New Technique for Environmental Monitoring in Clean Rooms: Real-Time Viable Particle Counting - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

New Technique for Environmental Monitoring in Clean Rooms: Real-Time Viable Particle Counting

Pharmaceutical Sciences, Manufacturing & Marketplace Report

Pharmaceutical and biotechnology clean rooms are designed to produce, package and transport medicines and health products.  Environmental monitoring (EM) programs are put in place to ensure product quality, and patient safety.  These EM programs typically include measuring or monitoring airborne non-viable and viable particles, as well as other environmental parameters.

For non-viable, or airborne particles, these clean rooms must comply with regulatory guidelines. These standards define particle count limits and methodologies for particle cleanliness classification and monitoring, directly referencing current ISO 14644-1 and -2 particle air cleanliness standards.

Viable particles are particles that include microbiological constituents that could contaminate the product.  These are typically monitored using an air sampling technique. Manufactured pharmaceutical product must wait, typically 3-5 days, for results.

Recent technological advancements, based on optical analysis of individual airborne particles, provide a new method of detecting viable particles, in Real-Time.  This technique is referred to Real-Time Viable Particle Counting.

TSI’s BioTrak Real-Time Viable Particle Counter, provide Quality Assurance professionals with additional, valuable information to find root causes of viable and non-viable particle excursions.

The fundamental technology found in these products is Laser Induced Fluorescence (LIF).  The basis of viability detection using LIF is the intrinsic fluorescence of microbiological constituents.  In simple terms, when laser light is directed at particles, the particles that have certain microbiological properties will "glow".  The wavelength and intensity of this "glowing" can be detected and categorized, to determine the viability of the particle.

About TSI Incorporated
TSI Incorporated serves a global market by investigating, identifying and solving measurement problems. As an industry leader in the design and production of precision instruments, TSI partners with research institutions and customers around the world to set the standard for measurements relating to aerosol science, air flow, health and safety, indoor air quality, fluid dynamics and biohazard detection.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
32%
Breakthrough designations
8%
Protecting the supply chain
40%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Sciences, Manufacturing & Marketplace Report,
Click here