GENERAL INFORMATION

ISOLAB plastic production consists of experienced staff, high-tech machinery and premium grade raw materials. Almost all of our products are certified with CE - Invitro Diagnostic Directive council directive 98/79/EC, concerning in vitro diagnostic instruments.

We use the best quality raw materials purchased from the worldwide plastics leaders in order to manufacture our high quality products. Before the production begins, every batch of raw material is controlled in the quality control laboratories. They are approved according to MFI (melt flow index) value, OIT (oxidative induction time) value, density and humidity.

In sterile production area, well equipped clean rooms with HEPA filters (high efficiency particulate arrest) and positive pressure area are held with air locked doors. With special outfits and approved cleaning chemicals; these clean rooms are validated according to DIN and ISO standards.

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Reliability and customer satisfaction are of highest importance for ISOLAB. That’s why, like all of its other products, ISOLAB applies a detailed cross check system and multiple tests on products at every stage. Usually, the manufacturing process and also the environment in which the plastic products are moulded and packaged are potential sources of contamination. If products are manufactured in an open environment, they might be contaminated.  Equally important are automated, clean production conditions, starting from the raw material to the final product. Thus, the following precautions are taken:

 

In order to minimize the risk of any contamination, special particle filtration (HEPA) and positive pressure are applied to keep contaminants out of the manufacturing area. 
To avoid any contamination from human contact, the whole manufacturing process is almost automated - pure plastic raw material is automatically fed from silos to moulding machines, through vacuum loaders. 
The moulding machines are located in closed environments and directly connected to automated loading machines. 
All parts of the machinery are constantly monitored by special software. All the workers are equipped with appropriate, specially designed, protective clothes, masks, hair nets and gloves in order to diminish the contamination risks. 

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