Featured Articles

31. 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. 

32. Viable Monitoring Solutions To Prepare Your Contamination Control Strategy For Annex 1 FAQs 12/4/2021

    In our recent webinar many thoughtful questions were asked that concern how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Here we answer questions submitted after the webinar regarding active air and settle plates, rapid micro methods, and specific applications.

33. Particle Counting In Injectable Solutions 12/2/2021

    In this paper, we review counting particle specifications based on the type of injectable solution as well as the apparatus and methodologies you can use to demonstrate compliance.

34. Trend Analysis Of Total And Viable Particle Monitoring Data 10/26/2021

    Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess environmental control performance.

35. EU GMP Annex 1: Non-Viable Environmental And Process Monitoring 10/26/2021

    This paper covers many of the new EU GMP Annex 1 topics including system design, monitoring, cleaning and disinfection, risk assessment, microflora, events and deviations.

36. Alarm Rationale For Continuous Particle Counting Systems 10/26/2021

    Here we review the description of current good manufacturing practices (cGMPs) and how they can be applied to a continuous monitoring system installed within a facility.

37. Selecting The Most Suitable Cleanroom Particle Sample Point Locations 5/14/2021

    Learn how to establish the most suitable location for monitoring a process and build a scientific rationale for that decision when considering where to place sample points for particle monitoring.

38. Managing The Expectations Of Auditors For Microbial Data Collection 5/4/2021

    Microbial environmental monitoring is a growing challenge for the pharmaceutical industry in an increasingly digitized industry, otherwise known as Industry 4.0. Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.

39. Steps To Ensuring A Successful Audit: Effective Risk Assessment Design 4/29/2021

    When designing a process, product quality is an important measure of success. To ensure product quality, it is imperative that the environment is monitored for contamination. 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 enacted.

40. Microbial Control And Monitoring In Aseptic Processing Cleanrooms 4/27/2021

    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. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.