Continuous Liner Manufacturing GMP in Clean Room Environment

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The CONTINUOUS LINER MANUFACTURING by CSV Containment.

Our “Donuts” are made of plastic material which is wound, compressed, and pre-packaged in order to obtain several meters of material which may be applied on discharge or transfer pipes, occupying the lowest amount of space. The CONTINUOUS LINER, packed in this way, allows to obtain cylindrical volumes (drum liner) which may be then unwound or unrolled from the Donut into the drum, making it possible to load dusty material avoiding any contact with the drum itself (packaging).

Most of all, the CONTINUOUS LINER makes it possible to never open the discharge circuit, replacing a drum with the following one during discharge/transfer phases, which usually require several containers.

An extreme versatility which allows the creation of several solutions in different shapes and colors, even specific ones, thus favouring the realization of FLEXIBLE ISOLATORS to confine all the exposed operations. Sometimes called GLOVE BAGS are similar to plastic bubbles equipped with gloves, filtersusually put into place as AD HOC solutions for specific needs, assessing which atmospheres must be sealed and molding the shapes which may be ergonomically more appropriate in order to allow for the best use by the operators.

The scope of our applications (chemical-pharmaceutical), has inevitably pushed us to increase the quality of our internal manufacturing capacity and quality, in terms of control and tracking of the production processes and supplied products as well as the environments in which the production, packaging and storage operations are carried out, in accordance to specific pharmaceutical requirements (GMP or Good Manufacturing Practice) and quality standard (ISO 9001: 2015)

This development has led to a radical transformation of the MANUFACTURING FACILITY towards an ISO 7 and 8 classification, using areas with controlled atmosphere, filtered air, differential pressures cascade, clean room particle monitoring, separate material and personnel flows.

In summary, environments, production processes, process controls and materials had to comply with the quality requirements indicated by pharmaceutical rules and practise as well as our customers requirements. Indeed, our customers have led the development of this process by suggesting the improvements needed to become a Qualified flexible technology supplier.

Our production process involves the use of basic material (low density polyethylene) directly supplied by CSV, rigorously certified and accompanied by the documentation required by the pharmaceutical industry. Furthermore, we can also transform material provided by third parties or other suppliers indicated by the final customers, especially in case stability studies have already been carried out. All of this, with the purpose to speeding up the production of the items required, without compromising the quality assessment on the material already validated by our customers.

The presence and use of qualified automated heat-sealing equipment allows a RELIABLE and HIGH QUALITY MANUFACTURING of several designs of liners and flexible isolators.

Given that our work can be considered as a form of industrial tailoring, we have the habit of involving our final customers in the definition of the shape which they may like and need, in order to ease the use of the devices, make their installation simple and their decontamination, removal or replacement quicker.

 

CSV Containment is present in the pharmaceutical market and is focused on providing engineering, construction and validation solutions for the LifeScience world. For more information:containment@csv-ls.com

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