AsepticTechnologies Press Releases

Closed Vial Technology

Press Release – Aseptic Technologies S.A.
Closed Vial Technology

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Contact Supplier: Aseptic Technologies S.A.
Supplier Press Release: Closed Vial Technology
Address: 7 rue C. Hubert, B-5032 Gembloux, Belgium
Tel: +32 81 409 410
Fax: +32 81 409 411
Website: www.aseptictech.com


28 JUNE 2012

Closed Vial Technology

Worldwide demand for our equipment and technology which includes our closed vial technology is increasing.

Through the demand of our equipment, and feedback from those using it, some interesting trends have become apparent:

• Positive moves have been made towards Closed Vial Technology with several companies setting up additional equipment to expand production capabilities or to move from R&D to GMP setting. This confidence indicates that our technology is meeting our client’s expectations in preliminary investigation and provides strong solutions for their products.
• Equipment fully dedicated to cell therapy has been installed or ordered by twelve clients, proving our solution is a success within this field.
• Interest in our technology has increased following the EMA approval of GSK’s vaccine against pneumococcal infections, SynflorixTM last June.
• Our technology has been acquired by a hospital to supporting their move to GMP compliance
• At a very low investment, our technology has been acquired by a hospital to support their move to GMP compliance for aseptic filling. In addition, to improve the quality for the patient, our highly effective system keeps the container permanently closed. Several other projects with hospitals are under discussion.
• Our technology is becoming recognized further a field, in addition to the US (12 projects) and Europe (12 projects), we also have interest in Mexico, Singapore, Israel and India.

For more information or to discuss our closed vial technology please contact us directly.

Contamination Risk of Filling Technologies

Press Release – Aseptic Technologies S.A.
Contamination Risk of Filling Technologies

Contamination Risk of Filling Technologies

Contact Supplier: Aseptic Technologies S.A.
Supplier Press Release: Contamination Risk of Filling Technologies
Address: 7 rue C. Hubert, B-5032 Gembloux, Belgium
Tel: +32 81 409 410
Fax: +32 81 409 411
Website: www.aseptictech.com


06 APRIL 2012

Contamination Risk of Filling Technologies

Aseptic Technologies has produced a report on the contamination risk of filling technologies. Benoit Verjans and Charles Reed have compared four recognized aseptic filling technologies, ampul, open vial, blow-fill-seal (BFS) and prefilled syringes to the Crystal® closed-vial technology in regards to the exposure risk viable particles from the air supply.

The containers (i.e. vial, syringe barrel, ampul), container closures (i.e. stopper, plungers) and filling needles have been taken into consideration and weighted by exposure time and exposed surface.

The analysis demonstrated that two technologies, closed vial technology and BFS, substantially lower the risk of contamination due to exposure to the environment.

A recent article published in the Pharmaceutical Technology Europe has mentioned the risk of contamination due to exposure of internal surfaces of the container throughout the filling process. The article explained the model of an environmental risk approach established on laminar airflow that is prone to carrying viable particles. The preliminary analysis was done using only three kinds of containers, large vial, small vial and ampuls and took into account entry of the bacteria through the container neck.

Our analysis into the contamination risk of filling technologies has broadened this to involve extra packaging types employed for aseptic filling of liquid products ie., vials, ampuls, blow-fill-seal containers, prefilled syringes and closed vial technology. The contamination sources have been methodically screened. The report concentrates on risk arising from environmental contamination during filling operations.

The analysis concluded that aseptic filling definitively contains an element of risk introduceddue to potential presence of living organisms into the production environment. It is estimated that at least 300,000 people worldwide face contamination each year due to contaminated sterile drugs according to analysis from Vonberg and Gastmeier. Cutting edge technologies like Crystal® closed vial technology and BFS can lower the risk of product contamination by more than two logs compared to classical technologies such as open vial filling. This is obtained by reducing the exposure to the environment.

Our analysis shows that invested patient safety can be strongly increased through the use of Crystal® closed vial technology and BFS compared to other open container technologies. Further to this, the pharmaceutical industry will gain from more robust and easier to use technologies.

For more information or to discuss the contamination risk of filling technologies please contact us directly.