MARCH 26-28, 2008
Pennsylvania Convention Center
Interphex 2008™: Conference & Exhibition
Wednesday, March 26: 9:00 a.m.–4:15 p.m.
Thursday, March 27: 9:00 a.m.–4:15 p.m.
Friday, March 28: 9:00 a.m.–1:00 p.m.
For more information, or to register for INTERPHEX 2008, visit www.interphex.com or call (888) 334-8704.
Now in its 29th year, INTERPHEX will host more than 1,000 global companies serving the pharmaceutical and biotechnical industries, making it one of the world’s largest and most comprehensive pharmaceutical exhibitions. Featuring the latest equipment, technologies, and services, the event will offer an application-oriented conference program specifically designed for pharmaceutical and biotechnical professionals. Access the complete conference schedule at www.interphex.com.
G. Steven Burrill
Biotech 2008: A 20/20 Vision of 2020
Wednesday, March 26
Ballroom ~ 11:30 a.m.–12:30 p.m.
G. Steven Burrill, CEO of Burrill and Company, has been a biotech investment visionary for more than 40 years. He is an active advisor and catalyst in the growth and prosperity of the biotechnology industry and works closely with the industry’s most notable companies.
Ray Krauss, Adrian Rawcliffe, and David King
Innovation to Commercialization: Executive Life Science Panel Discussion
Thursday, March 27
Ballroom ~ 11:30 a.m.–12:30 p.m.
Attend this high-level panel discussion featuring CEOs from the three life science industries–medical device, pharma, and bio–addressing current trends in innovation, global market challenges, and collaborations across the industries as they impact future generations of product development and commercialization.
More than 1,000 pharmaceutical and biotech companies will display their latest innovations at INTERPHEX 2008. Many of those innovations will be of particular interest to the contamination control community. Here are just a few.
Location: Booth 4338
AdvanceTEC is a design/build cleanroom contractor specializing in the integration of modular cleanroom systems for pharmaceutical and biotechnology industries. The company has extensive staff experience in designing, constructing, retrofitting, and coordinating interstitial spaces for cGMP suites, sterile fill facilities, and related requirements. AdvanceTEC works with end-use clients, architectural engineering firms, and general contractors to define requirements, select the right modular systems and design approach, and execute construction plans to deliver projects on time and within budget.
Location: Booth 1113
Consisting of silicone tubing, molded silicone components, and other processing-related parts such as bags and filters, single-use process systems from AdvantaPure offer cost reductions and increases in productivity. The systems will be introduced at Interphex. Advantages of single-use process systems include reduced risk of product cross-contamination, decreased production downtimes for cleaning activities, simplified cleaning validation procedures, and flexibility for process system changes. Another benefit of the company’s systems is the availability of GammaTag™ gamma-irradiatable RFID tags. These tags may be attachment directly to process systems and components for reliable, electronic identification from manufacture through disposal.
Location: Booth 206
A polyphenylsulphone (PPSU) sight glass system is targeted for visual inspection of process media. Sight glass components provide excellent means of confirming flow conditions, proper media agitation, and/or system cleaning parameters. The product is steam-in-place compatible and rated for service up to 266°F. The lightweight, single-body design eliminates undesirable mechanical connections and seals. PPSU sight glasses are manufactured specifically for demanding food handling, dairy, and life science applications in which visual indication of process media is required. USP, NSF 3A, and FDA approved Radel® PPSU resin with integrally molded IDF standard ferrules are exclusively used in the manufacturing process to ensure maximum cleanliness. PPSU components may be easily incorporated into existing systems, and custom sizes are available.
Les Isnes, Belgium
Location: Booth 1436
Aseptic Technologies has developed a new technology for aseptic filling: the closed vial technology. It consists of a closed vial molded and assembled in ISO certified facilities and sterilized by gamma irradiation. The filling is done with a needle passing through the stappes, and the piercing is resealed with a laser.
Blue Thunder Technologies, Inc.
East Windsor, CT
Location: Booth 108
Blue Thunder Technologies, Inc., a manufacturer of high-quality wiping products and a supplier of consumable items used in cleanrooms, will feature Free-SAT presaturated wipes at the exhibition. Free-SAT wipes are for Class 1000 (M4.5) and higher applications. Comprised of 70 percent isopropyl alcohol and 30 percent deionized water, the general-purpose wipes feature ultra-low lint and non-volatile residue and also come in user-friendly containers. The low-static charged wipes use NOVA-TECH 1000 material, which is non-woven, absorbent, and strong. This technology offers a blend of absorbent cellulose reinforced with strong polyester fibers as well as low levels of particle emissions, non-volatile residue, and ions.
Burkert Fluid Control Systems
Location: Booth 317
Burkert, a leader in fluid control systems, offers innovative and reliable process actuation/control systems, mass flow meters/controllers, and valves–ball, diaphragm, globe, solenoid and Y-pattern. Burkert solutions find use in markets such as water treatment; food and beverage, pharmaceutical and medical devices, biotechnology, textile, and semiconductor and industrial processing. The company will be showcasing its Burkert Robovalve, which uses a two-shut-off–one diaphragm, one actuator technology. No hold-up volumes are achieved by the valves, which are independently actuated and mounted under a single diaphragm, thus saving space and eliminating T-pieces.
Christ Water Technology Group
Location: Booth 1663
Christ introduces Ultrastil, a ready-to-connect membrane filtration plant for the removal of suspended solids from aqueous solutions. It is suitable for the filtration of raw water capacities up to 8 m3/h. The system may be installed upstream of reverse osmosis and electrodeionization units, and ensures an SDI (silt density index) of <3. The ultra-filtration membranes installed have a pore diameter of approximately 0.01 µm, ensuring a cut-off of 100 kD (kilo Dalton) for the retention. This guarantees fulfilling the recommendations of cGMP, GAMP, and ISPE. The filtration module, made of PE/PES, is pre-qualified ex works. On request, installation qualification and operational qualification may also be executed. Assembly work during the commissioning of the plant on site is not necessary; the membrane filtration system is supplied ready to connect, or as a component of the compact high-purity water treatment plant Osmotron.
Location: Booth 2107
As an ISO 9001:2000 certified national supplier with an extensive network of regional distribution centers, Cintas offers a large selection of cleanroom apparel, including aprons, beard and boot covers, bouffant caps, shoes, coveralls, face masks and veils, frocks and lab coats, hoods, and shoe and sleeve covers. In addition, Cintas offers custom-managed inventory programs and launders garments in accordance with IEST-RP-CC003.3. All reusable products are durable, cleanroom compatible, and gamma compatible to 200 megarad gamma sterilization and 100 launder cycles.
Location: Booth 1034
Contec, Inc. announces the release of the EasyCurve™ mop designed specifically for cleaning floors, walls, and ceilings in cleanrooms and controlled environments. Consisting of a flat, fabric-laminated mop head attached to a curved, stainless steel frame, the mop provides performance, ease of use, and effectiveness compared to any other all-surface cleaning system. Designed for use in pharmaceutical and medical device manufacturing plants, hospitals, compounding pharmacies, and other similar critical or controlled environments, the mop is an ideal upgrade alternative in applications where sponge roller and self-wringing mops are currently used. It is compatible with a wide range of disinfectants, solvents, and cleaning solutions.
Decon Labs, Inc.
King of Prussia, PA
Location: Booth 2319
Decon Labs, a leader in sterile alcohol and sterile disinfectants, has expanded its CiDehol ST Sterile 70 percent IPA to include a 32-oz. dispensing bag to be used with a hands-free infrared dispenser. The company also offers a new 12-oz. size in a trigger spray bottle. Its CiDehol ST is filtered to 0.2 µm and bagged in a Class 100 cleanroom. Each lot is tested for bacterial endotoxin and is subjected to a 14-day sterility test. Each case is shipped with a lot-specific document detailing parameters of QC, irradiation, endotoxin, and sterility testing. The infrared dispenser is activated by movement and can be set to dispense amounts of 1, 3, or 5 ml. The dispenser mounts to any wall and is powered by an AC adapter or batteries. Decon’s sterile 70 percent IPA is also available in 16- and 32-oz. spray bottles and 1 gal. bottles.
Location: Booth 4136
DuPont Controlled Environments products are specially engineered to enhance productivity in today’s demanding biotechnology, pharmaceutical, medical device manufacturing, and electronics cleanroom environments. The company offers a wide range of protective garments and products, including DuPont™ Tyvek® IsoClean™ garments, and DuPont Gripper™ shoe and boot covers with coefficient of friction properties. In addition, the company has industry experts who can help with site assessment and a variety of contamination control issues.
Location: Booth 2128
Dycem is an ISO 9001-2000 manufacturer of high-tack polymer flooring and mats that will remove 99 percent of particulates and bacteria prior to entering cleanroom or critical environments. Strategically placed in traffic areas, the mats will control bioburden, cross-contamination, and potent compounds. They eliminate the need for expensive adhesive mats, booties, and shoe cleaners. Dycem’s products offer an unavoidable “clean zone,” which is comfortable to walk or roll carts across, while also performing their job of eliminating contamination. The mats are easily maintained with facility approved disinfectants and carry a full three-year warranty.
EnGuard Systems and Chase-Logeman Corp.
Indianapolis, IN, and Greensboro, NC
Location: Booths 462 and 1711
ChaseGuard (Chase-Logeman Corp., Greensboro, NC, and EnGuard Systems, Indianapolis, IN) will soon unveil a turnkey, automated vial filling machine complete with isolation for aseptic vial filling. The system will be offered as a basic package with an extensive list of options and accessories allowing customization to suit research, clinical trial, and small volume batches. The system will be based on Chase-Logeman’s successful Model FS-2205 filling apparatus and will be integrated with an isolator from EnGuard Systems. The new product will combine the expertise from Chase-Logeman and EnGuard Systems that has resulted in previous joint venture success on similar projects.
Location: Booth 834
KIMTECH SCIENCE* STERLING* nitrile gloves from Kimberly-Clark Professional are latex-free gloves that provide the protection of nitrile and the sensitivity of latex. Their textured fingertips offer excellent tactile sensitivity for easy handling of delicate instruments. The gloves are 3.5 mils thick and are available in extra-small through extra-large sizes. The KIMTECH PURE* dispenser for pre-saturated alcohol wipes provides one-handed dispensing. A self-closing, self-sealing lid helps prevent wiper dry-out. An innovative extractor arm automatically lifts each wiper for easy pickup without damaging the wipers. The dispenser’s durable design does not generate particles and makes refilling easy.
Lighthouse Worldwide Solutions
Location: Booth 4546
Lighthouse Worldwide Solutions will be showcasing its latest technology in airborne and liquid particle counters and facility monitoring systems. Its particle counters process data recorded to meet requirements of regulatory agencies in manufacturing of aseptic products. Cleanroom certification and testing is an important part of any cleanroom facility. Lighthouse created particle counters specifically for cleanroom testing and certification. Contamination compromises product integrity in the aseptic manufacture of pharmaceuticals and medical devices. International regulatory organizations require particle counting and a comprehensive environmental monitoring program. Portable and fixed particle sensors are used for an effective environmental monitoring program.
Salt Lake City, UT
Location: Booth 1335
MasterControl Inc., a global provider of GxP process management software solutions, will demonstrate its Projects software. The company connects project plans to assigned tasks and provides automatic updates upon task completion. A module of the integrated solutions suite, the Projects solution manages document-oriented and process-based tasks, including tasks external to the MasterControl system. The software includes automatic task assignment, routing, escalation, and tracking capabilities. It connects all members of a project team, ensuring improved communication, better project control, and faster project completion. The company will also showcase its new PDM connectors and BOM solutions.
Microbial-Vac Systems, Inc.
Location: Booth 4038
Microbial-Vac Systems®, Inc., a leader in pathogen surface sampling, has released the latest technology in pathogen collection. The M-Vac™ wet-vacuum collection system utilizes LAMDAC™ principles to collect laboratory or field samples–typically from one to two square feet of surface area per sample in 100 to 150 ml of liquid. The product is designed to sample a larger area while recovering higher levels of pathogens in each sample than traditional methods. Validation tests have demonstrated the pathogen recovery rate of the M-Vac to be up to 90 percent higher than traditional sampling methods. Because the M-Vac reduces materials required for sampling, lab processing, and detection, it has also proven to be a cost- and resource-effective method.
Location: Booth 1618
Microfluidics will showcase its portable M-110P Microfluidizer® processor, a bench-top lab machine that requires no compressed air or cooling water for hydraulics. Designed to operate reliably, quietly, and efficiently at up to 30,000 psi process pressure, the portable M-110P only requires a standard 20-A, single-phase “household” electrical outlet and can easily be incorporated into any laboratory setting. Utilizing Microfluidics’ fixed-geometry diamond interaction chamber technology and ceramic plunger, the processor easily enables the production of nano-suspensions and nano-emulsions, as well as liposomal encapsulation and cell disruption with the fewest number of passes. Additionally, the M-110P allows flow rates between 110 and 155 ml/min depending on process pressure. All results from the M-110P machine are guaranteed to be scalable to pilot and/or production volumes.
NETZSCH Fine Particle Technology LLC
Location: Booth 1412
NETZSCH Fine Particle Technology LLC is featuring the MicroCer, a laboratory-sized mill that offers metal-free fine grinding with chamber parts in wear-resistant Yttria stabilized zirconium oxide. It features NETZSCH’S proprietary ZETA® grinding system and improved centrifugal separation system that employs grinding media from 0.05 to 0.8 mm in size, the smallest in the industry. The MicroCer is part of NETZSCH’s MicroSeries line of agitator bead mills for wet grinding of small batches (0.14 to 0.5 L) with resultant particles down to 10 to 20 nm in size. This laboratory-sized equipment minimizes product loss, making it suitable for grinding high-quality, high-priced, and scarce pharmaceutical materials. The line features three different mills for traditional, solvent-based, or water-based applications that can be scaled up to full-size production equipment.
Location: Booth 1201
In today’s pharmaceutical industry, cleanroom personnel must dispose of collected dust and debris without recontaminating the working environment. Nilfisk CFM has developed Safe-Pak™ technology, reportedly the first disposable, HEPA-filtered vacuum cleaner collection container designed for potent compound and hazardous material applications. The system was designed to retain collected sub-micron particles in a HEPA-filtered container, protecting the vacuum from contamination as well as providing a safe and easy means of disposing of the collected waste. The user simply removes the container and disposes of it as outlined in each company’s maintenance plan. The Safe-Pak is compatible with the Nilfisk CFM IVT 1000 CR, 3156, and 3306 industrial vacuums.
Particle Measuring Systems, Inc.
Location: Booth 1515
With its comprehensive software and large, easy-to-use touch screen, the Lasair III particle counter establishes a new level of performance in portable particle counters. The large, 8.4-in. LCD infrared touch screen makes it easy to see data and navigate through the screens. The navigation structure is intuitive and easy to use. The counter is available in 1 CFM and 50 LPM flow rates from 0.3- to 25-µm size particles. The 100-LPM flow rate is suitable for monitoring 0.5- to 25-µm size particles. With the new 100-LPM flow rate, one cubic meter can be sampled in only 10 minutes. This comprehensive unit is ISO 21501 and 21 CFR Part 11 compliant.
Location: Booth 545
STRONGARM Designs, a manufacturer of operator interface mountings and systems for the pharmaceutical industry, will showcase its line of stainless-steel mountings and systems. STRONGARM’s operator interface mountings and systems are engineered to improve efficiency, ease of use, and cleanability in sensitive pharmaceutical environments. Their durability and construction reduce data inaccuracies and unnecessary downtime. Products to be exhibited include Pharmaceutical Suite-Station™, MiniStations™, stand-alone mobile stations, mobile weigh stations, MightyMount™ for desktop displays and keyboards, and wall stations.
Location: Booth 2240
Tiger-Vac, Inc. offers explosion-proof vacuum cleaners for potent compound recovery. The compounds are recovered into a static-dissipating disposable cloth filter bag placed within a conductive poly liner. An internal upstream disposable HEPA filter will capture particles as small as 0.3 µm with an efficiency of 99.995 percent. A secondary external downstream HEPA/ULPA filter captures particles down to 99.999 percent on 0.12 µm. The vacuum is ISO Class 4 cleanroom compatible and is available in electric and pneumatic versions.
Location: Booth 2355
Valutek offers products used in cleanrooms and controlled environments that are specially designed for the pharmaceutical industry. The company offers a variety of disposable and reusable cleanroom products designed to provide complete protection. These include wipers, apparel, gloves, glove liners, mats, cleaning, and documentation, all of which conforms to the most rigorous and documented test standards and undergoes independent quality testing to ensure consistent performance. With the convenience and simplicity of one-source shopping, Valutek is a trusted partner dedicated to its customers.
Weiler Engineering, Inc.
Location: Booth 2031
The Asep-Tech® Model 628 blow/fill/seal machine from Weiler Engineering, Inc. features a two-piece stepped base design for easy maintenance and convenient product discharge. All existing Model 624 tooling (molds, fill systems, parison heads) can be used on the 628 machine, making it an attractive upgrade for current users. The versatile Model 628 has the flexibility to produce sterile, liquid-filled, tamper-evident containers ranging in size from 0.5 ml up to 250 ml, in full-scale production quantities. Several other machine models are offered to fulfill higher output and/or larger container size requirements.