INSIGHTS ON CRITICAL ENVIRONMENTS

• Techniques To Understand And Mitigate Variability In Aerosol Particle Measurement Applications

  Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively.

• Proper Biological Indicator Placement During Vaporized Hydrogen Peroxide Decontamination Cycles

  We discuss the three general BI types used for monitoring the VH₂O₂ cycles and directions on their proper placement in the isolator.

• Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development

  The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.

• Replacing Settle Plates With Active Air Sampling

  Settle plates are a non-validatable method as it is simply based on the physical principle of the downfall of a particle on a surface. We discuss the using active air sampling versus passive air settle plate monitoring in routine environmental monitoring.

• A Practical Guide To Aerosol Particle Counter Matching

  1/15/2021

  This short application note provides a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.

• Data Quality - The Journey Of The Data Management Life Cycle

  9/30/2021

  Sometimes we focus on data while forgetting how poor practices, bad decisions, incorrect definitions, and lack of evaluations effect the outcome. In this webinar, we analyze how to go from “data” to “data quality” to improve your overall contamination control strategy.

• Deliver Contamination Control Solutions To An AUSTAR Customer

  10/31/2021

  In this video interview, the team from AUSTAR UK discuss why and how they worked with Particle Measuring Systems’ (PMS) exclusive UK distributor, EMS Particle Solutions, to provide an AUSTAR Sterility Test Isolator customer with a complete viable and non viable contamination monitoring solution using PMS instrumentation and equipment.

• SP i-Dositecno EVW-100 External Vial Washer

  10/5/2021

  Compact in-line vial decontaminating machine designed to rinse pharmaceutical vials.

• A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter

  12/4/2021

  A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more.