Biological Safety Cabinets. These cabinets, also called Laminar Flow Biological Safety Cabinets, combine product, operator and environmental protection. They were developed to provide protection from diverse types of biohazardous material. They are similar to conventional fume hoods in providing protection for the operator, but they also offer protection for the work in progress and for the environment. In most types of these cabinets, the work area is continuously bathed with positive pressure HEPA filtered air to protect product from contamination while an inward airflow protects the user. Some units re-filter a percentage of the air for re-use while venting the remainder to the outside, while others vent all air to the outside.
Things to Consider: Compliance: NSF International Standard 49 for Biohazard Cabinetry, UL Standard 61010-1, CAN/CSA Standard C22.2 No. 1010.1, CE conformity for 230 V models, Cabinet type by class, Inflow air velocity, Downflow velocity, Recirculated air percentage, Exhausted air percentage, Interior-mounted line of sight LCD information center, Filter life indicator, Alarm conditions, Alerts for filter life, Filter monitoring system to maintain airflow, Programmable start up and shut down, Interval or elapsed timer, Stainless steel interior, Removable work surface, HEPA filters, GFI electrical duplex receptacles, 100 foot-candle fluorescent lighting outside contaminated work area, Electronic security lock, NSF-listed, ETL listed, EN 12569 compliant, Dimensions, Mounting method, Adjustable height base stand, Power requirements, Width options, UV lamp option, Service fixtures with ball-type valves option, 99.999% ULPA filters option, Warranty.
Biopharmaceutical Components: This refers to components and accessories used to operate, maintain, inspect, and modify equipment, as well as devices used to perform tests or experiments. These include tubing, hoses, fittings, glassware, sampling sets, meters, analyzers, etc.
Things to Consider: Application, Capacity, Graduation range, Graduation interval, Dimensions, Type of glass, Fitting types and sizes, Electrical requirements, Battery type and lifetime, Materials of construction, Chemical compatibility, Reusable, Recyclable, Disposable, Autoclavable, Dimensions, Weight, Warranty, Agency approvals.
Biopharmaceutical Containment. Also called biocontainment, is a strategy designed to prevent the escape of microorganisms. Ensuring biocontainment requires a combination of procedures and equipment, and applies to specified facilities or dedicated areas. There are four levels of biocontainment: BSL-1 through BSL-4. A BSL-1 facility has few restrictions on who may enter, connects directly with the remainder of the building, and has few specialized safety features. A BSL-2 facility is similar to a BSL-1 facility with additional safety features in place to allow potentially hazardous microorganisms to be studied. Access is restricted and doors remain closed when experiments are in progress. A BSL-3 facility is designed for work with microorganisms that can become airborne and carry a great risk of infection. Work is done within biological safety cabinets or other containment equipment, or by personnel wearing protective clothing. Access to these facilities is usually through double doors, which are sealed around their edges.Exhaust air is filtered. A BSL-4 facility is designed for work with microorganisms that pose a dire health threat. These facilities prevent the release of these microorganisms into the environment and protects researchers from infection. All work in a pressurized and ventilated suits.
Things to Consider: Criteria to be considered when deciding containment level: Potency, OEL range, Acute toxicity, Acute adverse effects, Chronic adverse effects, Genotoxicity, Mutagenicity, Neurotoxicity, Reproductive disorders, Teratogenicity, Sensitization potential, Carcinogenicity, Epidemiology, Exposure route/Pharmacokinetics, Irritation potential (Skin/Eye). Original source of information is American Industrial Hygiene Assn., 1996. Table for Performance-Based Occupational Limits is included in an on-line article by M. C. Griffiths, Solutia Inc. (2003) Facility Design with Containment Chemistry in Mind. Pristine Processing [journal]. September 2003.
Biopharmaceutical Cryogenics. This refers to equipment and practices directed at the safe long-term storage of viable cells, tissues, etc., normally associated with disciplines such as cell-based therapies, tissue engineering, regenerative medicine, gene therapy, cell transplantation and biopharmaceutical research. Biopreservation can be defined as the process of reversibly arresting the biochemical reactions and therefore the metabolism of an organism in order to sustain function after prolonged exposure to otherwise lethal conditions. The state of the art for the preservation of most mammalian cells is cryopreservation, which requires processing at very low temperatures and storage in liquid nitrogen. There are many cryogenic storage vessels designed and manufactured to realize these goals.
Things to Consider: Type of cryogenic (dry ice/liquid methane/Liquid oxygen/Liquid nitrogen), Environmentally safe refrigerant, Type of equipment (handling/vessels/storage/ice makers/refrigerators/freezers), Capacity, Dimensions, Packaging, Color coding, Materials of construction, Cooling rate, Labels and markers, Temperature range, Minimum temperature, Safety guidelines, Insulation, Evaporation rate, Static holding time for vessels (days), Cryogenic media consumption rate, Cryogenic media low level alarm, Electrical requirements, Control systems, Alarm systems, Agency approvals.
Flask Shakers: Devices designed for the agitation of solid phase peptide synthesis flasks and other similar glassware. They can be used with both sealed and stoppered glassware. They provide a thorough gentle agitation for such applications as peptide synthesis, dissolution of solids, culture flask agitation, and viscous polymer mixing.
Things to Consider: Speed range, Orbit size, Maximum load, Platform dimensions, Ambient conditions, Overall dimensions, Size of flask held, Quantity of flasks held, Shipping weight, Electrical requirements, Agency approvals, Warranty.
Floor Scales. These scales are intended for use in general industrial weighing applications such as shipping and receiving, bulk loading. They are ruggedly designed to withstand the abuse of factory-floor activities. Models are designed to handle loads from hundreds of pounds to those handling thousands of pounds. These scales are offered in both mechanical and electronic types, fixed location or portable, low profile or with eye-height analog or digital readouts. They are designed to withstand repeated washings and can be provided with access ramps.
Things to Consider: Capacities, Resolution, Display type, Controls, Indicators, Power requirement, Units, Output port, Materials of construction, Dimensions, NTEP (Legal for Trade) Certifications, Warranty.
Biopharmaceutical Freezers: Laboratory grade refrigerators used for high-precision storage or research applications. These refrigerators employ computer-controlled temperature stability and uniformity throughout the containment volume. Integrated alarms alert users to out-of-range temperature changes.
Things to Consider: Capacity, Number of doors and shelves, Shelf adjustability, Flammable material storage version, Explosion-proof version, Materials of construction, Power requirements, Temperature range, Exterior dimensions, Shipping weight, Warranty.
Fume Hood: A piece of laboratory equipment used to limit a person’s exposure to hazardous or unpleasant fumes. Two main types are manufactured: ducted and ductless (recirculating). The working principle is the same for both types. Air is drawn in from the front of the cabinet by a fan and either expelled outside the building or filtered and fed back into the room.
Things to Consider: Size, Static pressure loss at specified face velocity, Maximum external pressure to overcome, Lights and switches with explosion-proof rating, Power requirements, Ductwork connection size, Self-monitoring features, Accessories available, Dimensions, Shipping weight, Warranty.
Laboratory Glassware. These are glass items and devices normally found in a well stocked laboratory. They include such items as: beakers, Buchner funnels, burettes, cold fingers, condensers, conical measures, crucibles, cuvettes, eudiometers, gas syringes, graduated cylinders, pipettes, Petri dishes, pycnometers, separating funnels, Soxhlet extractors, watch glasses, etc.
Things to Consider: Application, Capacity, Graduation range, Graduation interval, Dimensions, Type of glass.
Biopharmaceutical Incubators. A device for controlling the temperature, humidity, and other conditions in which a microbiological culture is being grown. The simplest incubators are insulated boxes with an adjustable heater. More elaborate incubators can also include the ability to lower the temperature through refrigeration, or the ability to control humidity or CO2 levels. Most incubators include a timer. Some can also be programmed to cycle through different temperatures, humidity levels, etc. Incubators can vary in size from tabletop to units the size of small rooms.
Things to Consider: Door opening from right or left, Data recorder output, Protection from accidental change of set point, Backup system to protect temperature control and set point values in event of power failure, Stackable for maximum space utilization, Number of shelves, Temperature range, Accuracy, Uniformity, Display, Resolution, Materials of construction, Electrical requirements, Chamber dimensions, Exterior dimensions, Shipping weight, Agency approvals, Warranty.
Pharmaceutical Isolators. Isolators are cabinets or workstations that environmentally separate the user or technician from the product being handled. With minor differences in design, some isolators protect the user from the product and others protect the product from the user or the external environment. Those protecting the user may have controlled negative pressure, filters on all gas exhaust, integrated hepa filters, and closed cleaning systems. Those protecting the product may have controlled positive pressure, multiple inlet filters, inert gas systems, humidity and temperature control, and closed cleaning systems. Interaction between user and product is usually through robotic devices or impermeable gloves that are attached to and protrude through the isolator bulkhead.
Things to Consider: GMP grade A as defined in GMP reference PICS GMP Guide 2002, Agency approvals, Exterior dimensions, Capacity, Internal dimensions, Tough hygienic construction, Surfaces resistant to corrosion and cleaning agents, Quick change glove system, Transfer devices, Electrical sockets for use inside workzone, Work surface dished to contain spills, Work surface free from crevices and with radiused corners, Lockable casters on frame, Fan variable speed, Sound power from sound sources < 65dB(A) at one meter, Filtration double in line safe change HEPA filters on both inlet and outlet, Filter size, Airflow unidirectional Grade A downflow at 0.3 to 0.6 meters per second, Air change rate 1800 per hour in the workzone, Airflow must sweep entire controlled workspace with no standing vortices or stagnant areas, Preferable to exhaust air from isolator to outdoors, Recirculation option needs to consider impact on sited room air quality, Negative air pressure with gradient -70 to -100 pascals, Air leak rate < 0.5% volume/hour as ISO 14655-7 for the isolator, Vibration < 0.005mm RMS amplitude in center of work surface between 20 to 20000Hz when isolator is operational, Control panel alarms audible and visual for low air flow/high or low internal pressure/filter blocked or damaged, Visual displays for air flow and internal pressure and HEPA filter pressure drop for each filter, Enclosed lighting units for 750 to 1000 lux at work level, DOP test port on each HEPA filter, Heat gain < 4 to 6C above ambient, Glove leak tester built-in, Control unit failsafe, Maintenance service, Spare parts availability, Instrumentation with calibration certificates traceable to standards, Re-calibration schedule, Validation procedure, Training for users.
Laboratory Casework. Laboratory casework includes base cabinets, wall cabinets, and storage and supply cabinets, and desks. Items that complement casework include and may include fume hoods, countertops, sinks, plumbing fixtures, and a robust wiring service with an abundance of electrical outlets. Modern laboratory casework is modular, allow it it to be customized and rearranged to fit the laboratory’s changing needs. Casework is made from several different materials: wood, plastic laminate, and metal. Stainless steel is a good choice for areas subject to high moisture, frequent cleaning, heavy abrasion, and abuse. Good casework has a smooth, chemically resistant, and easily cleaned surface with the durability to stand up to strong chemicals and abrasion.
Things to Consider: Type of laboratory and materials to be handled, Nature of work to be performed, Government codes and regulations, Laboratory workflow, Number of workers, Workstation functions, Materials of construction, Equipment and material locations and storage needs, Number of drawers and cupboards, Size and location of sinks, Utility outlets (gas/electricity), Furniture mobility requirements, Modular or custom sizes, Color scheme.
Laminar Flow Hood: A laminar flow hood, or cabinet, is a carefully enclosed workbench designed to prevent contamination of particle-sensitive devices such as semiconductor wafers and biological samples. Air is drawn through a filter and blown in a smooth, laminar flow towards the user. Hoods are manufactured in both horizontal and vertical configurations in a variety of airflow patterns. Some have a germicidal lamp to sterilize the shell and contents when not in use.
Things to Consider: Overall dimensions, Work area dimension with lid, Weight, Cabinet material and coatings, Lid material, Motor type, Average inlet velocity with clean filter, Electrical requirements, Sound level, Warranty.
Biopharmaceutical Low Temperature Chillers: A precision machine that removes heat from a liquid using a vapor-compression or absorption refrigeration cycle. In their industrial application, cooled water or other liquid from the chiller is pumped through process or laboratory equipment. They are used for controlled cooling of products, mechanisms, and machinery. They are often used in chemical processing and pharmaceutical formulation. They are typically closed-loop systems. They recirculate a clean coolant or clean water at a constant temperature and pressure to increase the stability and reproducibility of water-cooled machines and instruments. Most industrial chillers use refrigeration as the media for cooling, but some rely on simpler techniques such as air or water flowing over coils.
Things to Consider: Heavy gauge steel cabinet with expoxy coating, Minimum 5 inches foamed in place insulation (3.5 inches in doors and lids), Casters for mobility, Access port for accessories, Microprocessor control system, Low voltage compensation, Surge suppressor, Digital temperature display, Key operated main power switch, Battery back-up for alarm during power failure, Push button alarm test, Power failure and temperature deviation warnings audible and visual, Independent and tamper resistant adjustable high and low temperature alarm setpoints, Data port and system software, Industrial grade compressors, Refrigerant type, Washable air intake filter, Clean filter indicator light, Capacity, Interior dimensions, Exterior dimensions, Power requirements, Shipping weight, Warranty.
Water Baths. Laboratory grade appliances for heating water and maintaining it at precisely controlled temperatures. Water baths are used in industrial plants, clinical laboratories, academic facilities, and research laboratories to conduct bacteriological examinations, food processing QC procedures, and microbiology assays. These baths are manufactured with either analog or digital controls.
Things to Consider: Bath capacity, Bath opening, Working depth, Overall dimensions, Shipping weight, Heater wattage, Electrical requirements, Temperature setting method (Digital/Progammable), Temperature display method (LED/LCD), Temperature range, Chilling option, Temperature control method, Temperature stability, Temperature sensor type, High temperature cutoff, Low-level cutoff, Wetted materials, Pressure pump maximum head at 0 flow and maximum flow at 0 head, Suction pump flow rate (if applicable to unit), Warranty.