Our new facility located in Ireland, is focused 
on providing sterile fill-finish services to the 
biotechnology and pharmaceutical industries. 
In this new facility, we use the latest technology 
to ensure the attention your sterile product deserves. 

Sterile Fill-Finish Facility (pdf)

Features of this new facility include:

We are dedicated to understanding and fulfilling your requirements, engaging in flexible and collaborative work practices in order to best suit your needs. 

Plant Details 
The plant is built with visibility and transparency in mind with glass featuring prominently throughout the facility. From grade D areas it is possible to see all plant operations, including the filling operation. The clean room layout is designed on the basis of nested areas, with the most sensitive areas in the center of the facility. The circulation corridor, which provides access to all manufacturing areas, also acts as a “cordon sanitaire” around the areas of higher classification, ensuring no processing areas are adjacent to the outside building walls. A Qualified Building Management system controls the entire clean room facilities.

Dispensary
On a batch-by-batch basis, raw materials are weighed under Laminar Airflow in the Grade C
Dispensary area. Within the Dispensary is a glovebox isolator, which can be used for dispensing potent or hazardous materials. The glovebox is built to operate with either positive or negative pressurization. It also has a nitrogen purge capability, a low humidity capability, and a humidity monitoring system for handling air or moisture-sensitive materials. 

Compounding
Using a computerized management system, products are compounded in a Grade C area with a laminar flow arrangement over the compounding vessels for raw material additions. The area has three compounding stations, each of which can accommodate vessels up to 1,000 liters in size. The compounded product is fed through sterilizing filters from this area through to the filing line. All vessels and the product pathway are Cleaned in Place (CIP) and Steamed in Place (SIP). 

Stopper Unloading
Stopper processing is carried out in a completely closed system. On exiting the stopper processor, stoppers are unloaded under Grade A conditions into a Steamed in Place (SIP) sealed container. The container is then docked to the vial filler. This system ensures that the stoppers are fully contained until they are inserted into vials. The filling line also has an IDC port mechanism so that “ready to use” pre-washed and pre-sterilized stoppers can be loaded directly. 

Vial Washing
A Grade D viewing corridor has been deliberately designed to provide visibility of operations. It allows personnel from Grade D areas to view the vial washing, filling and capping operations without entering the cleaner areas. The integrated filling line runs in a “U” shape. The linear vial washer and sterilizing tunnel are located in a Grade C area. The sterilizing tunnel has a heat sterilizable cooling zone. 

Vial Filling
Filling is carried out under Grade A conditions with a Grade B background. The filling machine which is "an against the wall design" allows supervisory staff, visitors or auditors to view aseptic filling operations literally from the heart of the operation. The filling machine can fill 2 ml to 100ml vials at a speed of 120 vials per minute. It carries out a 100% check weigh of vials while in operation.

Capping/Labelling
The capping room is immediately adjacent to the filling room and like filling, capping is carried out under Grade A conditions with a Grade B background. Capped vials exit from the Grade A/B capping room into a Grade D room. Here the vial cap is printed with a designated batch number and can also have a unique sequential vial number added if required.  Vials are placed in trays using an automated tray loader. 

For more information contact
Susan Neenan (susan.neenan@elan.com)