We Can Support with Your IV Filtration Requirements
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Pall Medical Scientific Laboratory Services (SLS) offers solutions for both healthcare providers and original equipment manufacturer (OEM) customers. In the OEM space, customers include infusion set manufacturers that want to incorporate a filter into their set, a biopharmaceutical drug manufacturer that wants to co-package a drug with a filter, or a customer who wants to develop a customized device. In the healthcare space, clinicians are concerned with selecting the appropriate filter for specific applications, such as drug preparation and intravenous (IV) in-line administration.
Simulated Clinical Infusion
The purpose of this test is to determine the liquid handling capabilities of IV filters during simulated clinical infusion. It is essential to be able to understand the ability of a filter device to handle the fluid being administered in conjunction with the components of the infusion system. Especially for higher viscosity solutions (eg. parenteral nutrition solutions containing lipids), it is critical to determine whether the IV filter can successfully administer the volume needed, at the appropriate flow rate, and for the required time.
Drug Binding Studies
Drug substance or formulation materials may adsorb to membrane, filter, or device components. Adsorption studies can identify the impact of filtration on a drug substance and thus assist in the best choice of filter media. To establish adsorption characteristics, a study will be developed in consultation with the client to simulate the intended application.
Bacterial challenge studies may be necessary to provide documented evidence of a filter’s capability to remove inadvertent bacterial contamination. Pall Medical typically use a method based on the industry standard ASTM F838-20 “Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration” using Brevundimonas diminuta (ATCC 19146) to determine filter’s capability to retain inadvertent bacterial contamination only (this does not imply sterilizing grade filters). Other micro-organisms can also be utilized, and tests can be performed using a model system or a specified fluid; in which case protocols are developed in consultation with the client. These may include for example, special consideration for drug formulation and filter compatibility.
Endotoxin challenge studies may be necessary to provide documented evidence of a filter’s capability to remove inadvertent bacterial endotoxin. These studies test the ability of IV filters to retain endotoxins produced from microbial contaminants. Pall Medical use an appropriate infusion solution spiked with endotoxin generated directly from gram negative bacteria. The challenge solution is infused through the filter at a defined flow rate over the claimed life of the filter. Samples are periodically taken from the infusion solution and the filtered effluent and analysed for endotoxin.
Drug Product Kit Co-Packaging
We have analytical techniques at our disposal to support root cause analysis of infusion filter blockage events. For example, Scanning Electron Microscopy and Energy Dispersive Spectrometry, SEM/EDS, analysis of the IV filter membrane can provide visual evidence of particulate contamination causing blockage and a chemical analysis of the contaminant. This analysis helps us to identify the root cause and offer solutions.
As regulatory pressure increases to investigate the potential interaction between a dosage form and the components of the delivery system employed, extractable studies are becoming essential. SLS assists clients to identify and quantify the nature of the compounds present and the likelihood of clinical exposure to these. Appropriate model solvents are offered to provide qualitative characterisation and quantitative measurement of non-volatile extractables. A range of analytical methods may be applied, including non-volatile residue analysis, UV spectroscopy, and Fourier Transform Infrared (FTIR) analysis.
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