shortcomings of ADE/PDE Values for Cleaning Validation

Let’s cut to the chase (as they would say when making old movies). The reason that ADE/PDE values alone should not be adopted for cleaning validation is that those values only address one of the concerns in setting limits. Toxicity to the patient is only one of the concerns in setting limits. Risk-MaPP states that […]

Apr

2014

Cleaning Validation for Continuous Manufacture

An internet search for “pharmaceutical continuous manufacture” will turn up a number of recent articles discussing the possibility of continuous manufacture to supplant batch manufacturing for pharmaceuticals. While for most companies this is in the future, it may be applicable in certain situations now. What does “continuous manufacture” mean for cleaning validation? Or, how might […]

Mar

2014

Test Until Clean?

An advertising promotion for a recent report called “Preparing for the EU GMP Inspection” (https:// www.fdanews.com/products/44215-preparing-for-the-eu-gmp-inspection) made an unusual statement about a difference between the EU and the FDA for cleaning validation. The statement was “The EU allows a testuntil-clean approach to cleaning validation; the FDA does not.” That statement was made in the context […]

Feb

2014

Mock Soils and Mock Soiling

A “mock soil” and “mock soiling” are two different things. A “mock soil” is a soil which is not a routinely manufactured product that is used in the validation protocol to represent the actual soil present on the equipment surfaces at the time of cleaning. “Mock soiling” is a process by which I apply a […]

Jan

2014

Setting Limits for Cleaning Agents

In the last two months, I published Cleaning Memos critiquing the EMA approach to setting limits (November 2013) and then suggested a way forward for health-based limits (December 2013). I thought I was done with these issues for a few months; however, Andrew Walsh et al published an article in the November/December issue of Pharmaceutical […]

Memo Year: 2014

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

Is Pre-cleaning Allowed?

White Rings in Buffer Tanks

Cleaning Validation Limits for Lyophilizers – Part 3

Cleaning Validation Limits for Lyophilizers – Part 2

Cleaning Validation Limits for Lyophilizers – Part 1

Dealing With Preferential Transfer of Residues

Issues in Equipment Grouping

Addendum Shortcomings of ADE/PDE Values for Cleaning Validation

Cleaning Validation for Continuous Manufacture

Test Until Clean?

Mock Soils and Mock Soiling

Setting Limits for Cleaning Agents

Take me to the memos

Subscribe to Destin LeBlanc's cleaning validation memos.