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news.Vetter has expanded its portfolio for lyophilized substances by providing its filling service for high-quality sterile water for injection (sWFI) syringes with five years of stability data.
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The company’s stability data and bracketing concept gives drugs a longer shelf life, and high flexibility while defining the filling volume.
The filling service for syringes with sterile water-for-injection (sWFI) contains the exact defined amount of solvent required by the customer in order to obtain the required dosage.
Vetter’s filling service for sWFI syringes are available in 1.5ml formats with a volume of 0.5ml to 1.3ml, and a 3ml format with a volume of 1.4ml to 3.0ml.
The syringe features the company’s V-OVS tamper-evident closure, intended to give a prefilled syringe system effective protection features.
The company supports its sWFI filling service with five years of stability data and can produce batches of maximum 120,000 / 140,000 pieces, while its sWFI syringes has ICH compliant, validation and stability data according to USP, Ph.Eur., Ph.J., and ICH guidelines are also available.
Vetter managing director Peter Soelkner said that the lyophilized drugs are an international growth segment for CDMO’s.
"Our filling service for WFI syringes represents a reliable and patient-friendly solution offering our customers high-flexibility due to Vetter’s bracketing concept, and fast time-to-market by using the ready-to-submit documents.
"In addition to documents for approval in the USA and Europe, we also have all the necessary documentation for Japan available for pharmaceutical and biotech firms, which can considerably abridge the approval process," Soelkner added.
Image: Vetter’s 1.5 ml sterile Water for Injection syringe. Photo: Courtesy of Business Wire.