Services

LCS Process
washing, disinfection, assembling
and packing

The LCS service of washing, assembling, packaging is located by Bioster facility of Seriate Bergamo. This service was born with the aim to give the possibility to the producers of special medical products with very few production batches, to have an industrial quality controlled process of washing, assembling, packing and labeling of medical devices, in a validated clean area, following their specific and particular needs.

Bioster can manage the complete LCS service, from the arrival of the single pieces and parts to the final products to be sold in the market or single phases of the complete process, in order to prepare and deliver the products for the customers, ready for the final sale.

The phases of the LCS process are managed inside a certified quality system, designed and checked in compliance with the European Community Standards EEC, and to the Guide Lines of the different sectors: MDD ( 93/42/EEC), EN ISO 9001, EN ISO 13485, 2001/83/CE, 2003/94/CE, GMP; Italian and European Pharmacopoeia, USP. The producer is free from all the requests related to quality procedures, calibration and controls on the plants; the activity are managed and certified by Bioster inside its quality procedures.
The washing, assembling and packaging service is developed in a certified clean room, ISO class 5 (100). Automatic washing stations, ultrasounds vats, automatic drying systems for the single component, with validated and calibrated characteristics, are the ideal instruments to remove the residual of production, as solvents, oils, dusts, for superficial treatments or the decreasing of the microbiological pound related to the production into grey areas.

The assembling and preparation of the components is developed by specialized operators with many years of experience in this specific activity, with the personalization of the assembling activity for each different need.

Bioster has a large numbers of primary packaging, different and validated types and dimensions with many personalizing possibilities. The final packaging and labeling are performed using specific materials and according to the requests of the single customer.

Each phase of the process can be certifies, through specific analysis on the product managed by Bioster laboratory, located in the same facility.

The final sterilization process is managed using the method more convenient considering the product, considering the high range of Bioster offer (ethylene oxide, irradiation or steam).