Bio Most Popular

41. Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview 12/1/2022

    This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

42. FDA Seeks Comment On ICH Q9(R1) Quality Risk Management 7/5/2022

    ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. 

43. Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon 1/10/2022

    This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

44. The Essential Components Of A Sterility Assurance Program 10/15/2021

    The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.

45. How To Advance Continuous Bioprocessing Using Continuous Countercurrent Tangential Chromatography 8/30/2021

    Continuous countercurrent tangential chromatography (CCTC) addresses the inherent limitations of column-based systems by conducting the chromatographic operations (binding, washing, elution, stripping, and regeneration) on a flowing slurry, with inline static mixers used to ensure good contacting between the resin slurry and the clarified cell culture fluid/required buffers.

46. An Introduction To Trending In Environmental Monitoring Programs 4/5/2021

    Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM. 

47. Best Practices: Risk-Based Environmental Monitoring Of Biopharma Facilities 2/3/2021

    While EM programs are one of the most effective tools in monitoring the state of control of classified manufacturing areas, designing an EM program is a relatively complex task. Facilities vary considerably and there is inadequate specific guidance on how to design EM programs and no single standard risk assessment methodology exists.

48. Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219 5/6/2020

    This article discusses some of the history that began the movement from compliance-based approaches to cleaning validation to the science- and risk-based approaches introduced in the American Society for Testing and Materials (ASTM) E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation and the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs).

49. How To Establish Sample Sizes For Process Validation Using Statistical Tolerance Intervals 10/27/2016

    This article demonstrates how to use statistical tolerance limits, which use the confidence level (how sure we are) and reliability value (population value) to determine appropriate statistically valid sample sizes for process validation.