Particle Measuring Systems

4 Current Events found

Current Events

  • Effectively Removing the Pain of Passive Air Monitoring from Critical Environments

    Effectively Removing the Pain of Passive Air Monitoring from Critical Environments

    Online, CO, USA

    The most universally applied method for cleanroom classification is the one suggested in 1963 by Federal Standard 209 of the USA. In this standard the number of particles equal to and greater than 0.5 µm is measured in one cubic foot of air. This count is then used to classify the room (1 particle = class 1; 10 particles = class 10…). In the same period, scientific publications ...

  • Particle College - 2019

    Particle College - 2019

    Boulder, CO, USA

    Learn theory, regulatory requirements, and practical application of contamination monitoring and control for aseptic process and clean / controlled environments. To meet your specific needs the class is broken into three groups, each with specialized training material and instructors: Electronics/ Semiconductor (Air Focus): Particle counting and molecular monitoring. Electronics/ Semiconductor (Liquid Focus): Particle counting. Life Sciences ...

  • Batch Record Design and Review - Webinar

    Batch Record Design and Review - Webinar

    Online, CO, USA

    The production batch record is one of the most important documents to demonstrate the compliance and the quality of a batch of pharmaceuticals. For this reason, it must be designed and reviewed from a scientific point of view. Rationales and procedures should be in place to manage the batch data. This webinar concentrates on the practical applications of GMP and FDA compliance requirements, from the batch record review ...

  • Cleanroom Energy Savings - Webinar

    Cleanroom Energy Savings - Webinar

    Online, CO, USA

    Cleanrooms consume large amounts of energy–anywhere from 2 to 50 times more than is consumed by non-classified areas depending on the specific application. Special attention needs to be given to reducing air change rates (ACRs) and to considering real particle generation in cleanrooms to determine the actual ACRs needed once ‘in operation.’ Energy consumption grows rapidly with an increase in cleanliness ...

9 Past Events found

Past Events

  • Understanding & Complying with ISO 21501-4: 2018 Particle counter calibration requirements

    Understanding & Complying with ISO 21501-4: 2018 Particle counter calibration requirements

    Online,

    With the recent release of ISO21501-4, the International Standard Organization introduced additional requirements for airborne particle counter calibaration. This webinar will provide basic knowledge about particle counting technology and what your calibaration provider should verify while calibrating your equipment.

  • Understanding and Applying USP 797 Updates - Webinar

    Understanding and Applying USP 797 Updates - Webinar

    Online, CO, USA

    Here are the requirements and the steps to creating your contamination control.

  • Sterility Assurance Applied to Stem Cell Therapies - Webinar

    Sterility Assurance Applied to Stem Cell Therapies - Webinar

    Online,

    The complexity of modern medicines and their potential to do harm if manufactured inappropriately makes the need for quality assurance appear obvious. This was not always the case. Improvements in the safety and quality of medicines have nearly always been made as a corrective action to tragic events. Cell therapies and regenerative medicines require a high degree of informed control in order to ensure that their quality are ...

  • From Paper to Paperless-Tackling the 21CFR11 Challenge - Webinar

    From Paper to Paperless-Tackling the 21CFR11 Challenge - Webinar

    Online, CO, USA

    Today, both the MHRA and FDA are highly focused on data integrity and discourage methods which manually record data. Modern data management systems provide secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes. Complying with the new requirements present more challenging requirements. Bringing manufacturing processes and controls to a new level can appear simple in theory but ...

  • Complying with USP 729 / 788-1788 Regulatory Requirements - Webinar

    Complying with USP 729 / 788-1788 Regulatory Requirements - Webinar

    Online,

    Release of parental drugs for injection requires test apparatus to be accurate, precise, reliable and compliant with the latest international regulation. Learning how to keep a Light Obscuration particle counter under continuous control, guarantying steady performance, is the key to commercialize quality products and ensure patient safety. This webinar will cover the key international requirements to properly perform particle ...

  • Increasing Productivity by Leveraging Single Use Technology in Air Monitoring - Webinar

    Increasing Productivity by Leveraging Single Use Technology in Air Monitoring - Webinar

    Online,

    The impact of new and alternative monitoring technologies on labor costs in the laboratory and in manufacturing can be significant. The practice of single-use air sampling techniques to increase productivity results in reduced OOS/OOT, costs of investigation and regulatory interactions. We will look at the advantages of single-use technologies to mitigate and remove the risk of air ...

  • Cleaning Validation in Pharmaceutical Manufacturing Facilities

    Cleaning Validation in Pharmaceutical Manufacturing Facilities

    Boulder, CO, USA

    Cleaning validation is the process of assuring that a cleaning procedure effectively removes the residue (chemical, physical and microbiological) from manufacturing equipment/facilities below a predetermined level. Cleaning validation is primarily used for the cleaning of process manufacturing equipment. The webinar will describe the requirements for establishing an effective cleaning validation program, including the ...

  • Achieve a Safe Bioburden Level by Applying Alcohol Cleaning & Disinfection Best Practices

    Achieve a Safe Bioburden Level by Applying Alcohol Cleaning & Disinfection Best Practices

    Online,

    Alcohol is the most used disinfectant in GMP cleanrooms. Alcohol’s most appreciated features, the almost total absence of residues and its detergent action, depend on its quick evaporation. This means that a short contact time should be considered as a effectiveness limiting factor. Even if GMP guidelines clearly request a specific detergent step before disinfection, IPA is widely ...

  • Developing an Isolator Filling Line Using a Quality Risk Management Approach

    Developing an Isolator Filling Line Using a Quality Risk Management Approach

    Boulder, CO, USA

    Following the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line. Particle Measuring System’s advisory team oversaw the development of the aseptic filling process and the environmental monitoring system of this project by applying proven risk ...