A leading contract manufacturer offers an in-depth look at best practices
Ravensburg, Germany, March 27, 2012 / B3C newswire / – Vetter, an international specialist in aseptic filling, will present on best practices in sterile manufacturing and packaging at Pharma Congress 2012 in Dusseldorf, Germany, April 24 and 25. Company experts will address four topic areas, including RABS technology, glass monitoring in aseptic filling, and new developments in drug-delivery systems. For the past 14 years, Pharma Congress has convened manufacturers, service providers and international regulatory bodies, including the U.S. Food and Drug Administration, to discuss industry issues. Global pharmaceutical and biotech firms face a constantly changing environment. Rigorous regulation, growing competition and increasing pressure to innovate are just some of the challenges the industry is confronting. Topics to be discussed at this year’s Congress include trends and advances in sterile technologies, barrier systems and state-of-the-art manufacturing processes.
Faster high-volume drug manufacture
The ability to manufacture large batches of product in a short period of time is sometimes critical. Vaccines, for example, which comprise a growing segment of the global drug market, must be produced rapidly and in great quantities. Gerald Buerkle, Director Pharmaceutical Production at Vetter, will explain how manufacturers and pharmaceutical service providers can meet this challenge by marrying pre-sterilized syringes with high-performance production lines. In addition, Mr. Buerkle will explore innovative methods for disinfecting and introducing pre-sterilized syringes into the cleanroom, as well as efficient waste disposal procedures for packaging materials.
RABS technology for higher-quality cleanrooms
Achieving the highest level of sterility possible is fundamental to fill and finish. An effective tool for maintaining rigorous cleanroom standards is the Restricted Access Barrier System (RABS). Joerg Zimmermann, Director Process Development and Implementation at Vetter, will present recent developments in RABS technology, along with a variety of RABS models. He will discuss how to incorporate RABS into the design of pharmaceutical processes; cover elements of an effective RABS, such as the integrity test for RABS gloves; and demonstrate the system’s benefits through case studies. This session will be delivered under the auspices of Pharma Congress’s ECA Barrier Systems Conference, which will be moderated in its entirety by Mr. Zimmermann.
Requirements for autoinjector assembly
Mr. Zimmermann will also present on the assembly of patient-friendly autoinjectors, the demand for which is growing as the homecare segment expands. Using a real-life example, he will report on the benefit to patients offered by autoinjectors, as well as requirements for autoinjector assembly. A core area of focus: the challenges of siliconization and bulk syringe manufacturing.
Both regulatory authorities and drug manufacturers are becoming more rigorous in their quest to prevent glass breakage during the aseptic filling process, in order to safeguard product integrity and increase patient safety. Sigrid Lieb, Project Manager at Vetter, presents the results of a baseline study on monitoring glass breakage during sterile production. In her presentation, she will take an in-depth look at the causes of glass breakage in conventional drug-delivery systems like syringes, vials and cartridges, and highlight critical points in the manufacturing process. She will demonstrate how quality control and quality assurance during incoming inspection can minimize the risks of glass breakage. Ms. Lieb will also explain how evaluation and trending processes in manufacturing help prevent glass breakage.
Vetter is an international contract development and manufacturing organization (CDMO) specializing in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with a broad array of compounds, including monoclonal antibodies, peptides, interferons and vaccines. An independent firm headquartered in Ravensburg, Germany, Vetter provides support for pharmaceutical and biotech clients from preclinical development through regulatory approval and global market supply. Vetter’s new Chicago facility, an expansion of Vetter Development Service, supports early-stage products. The CDMO works with the world’s top 10 pharmaceutical/biotech firms and emerging companies alike, and employs approximately 2,700 staff across Europe and the United States. The innovator of the Vetter Lyo-Ject® dual-chamber syringe and V-LK® cartridge, the company holds numerous patents and is a leader in the use of RABS technology in cleanrooms. Approved as a foreign manufacturer by the government of Japan, Vetter’s global regulatory experience includes numerous customer product approvals by the FDA, EMA and other authorities. Over its more than 25-year history in aseptic filling, Vetter has won many awards for its facilities and operations, including Frost & Sullivan’s 2011 European Prefilled Injection Systems Customer Service Leadership Award.
For more information contact:
Vetter Pharma International GmbH