CSTD & CSSTD

FillChoice® Lung CSTD

Ready-to-transfer

Sterile Connection

Drug Reconstitution

IV Therapy

Oncology

Ready-to-transfer CSTD with Smart Pressure Equalisation system for hazardous drug reconstitution and safe handling.

In compliance with NIOSH recommendations

The toxic effects of antineoplastic drugs used for cancer treatment, beyond the patient safety concerns, bring the occupational risks to health care workers handling hazardous drugs in the course of their duties. Multiple international studies(1) have documented, that healthcare workers who handle cytotoxic drugs have an increased risk of developing health-related problems on the reproductive system, such as infertility, abortions, premature births, as well as other medical symptoms on the renal, pulmonary, and cardiovascular systems.

Haemopharm Healthcare is proud to present a new innovative product FillChoice® Lung, designed with the mission to prevent the exposure of healthcare professionals to harmful effects of cytotoxic drugs during reconstitution and delivery to the patients in need.

FillChoice® Lung is a pioneer closed system transfer device (CSTD), compliant with the NIOSH protocols and definitions for CSTDs. FillChoice® Lung is a patented needle-free and filter-free CSTD, filled with a sterile air for pressure equalisation, designed to be suitable for different vial sizes and a standard luer-lock syringe.

  • CLOSED CIRCUIT. FillChoice® Lung is a completely closed-system circuit with safe-sealed connections that ensures the preparation of medicine according to the medical prescription in conditions of maximum safety for healthcare professionals.
  • NEEDLE-FREE. Thanks to the proprietary Needle-free Injection Port – NIP®, FillChoice® Lung provides a completely hermetic and totally safe needle-free connections to the components of the system, that prevent accidental drug release.
  • FILTER-FREE. FillChoice® Lung is based on the pressure equalisation within the system itself, that guarantees safe, easy and efficient handling of the device, excluding the risk of wet filters and accidental drug vapor release.
  • EASY-TO-USE. The linear pre-assembled closed-circuit system significantly reduces the time for reconstitution and administration, while the proprietary know-how and hermetic connections save medical workers from extra steps and device manipulations.

(1) Fransman, W., Roeleveld, N., Peelen, S., de Kort, W., Kromhout, H., & Heederik, D. (2007). Nurses with dermal exposure to antineoplastic drugs: reproductive outcomes. Epidemiology (Cambridge, Mass.), 18(1), 112–119. https://doi.org/10.1097/01.ede.0000246827.44093.c1

 “FillChoice® Lung: Closed System Drug-Transfer Device” – Download the brochureS

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FillChoice® SIV CSSTD

Ready-to-use

Sterile connection

Drug Reconstitution

IV Therapy

Oncology

“Sterile Injection Vial”. Closed-system transfer device for sterile connection between the bag and the vial.

The preparation of cytotoxic drugs requires a delicate and complex multi-step procedure, to be performed with extreme care. Ina typical reconstitution process, the drug contained in the vial is solubilized and transferred into the bag for administration to the patient, with the use of a syringe with a needle. At each step, the contact surfaces must be disinfected to avoid microbial contamination of the drug. These operations require the utmost caution, in order to not compromise sterility and avoid damage to the health of the operator and patient. The procedure is performed by healthcare personnel in a controlled environment in compliance with the strictest hygiene and safety standards such as, for example, under a laminar flow hood in the pharmacy departments of hospital facilities.

SIV® CSSTD is a patented closed transfer device that allows the sterile connection between the vial containing a drug to be reconstituted and a bag with solvent.

The SIV® CSSTD System consists of a connector and a dedicated vial stopper, suitable for all standard sized drug vials. No modification is required in the capping system of the pharmaceutical manufacturing process.

In compliance with NIOSH recommendations SIV® CSSTD allows operators to perform a sterile operation in an uncontrolled environment, thanks to the patented connection between the stopper and the connector. This feature speeds up and simplifies the logistics of healthcare facilities, guaranteeing the safety of operators and patients.

  • STERILE CONNECTION With SIV® CSSTD the drug vial connects to the bag in sterile conditions with a simple handling, even in a NON-controlled environment, such as, for example, the hospital ward. The patented SIV® system prevents any microbial contamination, without the need for manual sanitization with disinfectant, required with common CSSTDs on the market.
  • EASY TO USE SIV® CSSTD simplifies the reconstitution procedure: the entire operation can be performed directly in the administration bag, in a single step and with a single device, minimizing the risks and the possibilities of error.
  • SAFE RECONSTITUTION WITHOUT NEEDLES SIV® CSSTD is designed in accordance with international needle-free policies: this eliminates the risk of accidental needle sticks, which could cause serious damage to the operators’ health, especially in the presence of cytotoxic and dangerous drugs.
  • VIAL STOPPER IN INNOVATIVE MATERIAL The stopper of SIV® CSSTD system is produced in an innovative material and with a patented geometry that allows the connector to connect the vial stably and hermetically without the risk of detachment of particles from the cap.
  • SAFETY OF THE CLOSED CIRCUIT During reconstitution operations, there is a significant risk of leakage of hazardous drugs in the form of droplets, particulates or aerosols into the surrounding environment. This poses a serious health hazard to healthcare workers performing drug reconstitution. Thanks to the validated closed system, SIV® CSSTD avoids possible contamination from the external environment and prevents the risk of drug leakage, as prescribed by the NIOSH recommendations for healthcare worker safety.
  • ALL IN ONE & READY TO USE The combination of the dedicated bag and SIV® CSSTD allows to prepare, reconstitute and administer the drug to the patient, with a single ready-to-use device.The system simplifies and speeds up the operations performed by healthcare personnel.
  • HOME THERAPY The safety and ease of use of SIV® CSSTD make it suitable for the preparation and administration of drugs at home.
  • CONVENIENCE AND SUSTAINABILITY The possibility of performing all the reconstitution and administration operations using a single device, without additional consumables (syringes, gauze, disinfectant, and more), speeds up and simplifies the logistics and warehouse management of healthcare facilities, reducing consumables and waste, and therefore the environmental impact.

Download the brochure here.

FillChoice® ROOM CSSTD

Ready-to-use

Sterile Connection

Drug Reconstitution

IV Therapy

Oncology

System for drug reconstitution. Closed-system transfer device for sterile connection between the bag and the vial.

FillChoice® ROOM is an innovative system for drug reconstitution and pharmacy compounding that provides both the vial and the solvent in one single closed package and maintains sterile conditions when connecting the vial and the solvent.
FillChoice® ROOM allows to replace the multistep procedure of standard practice and to make the drug reconstitution and compounding pharmacy directly in the bag.

  • TOTAL SAFETY. FillChoice® ROOM is not only a closed system but it guarantees 100% isolation: isolation of the drug from external environment and contamination, and isolation of the pharmacist and nurses from the dangerous drug, with no harms in case of leakages, aerosol or accidental break of the vial as everything remains inside the bag with no possibility to exit. Safety is increased by the direct sterile connection vial-bag: Fillchoice® room is the first system that connects the vial and the bag in sterile conditions.

  • EVIDENCE OF THE DRUG IN SITU. As the packaging is completely transparent, the operators perfectly know what’s inside the bag as they can see the vial, the label on the vial (wich contains important data, such as the name of the drug, the quantity, the concentration, the expiry date, etc.). This way there are no problems of unreadable datas and this minimizes medical errors and favours the correct match therapy-patient. Furthermore, Fillchoice® room system contains the precise amount of diluent and drug and guarantees the complete emptying of the vial content, improving dosing accuracy, so that the patient receives the correct dose of the drug.

  • READY TO USE. Using FillChoice® ROOM there is no need of the hospital pharmacy and the multi-step procedure to make the reconstitution because the vial and the drug are already in the same package and the reconstitution can be easily performed directly in the ward, next to patients bed. FillChoice® ROOM is also ready to hang for making the infusion to the patient from the same bag where the drug has been reconstituted, saving time and work for the pharmacist and the nurses. It is also important to underline an added value of the FillChoice® ROOM system as this is perfectly in compliance with the home-care therapies: in most instances, reconstituted drugs are administered in non-clinical settings (typically at home) by patients or caregivers who are not trained health care Professionals. FillChoice® ROOM is totally safe, very easy to use, with no harms for the user and then suitable also for the non-professionals.

  • NO NEED TO MODIFY THE STANDARDS. The main players are the same used in standard practice: the vial and the bag.
    There is no need for special regulatory and the system can be easily adjusted for several drugs.

  • CUSTOMIZATION. FillChoice® ROOM is available for every kind of drug and solvent, any vial size and any solvent volume. There is also the possibility to customize the bag with multiple connectors for multiple vials if a particular compounding is needed (this could be very useful for some antibiotics) and the system remains completely the same: sterile connection vial-bag, one single package, 100% isolation, ready to use. Fillchoice® room can also be provided with different bag material, for special requests of compatibility with drugs or solvent.

  • SUSTAINABILITY. Thanks to its configuration and method of use, FillChoice® ROOM allows the complete emptying of the vial, even if the drug forms a layer of foam. This means that the patient receives the correct amount of drug and that there is less waste of the active principle: no drug stays unused and thrown away in the vial as it is totally returned to the bag and infused to the patient. For the same reason FillChoice® ROOM also helps in limiting the overfill of the vial performed by many Pharmaceutical manufacturers (up to 35 percent). Furthermore, there a lot of saved costs for the solvent that is already inside the bag, for the Consumables and disposables that are not needed any more, for the Pharmacist work and time, for the Hospital Pharmacy equipment management and for the logistics: it’s easier to manage one single product instead of multiple products for a multi-step procedure.