Accelerating and Automated Rapid Microbial Testing

Validation of rapid methods continues to be an obstacle to greater adoption of these technologies. Some of the benefits of rapid methods are well articulated across industry literature, including the ability to release products much faster as well as intervene faster in the event of contamination in any part of the manufacturing process. Regulatory approval and the challenge of actually validating the rapid method for many applications continue to be viewed as stumbling blocks.

Focused on Rapid Microbiological Methods (RMMs), this one hour webinar will deliver information and insight from both an end user and a supplier in order to share with you compelling reasons to consider the use of RMMs to gain a better understanding of your environment while improving your competitive advantage.

A combination of knowledgeable suppliers, a competitive market, motivated end users, and encouragement from regulatory bodies has placed a number of companies at the forefront of the race to implement an instantaneous and continuous rapid microbiological method (RMM) in their pharmaceutical manufacturing environment.

A number of rapid microbiological methods have emerged, and various degrees of testing have been performed by RMM system suppliers and their end users to determine how such systems may be beneficial to and implemented in an environment where traditional monitoring methods have been utilized for over 100 years.

Rapid microbial testing methods in quality control continue to gain acceptance in pharmaceutical manufacturing, but most companies continue to use manual, traditional methods. The ability to uncover results in less time than traditional methods provides compelling benefits to manufacturers. These benefits can be realized in environmental monitoring, sterility testing, water and bioburden testing.

Learn from experts where rapid technologies, like the Growth Direct™ System can have an impact on microbial quality control and ultimately manufacturing.

Attendees will learn:

- The limitations of the traditional methods
- The importance of non-destructive testing
- The benefits of automated, rapid detection

Technology overview and applicability to pharmaceutical quality systems.

A new family or Rapid Micro Method (RMM), real time viable particle detection based on Laser Induced Fluorescence (LIF), has recently been introduced. Sometimes referred to as optical spectroscopy, these instruments provide the ability to continuously measure for the presence of viable particles in real time. An overview of LIF technology will be presented along with a detailed look at TSI’s implementation in the BioTrak® Real Time Viable Particle Detector highlighting critical instrument performance parameters.

Several application scenarios will be reviewed in the context of current regulatory initiatives such as QbD, ICH Q8, Q9, Q10 and PAT. These applications can form a framework of increased knowledge resulting in a better understanding of the manufacturing process leading to improved product quality in addition to financial benefits.

In this one hour instructional webinar, we discuss how handheld Raman is being used to streamline the pharmaceutical manufacturing process and reduce pharmaceutical product recalls and plant shutdowns. We provide a brief overview of typical incoming raw material inspection processes and discuss how handheld Raman increases productivity and satisfies stringent cGMP requirements. We also discuss how recent developments in handheld Raman technology will continue to enable wider and faster deployment to achieve the goal of 100% testing of raw materials. Lastly, we discuss the importance of a simplified user interface for non-technical users and how advances in technology have addressed this need.

This webinar covers the different approaches to the detection of mycotoxin contamination in food by LC-MS/MS. Examples are covered using highly sensitive systems to simplify the extraction and analysis and detection of these toxins at low levels. The additional benefits of using accurate mass or SelexION™ ion mobility in this application area are also covered.

Presentations:

* Screening of mycotoxins in Food by triple quadrupole and qtrap LC-MS/MS - Dr Stephen Lock PhD

* High Resolution Tandem Mass Spectrometry in mycotoxin analysis: higher selectivity to improve analyte confirmation - Dr Ondrej Lacina PhD

* Boosting the performance of LC-MS/MS analysis of mycotoxins and their transformation products by using innovative separation techniques - Dr. Florian Huebner

Watch presentations from experts in the fields of monitoring and compliance to pharmaceutical water and cleanroom facility standards:

In this webinar you will learn:

* How to stop using paper printouts for particle counting results while maintaining 21 CFR part 11 Compliance

* How to meet EP TOC requirements with an on-line TOC analyzer designed for PAT and Real-Time-Release

* What changes can we expect in ISO 14644 and 14698