Transcript Your complete source for drug delivery in flexible bags

Your complete source for drug delivery in flexible bags
Technoflex:
A brief introduction of the company.
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for direct link
Premixed drugs:
Packing solutions for your IV Premixed Drugs.
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for direct link
Drug Reconstitution:
A new concept for Drug Reconstitution.
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for direct link
Overview
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European leader in design and production of flexible bags for
injectable solutions and drugs, and associated connectors,
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20 years experience in the Pharma industry,
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HQ and production located in Bidart, south west France,
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ISO 9001-2000 certified, GMP compliant,
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World wide presence through direct sales forces and agents
(52% International sales).
Main figures
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Turnover of € 30 MM in 2006, 240 employees, 15 R&D people,
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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
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13 500 m² (145,000 sq.ft) facilities, HQ and production on the same site,
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4000 m² (43,000 sq.ft) Global Clean room surface
ISO 7 and 8 (Class 100,000 and 10,000),
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Active investment policy: more than 7 million € investment in the past 2 years.
Markets & References
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Pharma: Premixed drugs already packed in our bags:
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Ciprofloxacine,
Ofloxacine,
Fluconazole
Ranitidine,
Metronidazole…
References: Sanofi-Aventis, Pfizer, Merck Generiques, Mayne Pharma,…
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IV Solutions: Sodium Chloride, Dextrose, Ringer Lactate…
References: Fresenius Europe , Mexico, South Africa, Grifols-SP….
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Dialysis (Fresenius, Gambro,…)
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Blood derivatives and apheresis (Haemonetics (US), Gambro Bct, …)
Bags Benefits
• Medical advantages:
– Closed system (no risk of contamination by air)
– Minimized Touch contamination (Twist off)
– Convenient and safe drug addition
• User advantages:
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Integrated hanging system
Un-breakable
Light weight
Reduced storage (8 glass bottles = 12 bags in same volumes)
Large and flat printing surface (barcode)
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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
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
 ...
Polypropylene (PP) Bags
Inerta: an Inert multi-layer
Polyolefin compatible with
a wide range of drugs
Raw materials in compliance
with pharmaceutical
requirements
1 or 2 color printing
Tube in PP
Twist off in PP
Injection Site
- Rubber
- PP Inerta membrane – Technoflex Patent
- Polycarbonate body
Twist Off
- 2 versions:
- Vented (Over wrap after autoclave)
- Gamma Sterilised (Over wrap before autoclave)
- Raw material: Inerta
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
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
Methylprednisolon
e
Omeprazol
Piperacillin
Vancomycin
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
Drug powder in
standard vial
= No additional
compatibility
study
 Unbreakable system
 CE mark or 510K
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:
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No risk of needle-stick injuries = Improved safety
Luer lock connection  limited contact with the solution Needle-free
Sterile connection
Safe and secure for both the patient and the healthcare staff
Kit concept for reconstitution:
- Easier inventory management for hospital pharmacists
- Immediate available supply for pharmacy personnel
 time saving and reduced admixture errors
6 steps to safe Drug Reconstitution
N°1
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
Stage 5 - Turn the bag and press
to transfer the reconstituted
solution
Shake the vial
Stage 3 - Push the vial into the
Mapset® to pierce it, break the
frangible port
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…
Contact
Christian Frayret
[email protected]
+33 5 59 54 66 66
www.technoflex.net
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