August 30, 2022

Principal mechanisms of IV filtration

By Dr. Volker Luibl, MBA, Cytiva

Inside an IV in-line filter: learn more about IV filtration mechanisms.


The problem

Risks for patients associated with infusion therapy

Intravenous drug infusions can be a life-saving therapy. It has been shown that these solutions may contain inadvertent particles, ambient air, microorganisms, their associated endotoxins, and enlarged lipid droplets which can potentially put the patient’s health at risk (1-4).

Our solution: Experimental and clinical studies have proven that our IV in-line filtration devices can retain particles, air bubbles, microorganisms, their associated endotoxins, and enlarged lipid droplets (5-7).

Read here about the mechanisms of IV in-line filtration and how IV in-line filter retain particles, air bubbles, microorganisms, their associated endotoxins, and enlarged lipid droplets.

Mechanisms of particles filtration

Mechanisms of particle filtration

Particulates above 10 µm in solutions for intravenous therapy are regulated by European and US Pharmacopeias (4). However, smaller particles and particles inadvertently produced during preparation and administration of the solutions to the patient are not/cannot be regulated. Intensive care patients who receive a multitude of IV infusions can therefore be infused with up to one million particles per day in the absence of IV in-line filters (8-11). Infused particles could lead to a disturbance in the microcirculation and compromised microvascular flow in vital organs resulting in organ dysfunction of ICU patients (9-12).

Our IV in-line filters retain particles by conventional mechanisms of direct interception which include size exclusion (A), cake filtration (B) and bridge filtration (C). Additionally, particulates may be retained by inertial impaction within the membrane or diffusion Interception where there are charge effects (D).

Mechanisms of air filtration

Mechanisms of air filtration

Estimates of the frequency of vascular air embolism (VAE) related to central venous catheters (CVCs) vary from study to study and are reported to range from 1 in 47 to 1 in 3000 catheterization events or from 0.1% to 2% per patient (13-15). While the frequency of this complication may be low, mortality rates attributed to venous air embolisms associated with CVCs range from 23% to 50% (16-20).

Hydrophobic vent membranes on our IV in-line filters allow effective air elimination that may be entrained in infusions (i.e., due to degassing, disconnection, etc.) and protect against air emboli in patients. Results from internal studies demonstrate that our filters can eliminate entrained air in both a vertical and horizontal position (21).

Mechanisms of microorganisms filtration

Mechanisms of microorganism filtration

Lipid-containing parenteral nutrition (PN) solutions are often considered as an ideal microbial growth medium, and slow administration at room temperature offers the opportunity for microbes to multiply and cause adverse effects (22-24).

Our 1.2 µm IV filters have the possibility to retain inadvertent microbes with a size above 1.2 µm, such as Candida species. Our 0.2 µm IV filters can retain smaller inadvertent microbes, which could include Staphylococcus epidermidis and Escherichia coli.

Mechanisms of endotoxin filtration

Mechanisms of endotoxin filtration

Previous studies have shown that gram-negative bacteria can multiply and will shed endotoxin in intravenous solutions (24-25). Inadvertent infusion of nonsterile fluids contaminated with endotoxins may be rare, but hospital cases of endotoxin in intravenous solutions leading to adverse reactions or even death have been investigated (26-30).

Our Posidyne™ positively charged membrane (+) retains endotoxin due to the binding to the negative charge of endotoxins (-).

Filtration of enlarged lipid droplets

Maintaining stability of lipid-containing parenteral nutrition solutions is critical, since destabilization can cause the lipid globules to coalesce, thus causing the particle size to exceed 5 µm. If particle size exceeds 5 µm patients can be at risk of pulmonary capillary occlusion and fat emboli (34).

Our 1.2 µm IV filters have the possibility to retain lipid droplets with a size above 1.2 µm.

With a strong focus on patient safety and satisfaction, our expertise on IV in-line filtration devices optimizes infusion therapy worldwide.

References

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  2. Merry AF, Gargiulo DA, Fry LE. What Are We Injecting with Our Drugs? Anaesth Intensive Care. 2017;45(5):539-542. doi.org/10.1177/0310057X1704500503.
  3. Holmes CJ, Kundsin RB, Ausman RK, Walter CW. Potential hazards associated with microbial contamination of in-line filters during intravenous therapy. J Clin Microbiol. 1980;12(6):725-731. doi:10.1128/jcm.12.6.725-731.1980.
  4. Perez M, Maiguy-Foinard A, Barthélémy C, Décaudin B, Odou P. Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients. Pharm Technol Hosp Pharm. 2016;1(2):91-103. doi.10.1515/pthp-2016-0004.
  5. Perez M, Décaudin B, Abou Chahla W, Nelken B, Storme L, Masse M, et al. Effectiveness of in-Line Filters to Completely Remove Particulate Contamination During a Pediatric Multidrug Infusion Protocol. Sci Rep. 2018;8(7714):1– 8. doi.10.1038/s41598-018-25602-6.
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  23. Holmes CJ, Kundsin RB, Ausman RK, Walter CW Potential hazards associated with microbial contamination of in-line filters during intravenous therapy. J Clin Microbiol. 1980;12(6):725-731. doi:10.1128/jcm.12.6.725-731.1980.
  24. Trautmann M, Zauser B, Wiedeck H, Buttenschӧn, Marre R. Bacterial colonization and endotoxin contamination of intravenous infusion fluids. J Hosp Infect. 1997;37(3):225-236. doi:10.1016/s0195-6701(97)90251-6.
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Author bio

Dr. Volker Luibl, MBA

Dr. Volker Luibl, MBA

Dr. Luibl is a Demand Generation Marketing Manager in medical device and clinical science.