Test Process and Results of Potential Masking of Sterilizing-Grade Filters.

Pre-use/post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate is because of the fact that scientific data were not available to provide additional clarity that could inform appropriate risk-based judgements and commensurate actions. To gain clarity, the Parenteral Drug Association (PDA) and BioPhorum Organizations Group (BioPhorum) formed the Sterile Filtration Quality Risk Management (SFQRM) consortium in late 2017.

A Review of the Aging Process and Facilities Topic.

Aging facilities have become a concern in the pharmaceutical and biopharmaceutical manufacturing industry, so much that task forces are formed by trade organizations to address the topic. Too often, examples of aging or obsolete equipment, unit operations, processes, or entire facilities have been encountered. Major contributors to this outcome are the failure to invest in new equipment, disregarding appropriate maintenance activities, and neglecting the implementation of modern technologies.

A consensus rating method for small virus-retentive filters. II. Method evaluation.

Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.

A consensus rating method for small virus-retentive filters. I. Method development.

Virus filters are membrane-based devices that remove large viruses (e.g., retroviruses) and/or small viruses (e.

Integrity testing.

To ensure that sterilizing grade filters in aseptic processing worked as required, such filters are integrity tested. Integrity tests, like the bubble point, diffusive flow or pressure hold test, are non-destructive tests, which are correlated to a destructive bacteria challenge test. This correlation verifies the integrity test limits the filters have to pass.

Filter construction and design.

Sterilizing and pre-filters are manufactured in different formats and designs. The criteria for the specific designs are set by the application and the specifications of the filter user. The optimal filter unit or even system requires evaluation, such as flow rate, throughput, unspecific adsorption, steam sterilizability and chemical compatibility.

Types of filtration.

There are a multitude of filter designs and mechanisms utilized within the biopharmaceutical industry. Prefilters are commonly pleated or wound filter fleeces manufactured from melt-blown random fiber matrices. These filters are used to remove a high contaminant content within the fluid.

The mechanics of removing organisms by filtration: the importance of theory.

Very often, the concept of filtration is only considered in terms of sieve retention, which can sometimes be misleading. In this review of the adsorptive particle-capture mechanism, the authors aim to familiarize the filtration practitioner with the possible optimisation of particle retention by the manipulation of factors such as ionic strength, osmolarity, temperature and the use of polymeric filters.