Needleless Injection Vial (NIV®), won the first prize as the best innovation in 2012 at CPhI Pharma Awards

NIV®

Closed needlefree cap for Vial Access

(three patents pending) 

NIV is a new closure for glass vials which contain drugs or nutritional active principles which are injectable medications, mostly sold as lyophilised or freeze-dried drugs, and require reconstitution, mixing or transfer before administration to the patient. It has a hermetic seal, using a needle free site on the vial seal, which is perforable with a needle-free syringe, which automatically closes again when syringe is removed from the site. This device replaces both standard vials used with normal syringe with needle, and needle free vial connector or adaptors which require another item for drug reconstitution.

The main innovation is the rubber top on the vial closure. The rubber top on medication vials, in general, protects the contents from outside contamination. Needles pierce the rubber stopper easily, allowing access to the medication. When medication is drawled from a rubber-topped vial, it is essential that the proper procedures are followed, to prevent contamination and ensure the correct dosage to be administered to the patient. Moreover, the rubber top needs to be also secured for the care giver or to the patient itself in home care, avoiding backflow and dangerous aerosol release from the vial, in case of toxic substances, as some oncology drugs can be.

NIV (Needleless  Injection  Vial)  is  introduced  as  the  first  needlefree  system  of connection between Vial and syringe, having as main assets:

Needlefree device, in compilance with needlefree policies; Possibility to be Custom designed;

Minimizes drug foaming during drug reconstitution, assuring the correct drug dose to the patient and avoiding drug waste and overfilling;

Reduces aerosol and leaks caused  by pressurization when accessing the vial;

Mechanically and microbiologically closed system during and after multi- use, and therefore hermetically closed, avoiding contamination of the vial’s contents;

Innovative material.

        FASTER: all the process of reconstitution, mixing and administration to the patient is shorter

        SECURE: better protection for nurses and other caregivers

        COST: effective

        DOSE: less failure due to suboptimal dose

A wide range of infusional solutions ranging from 20 ml to 10,000 ml in PVC or PVC free bags, Haemo-Dialysis concentrates, KCl fluids for dialysis concentrates and preparations for rinsing and irrigations are available.

• Haemofiltration solution (lactate buffer) in PVC bags from 2,000 to 5,000 ml.
• Haemofiltration solution (bicarbonate buffer) single compartment PVC bags from 2,000 to 5,000 ml.
• Haemofiltration solutions (bicarbonate buffer) double compartment in PVC free bags of 4,500+500 ml and 5,000+500 ml
• Priming and IV solutions in PVC or PVC free container
• Closed and safe infusion System with patented spike SharpBag® and customized connectology to fit the infusion set.
• CAPD System and Solutions for peritoneal dialysis in PVC or PVC Free bag of 1,000 - 1,500 - 2,000 - 2,500 ml

Galenic preparation and IV solutions under medical prescription as per D.L.219/06 ART.5 COMMA 1.

• Haemo Dialysis
• Haemofiltration
• Sharp Bag - Safe and closed Infusion System
• PERIline CAPD System
• Cleansing bag

The pharmacological therapy includes all the drug chain, that is, all the activities and processes that are performed for the material implementation of the pharmacological therapy, and it represents a vital and critical element in medical care. A research from 2003 (Taxis, 2003) has shown through direct observation of infusion administration practice, that 73% of the infusions are performed with excessive speed and that in 14% of cases, prepration mistakes have been found. The most common mistakes result from a very wide typology: unreadable writing of data on the packaging of the drug to be administered, wrong drug cocktails, mistakes in administration phase, etc. Active principles which can cause major damage to the patient in case of wrong administration are considered at high risk. The ISMP (Institute for Safe Medication Practices) has drafted a list of these principles, basing on damaging mistakes reported. Haemopharm's research and development department dedicates itself to the study and research of suitable systems which can guarantee a simple and safe pharmacological therapy.

FILLchoiceTM Bag RECONSTITUTION AND ADMINISTRATION/INSTILLATION OF SINGLE ANTIBLASTIC DRUGS, ANTIBIOTICS, NUTRITIONALS The FILLchoice bag, created by Haemopharm's research and development, guarantees the reconstitution of drugs, in powder, liquid or gel form, in absolute safety and simplicity, thanks to its patented closed circuit system. The bag can contain a basic infusional solution (solvent) with the volume and formulation requested, for the final reconstitution. The main advantages are: closed circuit system during all preparation, reconstitution and infusion operations to the patient, physical and microbiological tests performed by Haemopharm's Laboratory; Simple use and a significant reduction of the handling operations; No drug aerosol nor particulate leakage outside of the system; No needles; No liquid leakage, no aerosol drug particulate leakage; Drug evidence during the infusion session. Cost control.

FILLchoiceTM dose BAG RECONSTITUTION, ALSO IN ASSOCIATION, DOSING AND ADMINISTRATION/INSTILLATION OF ANTIBLASTIC DRUGS

The FILLchoiceDose bag, created by Haemopharm's research and development, guarantees reconstitution also in association of antiblastic drugs in absolute safety and simplicity, thanks to its patented closed circuit system. The bag can contain a basic infusional solution (solvent) with the volume and formulation requested for the reconstitution. The main advantages are: closed circuit system during all preparation, reconstitution and infusion operations to the patient, physical and microbiological tests performed by Haemopharm™s Laboratory; possibility of dosing the drug; No filters, which are potential cause of drug particulate leak by aerosol effect, and the access of microorganisms; Handling of the pressure during the use, guaranteed by the special connector registered at the FDA (USA Food and Drug Administration) N. 1000324175 and complying with European ISO/CE rules; Simple use and a significant reduction of the handling operations; No drug aerosol nor particulate leakage outside of the system;

No needles

Drug evidence during the infusion session

Cost control