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rochling

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Clean Room Medical Packaging

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By Bhaskar Ch on Wed, 12/16/2015 - 14:26

Top Clean Packaging is an international family group, which is specialized in the ultra-clean plastics industry. This group gathers 5 companies, which provide complementary solutions for various medical specialties: thermoforming medical packaging, thermoplastics injectionmoulding, liquid silicone rubber (LSR) injection moulding in clean room and recycling of plastic production waste.

Top Clean Packaging is established in France, in the Netherlands and in China. This group offers to its customers the benefit of a global support, provided by a single supplier, including project design, implementation and follow-up, even though several companies of the group may take part.

On every step in the process, designers and technicians give a full technical support and assure the materials compatibility, the packaging reliability, and they work together to optimize solutions such as cost issues.

Every step of the manufacturing performed in a clean room takes place within the group. Thus risks of non-conformity are reduced and the “clean” chain remains intact.

Specialized in clean room thermoforming, Cartolux-Thiers produces packaging and thermoformed technical products for the medical and pharmaceutical markets: blisters, mount sheets, trays, clamshells, packaging for the surgical kits and other technical packaging.
Cartolux-Thiers provides complete medical packaging:

  • Thermoformed blisters,
  • Tyvek® Lids (including printing and cutting),
  • Sterilizable foams (including cutting and thermoforming) and other wedges.

With 80 years experience in the packaging industry, Cartolux-Thiers is ISO 13485, ISO 9001, and ISO 14001 certified. Additional services: Design office, tool-making workshop, HF welding, printing, stamping, manufacturing, assembly and others.

Cartolux-Thiers has a subsidiary in China for the Asian market, Cartolux-Suzhou; this company develops and produces high technical thermoformed products, in or out ISO7 clean room, for the medical, pharmaceutical and electronics markets. Cartolux-Suzhou is ISO 9001 certified.

Top Clean Injection is specialized in thermoplastics injection moulding in ISO7 and ISO8 clean rooms for the medical and pharmaceutical industry. Its expertise in the thermoplastics processing extends from standard raw materials, like PP, to the more technical as PEEK. Top Clean Injection is ISO 13485 certified. This company is also a medical device manufacturer: Top Clean Injection supports customers from the conception of the medical device to its sterilization in the packaging.

Additional services:

  • Product design, tool-making workshop,
  • Sterilization of medical devices by the STERRAD® process,
  • Technical documentation of CE labelling.

Quality:

  • Integrity tests (peel and burst) of medical device packaging,
  • Microbiological and particles follow-up on clean rooms,
  • IQ, OQ, PQ, qualifications of the process.

Top Clean Injection has 2 production plants: one intended to the medical markets and the other one to the pharmaceutics. With these 2 plants, the company answers to the customer’s safety requirements of a “back-up” production plant.

Top Clean Silicone is specialized in Liquid Silicon Rubber (LSR) and other elastomers injection moulding in ISO7 and ISO8 clean rooms. This company provides high technical silicon parts for the medical and pharmaceutical markets, from short runs to high volume production, from 0.1 to 300 grams part weights. Processed materials range goes from standard (SHA 10 to 80) to highly technical such as medical-grade silicon, auto-lubricated, auto-adhesive and fluoride silicon
Additional services:

  • Over moulding: thermoplastics, metal or glass insert,
  • 2K moulding: LSR/thermoplastics,
  • Pad printing, screen printing,
  • Ultrasonic welding, assembly.

Specialised in the grinding of wastes from plastics conversion, Top Recycling processes (shredding and grinding of plastics) only with clean or non-polluted industrial wastes. Indeed, our company aims to supply materials, which are admittedly recycled, but of high quality and which guaranteed a complete traceability on all the products.

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plas-tech engineering - Supplier for COC/COP PFS Syringes
YUKON MEDICAL
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