Global BioPharmaceutical Resources Inc.

Presentation Description

Biofilm formation seems inevitable. It poses risks to all water systems whether pharmaceutical or not. Organisms are randomly sheds into the liquids contacting biofilm, threatening to disqualify the pharmaceutical waters undergoing preparation. Unceasing efforts are made to avoid its formation while its containment is managed by periodic sanitizations at intervals defined by planktonic assays.

The nature of biofilms is set forth. It is a surface based phenomenon protective of its organism content. Its destruction by different sanitizing agents is detailed; its hoped-for avoidance by surface modifications involving the use of surface smoothness and/or fluorinated surfaces, largely based on dental studies; and its known prevention by the employment of ozone or hot water, whether continuously or intermittently is discussed.

Its present status is emphasized as requiring careful and patient management based of periodic sanitizations. Searching for its avoidance, while desirable, should not be a main focus of one’s efforts.

Who is the Target Audience?

The operational staff responsible for the preparation and the quality of water for WFI, particularly with regard to endotoxin and bioburden, should attend. Supervisory personnel in charge of the project should be cognizant of the teaching so as to ensure a team understanding of the factors involved. In particular, microbiologists whose technical specialty guides the project should attend the presentation to endorse or challenge the presenter with the view towards eliciting in the Q & A period an assessment of the speaker’s approach and recommendations with reference to their own.

Given the importance of biofilm management, some representative of the company’s top echelon should attend to become alerted to the problem’s present intractability and cost.

Learning Objectives

An adequate comprehension of the several factors mentioned in the above Presentation Description will be gained by the attendees. A careful and responsible evaluation of the data now available will inform those in attendance regarding the present status, and future approaches to the biofilm problem.

Presenter

Theodore H. Meltzer, Consultant at Capitola Consultancy

About Presenter

Consultant: Pharmaceutical Filtration; Pharmaceutical Water.

Parenteral Drug Association; Honorary Member; Pharm Water Interest Group Chair. Authored two books: Pharmaceutical Water Systems and High Purity Water Preparation; Several Chapters on this matter; numerous papers; Lecturer on subjects of specialization.

Registration Fee

$85