Biopharmaceutical manufacturing will continue to expand. Within this market Single Use Disposable Systems are emerging as a preferred method of fluid handling. These Single use systems offer distinct advantages compared to fixed stainless steel systems in cleaning and validation, and can significantly reduce the time required to get a facility up and running, compared to the installation of a fixed, stainless steel facility.
Based on extensive experience with plastic processing for all kinds of medical applications for over 30 years, Medistad has entered the bio processing market with technology to support the development and manufacturing of single use products. In almost 10 years Medistad has build up experience with a range of different applications. In general the products, developed and manufactured in close cooperation with our customers, can be categorized as following:
- Custom made pillow bags ranging from 50ml up to 50 litres
- Liners, 2 dimensional and 3 dimensional (or cubic) bags up to 4,000 litres, for storage and transportation of bulk media
- Complex tubing manifolds, bag and filtration systems for biopharmaceutical processing
- Sterile sampling systems
- Single use mixers
- Single use bioreactors
A new state of the art production facility has been released to manufacture single use containers ranging from 50 ml up to 4,000 litres, pillow style, 2- and 3-dimensional. Our operators are trained in the assembly of large and complex manifolds and single use systems for biopharmaceutical processing. We have adjusted our working practices and procedures to support a high level of flexibility, short lead times and small batch quantities. Several polyethylen based films or your proprietery film can be used to develop and manufacture your single use product range.
Compared to the healthcare market, there were significant differences to address. We have invested in the ability to produce large bags from 50 litres up to 4000 litres, 2- and 3-dimensional. We have trained ourselves in the assembly of large and complex systems for biopharmaceutical processing. We have adjusted our working practices and procedures to support a high level of flexibility, short lead times and small batch quantities. Medistad initiated with one of its key suppliers the development of a film that shows outstanding qualifications for use in biopharmaceutical processing against USP class VI, USP 661, ISO 10993 -4, -5, -6, -10 and -11 and EP conformity analysis. The film is now commercially available.