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Real-Time Viable Particle Detection For Definitive Root Cause Investigation

Real-Time Viable Particle Detection For Definitive Root Cause Investigation
By Mike Dingle, Field Application Specialist, TSI Inc.
Investigations into viable air excursions are very difficult to perform using traditional methods. The data generated is very limited and not very timely. This often leads to high levels of frustration as the problem persists, with vast amounts of time and resources being consumed while the root cause remains elusive.
No matter how extensive the investigation, due to the limitations of the traditional tools available, luck often plays a large role in actually identifying an elusive “smoking gun.” As stated by the FDA in the Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice: “Environmental monitoring methods do not always recover microorganisms present in the sampled area. In particular, low-level contamination can be particularly difficult to detect.” ....

Mike Dingle , Field Application Specialist , Sterile Drug Products Produced , Aseptic Processing , Current Good Manufacturing Practice , மலட்டு மருந்து ப்ராடக்ட்ஸ் ப்ரொட்யூஸ்ட் , அசெப்டிக் ப்ரோஸெஸிஂக் , தற்போதைய நல்ல உற்பத்தி ப்ர்யாக்டீஸ் ,

05.25.21 -- Are You Approaching LIMS Validation Correctly?

05.25.21 Are You Approaching LIMS Validation Correctly?

Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights ....

Dominic Hyde , Stephen Natoli , Alex Nancekievill , Kashif Ghaffar , Jason Osman , Peter Poechlauer , John Mcguire , Todd Andrews , Gabriela Mikhaiel , Jeff Tremain , Lonnie Barish , Matthew Jones , Mike Dingle , Bora Pharmaceuticals , White Paper Alconox Inc , Nidec Group , Natoli Engineering Company Inc , Qa Ajinomoto Bio Pharma Services , Pharma Services , Thermo Fisher , Per Hammer , Natoli Engineering Company , Coperionk Tron , Ajinomoto Bio Pharma , Fisher Clinical , ஆதிக்கம் செலுத்தும் ஹைட் ,