Healthcare workers too often can be unintentionally exposed to Cytotoxic drugs by way of splashes onto the skin or eyes, contact with contaminated surfaces, inhalation of toxic residues, and injection through needlesticks. Effective spill prevention and clean-up procedures are essential to prevent accidents, to reduce drug contamination in the work environment, and to protect workers from exposure to cytotoxic agents.
Note: a spill or leak occurs when a liquid, spray or particulate is not confined in its intended container.
Healthcare facilities need to develop and implement very complex and long procedures to prevent spill and leakages during the reconstitution of drugs, thoroughly clean-up possible toxic spills and leaks. These complex SOPs could be in contrast with the reduced stability of the drug itself and with the efficacy of the treatment. Spill management is a required worker competency that must be initially trained to workers before independently handling HDs as well as annually assessed”.
Our Company is constantly engaged in promoting possible initiative to control and mitigate the risks associated with the handling of cytotoxic drugs on health care professionals at the workplaces where these combination products need to be prepared, manipulated and administered.
ADIENNE’s Fill Choice Room and Fill Choice Dose ready to use solutions are the expression of the valuable commitment and contribution to safety and protection of health care workers involved in the handling of high potent and antineoplastic injectable products.
FILL CHOICE ROOM is a device designed to provide an integral protection from possible external microbial contamination and at the same time erasing the risk of drug spillages or aerosol dynamics.
Fill Choice Room is the best choice for the complete dose reconstitution, dilution and administration of higly soluble drugs.
FILL CHOICE DOSE is a device designed to perform safely and accurately more complex reconstitution procedures for poor soluble drugs or suspensions in a closed system, free from possible external microbial contamination.
Fill Choice Dose is equipped with a two-way valve to apply an error free reconstitution sequence.
ADIENNE’s FILL CHOICE DOSE and FILL CHOICE ROOM support the following features:
- Ready to use reconstitution and dilution practice is guarantee (needle and spillages free procedure).
- Sterile Closed system free from external possible contamination: activation of the combination product is realized without exposing product to external interfaces or environment.
- Safe from activation down to the waste disposal phases.
- Primary container material for large volume diluent can be designed and customized around the API and solvents.
- Primary container material for large volume diluent has chemical & physical drug contact properties similar to glass.
- Faster reconstitution of lyophilized powder and/or error-free dilution of concentrated powder or liquids drugs maximize drug preservation until and along the administration.
- Flexible Clear plastic film allow to evaluate and check the complete reconstitution of drug.
- Error free in reconstitution of all the drug amount, multiple rinsing step in the closed system are facilitated.
- The specific design of the vial connector and spike diameter allows the complete recovery of the vial content once reconstituted, as a consequence no overdosages of API and solvents are needed.
- Suitable for accurate dose adjustment.
- Suitable for activation at time of use, avoids useless holding and storing time for reconstituted powder in intermediated reconstitution diluent.
- Activated at time of use without the need safety hoods or cleanroom environment.
- Product and device are designed together around final target combinational product dose profile, reducing the risk of errors in dose administering.
- Suitable for cold chain storage conditions.
- Suitable for combination therapies and co-administration from a single device.
- Compatible with continuous infusion volumetric pumps.
- PVC and DEHP-free films available US and EU Pharmacopeias compliant.
- Free from silicon or lubricant coatings.
- Sterile aseptic fill and finish manufacturing process applied.
- Gamma irradiated product.
- Multiple Luer Lock dose adjustment and twist-off ports compatible with US and EU spike devices.
ADIENNE operates as an integrated CDMO, contact us to check the suitability of your product with our devices and design your combination product in our lab scale development plant.