Particle Measuring Systems

19 training found

Particle Measuring Systems Training

  • Onsite Training

    Onsite Training

    Our experts provide onsite training including: Fundamentals of microbiology. Personnel hygiene GMP. Contamination control. Cleanroom protocols. Cleaning and sanitization GMP. Alternative microbiological methods implementation. Quality Assurance and Quality Control Laboratories. Engineering and Maintenance personnel. We can also provide evaluation tests for competency and training certificates.

  • Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements - Webinar

    Combining Particle and Microbial Sensors to Fully Meet Regulatory Requirements - Webinar

    Monitoring of nonviable and viable particles in a cleanroom is critical to meet regulatory requirements. An environmental monitoring system effectively collects, manages and reports on data from both types of sensors. Total particle contamination is a mixture of nonviable and viable particles. Historically, nonviable particles are monitored continuously while viable particles have been monitored on a less frequent basis. In modern aseptic...

  • Reducing Sampling Variation in Offline Particle Counting - Webinar

    Reducing Sampling Variation in Offline Particle Counting - Webinar

    Chemical quality monitoring programs includes data gathered from the time chemicals are received all the way to the point of process. This may involve the use of grab samples and offline particle contamination monitoring to understand chemical quality. Establishing a well-controlled sampling protocol that does not contaminate the fluid and produce false positives is critical for successful grab sampling. Best known methods to minimize external...

  • Steps to Ensuring a Successful Audit – Effective Risk Assessment Design - Webinar

    Steps to Ensuring a Successful Audit – Effective Risk Assessment Design - Webinar

    The best way to locate sources of contamination is via risk assessment, best performed before a process has been implemented. There are multiple tools to assist in completing a risk assessment, and once completed, it is imperative to continually update this body of knowledge to guarantee a defensible monitoring program is developed and enacted.

  • Effective Compressed Gas Contamination Monitoring: Particles and Microbials - Webinar

    Effective Compressed Gas Contamination Monitoring: Particles and Microbials - Webinar

    Control of the environment in which pharmaceutical products are manufactured is a key element of Good Manufacturing Practices (GMP). Monitoring of particles & microorganisms in manufacturing cleanrooms, Restricted-Access Barrier Systems (RABS), and isolators consists of clearly defined components. Absence of viable and non-viable contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or...

  • EU GMP Annex 1 Revision 2017 Draft - Webinar

    EU GMP Annex 1 Revision 2017 Draft - Webinar

    On December 20th, 2017,  the draft for a Revision of ANNEX 1 (“Manufacture of Sterile Medicinal Products”) of the EU Guideline for GOOD MANUFACTURING PRACTICE for drug products and drug substances was published. This updated guidline will set a milestone for adjustments needed within European agencies overseeing drug products regulatory applications. During the creation process, the US FDA and PIC/S were...

  • The Significance and Detection of VBNC Microorganisms - Webinar

    The Significance and Detection of VBNC Microorganisms - Webinar

    Download this On Demand webinar to learn about and compare various VBNC detection methods including: Direct counting methods, Dye reduction tests, Immunological-based methods, Genetic methods, ATP bioluminescence, Fluorescent labeling methods, Optical fluorescence.

  • Understanding 21 CFR 11 and Data Integrity Regulations - Webinar

    Understanding 21 CFR 11 and Data Integrity Regulations - Webinar

    Today, both the MHRA and FDA are highly focused on data integrity and currently discourage methods by which data is recorded manually. Modern data management systems provide a missing link in such circumstances, allowing secure data transfer, automated reporting without data integrity fears, and electronics batch release approval processes. Complying with the new,...

  • Understanding ISO Standards: 14644-2:2015 Cleanroom Monitoring (English) - Webinar

    Understanding ISO Standards: 14644-2:2015 Cleanroom Monitoring (English) - Webinar

    ISO 14644-2:2015 is not only a new standard with which to be compliant, but is also a beneficial tool to use in achieving mature cleanroom environmental control. After the recent release of the ISO 14644-1:2015 Revision Summary and Understanding ISO 21501-4 application notes, Particle Measuring Systems continues the ISO Standards interpretation series of documents with the evaluation of the newly released ISO 14644-2:2015.

  • USP 1116 & Implications of Measuring Microbial Recovery Rates

    USP 1116 & Implications of Measuring Microbial Recovery Rates

    The recently revised United States Pharmacopoeia (USP) chapter Microbial Control and Monitoring of Aseptic Processing Environments Chapteris arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (CFU).

  • Learn Efficient Troubleshooting Techniques for Airborne Molecular Contamination Monitoring - Webinar

    Learn Efficient Troubleshooting Techniques for Airborne Molecular Contamination Monitoring - Webinar

    Decreasing the time to detect, contain and mitigate very low levels of Airborne Molecular Contamination (AMC) is critical for high tech manufacturers. Costs associated with AMC-related quality issues and yield losses are well understood, and adequate reduction of AMC is critical for clean manufacturers to stay competitive. Technical personnel need the flexibility to efficiently collect AMC data with good temporal-spatial resolution anywhere in the...

  • Identifying the Best Rapid Microbial Monitoring Solution for Your Critical & ISO 5/ Grade A Surfaces - Webinar

    Identifying the Best Rapid Microbial Monitoring Solution for Your Critical & ISO 5/ Grade A Surfaces - Webinar

    Managers need the assurance that the surfaces in their facilities are aseptic. Gaining that knowledge in a fast and accurate way that also provides results for all surfaces, even and uneven, is a challenge. This webinar helps you identify which critical surfaces you should be monitoring, and discusses and compares various solutions. A new approach to rapid microbial monitoring will also be presented. Learn how operators can rapidly...

  • Identifying a Safe and Reliable Microbiological Air Sampling Solution for ISO 5 Environments - Webinar

    Identifying a Safe and Reliable Microbiological Air Sampling Solution for ISO 5 Environments - Webinar

    Personnel pose the greatest risk of false positives in aseptic processing. Investigations are required when microbial activity is detected, costing per investigation and the risk of batch loss. The BioCapt® Single-Use eliminates false positives and costly investigations by preventing direct operator contact with the media plate. The innovative design combines the media plate and sampling head into a single unit. This unique solution...

  • Assuring Data integrity in an Environmental Monitoring System - Webinar

    Assuring Data integrity in an Environmental Monitoring System - Webinar

    The current trend in Environmental Monitoring Systems (EMS) is to focus on data integrity by using an industrial automated solution instead of the older PC based approaches. PC-based Environmental Monitoring Systems were common in the late 1990 and early 2000s and were the preferred solution because they cost less upfront and have reduced installation times compared to Automated Control Systems.

  • Quality by Design and Single-Use Air Sampling Approaches - Webinar

    Quality by Design and Single-Use Air Sampling Approaches - Webinar

    Quality by Design (QbD) is a well-known concept in the pharmaceutical industry to increase the overall quality of pharmaceutical drugs and increase patient´s safety. Controlling the quality of air inside an environmental monitoring program is a vital aspect of managing the risk towards the patient.

  • Controlling Quality in Advanced Optics Manufacturing - Webinar

    Controlling Quality in Advanced Optics Manufacturing - Webinar

    Performance trends in the optics industry are driving manufacturers to reduce contamination to levels which a component is exposed during manufacturing including cleaning, handling, coating and assembly. Quality control can be compromised through component exposure to particulate and molecular contamination, affecting laser damage thresholds in coatings, yields in nano-optics and LED production, and causing optical defects in high energy UV...