Global BioPharmaceutical Resources Inc.

Description

Pore size ratings are key to the filtrative removal of particles, including organisms, from fluid suspensions by way of the Size Exclusion or Sieve Retention mechanism.

The course will consider:

• The water-wet and product-wet bubble points, and their interchange.
• The conversion of product-wet values to log reduction values.
• The multipoint plotting of LRVs versus differential pressure levels.
• The extrapolation of Single Point diffusion readings.
• The Direct Bubble Point Measurement.
• The pros and cons of each method, and the singularity of each.

Who should attend

• Technical personnel directly responsible for filter testing and analysis should obviously attend the course.
• It were best that their supervisors should be similarly instructed.
• The individuals tasked with selecting the filter for its purpose should certainly attend as the suitability of their choice is most important.
• If the shift managers are responsible for several ongoing operations, their attendance may provide them the reassurance that they are adequately detailed even at the nut and bolt level of  operations.
• The bubble point method is also important as an integrity test for filters.

Although not used as such in this operation, it could be advantageous for those who handle filters to reinforce by their attendance what they already know

Learning Objectives

• Recognize that airflow may be diffusive, or may be of a bulk nature, and why their origin matters.
• Understand why single point readings are extrapolated from 80% of the bubble point instead of from the 5 psi position.
• Learning the Why and the How of performing the bubble point procedure.
• Why the water-wet and product -wet bubble points inter-relate mutually, while the log reduction values are not so related.
• Understand when a given bubble point procedure should be used.
• Learn why a technique based on adsorptive interactions is applicable to a process based on sieve retention .
• Be made aware of the involvement of competitive marketing rivalries in selecting the bubble point method.
• Be informed of the present practice wherein safety margins assure against the violation of minimum acceptable water-wet bubble points and the filters' LRVs derived therefrom.

Presenter

Ted Meltzer, Ph.D.- Consultant at Capitola Consultancy;

About Presenter

Have written numerous papers on Pharmaceutical Filtration, as well as having authored or coauthored a number of books on the subject with Maik W. Jornitz:

• "Filtration in the Pharmaceutical Industry"
• "Filtration in the Biopharmaceutical Industry"
• "Filtration and Purification in the Biopharmaceutical Industry"
• "Sterile filtration: A Practical Approach"
• "Pharmaceutical Filtration: The management of Organism Removal"
• "The Anatomy of a Pharmaceutical Filtration: Differential Pressures, Flow Rates, Filter Areas, Throughputs, and Filter Sizing"
• A series of Filtration Handbooks on Liquids; Air and Gases; and Integrity Testing.

Honorary Member of PDA.   Pharmaceutical Water Interest Group Leader.  Frequent Lecturer on subjects of specialization, both home and abroad.

Registration Fee

$85