Training and Education from Particle Measuring Systems (PMS) ...

Cleanroom Contamination Control - Training

Our experts can train you at your site or organize events and company seminars. Basic training includes: Environmental and personnel monitoring. Cleanroom behavior and best practices. Cleaning and disinfection strategy. Good Distribution Practices (GDP). Microbiological laboratory best practices. Qualification vs. ...

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

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

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 ...

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 ...

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 ...

Understanding ISO 21501-4: Particle Counter Calibration - Webinar

ISO 21501-4 has two main goals; to improve instrument-to-instrument data correlation and count accuracy, and to enhance compliance with ISO ...

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 ...

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 ...

SO 14644-1:2015 Revisions Summary - Webinar

Over the last five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and ...

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

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

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

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 ...

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 ...

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 ...

Cleanroom Contamination Control Education Training

Environmental Monitoring Risk/Gap Analysis: Define or review the monitoring sampling points for your environment with a scientific and risk-based ...

Particle Measuring Systems (PMS) Training