About Us


Founded in 1969, Plastitec is mainly focused on the pharmaceutical market by providing accessories, components and packaging materials. Being vertically integrated, we make our own granule compound and have our own processes of extrusion, injection molding, welding, printing and assembly of the product. The most common finished products are Bags for parenteral solutions (IV), Bags for peritoneal dialysis (CAPD/APD), parenteral nutrition Bags (TPN), Blood Bags, platelet collection Bags and drainage Bags. Furthermore, the company produces a variety of accessories and medical devices.

Professionalism Quality Innovation Technology

Our solutions to your safety


Customers of Plastitec use our bags and medical devices to provide health care treatments and, ultimately, save lives. Regarding IV or infusion therapies, the standard solutions are: Water for Injection, Ringer Solutions, Sodium Chloride 0.9%, Glucose 5% and 10%, Ringer Lactate, Sodium Chloride 0.9% with Glucose 5% and Mannitol.

Polyolefine
Polyolefine
PVC
PVC
EVA bags
EVA bags
Blood bags
Blood bags
PP Film
PP Film
PVC Layflat
PVC Layflat
Medical Devices
Medical Devices
Accesories
Accesories
Blood transfusion set
Blood transfusion set
Platelets transfusion se
Platelets transfusion set
IV infusion set
IV infusion set
Irrigation set
Irrigation set



Quality


The ISO 13485, the quality system that supports us

Since 2002, Plastitec was certified under the ISO 9001 Quality System. In 2018 the company update the system to a more specialized standard focusing on medical devices and to its pharmaceutical customers requirements, the new certification is under the ISO 13485:2016. Plastitec guarantees the fulfillment of ISO 10993, European and US Pharmacopoeia norms by granting each customer a third-party certificate of the tests that are made of our materials. These include:

  • Elution test – ISO Cytotoxicity.
  • Intracutaneous Test – ISO (2 extracts).
  • Material Mediated Pyrogen – ISO
  • Direct Hemolysis – Rabbit Blood.
  • 14 Days Muscle Implantation Test.
  • Biological Test for Plastic Class VI.
  • Physicochemical Test USP.
  • European Pharmacopoeia, Chapters 3.1.14. – 3.1.7 – 3.2.2

Other test certifications that depend on specific requirements are documented.
ISO 13485:2016 - ISO Cytotoxity - Quality Materials
ISO 13485:2016 IQ NET 13485:2016

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