This new state-of-the-art, flexible fill and finish facility was approved by the Swedish MDA in January 2009 to expand the offer to include sterile production of medicines according to European regulations. Medicines are filled in single-used syringes or injected vials while meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.

The facility is helping customers with projects for clinical trials and commercial scale, and is capable of manufacturing finish product that are approved for trials on human subjects that require aseptic production and lyophilisation. Pharmaceutical products can be both sterile filtered (aseptic) and terminally sterilized by autoclave.

The facility has a production space of 1000 m² (10 765 ft²) of which 500 m² is in current use.

• The facility will be able to manage:
• Filling of vials (3 – 100 ml).
• Filling of presterilized syringes (0,5 ml – 10 ml)
• Filling capacity of approximately 4,000 syringe units/hour.
• Freeze drying capability of approximately 5,000 bottles/hour (10 ml)/batch.
• Finished product can also be made manufactured in frozen solution.  This is advantageous in early stages of a project to keep costs down.
• Stability studies.
• Batch sizes from 1 to 600 litres.

Clean Rooms, equipment and personnel are governed under the regulations (cGMP) of EU and FDA.

All production areas are regulated according to access, methodology and clothing. Classified zones adhere to EU-classification (Eudralex, Annex 1, grades A-D) which is comparable to US-classification (grades 1,000; 10,000 and 100,000) and ISO-classifications (cf ISO14644-1,2).