Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas

  title={Application of Quality Risk Management To Set Viable Environmental Monitoring Frequencies in Biotechnology Processing and Support Areas},
  author={Tim Sandle},
  journal={PDA Journal of Pharmaceutical Science and Technology},
  pages={560 - 579}
  • Tim Sandle
  • Published 1 November 2012
  • Environmental Science
  • PDA Journal of Pharmaceutical Science and Technology
Environmental monitoring programs are essential for pharmaceutical facilities in order to assess the level of environmental control. For biotechnology facilities there is little advice as to the frequency at which viable environmental monitoring should be conducted. This paper outlines an approach, based on the principles of quality risk management, for the development of a framework from which monitoring frequencies can be determined. This involved the identification of common hazards and the… 

Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study

In this case study, the principles of quality risk management were applied to review sampling points and monitoring frequencies in the hormonal tableting unit of a formulation development pilot

Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control: Assessing microbial risks and to determining environmental monitoring locations

Quality Risk Management has been an essential feature relating to the manufacture of pharmaceutical and healthcare products for several decades, and its centrality is embedded in key regulatory

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control

Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis, and quality risk management tools were applied to compare the techniques.

Hazard Analysis and Critical Control Points as a Quality Risk Management Tool in the Pharmaceutical Industry: A Systematic Review

For several years, quality risk management (QRM) has been such an integral component of healthcare as well as pharmaceutical product manufacturing. Effectual QRM can help companies make better

Cleanrooms and Environmental Monitoring

  • Tim Sandle
  • Environmental Science
    Biocontamination Control for Pharmaceuticals and Healthcare
  • 2019

Project Management in Risk Analysis for Validation of Computer Systems in the Warehouse System

This chapter shows a case study in a pharmaceutical industry with the proposition of a methodology for validation of emerging technologies in the computerized systems, and proposes a risk analysis to help companies with validation.

Settle plate exposure under unidirectional airflow and the effect of weight loss upon microbial growth

Environmental monitoring forms an important part of the biocontamination control of pharmaceutical facilities. One element of this concerns the assessment of airborne microorganisms1. Monitoring the

Manufacturing of Microfluidic Sensors Utilizing 3D Printing Technologies: A Production System

This state-of-the-art review highlights the recent advancements in the field of 3D printing technology for the rapid fabrication, and therefore mass production, of the microfluid chips.

Proposta de modelo de análise de risco para a implementação da Liberação Paramétrica de produtos com esterilização terminal

A model of risk analysis for the implementation of parametric release of products with terminal sterilization and the regulatory status of PR in Brazil is reviewed briefly discussing the importance of consistent guidelines for the adoption of PR.

Designing and Implementing an Environmental Monitoring Program

  • Tim Sandle
  • Computer Science
    Biocontamination Control for Pharmaceuticals and Healthcare
  • 2019



Statistical analysis of environmental monitoring data: does a worst case time for monitoring clean rooms exist?

The conclusion reached in the study was that there is no worst case time for environmental monitoring at that facility and that sampling any time during the aseptic filling operation will give a satisfactory measure of the microbial cleanliness in the clean room during the set-up and aseptic filling operation.

Microbiological contamination models for usein risk assessment during pharmaceuticalproduction

The fundamental mechanisms of microbial contamination during manufacture of pharmaceutical products are described and models derived that describe air and surface contact contamination can be used to develop and improve methods of microbial risk assessment.

Quantitative risk modeling in aseptic manufacture.

The fundamental steps and requirements for an assessment of the risk of bioburden ingress into aseptically manufactured products are described and a case study exemplifies how quantitative risk modeling and Monte Carlo simulations achieve a more rapid and improved determination of the risks during the aseptic filling of a parenteral product.

Probability Concepts in Quality Risk Management

  • H. Claycamp
  • Business
    PDA Journal of Pharmaceutical Science and Technology
  • 2012
Probability as a concept that is crucial for understanding and managing risk is discussed through examples from the most general, scenario-defining and ranking tools that use probability implicitly to more specific probabilistic tools in risk management.

Environmental Monitoring

  • A. Harmer
  • Environmental Science
    Fieldwork Ready
  • 2021
This lecture covers the principles of optical fibre sensors for chemical and biochemical measurements applied to environmental sciences. Optical techniques and optical spectrometry are widely used in

Environmental monitoring risk assessment

in the testing of endotoxins and pyrogens for protein-based products, establishing the monitoring regime for a network of over two-hundred cleanrooms, and validating a sterility testing isolator

Pharmaceutical Manufacturing: How to Understand the Process and Assess the Risks to Patient Safety

Introduction At the entrance to the Temple of Apollo, at Delphi, there was a famous inscription, commonly translated as, “Know Thyself.” It was adopted by the philosopher Socrates (470 BC – 399 BC)

Developing a viable environmental monitoring program for nonsterile pharmaceutical operations

No standards currently exist for establishing a viable environmental monitoring program for nonsterile pharmaceutical manufacturing operations. This article presents one approach to establishing such

Successfully implementing total quality management tools within healthcare: what are the key actions?

It was concluded that without careful planning the programme for implementing total quality management was likely to fail resulting in an opposite effect on the quality of healthcare delivery to the one that was intended.

Elicitation of Expert Knowledge about Risks Associated with Pharmaceutical Manufacturing Processes

This article describes the development, implementation, and results of an expert elicitation survey about risks associated with pharmaceutical manufacturing processes, and discusses potential