CleanRooms East/PDA SciTech Summit
NEW PRODUCTS SHOWCASE
On exhibit, March 8-12, Orange County Convention Center, Orlando, FL
Highly absorbent wipers and mops
Anticon by Milliken's cleanroom wipers and mops are billed as the cleanest and most absorbent products of their kind, according to the manufacturer. Sterilization for use in the pharmaceutical, medical device and biotech industries is available, as well as pre-saturated wipers with various cleaning solutions. Knit brands include the Gold and Anticon series, while new nonwoven wipers include the Matrix and Captura brands.
Anticon by Milliken
Online system measures endotoxin
Cambrex Bio Science will preview a new online endotoxin detection system that will allow in-process monitoring of fever-causing, gram-negative bacterial endotoxin in water-for-injection (WFI) systems used for production of injectable drugs, medical devices, and other therapeutic products. The PyroSense system automatically and continuosly monitors endotoxin levels in WFI and high-purity water systems. 21 CFR Part 11-compliant host software stores raw data and test results, provides immediate feedback on water quality across a company network, and provides what the manufacturer claims is an efficient tool for trending endotoxin levels. The company says the new technology moves endotoxin testing from the lab bench to the water loop, and replaces manual collection and testing of samples with an automated process. Consistent testing techniques are achieved using robotics and a snap-in reagent cartridge for replenishing supplies.
Cambrex Bio Science
Portable airborne particle counter
Portable APC airborne particle counters are used for the detection of particulate contamination in controlled environments, or anywhere particulate contamination is a concern. Features include 0.2-micrometer particle sensitivity, ability to measure six size ranges simultaneously, 1 cfm flow rate, and three concentration modes (total particles, particles/m3, particles/L and particles/ft3.
Biotest Diagnostics Corp.
Digital photometer with sensors
The 2H digital photometer replaces the company's TDA-2G device and offers new features such as flow and optics sensors, integrated HEPA filter on the vacuum pump exhaust, and expanded menu items.
Air Technologies Inc.
Owings Mills, MD
Sterile alcohol, disinfectants
A line of contamination-control supplies for cleanrooms and labs includes 70 percent sterile IPA alcohol, which is filtered to 0.2 µm, bottled, and double-bagged in a Class 100 cleanroom, then gamma-irradiated to a sterility assurance level of 10-6. Sterile alcohol meets or exceeds water-for-injection (WFI) quality in endotoxin limits.
Decon Labs Inc.
Bryn Mawr, PA
Series 1411 fume hoods are available in stainless steel, white polypropylene and fire-retardant white polypropylene. They are available in 3-, 4-, 5-, 6- and 8-ft. widths and 30-, 36- and 42-in. depths, with custom sizes also available. Various options are offered to meet specific application requirements.
Clean Air Products
Garments for all applications
A comprehensive line of cleanroom and controlled environment working apparel include the Tyvek IsoClean and ProClean protective apparel, the Summus garment line for barrier protection and comfort, SureStep shoe covers and Gripper boot covers for anti-slip solutions, Sierra facemasks, and Sontara engineered wiping products.
Dupont Contamination Control
Battery-operated particle counter
The SOLAIR 5100+ line of laser particle counters use the latest in optical particle counting technology. Devices offer a sensitivity of 0.5 µm and a flow rate of 1 cfm (28.3 LPM), with a wide dynamic range up to 25 µm. Featuring a 5.7-inch color backlit touch-screen interface, the SOLAIR 5100+ is designed to store a large amount of particle count data from six channels, and data from up to four environmental sensors. Data can be downloaded to a computer or sent to its built-in printer. It can be used as a portable instrument or integrated into a larger facility-monitoring or management system.
Lighthouse Worldwide Solutions
Bucketless floor mop
The EastSat bucketless floor mop is designed specifically for the cleanroom, and its built-in 52-ounce solution tank eliminates the need for a bucket and wringer. A trigger mechanism flow control releases cleaning solution on demand or continuously for cleaning up to 5,000 square feet. The mop head is constructed of a durable polyester fabric that is laser-cut and laminated to clean ester foam without the use of glues or adhesives. The angled head cleans hard-to-reach areas, and be attached and removed easily. Mop head choices include textured for more abrasive action, or flat for standard floor cleaning.
The RiboPrinter microbial characterization system uses genetic information to provide a snapshot for automated identification and strain-level tracking in less than eight hours. RiboPrint patterns characterize environmental isolates, pathogens, control strains, or any bacteria important to the pharmaceutical, personal care and food safety industries.
Class 10K workstation
The new Class 10K workstation is designed to provide limited HEPA-filtered airflow across double-sided work areas to reduce FM contamination. The product was designed specifically for medical device assembly work, and the manufacturer claims its workstation is more cost-effect than typical laminar flow benches since it allows for two or four workers per station. Options include electrical outlets, storage cabinets and pneumatic connections.
Gerbig Engineering Co.
New Brighton, MN
Validated sterile wipes
The company's validated sterile wipes are gamma-irradiated with Cobalt-60 to a sterility assurance level of 10-6 in accordance with procedures outlined in Standard AAMI/ISO 11137-Method 1. Each shipment is accompanied by Certificates of Processing and Sterility. Linear-tear packaging is designed for easy use with a gloved hand.
Facility monitoring software
CIMScan facility monitoring software is designed for simplified monitoring of particle counter instrumentation and key parameters in critical areas of a facility. The software provides a complete environmental monitoring solution and, according to the company, typically requires no special training for configuration and use. Parameters monitored include particle counts, filter conditions, airflow rates, electrostatic discharge, temperature, relative humidity and differential pressure. Collected data can be analyzed in real time or linked to an ODBC database or Microsoft Excel program.
Hach Ultra Analytics
Grants Pass, OR
Garment tracking system
The GTS Bar Code System, developed in coordination with the company's customers, provides a complete account history report for each garment, from installation to any repairs. It also tracks usage analysis by wearer, department and distribution point. The system identifies: type of fabric, customer name, when installed, style and size of garment, and history. Reports include: soiled count pick up, inventory usage, package/delivery slip, cancelled items, repairs, and monthly accountability.
Prudential Cleanroom Services
Benchtop crossflow system
The Sartoflow Slice 200 Benchtop Crossflow (TFF) System is designed around the Sartocon Slice 200 (200 cm2) Cassette. The system includes a Sartorius precision balance, stainless steel Sartocon Slice 200 cassette holder, 500 ml reservoir and integrated magnetic stir plate, disposable pressure transducers, fittings, tubing, valves and SartoWedge PC data acquisition software. The software collects and provides automatic graphic profiles. The system monitors and automatically controls and records flow rates and pressures, and is designed for scale-up and scale-down process development. Slice 200 cassettes are available in a variety of MWCOs, from 1000 kD to 0.45 µm in PES and 1N NaOH stable non-fouling Hydrosart (stabilized regenerated cellulose). The TFF system's pump has flow rates up to 2,200 ml/min, making it possible to integrate standard Sartocon Slice cassettes (1000 cm2) or Sartocon Slice Disposable cassettes for seamless linear scale-up work.
Disposable HEPA-filtered collection container
SafePak is billed as the first disposable HEPA-filtered vacuum cleaner collection container designed for potent compound pharmaceutical applications. SafePak lets manufacturers safely collect, handle and dispose of potent compounds. When integrated with the company's CFM 3156 or 3306 vacuum cleaners, SafePak lets users continuously collect materials that are then retained with the HEPA-filtered unit. When full, users simply dispose of the entire container, avoiding potential contamination and exposure.
TexShield Sterile 70% Isopropyl Alcohol and Sterile 70% Isopropyl Alcohol with WFI were created to maintain their sterility assurance level throughout prolonged normal use. One-liter and five-liter bottles are recyclable, and the contents can be completely dispensed. Products are packaged under the patent-pending SteriShield Delivery System, which holds the liquid inside an ultra-clean, medical-grade polyolefin bag that does not allow air to be drawn back into the bag when the trigger spray mechanism is operated. Testing shows the contents remain sterile for three months after first use.
Upper Saddle River, NJ
The WK 3000 reusable protective apparel is woven from 100-percent filament polyester yarn with carbon filters laced into a stripe throughout the material. The durable fabric is designed to repel fluids, prevent particulation, and dissipate static electricity.
White Knight Engineered Products
Aerosol particle sensors
IsoAir Plus sensors are designed to be compact, rugged and simple to install for trouble-free aerosol monitoring. Sensors, say the company, are built to provide outstanding performance in a chemically-resistant, easy-to-disinfect stainless steel box. The quiet internal pump makes IsoAir Plus suitable for cleanroom and isolator applications. IsoAir Plus feature 0.5 and 5.0-µm channels for GMP, and has Ethernet as well as 4-20 mA output that exceeds 21 CFR Part 11 regulations. It interfaces with Pharmaceutical Net software to provide advanced reporting features as well as alarm paging for instant responses to particle events. System validation documenting is available.
Particle Measuring Systems
The VhyPer Vaporized H202 BIER (biological indicator evaluator resistometer) Vessel features multiple VHP and relative humidity set point operating parameters centered on current industry practice, and exposure kill times adjustable for D-value and survival-kill testing. Data can be saved to a network disk via corporate LAN. Hydrogen peroxide solution cartridges are available.
Pharmaceutical Systems Inc.