SERUM EYE DROPS

THE INNOVATIVE AND SAFE PRODUCTION OF SERUM EYE DROPS IN A CLOSED SYSTEM

The prevalence of dry eye disease is increasing in developed countries. This is mainly caused by environmental pollution, computer screen work and other working conditions that are harmful to health. However, it also frequently occurs as a concomitant disease in indications such as GvHD, Sjogren’s syndrome, etc. Serum and other blood components (e.g., platelet lysate or PRP) in the form of eye drops have proven to be a highly effective therapeutic option with impressive prospects of success.

The production of serum eye drops is usually time-consuming, labour-intensive and costly. With our closed system, the drops can be produced safely, quickly and effectively outside a clean room.

Different systems are available for bottling the eye drops. Larger applicators with 1.5 ml or 3.0 ml cover the need for drops in severe cases of the respective clinical picture. Smaller 0.5 ml and 1.0 ml applicators can be used for patients with less need for drops.

The filling of the applicators takes place in just a few steps. The equipment available in blood banks (e.g., welders, centrifuges, etc.) is used for this purpose. Only the use of the systems with very small applicators requires a newly designed sealing device. The small applicators and the corresponding welding equipment are currently under development

serum augentropfen

Benefits

Applikatorenfertigung in Spritzgußtechnik
Reduzierung des Arbeitsaufwandes beim Befüllen durch Fixierung in Blistern
einzeln versiegelte Applikatoren durch einen Brechverschluß der Kappe
verbesserte Tropfspitze zum einfachen Applizieren der Tropfen
breitere Einsatzmöglichkeiten durch eine Neufassung der Zweckbestimmung

APPLICATION OF THE APPLICATOR SYSTEMS

The production of serum in bag systems has proven to be particularly efficient. The highest yields - compared to production in tubes - are achieved with simple steps. This method of preparation minimises the cost of labour, time, and necessary infectious serology testing. The empty bag systems of the TF304 family can be used to produce serum preparations of high purity. Different configurations are available for the dilution option.

After the serum has been produced, the filling process takes place. It can be done outside a clean room, as the use of a sterile welder ensures the integrity of the closed system. The set is removed from the sterile outer packaging and connected to the serum bag. Optionally, a microaggregate filter (e.g., TFZ1) can be integrated between the serum bag and the applicator system. For tracking purposes, the applicators are labelled according to the manufacturer's internal specifications.

The serum bag is attached to an infusion stand with the suspension eyelet at the bottom of the bag. To start the filling process, the connection between the serum bag and the applicator system is opened by pressing lightly on the tube, and the applicators are filled by gravity. When the serum has reached the vent bag, the filling process is finished.

To increase the yield, the hose sections between the applicators can be aerated in the ATS system. To do this, the sterile air that has been collected in the system's air bag is transferred to the serum bag by applying pressure to this bag. If there is still serum left in the serum bag, another applicator system may be connected to the serum bag. As needed, consider using a short system (ATS12 or ATS12.1). Thus, the maximum number of applicators can be provided for the patient.

The contents of individual applicators or serum that has been allowed to flow into the vent bag after the filling process can be used for the necessary sterility tests. The vent bag is equipped with transfusion ports through which serum can be collected for sterility tests. However, an adapter for inoculating blood culture bottles (e.g., AD821.1) can also be welded on.