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Octapharma

ÅF has implemented process installations and carried out equipment validation for Octapharma to ensure regulatory compliance.

Octapharma is a Swedish pharmaceutical firm and one of the largest companies in the world for protein-based drugs, with sales totalling SEK 100 billion. ÅF has implemented process installations and carried out subsequent equipment validation to ensure regulatory compliance. The result was greatly increased capacity at Octapharma’s Stockholm factory.

Challenge

Octapharma needed to up production capacity at existing premises in Stockholm. ÅF was charged with initiating a pilot study to assess opportunities and the extent of installation and validation activities. The outcome of the investigation marked the start of a capacity expansion project, which was launched in 2006.

Solution

We grouped installation and validation activities based on the identified activities and according to their function in the process. In order to increase production capacity we made changes to the building and fitted new installations for media and equipment. The existing plant was upgraded with new equipment and we also made modifications to some of the existing equipment.

We then carried out installation and validation work, which included requirement specifications, purchasing, project management, validation activities regarding IQ/OQ/PQ for WFI, IQ/OQ of process equipment and IQ/OQ of the existing control system.

Result

Following completion of the project, Octapharma was able to increase capacity considerably, which boosted production at its Stockholm plant.

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