Valembal Isotherme - secteur médical

MEDICAL

Compliant with the ISO 14644 standard and GMP requirements, with a 240 m2 ISO 7 clean room, VALEMBAL is equipped with two heat sealing lines, a traysealer as well as around ten sealing equipment allowing packaging and vacuum packaging of manufactured packaging.

We guarantee the selection and monitoring of our reference suppliers, the control, storage and traceability of the raw materials used. and finished products delivered, training staff and carrying out regular internal audits in order to meet the requirements of the pharmaceutical sector.

In order to meet the requirements of medical device manufacturers, VALEMBAL has implemented strict control and use procedures for its equipment and raw materials to minimize the absence of direct and cross contamination.

Our packaging meets clean room requirements, and we ensure the conformity of the materials used (European Pharmacopoeia, and/or food safety).

We maintain upstream (supplier certificates) and downstream traceability of our production (batch files and production samples) for 5 years.

All our clean room productions are controlled according to the sampling rules of the ISO 15378 standard.

VALEMBAL symbolizes the commitment to excellence, putting quality and transparency at the center of our approach. As a partner in the medical and bio-industrial fields, we are building an integrated supply chain: from design to distribution. Drawing on our expertise, we design personalized solutions that guarantee the integrity of your products.

Salle blanche pour la réalisation de pochettes pharma chez Valembal, fabricant et fournisseur de solutions d'emballage.
Salle blanche pour la réalisation de pochettes pharma chez Valembal, fabricant et fournisseur de solutions d'emballage.

Packaging solutions for Medical

We offer packaging solutions for all companies in the medical device sector, adapting to your requirements and specifications and can produce large and medium series as well as small personalized series for specific requests.

We carry out the internal processing of sheaths and films supplied from selected extruders, audited and certifying the quality, cleanliness and traceability of the products delivered. The materials we transform (non-exhaustive list)

  • LDPE pharmacopoeia grade without additives
  • LDPE pharmacopoeia grade semi-slip with low additive
  • LDPE/PEMD food grade slippery
  • PE/PA/PE complexes
  • PE/EVOH/PE complex

 

By purchasing the company Polyma in 2021, Valembal added the know-how and expertise of several historic partners in Europe and Asia in order to be able to meet a large demand for health and medical device professionals, on the flexible packaging. The partners we work with are all ISO 13485 certified, Dupont de Nemours approved, products manufactured in ZAC corresponding to class ISO7 in operation according to the ISO14644 standard.

We study all your requests and all your needs in partnership with the methods and R&D departments of our suppliers.

Among the products we offer:

  • Complete range of coated and uncoated papers (36 to 100g per M2) for medical packaging, printable or not, suitable for all types of sterilization methods. The coating can be solvent or non-solvent, hot or cold sealable, to provide a fully fiber-free peelable opening when sealed to a wide range of partner tapes.
  • Aseptic transfer packaging / medical device / hospital and dental needs: TYVEK® bags for steam sterilization, TYVEK® rolls for steam sterilization, peelable pouches, header bags, aluminum bags, self-sealing bags, PET film and bags / PP, film and bags Paper/PET/PP, film and lacquered grid bags.