pharm-development-manu-995x60.png

The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.

Umbra manufactures bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags from 2lbs to 55lbs with a variety of pouch materials and closure techniques, providing an extremely versatile solution to customers looking for high flexibility. Umbra specializes in the filling and sealing of dry pet food and pet care products, providing a full range of equipment from basic filling and sealing machines to fully automated lines, including multi-head weighers, case loading systems, palletizing and stretch wrapping systems. Umbra's expertise in the design and development of fill technologies allows for filling of powdery and granular products, as well as longer and stickier products that tend to bunch or bridge in the filling chutes.

One (1) used Alexanderwerk Roller Compactor, Model WP120X40V. With stainless steel construction, 120mm diameter x 40mm faced rolls; horizontal screw feeder with pre-breaker, cantilevered rolls, flake crusher, pre granulator and fine granulator attachments; rated +/- 5g batch, 8 - 40 kg/hour continuous; with Allen Bradley operator interface and PLC controls, portable design.

One (1) used Glatt Fluid-Bed Dryer Granulator, Model GPCG15. With stainless steel construction, 10-bar shock rated with 12" HS Wurster, 68-liter top spray, 27-liter top spray inserts and 19.5" Rotogranulation bowl; less drive and expansion chamber; pump skid, steam-heated with air handling unit, HEPA filter, blower, controls and operator interface controller.

One (1) used TL Bosch Vial Filling Line, Model FSM 2700C. Consists of Bosch In-line Vial Washer, 20-position, 6-head undercarriage wash position alternating air to water, 3-head top wash positions alternating air to water, last position for silicon; with TL Systems Feed system and 3 basins with Waukesha feed pumps; Despatch Depyrogenation Tunnel, approximately 46" wide x 14' long tunnel section, 20' overall length; electrically-heated, 2-zone, 80kw hot zone, 40kw cool zone; 400 C max temp, 350 C max operating temp, 96.2/48.1 amp heaters, 480 volt, with motor VFD controllers.

The pharmaceutical capsule is opened and the product separated from the capsule halves.

Standard Flexsafe 2D validation bags made of the new polyethylene S80 film are designed for small scale investigations and for the validation of the Flexsafe bag family. They are available in 150 mL and 500 mL volumes to support end users’ process development and validation testing. Flexsafe bags have been designed by combining material science and a Quality by Design approach to provide outstanding cell growth, robustness and assurance of supply for all process steps of biomanufacture.

Green PODs represent a cost-efficient and flexible alternative to traditional growth chambers and greenhouses for a wide variety of applications.