Isolator glove management evaluation of regulatory guidance and framework of recommendations
How does your organization perform glove management? Are you following best practices and using standard industry terminology? Can you benchmark your procedures within your company or with your peers? Are you able to demonstrate a harmonized approach that gives confidence to regulatory inspectors?
As many biopharmaceutical companies struggled to know how to answer these questions, they organized themselves in BioPhorum to develop the answers and write Isolator glove management: evaluation of regulatory guidance and framework of recommendations, which is a guide on best practices for the management of gloves in aseptic isolators used for filling biopharmaceutical products.
The guide has been written by a team of experts involved with creating, maintaining, justifying and operating glove programs. It evaluates regulatory and industry views on the maintenance, integrity testing and risk mitigation requirements for isolator gloves—all with the aim of building recommendations for industry best practices.
The need for guidance was highlighted in a 2018 survey of BioPhorum members, which found that organizations had significant differences in their approach to glove management that were heightened by a lack of guidance on the best practices they should adopt.
The specific weaknesses identified in the survey included:
- Some organizations had received regulatory challenges about the ways they described different parts of a glove
- Different procedures exist, including the frequency and methods of testing gloves, determining when gloves should be replaced and assessing the risk on product quality of defects found in gloves
- Organizations have different nomenclature for the various parts of gloves, making comparisons of performance difficult.
It is worth noting that the proposed Annex 1 recommends conducting mechanical testing of gloves for every batch.
The review found that, as a minimum, these actions should be considered:
- The upfront design of the overall isolator system
- A well defined maintenance program that includes a risk-based, pre-emptive glove replacement procedure
- A justified and defined glove inspection/testing procedure
- A risk mitigation process.
The guide can be used by organizations to help them develop a program to manage the gloves they use in isolators. And those who are using isolators for the first time now have a starting point on which to base their new procedures. The guide will help minimize the likelihood of holes in gloves that may adversely affect production and so require time-consuming investigations.
“Having a best practice guide, developed by leading pharmaceutical companies and that complies with the various regulatory authorities, will help us further develop a more robust Glove Management Program within our company,” said Ed Roman, Deputy Director Filling Operators at Sanofi Pasteur.
Using the guide will help organizations:
- Understand glove-related risks and thus facilitate deviation investigations — a harmonized glove defect approach allows for more confidence in presenting deviation investigations to inspectors
- Understand the rationale for supplier recommendations about glove lifecycle management
- Reduce the need for them to develop glove lifecycle management strategies on their own
- Standardize the language for collecting data across multiple companies and so support benchmarking and improvement activities.
The team has also collaborated with a leading manufacturer that is preparing a complementary guide on the management of pinholes in gloves. This will be published in 2020 and the BioPhorum guide will be updated to ensure its content is cross-referenced to this complimentary guide.
For more information about the glove management guide, contact Justin@biophorum.com.
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