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Technoflex: Premixed drugs: Drug Reconstitution: Your complete source

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Presentation on theme: "Technoflex: Premixed drugs: Drug Reconstitution: Your complete source"— Presentation transcript:

1 Technoflex: Premixed drugs: Drug Reconstitution: Your complete source
for drug delivery in flexible bags Technoflex: A brief introduction of the company. Click on image for direct link Premixed drugs: Packing solutions for your IV Premixed Drugs. Click on image for direct link Drug Reconstitution: A new concept for Drug Reconstitution. Click on image for direct link

2 Overview European leader in design and production of flexible bags for injectable solutions and drugs, and associated connectors, 20 years experience in the Pharma industry, HQ and production located in Bidart, south west France, ISO certified, GMP compliant, World wide presence through direct sales forces and agents (52% International sales).

3 Main figures Turnover of € 30 MM in 2006, 240 employees, 15 R&D people, Production capacity, per year: PVC bags: 70 million, PP Inerta bags: 2005: 8 million bags 2006: 25 million bags 2008 projection: 30 million bags Connectors : 300 million units m² (145,000 sq.ft) facilities, HQ and production on the same site, 4000 m² (43,000 sq.ft) Global Clean room surface ISO 7 and 8 (Class 100,000 and 10,000), Active investment policy: more than 7 million € investment in the past 2 years.

4 Markets & References Pharma: Premixed drugs already packed in our bags: Ciprofloxacine, Ofloxacine, Fluconazole Ranitidine, Metronidazole… References: Sanofi-Aventis, Pfizer, Merck Generiques, Mayne Pharma,… IV Solutions: Sodium Chloride, Dextrose, Ringer Lactate… References: Fresenius Europe , Mexico, South Africa, Grifols-SP…. Dialysis (Fresenius, Gambro,…) Blood derivatives and apheresis (Haemonetics (US), Gambro Bct, …)

5 Bags Benefits Medical advantages: User advantages:
Closed system (no risk of contamination by air) Minimized Touch contamination (Twist off) Convenient and safe drug addition User advantages: Integrated hanging system Un-breakable Light weight Reduced storage (8 glass bottles = 12 bags in same volumes) Large and flat printing surface (barcode) Click logo to go back to menu

6 Technoflex: Premixed drugs: Drug Reconstitution: Your complete source
for drug delivery in flexible bags Technoflex: A brief introduction of the company. Click on image for direct link Premixed drugs: Packing solutions for your IV Premixed Drugs. Click on image for direct link Drug Reconstitution: A new concept for Drug Reconstitution. Click on image for direct link

7 Bags for Premixed drugs
Technoflex manufactures bags for injectable, pre-mixed drugs such as: Anti-Infectives (quinolones) Antibiotics Anesthetics Cardiology products Contrast media Pain killers ...

8 Polypropylene (PP) Bags
Inerta: an Inert multi-layer Polyolefin compatible with a wide range of drugs Raw materials in compliance with pharmaceutical requirements Technoflex Premix Bag 1 or 2 color printing Tube in PP Twist off in PP 

9 Injection Site Rubber PP Inerta membrane – Technoflex Patent
Polycarbonate body

10 Twist Off Vented (Over wrap after autoclave)
2 versions: Vented (Over wrap after autoclave) Gamma Sterilised (Over wrap before autoclave) Raw material: Inerta

11 Technoflex: Drug Reconstitution: Premixed drugs: Your complete source
for drug delivery in flexible bags Technoflex: A brief introduction of the company. Click on image for direct link Premixed drugs: Packing solutions for your IV Premixed Drugs. Click on image for direct link Drug Reconstitution: A new concept for Drug Reconstitution. Click on image for direct link

12 Drug Reconstitution Technoflex has developed a new concept for the reconstitution of injectable drugs such as: Acyclovir Amikacin Amoxicillin Amox.- A. Clav. Cefepime Cefuroxime Ceftazidime Cefotaxime Ceftriaxone Erythromycin Fosfomycin Imipenem Ketoprofen Methylprednisolone Omeprazol Piperacillin Vancomycin

13 A complete needle free kit
A new concept for Drug reconstitution: A complete needle free kit PP Diluent bag* with 2 tubes: Exclusive Inerta Polyolefine (DMF N°19057 at US FDA) Fitted PP* twist off Sterile Luer connector * PVC option also available MAPSET®: a needle free Transfer Set adapted to vials Safe Luer connection Unbreakable system CE mark or 510K Drug powder in standard vial = No additional compatibility study

14 A needle free system for drug reconstitution
National Health organizations require hospitals to replace needle-based systems with needle-less ones in order to reduce the number of needle stick injuries. Needle-free concept via Luer Lock connection: - No risk of needle-stick injuries = Improved safety - Luer lock connection  limited contact with the solution - Sterile connection - Safe and secure for both the patient and the healthcare staff Easier inventory management for hospital pharmacists Immediate available supply for pharmacy personnel  time saving and reduced admixture errors Needle-free Kit concept for reconstitution:

15 6 steps to safe Drug Reconstitution
Stage 1 - Withdraw the Mapset from the blister and introduce the vial without piercing it. Stage 6 - Open the twist off and spike Stage 2 - Remove the male luer cap, connect to the bag Stage 4 - Press the bag to send liquid into the vial in order to reconstitute the drug Shake the vial Stage 5 - Turn the bag and press to transfer the reconstituted solution Stage 3 - Push the vial into the Mapset® to pierce it, break the frangible port

16 Full service For your Reconstitution Kit, Technoflex supplies the following: Mapset®: Transfer set adapted to the vial Diluent bags: Bags produced by Technoflex Introduction of the filling partner – FDA approved Transfer of Registered files for diluent in bags (Saline Solution,Dextrose,Wifi) from 50 to 250 mL. Services: Regulatory affairs and assistance to development Assistance in the compilation of files for registration by authorities…

17 Contact www.technoflex.net
Christian Frayret Click logo to go back to menu


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