The companies featured in this issue’s Product Showcase will be exhibiting at INTERPHEX 2018, which will be held on April 17-19 at the Javits Center in New York. www.interphex.com
Prefabricated Cleanroom POD
G-CON Manufacturing Inc. offers its prefabricated cleanroom POD, iCON, a turnkey podular facility platform solution for biomanufacturing. The facility can be established in less than a year and can be transformed from the development stage facility to clinical and commercial phases without interrupting existing processes. These turnkey solutions are cost efficient and provide robust containment for therapies that require the same. A variety of dimensions are offered to accommodate fill-finish operations and mAb facilities, as well as personalized medicine and OSD applications.
Lab Filter Dryer
Powder Systems Limited makes laboratory filtration and drying studies easy with the next-generation GFD automated benchtop Lab Filter Dryer. Also offered is the MSR MicroSphere Refiner for microsphere formulation. This product provides a solution to overcoming the typical manufacturing challenges associated with microsphere production which is experiencing growing demand due to its revolutionary applications. These biodegradable particles work as miniature time release capsules for parenteral drugs, treating various conditions from cancer to diabetes and mental illness.
Contec’s Compact Bucket System is available with either two or three buckets and a choice of a standard or a utility handle. The utility handle with the polypropylene system allows two small buckets (6L) or one large bucket (15L) to be positioned on the handle providing additional storage for extra supplies such as clean mop heads, solution spray bottles, wipes, and other items. The system is available with three stainless steel buckets and a standard handle.
Single-Use Filling Assemblies
Sterile molded filling assemblies from AdvantaPure are made from AdvantaSil silicone tubing and molded components or weldable and sealable AdvantaFlex biopharmaceutical tubing and components. Bags, filters, sterile connectors, filling needles, and other accessories complete the assemblies. The units are supplied sterilized and ready to use, and feature smooth, molded junctions for seamless flow and to reduce leak and entrapment issues associated with barbed fittings. The assemblies’ multiport Tri-Clamp design further reduces potential leak points and minimizes holdup volume.
Mecart manufactures cleanroom panels to fit specifically requested designs. Each panel is custom-built to ensure flexibility in height, width, utility integration, access and control panels for compressed air, purified water, or gases. Also offered are built-in air returns with a flush magnetized grille, choice of door and window sizes, oversized doors and panels, pass-throughs, etc. Panels are manufactured in a controlled environment for consistent quality. Since the panels are pre-wired and pre-cut during fabrication, on-site installation is fast and ultra-clean.
BlueMed’s Iris disposable shoe covers combine resistance and advanced anti-skid properties to offer superior barrier protection. Made of a polypropylene fabric coated with anti-skid polyethylene, the shoe covers are suitable for cross-contamination protection. Also available are rectangular shoe covers, hydrophilic shoe covers, and a shoe cover dispenser box that keeps things elegantly tidy. Products that answer the exact needs of clients are available, including personalized shoe covers. Custom designs, patterns, logo, or special messages printed on shoe covers are available.
Testing and Certification Services
STERIS provides a portfolio of services for cleanroom testing and certification, each of which is designed to not only reduce the risk of product contamination but to highlight and resolve deficiencies in cleanroom functional performance and SOPs to keep manufactured products safe. Services include the certifi cation and repair of HEPA-filtered devices, environmental monitoring, calibration, and validation. These services help facilities maintain regulatory compliance while utilizing current best practices to avoid the risk of compromising sterility. Certification services technicians are accredited by CETA.
UV Laser and Transporter
DPSS Lasers Inc.’s Samurai UV Laser and Transporter utilizes a 355 nm wavelength to provide a small spot size and large depth of focus. UV lasers take advantage of a “cold” marking process that does not require high average power levels and allows damage-free marking on many materials. Higher power UV lasers and shorter pulse widths are integrated — UV lasers with average power levels from 1 to 55 Watts are being integrated, as well as nanosecond, picosecond, and femtosecond UV lasers. Custom UV applications are available.
FMS Monitoring Software Version 5.4 from TSI enables real-time environmental data exchange with end user systems within a facility. The server removes common barriers to communication, allowing critical data to efficiently and securely move around a facility. The server decreases installation costs by simplifying facility monitoring system design, off ering easy and immediate access to real-time and historic data from multiple sensors. The software securely shares data between industrial platforms, enabling transfer of critical facility monitoring system data to centralized enterprise reporting systems.
Portable Glove Integrity Tester
Comecer’s Speedy Glove, including the OverPort feature, detects leaks arising from the whole flange assembly of the glove port in addition to the glove itself. The availability of specific adaptors extends the utilization spectrum of the device to any existing isolator glove port, whereby the CFR21p11-compliant tailored software allows the management of multiple devices and proper data tracking. It can be used in isolators or RABS where strict separation between the isolated area and the external environment is required.
Critical Cleaning Detergent
Alconox Inc.’s Keylajet Low-Foaming High Alkaline Liquid is a powerful and effective detergent suitable for extremely tough residues in a Clean-In-Place application. The detergent is suitable for the toughest residues that must be removed via automated, high pressure and/or CIP cleaning methods, as well as soaking, scrubbing, and sonication with proper PPE. Its corrosion-inhibited formulation is recommended for hard metals, steels, stainless steel, porcelain, ceramic, rigid plastics, cement, and elastomers. The detergent is free-rinsing, biodegradable, and free of interfering residues.
MG America, the U.S. subsidiary of Italy’s MG2, supplies Axomatic’s lineup of emulsifying equipment. Their portfolio of undervacuum homogenizer mixers is geared to a variety of industries. Also known as turbo-emulsifers, the machines feature a special triple coaxial agitation system for the reliable production of various substances. The emulsifiers can be constructed with a bottom-driven turbine, top-driven turbine, or both. The undervacuum system allows raw materials to be incorporated into the final product without air.
Rotary Piston Filler
Cozzoli’s RPF Rotary Piston Fillers can accommodate a wide range of containers and products of most viscosities for the cosmetics, food, and pharmaceutical industries. The system is available in different frame sizes and models. Overhead driven pistons feature a fine fill adjustment, achieving ±0.5 percent fill accuracy and are easily removed for cleaning and changeover. Features include a starwheel drive system with factory set overload clutches and a spiral drive clutch, both offering precise adjustment and never needing re-adjustment.
Material Transfer Station
The EHS Material Transfer Station is an ergonomic workstation for handling large quantity dispensing operations. This system is available in a range of configurations designed to achieve containment levels of less than 1μg/m³ during the dispensing of powders from drums. The integrated drum tipper and assortment of interchangeable containment modules can be configured to dispense and weigh into a wide range of container types (drums, single use bags, pails, etc.) and sizes. Modules are also available to facilitate weighing and dispensing into a vacuum transfer hopper.
Polytex garment dispensers from Cintas ensure convenient, hassle-free garment availability. The system dispenses tops and bottoms separately by size, and can dispense multiple types of garments. Multiple dispenser sizes and capacity levels are offered, with optional free-standing or in-wall return units. The unit works with existing employee identification cards, and software tracks inventory. Digital pictures are taken when garments are returned, and all garments are conveniently dispensed at an ergonomic height. Graphic instructions guide first-time users through the simple dispensing and return process.
Environmental Monitoring System
The FacilityPro 5010 from Particle Measuring Systems can sample either particles or microbial sampling points with a single module. Analog and digital inputs and outputs for sensors such as temperature, differential pressure, and light towers are integrated into the central processor module. The graphical operator interface off ers an intuitive map-based design, system confi guration, audit trails, and data/trend reports. The software has strict access controls and requires electronic signatures for all actions and changes.