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Isolator best practices:  Benchmark and analysis

Isolator best practices: Benchmark and analysis

This benchmark details the current industry operating practices on gloves testing, surface disinfection and interventions in isolators. It includes the practices from 26 biopharma drug product sites from 14 member organizations. The survey has been used to share practices and consider the opportunities for joint improvement in the industry.

in more detail the survey compares glove inspection both visual and automatic integrity testing, disinfection and cleaning methods as we as the use of H2O2.  Interventions, their categorization, tracking and approval, operator qualification and the handling of door seal failures.

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Isolator best practices:  Benchmark and analysis

Isolator glove management evaluation of regulatory guidance and framework of recommendations

The loss or delay of a batch for glove failure and uncertainties of glove management are perennial concerns for aseptic filling operations. Written by a team of industry practitioners who create, justify and manage glove programs, this guide defines current best practice and the actions we can all take to reduce risk. Specifically it enables users to understand glove-related risks, facilitating deviation investigations and building confidence when presenting to inspectors. Helps users understand the rationale for supplier recommendations about glove lifecycle management. Reduces the need for users to develop their own glove lifecycle management strategies and standardizes the language for collecting data in and across companies, that will support future benchmarking and improvement.

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Alternative and rapid micro methods (ARMM): Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations

Alternative and rapid micro methods (ARMM): Practical applications of bio-fluorescent particle counting in Environmental Monitoring investigations

Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or CAPAs. This paper outlines how bio-fluorescent particle counting (BFPC) can be used in investigations to eliminate the inherent delays of culture-based methods. The application for investigations supplements routine EM; acting as a risk reduction tool enabling real-time detection of viable microorganisms in air samples − supporting root cause analysis and remedial actions. The paper includes guidance on how to use the technology, a real case study involving a mold excursion, and examples of business benefits achieved by various companies.

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Particle classification: An industry-wide standardized methodology and risk classification tool for PC in biopharmaceutical parenteral products

Particle classification: An industry-wide standardized methodology and risk classification tool for PC in biopharmaceutical parenteral products

All companies need to classify the risks various types of visible particles provide. This is not a simple task and without a well supported, scientific basis companies lay themselves open to regulatory challenges and sometimes have to commit to questionable controls. The proof of concept, developed by a large group of industry practitioners, allows companies to underpin their particle classification practices with a rational, risk-based approach. It will not change how companies classify visible particles, but will provide a framework to support their current classifications. The methodology assesses a range of patient risk factors, such as the route of administration, and applies a simple scoring system to calculate an overall risk score for a visible particle in a product or presentation. When challenged by regulators or internal QA teams, the methodology helps companies respond to demands to change particle classifications using an assessment of risk, which in turn may save batches from being destroyed if a classification is unnecessarily severe.

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Particle classification: Risk classification tool

Particle classification: Risk classification tool

This is the Excel spreadsheet based tool that compliments the guidance document titled ‘An industry-wide standardized methodology and risk classification tool for particle classification in biopharmaceutical parenteral products’ As such it enables users to enter product information and particle details and create a risk classification score in line with the guidance.

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Environmental monitoring (EM): Continuous microbiological EM for process understanding and reduced interventions in aseptic manufacturing

This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and product safety and reduces operator manipulations, assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.

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Environmental monitoring (EM): harmonized risk-based approach to selecting monitoring points and defining monitoring plans

Environmental monitoring (EM): harmonized risk-based approach to selecting monitoring points and defining monitoring plans

Environmental monitoring (EM) is a fundamental control for the biopharmaceutical industry yet available guidance is quite general and open to significantly differing interpretation. This makes the full justification of sampling plans challenging in the face of regulatory scrutiny and it difficult for organizations to optimize and harmonize controls across plants and networks. Using the heightened requirements in and around grade A areas, a group of industry subject matter experts have written this highly detailed best practice guidance on EM risks assessments and sample location and method planning, to provide clarity on how to monitor and control our manufacturing environments. This is the first such detailed standard and will be the basis for consistent application of current best practice; thereby minimizing the risk of regulatory scrutiny and non-compliance, supporting business continuity while reducing unnecessary monitoring to a minimum

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Environmental monitoring (EM): Risk assessment template

Environmental monitoring (EM): Risk assessment template

This Excel spreadsheet tool compliments the guidance document ‘Environmental monitoring: harmonized risk-based approach to selecting monitoring points and defining monitoring plans’. This allows the user to assess a room against six factors, the amenability of equipment and surfaces to cleaning and sanitization, personnel presence and flow, material flow, proximity to open product or exposed direct product contact material, the need for interventions/operations and their complexity, frequency of intervention and score them

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Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper

The release of the expanded USP<1207> in 2016 cast doubt over the validity of so-called probabilistic analytical methods, including one the biopharmaceutical industry’s most universal tests – the dye ingress method for container closure integrity

With the dye ingress method ubiquitously used without issue for decades, this paper highlights the continued value and applicability of this and other probabilistic analytical tests. In addition, this paper also describes how any method, whether probabilistic or deterministic, stands or falls on the quality of its development and validation, and not necessarily on the properties of the test itself.

The most important factor is to apply a test method is not how it is labelled, but lies in its development, qualification and whether it meets the need for which it is designed.

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