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PMF NEWSLETTER a Publication of the Pharmaceutical Microbiology Forum DISTRIBUTED INTERNATIONALLY PMF NEWSLETTER A Publication of the Pharmaceutical Microbiology Forum DISTRIBUTED INTERNATIONALLY PURPOSE: To provide a forum for discussion of microbiology issues in the pharmaceutical and related industry. The information contained in this newsletter is the professional opinions of individuals and does not represent the policies or operations of any corporation or government agency to they may be associated. PMF Newsletter is intended to serve as an open forum. The information in PMF Newsletter is solely for information purposes and is developed from sources believed to be reliable. State- ments expressed constitute current opinions derived through analysis of available information and professional networking. Articles or opinions are for information only to stimulate discussion and are not necessarily the views of the PMF board or regulatory agencies. The PMF Newsletter cannot make any representations as to the accuracy or completeness of the information presented and the publisher cannot be held liable for errors. Volume 12, Number 2 February, 2006 Basic Microbiology In This Issue: The central theme of this newsletter is basic microbiology in the pharma- Editor’s Message 1 ceutical, personal products and medical device industries. This focus is Purified Water and WFI Alert and Ac- 2 very clear in this month’s issue of the newsletter. At a time where many tion “Limits” - TC Soli decisions are being made based on an estimation of what will get approval The Gram Stain - Scott Sutton 4 easiest, or what is the least expensive way to complete a study, we also need to go back to basic principles of microbiology in our work. That is USP Corner 6 not to say that product approval and unit cost are not important - we are, Internet Addresses 6 after all, working to support our companies and clients. However, exclusive focus on the Upcoming Events 7 “cost” of microbiology is false economy, Important Links: Discussion List Update 7 penny-wise but pound foolish. It seems we always have time to re-do a test, but it is Information on the Mike Korczynski, a Gentleman, a sometimes difficult to find the resources to do PMFList at http:// 9 www.microbiol.org/ Scholar, and a Friend - Roger Dabbah it correctly the first time. pmflist.htm Pharmaceutical Microbiology Forum (PMF) 2006 Editorial Board There are two articles in this month’s newslet- Past Issues of the PMF President/Editor-in-Chief: ter that stress this point, although in different Newsletter at ways. The first is an article on water system http://www.microbiology Scott Sutton, Ph.D. Vectech Pharmaceuti- alert and action levels by TC Soli. Dr. Soli forum.org/news.htm cal Consultants, Inc. , USA stresses the need for good science in setting .Editorial Board: control levels for your system, and provides Ziva Abraham, Microrite, Inc., USA some examples of how to get this done in a manner that should find accep- Phil Geis, Proctor-Gamble, CTFA, USA tance with both management and regulatory agencies. The second article Klaus Haberer, Ph.D., Ph. Eur., Germany is a review of the gram stain. Of little practical interest to those out of the Karen McCullough, Roche Labs, LAL lab, it is critically important to most microbial identification methods. It is User’s Group, USA also one of the most poorly understood and improperly controlled assays Paul Priscott, Ph.D., AMS Labs, Australia you are likely to see in visiting different laboratories. The article provides Eric Strauss, Teva Pharmaceuticals, Israel a review of the methodology, the areas of the test most open to error, and alternatives to the stain method that you might consider. The PMF gratefully acknowledges the contributions Finally, we are sad to note the death of Dr. Michael Korczynski. He of : passed away last month to the sorrow of his family and many friends. Dr. ▫ Vectech Pharmaceutical Consultants, Inc, (http://www.vectech.com) Roger Dabbah provides a tribute to his passing. ▫ High Peaks Associates, Inc. (http://www.highpeaks.us) Scott Sutton, Ph.D to the continued success of the PMF Newsletter Editor, PMF Newsletter Newsletter The PMF Newsletter is published by the Pharmaceutical Microbiology Forum. Copyright ©2006 by the Pharmaceutical Microbiology Forum. All Rights Reserved. Send all inquires, letters, and comments to [email protected] Pharmaceutical Microbiology Forum Newsletter – Vol. 12 (2) Page 2 of 9 Purified Water and WFI Alert and Action “Limits” T. C. Soli, Ph.D. formation can be acquired. But chose well – not every water confer- Consultant, Soli Pharma Solutions ence/course presenter or consultant is truly a water system microbi- Vice Chair, USP Pharmaceutical Water Expert Committee ology expert. I’m sure I hit more than a few hot buttons with the above statements. Scared Yet? If even only part of this scenario applies to you or your company, do not be offended, defensive, or give up hope. You are actually in the Ah, those title words send chills up my spine! Why? To majority, and that carries some weight, but frankly, that does not me, it’s scary. As a consultant, I see a strong correlation make it completely excusable. It does not justify continuing to use between the use of the term Action “Limit” (instead of Ac- fallacious concepts and antiquated practices when potentially only a tion “Level”) and the adoption of what some firms consider few simple corrections could turn everything around and take the to be the USP-recommended Action Levels of 100 cfu/mL worries out of the water system. All of the associated issues are just for Purified Water and 10 cfu/100mL for WFI (regardless too much to cover in a single article, so now that I’ve gotten your of their typical system performance), plus no hint of a bona attention, I’ll address the title concept and a few related ones in this fide water specification, and the use of PCA at 35°C for article and get to the other ones in future articles. 48hr – with absolutely no evaluation of alternative methods or even of the suitability of the selected test conditions for Using the Terms Alert and Action Limits their own water systems. Though intentioned to be microbial process control terms, they actu- So, why is that so scary? Simple. Though these are pretty ally imply “specifications”. This implication arises because a) there common practices, they are simply risky things to do with probably are no bona fide water specifications and b) the usage of water systems. It likely puts the user in a powerless posi- “limits” in the pharmaceutical product and raw material world means tion relative to analytical-based microbial control and a “specifications”. Even in USP there are numerous limit tests which weak position relative to compliance, especially when a are pass/fail attribute tests or specifications for monographed arti- water system design and/or its age are less than ideal. The cles. USP has the “Microbial Limits” test chapter <61> which is above practices also correlate with a firm’s GMP philoso- referred to from many a monograph! So the word “limit” is defi- phy being driven more by minimal “get by” adherence to nitely associated with specifications. industry precedent than doing the right things based on an understanding of their water system, its impact on their Process control levels should NEVER be used or even implied to be products and uses, and good science. used as specifications or limits. Specifications and limits are pass/ fail criteria, so to exceed an action limit could be interpreted to mean Many of those firms may not even have a microbiologist on only one resulting action – rejection, just like with other raw materi- staff that has an understanding of water system microbiol- als! That is certainly not the intended purpose of a process control ogy. Too often, a minimally trained technician who per- level. Process control levels are intended to do what the words state. forms microbiological tests is considered the They are levels established at values just high enough, based on past “microbiologist” and expected to advise decision makers in data trends of your system, to signal that changes may be occurring matters where they have even less technical knowledge – in the control of a dynamic attribute, such as microbial counts. It can hence the firm’s reliance on precedent rather than science. be exhibited by a single high level excursion, but more often it is In the microbiologist’s defense, they may not have a degree represented by a pattern of lower level excursions. It usually means in microbiology or any industrial microbiology training or that some sort of remedial action is needed to bring this dynamic experience that could afford them an understanding of the attribute under better control before it escalates to a level that makes idiosyncrasies of pharmaceutical microbiology, let alone the the water unsuitable for use. It DOES NOT necessarily mean that microbiology of that dynamic, unstable ecosystem we call a the water is currently unsuitable for use. pharmaceutical water system. This ecosystem is affected not only by the available nutrients (McAlister 2002), the composition of pipes (Burkhart et al 1996), the temperature Lack of Specifications of the distribution system (LaPara et al 2000) and other physical characteristics of the construction and operation of Most biopharmaceutical firms do not have such things as specifica- the distribution system, but also by the activities of the mi- tions for their water. This is somewhat ironic in that every other raw croorganisms themselves (Matiny 2003). Fortunately, there material in their facilities has such specifications. However, it is are several water consultants who DO understand these simply not, for the lack of a better term, the “tradition” to have true things and can train your staff to also understand.
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