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As experts in good manufacturing practice regulations (GMPs) for microbiology and environmental monitoring, we help you improve aseptic processes when and where you need it most.

See below to find some relevant papers written by our experts, products for your industry, and services that we can provide you with.

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Knowledge / Papers

ISO 14644-1:2015 Revisions Summary

The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.

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USP <1116> and its Implications for Measuring Microbial Recovery Rates

The recently revised United States Pharmacopoeia (USP) chapter <1116> Microbial Control and Monitoring of Aseptic Processing Environments Chapter <1116> is 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).

 

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Overview of USP 1223 and EP 5.1.6- Validation of Alternative Microbiological Methods

These documents provide guidance on the selection and implementation of assay methodologies to serve as alternatives to compendial microbiological methods.

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A New Rapid Microbiology Method based on Measuring Oxygen Depletion

In this paper we describe an oxygen, depletion-based method as a rapid microbiology assay to test surface microbial contamination in cleanroom environments.

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The Significance and Detection of VBNC Microorganisms

The purpose of this article is to assess the potential significance of Viable But Non Culturable (VBNC)
microorganisms in the pharmaceutical industry.

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Table of statistical corrections according to Feller

How efficient are you at capturing viable particles — colony forming units (CFUs) — on your media surfaces?

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Microbial Control and Monitoring in Aseptic Processing Cleanrooms

Environmental Monitoring (EM), particularly in Pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods.

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Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom (EL)

Choosing the location of the monitoring points suitable for monitoring should be based upon a formal risk assessment using data from the certification and qualification testing. Learn how to properly place particle counters to efficiently monitor your facility and save you money from yield loss. 

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Understanding ISO 21501-4 (LS)

Cleanrooms that manufacture products adopt procedures to improve yield and increase throughput

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Counting Efficiency and Resolution in Optical Particle Counters

Counting efficiency and size resolution are important concepts to understand when discussing the performance of a particle counting system.

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Particle Detection in Liquids with HV or HMW

High viscosity and high molecular weight liquids can scatter laser light, due to the molecules that comprise the chemical.

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Monitoring Precision Parts Cleaning

Continued miniaturization of high technology products in a wide range of industries has resulted in the increased need for cleaner parts.

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Particle Counting in Injectable Solutions 2007 Updates

This paper discusses the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards and includes the most recent USP <788> (April 2007)

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Particle Monitoring Requirements: Freeze Dryers

Lyophilization (Freeze Drying) is a critical process step in the manufacture of aseptic products and should be maintained within a sterile environment.

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LiQuilaz® Maintenance: Capillary Cleaning Procedure

For optimal performance of a liquid particle counter occasional cleaning of the liquid capillary is required.

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Selecting an Airborne Particle Counter

Do you know the right particle counter you need when it comes to monitoring environments, communications, monitoring purposes, desired flow rate and particle sizes?

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Microbial Monitoring of Compressed Gas

There is a need to monitor for particulates and microbial contaminants in pharmaceutical gas lines whether the lines are used for a process gas

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Powder Filling: When and Where to Monitor

Powder filling is the process predominately associated with active pharmaceutical ingredients (API) where bulk powdered materials are filled into vessels prior to shipping to secondary processors.

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Particle Transportation

Transportation of particles through tubing between the sample inlet and the optics of a particle counter has often been at the forefront of discussion regarding the truth of readings.

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Validation of the BioLaz® Real-Time Microbial Monitor

 Pharmaceutical manufacturers are required to prove control over their aseptic manufacturing, which requires monitoring for presence of airborne microbial contamination

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Testing Valves for Particle Generation

Industry standards continue to push toward cleaner processes, and valves have always been notorious for generating particles.

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Review of the PIC/S GMP Annex 1 Interpretation

There are two sections within the PIC/S document, GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS (PI 032-2), issued January 2010, which require further clarification from an industry perspective.

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Understanding ISO 21501-4 (EL)

ISO 21501 has the title Determination of particle size distribution—Single particle light interaction methods.

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Particle Counters and Power over Ethernet (PoE)

Connecting instruments and electronics to power outlets can be challenging—especially in remote locations where an outlet is not easily reached.

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Products

Airnet® II 4 Channel Air Particle Sensor

Airnet® II 4 Channel Air Particle Sensor

The Airnet II 4 Channel Air Particle Sensor measures the size and number of particles suspended in the air for real-time monitoring of defect-causing...

Airnet® II 2 Channel Air Particle Sensor

Airnet® II 2 Channel Air Particle Sensor

The Airnet II 2 Channel Air Particle Sensor measures the size and number of particles suspended in the air for real-time monitoring of defect-causing...

BioCapt® Microbial Impactor

BioCapt® Microbial Impactor

The BioCapt Viable Microbial Impactor enables the capture of microbiologically viable particulates on a suitable media surface for later...

Lasair® III Aerosol Particle Counter

Lasair® III Aerosol Particle Counter

The Lasair III Particle Counter is designed for cleanroom work with your unique needs in...

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