Online Safety Community

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

 

Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on ignorance, come in the way of proper implementation of effective water systems. When myths and hype surround these systems, it is but natural that they are doomed to failure.

Those in charge of pharmaceutical biofilms, more so those who deal with water systems need to be aware of all the aspects of water systems if they have to avoid failures. Lack of it can result in costly system downtime or even product recalls. It can result in costly system downtime or even product recalls.

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems3

Pharmaceutical biofilms, especially those in water systems, thrive on fear and hype. No long term biofilm control can be achieved using a one-size-fits-all set of rules for design and operation. Biofilm can be controlled only when it is fully grasped. This is all the more important because each water system is unique. Water systems professionals need to get to the root of how biofilm grows into their system, which, obviously, would be quite different from any other system.

This is why those in water systems need to have proper insights into what actually lies behind some common water system designs. They need to clear the air about several misconceptions on the topic.

Solid understanding of water systems

It is to clear these myths and misconceptions that the world-acclaimed guru of water systems, Dr. Teri Soli, will be presiding over a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. He has authored the complete rewrite of USP Chapter 1231, which many consider to be USP’s “pharmaceutical water bible”.

Want to understand the ways of implementing a water system that fulfils the conditions set out by the regulatory agencies? Just log on to All about Microbial Control, Monitoring, Validation and Troubleshoo... to enroll for this highly practical and useful seminar. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Learning on all aspects of water systems

In this microbiology-focused education about all aspects of water systems, Dr. Soli will offer knowledge of the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.

This interesting and interactive session will give participants insights into what actually lies behind some common water system designs and will bust a few myths about the same. The learning imparted at this course will is translatable to any system, with the result that uneventful microbial control can be achieved. This is the foundation to effective operation and design. Without this understanding, participants will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far outweigh the educational costs that could have prevented it.

Knowledge of water system validation and Change Control

A good way to get understanding of this topic is to be familiar with water system validation and Change Control. This knowledge is necessary to help them come up with ways of improving outcomes and reducing the frequency of excursion investigations. Dr. Soli will offer understanding on this at this seminar.

Dr. Soli has set out the following agenda for this seminar:

  • What makes water systems have microbial quality problems
  • Successful sanitization approaches for trouble-free water quality
  • Water system validation by logic instead of tradition
  • Understanding and controlling endotoxin
  • Harmonizing vs optimizing water microbial testing for system quality control
  • Microbial enumeration issues with high purity water systems
  • Water system investigation “how to’s” and example case studies
  • What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues.

Views: 18

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted events
Friday
Adam Fleaming posted a blog post

Having a [baby] is exorbitant and befuddling, notwithstanding for a wellbeing approach master

It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is unbelievable…See More
Thursday
Tytti posted a blog post

Safety Sign Colors and International Standards

Colors make a difference to our environment. They help us analyze the surroundings and distinguish between objects. We recognize plants as green and the sky as blue, whereas a frog, for example, can be either green or blue. Deviant colors, in this case blue, warns us about poisonousness. If we detect unusual colors in our food, for example, we associate them with rottenness, which then activates a warning in our mind “Don’t eat!” Colors cause diverse feelings and opinions, and even distinct…See More
Thursday
Mark Nilson posted events
Thursday

Forum

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service