2009 Post-Interphex Showcase: Manufacturing Equipment & Supplies
The “Sartopore 2 XLG” and “XLI” filters offer significant performance benefits in many biopharmaceutical applications. The units combine effective prefilter layers with a 30% increase in effective filtration area. The products are heterogeneous, double-layer polyethersulfone membrane filters. The XLG has 0.8-µm prefilter, and the XLI has a 0.35-µm prefilter.
Sartorius Stedim Biotech, Edgewood, NY
Vac-U-Max has introduced a vacuum conveyor for capsules, gel caps, and coated tablets. The device conveys 2500 units/min and gently delivers the product to the capsule-filling or packaging machine. The system conveys the product to the process without damaging it or separating the empty caps.
Vac-U-Max, Belleville, NJ
The “SciPure 200” single-use system is a purification platform designed to automate, document, and optimize protein purification. The system performs automated concentration and diafiltration and uses disposable fluid pathways. Its disposable tangential-flow filtration tube manifold incorporates temperature, pressure, and conductivity sensors.
SciLog, Middleton, WI
Ross offers a ribbon blender with a capacity of 515 ft3. The model is made of stainless steel and driven by a 200-hp drive. The blender includes a jacket for heating or cooling the product. The blender is also designed for internal-pressure operation.
Charles Ross and Son, Hauppauge, NY
SGM’s “DriAmp” biological-indicator culturing set features “Releasat” medium and is designed for high-temperature, direct-air exposure or submersion in nonwater-based solutions. The “DriAmp BI” is a 1-mL, snap-top glass ampul containing inoculated silica. The Releasat medium provides a reduced incubation time of 72 h. A color change indicates positive test results.
SGM Biotech, Inc., Bozeman, MT
Pall’s “Allegro 2D” systems provide a high degree of flexibility for process designs. The systems are available in volumes from 50 mL to 50 L and are suited for applications such as cell-culture media preparation and storage and bulk-product storage before filling.
Pall, East Hills, NY
Tabletop powder blender
“MiniBlend” tabletop powder blender is a research-scale machine. The device can be used with 0.5, 1-, and 2-qt V-shells. A bottle-blending attachment permits operators to blend small quantities of powders directly in bottles or vials. Three batches can be made at a time using bottles.
GlobePharma, New Brunswick, NJ
Fluid-bed dryer bags
Kavon provides custom replacement fluid-bed dryer bags for US and European equipment models. The bags are appropriate for wet granulation, dry filtration, and wet and dry coating applications. The company offers flexible 1–4-bag systems in various fabrics choices and also repairs bags.
Kavon Filter Products, Wall Township, NJ
Visual inspection system
Eisai Machinery USA offers semiautomatic, semimanual, and manual “VIS” visual inspection systems. Eisai provides validation expertise to help implement VIS 1000 semiautomatic inspection machines. The company also provides a program of continuous service and technical support for its clients. The program monitors clients’ machines to reduce downtime and improve production-line efficiency.
Eisai Machinery USA, Hackensack, NJ
Interchangeable turret tablet press
The “Hata CVX” tablet press from The Elizabeth Companies features removable turret technology and an easy-clean design for quick parts removal and changeover between product runs. The press also has an easy-access press interior and fewer parts with less weight on heavier press components. The tablet press is mechanically designed to operate turret speeds as fast as 100 rpm on single-sided models. Other features include an optimized take-off area.
The Elizabeth Companies, McKeesport, PA
Liquid-filling and sealing system
Capsugel’s “CFS 1200” liquid-filling and sealing system handles lipid-based formulations for poorly soluble compounds. The system is a fully automatic, CGMP-compliant machine that fills and seals as many as 1200 capsules/h and helps bring products to market quickly.
Capsugel, Greenwood, SC
The Asep-Tech “Model 628” blow–fill–seal machine from Weiler features a two-piece stepped base design to facilitate maintenance and product discharge. Model 624 tooling can be used on the Model 628 machine. The Model 628 unit produces sterile, liquid-filled, tamper-evident containers ranging in size from 0.5 mL to 250 mL.
Weiler Engineering, Elgin, IL
Rigid outer containers
The FlexStation rigid transport and shipping containers provide fluid-management solutions for intrafacility transportation and interfacility shipping. The durable outer containers are available in sizes of 50–1000 L to fit Meissner’s TepoFlex 3D biocontainers. The products are reusable and collapsible for storage and handling.
Meissner Filtration Products, Camarillo, CA
Gore has introduced its Gore Lyoguard freeze-drying tray, for use by HemCon Medical Technologies, as the delivery system for a freeze-dried plasma product.
Lyoguard products provide a stable and contaminant-free method for lyophilization.
W.L. Gore and Associates, Elkton, MD
Photoelectric communication sensor
A high-performance, photoelectric communication sensor provides users with remote control from an onboard interface or from a central plant-control station. The SmartEye X-PRO Model XPC unit was designed for monitoring and configuring machines for local or plantwide automation. It provides multidrop sensor feedback for overall process control.
Tri-Tronics Company, Tampa, FL
Split butterfly valve
The ChargePoint DL is designed to facilitate bulk handling of potent active ingredients. The product incorporates DiscLock technology, which maximizes containment performance with an efficient, high-integrity, metal-to-metal disc seal in conjunction with precision-machined seats that ensure optimal operational performance and interchangeability. The device achieves operator exposure levels of 1-10µg/m³.
ChargePoint Technology, Liverpool, UK
tel. +44 0 151 448 7700
Aseptic Technologies offers a system for aseptic filling 1–50 mL of injectable drugs, liquids, or lyophilized products. The system includes the ready-to-fill Crystal closed and stoppered vial, which is gamma sterilized. A special needle pierces the stopper and performs filling. The stopper is immediately heat-resealed by a laser.
Aseptic Technologies, Gembloux, Belgium
tel. +32 0 81 409 410
New 3- and 4-day, NVLAP-accredited calibrations announced by Burns Engineering.
Burns Engineering now delivers NVLAP-accredited (Lab Code 200706-0) precision with fast turn-around: 3-day calibrations on sensors and 4 days on systems. Introductory pricing also available on this new service.
Burns Engineering, Minnetonka, MN