Infusion Therapy & Drug Delivery Filtration Devices
The BQ+ line of IV filters is the culmination of more than five years of research, design, and production of the best quality filtering devices for healthcare applications. Integrating filtration devices into IV settings increases patient safety and provides medical practitioners with confidence in their capacity to eliminate air from the line while also minimizing the possibility of particle contamination.
Membrane filters used in-line are commonly employed in medication and fluid administration to remove germs and large aggregates of particulate matter created during the preparation, processing, and infusion of drug combinations used in a variety of patient therapy. The performance parameters of the membrane, in conjunction with the filter housing design, will dictate the system’s safety and effectiveness.
BQ+ provides non-shedding infusion treatment and drug delivery filtering systems with high flow rates, absolute pore size ratings, biocompatibility, and low extractables. For decades, prominent medical device and pharmaceutical manufacturers have relied on our membranes to assure the safe and successful delivery of intravenous medication formulations. BQ+’s knowledge and technology capabilities will continue to play a critical role in simplifying the preparation and enhancing the safety of IV medication infusions as the usage and advantages of new therapies grow.
Drug Delivery
Each time a liquid solution is administered intravenously to a patient, the possibility of accidental microbiological contamination, as well as particle and air microemboli delivery, must be carefully evaluated. In commercially manufactured intravenous (IV) fluids, particles such as glass shards and plastic fragments have been discovered.
When an ampoule is cracked to deliver medicine, glass particles may be sucked into the syringe and supplied to a patient along with the pharmacological product. In solution, lipid droplets may form micelles and agglomerate, forming enormous lipid globules larger than five microns in diameter. These aggregates may get stuck in the capillaries of the lungs, hence raising the risk of infection and possibly dangerous immunological responses. Additionally, under some circumstances, medicines such as paclitaxel, ganciclovir, and mannitol may precipitate out of solution. Precipitated medicines may irritate veins and cause phlebitis.
By preventing particles, aggregates, and precipitated medications from reaching the patient, in-line filtration devices can lower the risk of patient problems. Additionally, bacteria-retentive membrane devices may operate as an efficient barrier against germs introduced during the preparation, processing, and administration of parenteral solutions.
Based on decades of knowledge in the formulation and manufacture of membranes. Our broad range of infusion and drug/fluid delivery devices utilizes our medical-grade Supor membrane. All components and materials used in the manufacture of BQ+’s IV filtration devices comply with applicable biosafety, compatibility, toxicity, and other globally recognized criteria for medical device development programs. Additionally, the Supor membrane’s hydrophilic nature enables many re-primings as required throughout patient therapy.
Chemotherapies
Since the 1940s, chemotherapy has been utilized to treat cancer. Unfortunately, although chemotherapeutic drugs are very efficient against malignant cells, they are also quite hazardous, necessitating specialized administration. The overall objective of new chemotherapies is to administer drugs more precisely, to decrease dose, and, presumably, to minimize unwanted effects. Traditional infusion chemotherapy may cause difficulties such as infection of the access site, blockage of the route, drug toxicity, thrombosis, and emboli. Venous fragility is one of the most prevalent short-term adverse effects of chemotherapy. Around the IV sites, increased vascular fragility, bleeding, and bruising may develop. Additionally, anti-neoplastic drugs may cause irritation.
Particles in drug preparations are especially problematic when administering chemotherapeutic infusions. Chemotherapeutic drugs may crystallize when they come into contact with certain IV solutions or components, obstructing or altering the infusion route. Many medicine makers encourage the use of in-line filtration in their dose and administration instructions to avoid the issues that hazardous precipitates might cause. BQ+’s array of in-line filtering devices comprises materials that are both drug- and oil- and lipid-resistant, guaranteeing strong performance even in the presence of harsh chemicals. Along with particle removal, our hydrophilic membranes provide superior bacterial retention, minimizing the possibility of unintended contamination during the handling and administration of IV fluids.
Pharmaceutical Compounding
Pharmacists are responsible for all parts of the medicine formulation and dispensing process on a professional and legal level. Each nation, region, or academic institution has its own pharmacy practice standards. Additionally, there are professional standards of practice that provide a number of guidelines for practitioners providing treatment in alternative settings. The section on Sterile Drug Products for Home Use in the United States Pharmacopeia (USP) chapter 1206> summarizes some of the guidelines for sterile drug preparations intended for home use but is not a compendial requirement. USP 797>, Pharmaceutical Compounding – Sterile Preparations, was released as a modification to 1206> and sets a series of guidelines and procedures (including a chapter on general tests and assays) for drug compounding facilities with regulatory obligations.
Sterile compounding procedures and other quality control measures are critical throughout the manufacture of pharmaceutical products. Compounding practice is regulated by USP Chapter 797, which requires the establishment of established and recorded quality processes. It is mainly concerned with patient safety and was developed to safeguard patients from microbiologically tainted preparations, among other things. BQ+’s device portfolio contains a range of bacterial, viral, fungal, and yeast retentive membranes that adhere to the USP 797> standard.
Along with the USP 797> requirements, pharmacists are directed by standards developed by the American Society of Health System Pharmacists (ASHP). These guidelines provide the basic criteria for the operation and administration of home care pharmacies that offer pharmaceutical services. The guidelines emphasize the pharmacist’s duty for the sterile preparation, quality, and integrity of their formulations, emphasizing the critical nature of include a bacterial retentive device in the final delivery system. Additionally, the 1997 FDA Modernization Act (FDAMA) has rules impacting pharmacy compounding operations. These requirements are meant to guarantee that bulk pharmaceutical compounds are processed through a sterilizing grade membrane in order to assure patient safety.
Improved patient outcomes begin with the safe and effective manufacture of pharmacological solutions, according to hospital pharmacy specialists worldwide. Cytotoxic drug reconstitution requires special measures to safeguard patients and healthcare personnel during medication handling, dispensing, and administration. Even when normal preparation processes are used, undissolved medication may remain in solutions due to insufficient dissolving of the lyophilized powder. BQ+ IV filtration devices are intended for the delivery of pharmaceutical drugs and safeguard patients from possibly hazardous particles.
Choosing the Correct In-line Filter
Retention of Particulates and Bacteria
It is critical to appropriately identify the size and kind of particle pollutants to be kept or eliminated when choosing an in-line filter for infusion treatment or drug/fluid administration. Contamination of IV fluids with bacteria or fungus is a typical concern associated with long-term IV treatment. BQ+ filtration devices with 0.2 m membranes permit the flow of aqueous solutions while providing an effective barrier to microbial cells of comparable or greater size. In parenteral nutrition applications where the infused solution contains lipid globules that provide vital nutrients to the patient, it is recommended to use an in-line filter with a 1.2m Supor membrane to reduce the risk of yeast contamination while allowing unrestricted passage of suspended lipid micelles.
In-line filtration devices with pore diameters ranging from 0.2 m to 17 m are often utilized in applications where the primary purpose is the removal of undesirable particulate matter such as drug aggregates and precipitates.
Flow Rates
The pore size or rating of a filtering device determines not only its retention properties, but also its practical features, such as flow rate and throughput. For example, bigger hole diameters in membrane devices result in improved flow rates and throughput. It is critical to note that membranes manufactured with various polymers and casting techniques but with the same pore size might display significantly variable flow rates and throughput.
Similarly, the degree of porosity in the membrane has a significant effect on the flow rate and throughput capacities of the membrane. Porosity is a property of membranes that indicates the number of open spaces or holes present. The flow rate and throughput are directly related to the membrane’s porosity. The BQ+ membrane is very porous, allowing for high flow rates and good filtering efficiency. Combining the optimal membrane pore size with a filtration device that maximizes patient safety and comfort while maintaining the membrane’s integrity and flow characteristics is the goal of BQ+’s unique range of devices.
Adhesion and Compatibility of Drugs
When selecting membranes for drug delivery applications, it is critical to ensure that they have a low level of non-specific binding of the active component. The distribution and administration of today’s biotherapeutic medications need the use of low protein binding membranes. BQ+ Supor membrane’s low protein binding properties not only offer good protection against particle and microbial contamination, but also ensure the therapeutic dose’s integrity and consistency. Supor was developed specifically for essential fluid applications requiring low protein absorption, good bacterial retention, and a low pressure drop. BQ+ has conducted significant research on the adsorption capabilities of Supor membranes with a number of routinely infused and/or injected medicines.
Extractables
Membrane wetting qualities may be altered by impregnating a surfactant onto the membrane structure or chemically altering the base polymer prior to or after production. While wetting agents may provide performance benefits, one must consider the likelihood of extractables. Extractables are chemicals that leach or otherwise pass through a membrane or filtering system and are incorporated into the fluid being injected into a patient. BQ+ membranes are intrinsically hydrophilic (they do not need additional surfactants), which results in exceptionally low levels of extractables and considerably lowers the risk of secondary contamination.
Compatibility of Materials
As new medications are created, the possibility of incompatibility increases. Numerous variables, including preservatives, buffering systems, temperature, and concentration, might affect the compatibility and stability of pharmaceuticals. Chemical events such as oxidation, reduction, breakdown, and complex formation may also have an effect on the effectiveness of pharmaceutical formulations. Material incompatibility may also result in physicochemical interactions such as absorption, precipitation, and separation of emulsified systems. BQ+ maintains a comprehensive collection of material compatibility data for our line of hydrophilic infusion membranes.
Compatibility of Lipids
Parenteral lipid emulsions are tiny droplets of oil floating in an aqueous phase and enclosed by a phospholipid membrane. Clinical issues develop when free oil is released as a result of the emulsion “cracking” or when the droplets clump or increase as a result of “creaming.” Emulsions of lipids are thermodynamically unstable and exhibit some degree of instability over time. It may take up to three days for an emulsion’s instability to become visible. There are two main forms of lipid-based infusion therapy for which an in-line filtration device may help prevent lipid aggregates from reaching the patient.
The first is Total Nutrient Admixtures (TNA), which is a single bag that contains lipid emulsions, amino acids, dextrose, and micronutrients. TNA therapy has established itself as a standard of care in homecare, hospitals, and long-term care settings. Total Parenteral Nutrition is the second kind (TPN). Physical incompatibility between TPN solutions exacerbate patient hazards. When giving TPN solutions, calcium and phosphate precipitates are conceivable, as are other chemical incompatibilities. The addition of a lipid emulsion to the combination would hide the precipitates clearly. Filtration offers further safety in homecare settings when compounded IV admixtures are infused.
TPN and TNA solutions have been demonstrated to increase fungal growth, suggesting that the use of a 1.2-m filtration device to eliminate Candida species may help to mitigate the risk of TNA-related sepsis. Oil and fats in the transporting solution might deteriorate the filtration membrane, making it unsuitable for infusion treatment. Due to its shown compatibility with lipid-based solutions, the Supor membrane with a pore size of 1.2 m has been widely employed in nutritional treatment.
Enhanced Patient Safety
IV sets with filtration devices provide value to patients and healthcare institutions, while also expanding economic potential for healthcare vendors. By avoiding contamination, a filter set’s superior functionality might save several expensive issues linked with healthcare treatments. When the increased expense and liabilities associated with not filtering are considered, budget-conscious health systems perceive filter IV setups as a prudent investment. Choosing a medical filtration system that meets your individual requirements is important to your success.
