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  • Home/In The News/Press/KRS Global Reveals That It Has Produced Sterile Injectables in Closed Vial System Since Q3 of 2014

KRS Global Reveals That It Has Produced Sterile Injectables in Closed Vial System Since Q3 of 2014

Boca Raton, FL: KRS Global Biotechnology (KRS-GBT), FDA Registered Human Drug Outsourcing Facility under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is excited to reveal closed-system automation already in place.

FOR IMMEDIATE RELEASE

Colanar Modular Syringe, Vial and Cartridge Filling System – FSM

Boca Raton, FL., November 18, 2014 – KRS Global Biotechnology is stepped forward today to reveal that it has been using closed-system technology since the third quarter of 2014. KRS Global has started by utilizing the Colanar Modular Syringe, Vial and Cartridge Filling System – the FSM. Colanar, a global leader for compact pharmaceutical filling equipment offers modular bench top filling system. This modular system has been developed for the filling and vacuum stopper placement for pre-sterilized nested vials, cartridges and syringes. The FSM is suitable for clinical trials and small batches where flexibility, high accuracy, and short change over times are essential. Both high accuracy rotary piston pumps and peristaltic filling systems for single use applications are available. Each module features a state of the art control system including touch screen HMI, PLC, and servo drives.

There are numerous benefits to using a machine such as the Colanar. The machine is a modular filling system for pre-sterilized nested syringes, vials and cartridges which provides a high dosing accuracy of FSR rotary piston pumps or FSP peristaltic pumps. Another feature of the machine is that the Colanar is a bottom-up vacuum filling station and all movements are controlled by Servo drives.

A representative from the company stated, “This is just the beginning for KRS. We have plans, which will be revealed in time that will make waves. Our closed-system technology has only begun to be revealed. Expect more later this year and into the first quarter of 2015. Wherever possible we aim to eliminate human intervention in the preparation process.” KRS Global is an industry leading customized pharmacy that provides sterile and non-sterile compounding services to patients, surgery centers, ophthalmology clinics and hospitals nationwide. KRS is committed to developing quality processes that facilitates the highest level of safety for patients who are recipients of intravenous or oral preparations. KRS also touts the fact that every sterile injectable is tested for potency, endotoxins, and of course sterility before it leaves the facility and that in most cases this can be done with Rapid Scan technology in three hours or less.

Their early registration with the FDA as an out sourcing facility has propelled the company to the forefront of the compounding industry. They strive to be a leader and the example for others to follow with quality control and adherence to cGMP guidelines. They believe their state-of-the-art quality control workflow/processes will allow them to grow together with the needs of their customers and continue to provide the highest quality service and compounded pharmaceuticals.

For more information, contact:
Stephen Duffie, Vice President of Business Development
Phone: 888-242-7996 ext. 365 or 561-430-2365 – direct
E-mail: stephenduffie@gbtbio.com
www.gbtbio.com
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