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Biotechnology Labs: Operations
Table of Contents
Background and Overview
Operations
Reasons to Change
P2 Opportunities
Where To Go for P2 Help
Acknowledgements
Complete List of Links

Essential Links:

Lab Waste Management Guidelines (Updated 2012)
These guidelines are geared for any type of lab (schools, research, clinical, biotech, analytical et...

University of Delaware Shared Core Instrumentation Centers in the Life Sciences
Description of capabilities and typical operations for biotech research.


This section gives an overview of biotech-related laboratory research and operations, along with typical methods and research practices, material and resource inputs, and resulting outputs.

Biotech facilities in the drug and pharmaceutical realm offer services in preclinical research for development of drugs, and development of the chemical synthesis protocols to make the drug at bench scale quantities to be used in safety and clinical studies. Some biotech firms go on to license their products with the FDA. To manufacture biotech drugs, the manufacturing process must also be licensed by the FDA along with the product itself.

For the most part, this resource applies to biotech and laboratory research, although many of the opportunities to reduce pollution can also be applied to manufacturing.

Common Scientific Methods and Branches of Science

Capabilities of biotech research firms include tissue fixation and analysis (histology), chemical synthesis, isolation, structure elucidation, DNA sequencing and extraction, protein profiling, protein purification, protein identification, protein dissection, assays, radioactive labeling, biomarker discovery, and much more depending on specialized areas of research.

Some of the branches of science and medicine commonly employed by biotech research firms are:

  • Biochemistry, which is the study of the chemical substances and vital processes occurring in living organisms.
  • Other types of chemistry including diagnostic, analytical, synthetic, nuclear, computational, and combinatorial.
  • Molecular biology, which is the branch of biology that deals with the formation, structure, and function of macromolecules essential to life, such as nucleic. This discipline includes genetic engineering, which is the manipulation of a cell's or an organism's genetic endowment by introducing or eliminating specific genes.
  • Cytology, which is the branch of biology that studies the formation, structure, and function of cells.
  • Cytogenetics, which is the branch of biology dealing with heredity and the cellular components, particularly chromosomes.
  • Various medical professions, may include (but not limited to) dermatology, oncology, immunology, rheumatology, gastroenterology, and neurology.

Supporting Functions

Several different facility and laboratory functions are necessary to support the primary biotech research. These functions include, but may not be limited to, tissue processing, animal husbandry, image and photo development, specimen storage, glass washing stations, water purification, autoclaves, decontamination systems, waste management, gas management, and air control systems.

Tissue processing, or histology, is the study of cells and tissue, and may also be used for bones, on the microscopic level. To prepare tissue samples for viewing, the tissue is typically prepared with ethanol, xylene, and paraffin, and then sliced. Once cut, the tissue slices (containing paraffin) must then be taken through a reverse series to replace the water in the cells, allowing them to be placed onto slides and stained. Once the tissue has been removed from the fixative, the formalin is typically disposed of via the sanitary sewer. Once a predetermined number of samples have been processed, the used ethanol and xylene, having become contaminated, must then be disposed of as a hazardous waste under RCRA.

Animal care requires diligent upkeep so that the facility stays clean. This is important to minimize dander exposure to employees, and especially important for immune-compromised animals. Animal rooms are usually entered through airlocks to prevent the introduction or release of infectious agents. Rooms are usually equipped with either modified, custom-designed HEPA-filtered isolation cabinets or glove port isolation cabinets. Bedding changes, feeding, washing cages, and monitoring air conditions are some of the maintenance requirements.

Cage and rack washing systems have traditionally been a large consumer of both water and heat energy resources. The traditional cage and rack washer may be programmed with a cleaning cycle consisting of a pre-rinse, alkaline wash, rinse, and a final disinfection rinse phase. For each of these phases, the unit fills the sump (40-60 gallons), heats and recirculates the water through a spray system, and then the water is sent to the drain. Additionally, many washers are provided with an optional cold water discharge cool-down system. With this option, cold water is injected into the hot effluent as the unit drains, cooling the wastewater to an acceptable drain temperature. The cold water consumption for this process could be as much as 40-60 gallons per phase, thus doubling the total consumption of domestic water. A cycle could consume as much as 320-480 gallons of water per cycle.

Image and photo development may utilize conventional or digital photography, on-site dark rooms for photo developing, or x-ray film development.

Depending on the facility and nature of work conducted, specimens may be stored in a preservative solution, on ice or dry ice, and/or in cold storage containers, refrigerators, or freezers. Cold storage and ice machines consume a significant amount of energy.

Another energy-consuming function is autoclaving of dry biohazardous wastes to sterilize them so they can be thrown in the general solid waste. An autoclave uses high pressure steam to bake the waste raising the temperature to a level sufficient to kill the microorganisms. Some companies autoclave onsite while others outsource this operation.

Glass washing stations for reusable glass labware are typically water and energy intensive, and bleach and cleaning solvents may be used. Both automatic dishwashers and handwashing stations are available, depending on the amount and residues on the lab glassware. Ultrasonic cleaning baths may be used at benches.

Distilled, deionized, reverse-osmosis, pure, ultrapure, water for injection (WFI) and other grades of water are required for many research and manufacturing operations. In manufacturing, it is used to grow cells, filter drugs out of a growing solution, and clean vats and equipment after a batch of the drug is made. Since biopharmaceutical drugs are mostly proteins and therefore injected directly into humans, the water used in all facets of the research and manufacturing process must meet strict regulations set down by the U.S. Food and Drug Administration and the European Union. If water preparation and purification occurs on site, it can be an energy- and water-intensive process. Water conversion processes require more potable water than the yield, (e.g., produce ultrapure water may take 1.5 gallons of water to yield one gallon of ultrapure water [1]).

Decontamination (decon) is required in various instances. For example, when a biosafety cabinet is annually certified, or when an infectious substance is accidentally spilled or released. Options for decon include manual cleaning with toxic disinfectants such as paraformaldehyde, and automated systems that pipe in concentrated vaporous hydrogen peroxide.

Due to the variety of sanitary and regulated wastes that require different storage, handling, and disposal, waste management is an important function at biotech facilities. Recycling of spent solvents and batteries requires strict attention to segregation. Regulations will apply to most, if not all, of the following wastes: biohazardous/ infectious, radioactive/ radioactive mixed, hazardous waste, sharps, spent solvents, mercury containing devices and materials, fluorescent lamps, expired or unusable chemicals, lab glass, and batteries.

Heating, ventilation, and air conditioning (HVAC) systems and air quality control systems are critical at biotech facilities, and especially in vented work stations and storage areas. The HVAC systems used at biotechs are often regulated by the FDA. In most industries ventilation is important in protecting workers from the materials they are working with, but in the biotechnology industry one of the primary purposes of ventilation is to protect the products from contamination by the workers. The primary purpose of enclosed balances is to prevent air currents or other factors in the room from affecting balance readings. Operations, safety, and accuracy depend on proper air flow and exhaust within the facility and work areas. Gas and other continuous monitors or detectors may be necessary in certain areas of the lab to avoid exposure to leaking gas, chemicals, or other agents.

Gas management covers the purchase, handling, use, and disposal or recycling of empty gas cylinders. Compressed gas cylinders are the primary delivery system for most gases, and many of the cylinders are reusable or refillable. One industry analyst states that for every dollar spent on gases and cryogens, most users spend two to three dollars on inefficiencies in gas selection, storage, handling, administration, waste, and downtime [2].

Lab Equipment and Instrumentation

Various work stations and storage areas must be vented while working with toxic, infectious, or hazardous materials. The fume hood is a work cabinet that exhausts vapors and fumes away from the user and vents to the outside. These offer protection from chemical hazards. Fume hoods may also be used for very short-term storage of chemicals. Conventional fume hoods require significant energy since they need to exhaust large quantities of tempered air while in use. There are approximately 750,000 fume hoods currently in use in the U.S., which translates to an annual operating cost of approximately $3.2 billion, with a corresponding peak electrical demand of 5,000 megawatts [3].

The biological safety cabinet is used to protect the users from biohazards, and to protect the materials used in the analysis from contamination. It is equipped with 0.2 micron filters to capture microorganisms. These typically exhaust through the filter into a room and offer no chemical safety protection unless they have 100% exhaust and are rated for chemical protection as well. All BSCs must be certified annually, and need to be decontaminated before being worked on mechanically.

Certain other work and storage areas must also be vented, such as hazardous or toxic gas and chemical storage, and balance enclosures which provide user protection by keeping powders, particulates and fumes contained during weighing procedures.

Instrumentation for extractions and other analysis is used extensively in biotech labs. Some of the methods are chromatography (high performance liquid chromatography [HPLC], thin-layer, gas, or flash), mass spectrometry, spectrophotometry, electrophoresis, soxhlet extraction, solid-phase extractions, synthesis processors, microarray analyzers, solid phase protein adsorption and separation with surface-enhanced laser desorption/ionization, and nuclear magnetic resonance spectroscopy.

Glassware, thermometers, stir plates, agitators, centrifuges, aspirators, and other standard lab equipment is used.

Chambers are used to grow biological material. One type of growth chamber is a bioreactor, typically a stainless steel container or vessel, which can range in size from a few gallons for benchscale and research operations, on up to 500 gallons for manufacturing purposes. Incubators may also be used for cell culture growth.

Bioimaging is an important function, utilizing an array of different equipment: electron microscopes, confocal microscopes, conventional or digital cameras, x-ray equipment, and luminometers.

Cold storage is necessary for some types of specimen preservation. Cold rooms, dry ice storage chambers, storage in cryogenic liquid nitrogen, ice machines, freezers (if multiple freezers are placed side by side in one location, the space is termed a "freezer farm"), and refrigerators at different temperatures.

Materials and Reagents

Numerous consumable materials and reagents are used, with manufacturing typically using more significant quantities due to the production output compared to bench scale quantities used in research. Examples are categorized below:

Solvents

  • Acetonitrile
  • Dichloromethane (methylene chloride)
  • Methanol (methyl acohol)
  • Dimethylformamide
  • Acetone
  • Xylenes
  • Ethanol
  • Ethylene glycol

Some companies recycle certain solvents onsite, such as alcohol and xylene, however some opt to send solvents to off-site recyclers because of challenges with segregation, purity and concentration issues with recycled solvents, and fire permits.

Fixatives and Preservatives (for tissue processing)

  • Formalin / Formaldehyde - (typically, formalin, an aqueous solution of about 37% formaldehyde and some buffer salts, is diluted to 10% and used as a fixative to preserve tissue samples until they can be prepared for viewing)
  • Zinc formalin
  • Zinc tris buffer
  • Ethanol-acetic acid-formol saline
  • (For bone and some tissues), glycol and methyl methacrylate
  • Mercury-based (usually mercuric chloride)

Acids

  • Acetic
  • Sulfuric
  • Hydrochloric
  • Nitric
  • Phosphoric

Bases

  • Potassium hydroxide
  • Sodium hydroxide

Gases

  • Nitrogen
  • Carbon dioxide
  • Helium (in gas chromatography)

Other Materials

  • Liquid nitrogen
  • Radioisotopes for radioactive assays and labeling
  • Dry ice for storage and shipping
  • Disinfectants, including bleach
  • Decontamination agents, such as vaporous hydrogen peroxide, and paraformaldehyde
  • Adsorbents
  • Desiccants
  • Silica gels used in chromatography
  • Diatomaceous earth

Outputs

Biotech research and manufacturing generate hazardous emissions from point sources such as exhaust from fume hoods, storage rooms, boilers and generators, and autoclaves. Area or fugitive emission sources may come from breakage, spills, or leaks, as well as bench top operations and glassware cleaning.

Solid and liquid wastes that are uncontaminated and unregulated can be disposed of in general solid waste. Typical recyclable materials (e.g., cardboard, paper, non-lab glass, plastics, etc.) should be recycled as long as they are not contaminated with any hazardous, infectious, or other regulated waste. Regulated wastes are stored and handled per regulatory requirements and include biohazardous/infectious waste, radioactive/ radioactive mixed waste, hazardous waste (including most spent solvents and expired or unusable chemicals), contaminated sharps or lab glass, waste pump oil, contaminated wastewater, many types of batteries, and mercury containing devices or materials, especially fluorescent lamps.

Non-contaminated "sharps," such as glass pipettes, plastic pipette tips, glass vials and broken glass can be cleaned, then placed in designated cardboard containers. If the full container is sealed, it can be placed in general solid waste.

Sources:
[1] Resetar, Lachman, Lempert, and Pinto. 1999. Technology Forces at Work: Profiles of Environmental Research and Development at DuPont, Intel, Monsanto, and Xerox. Appendix D.
[2] Scheruing, S. 2005. Gas Selection/Management for the Biotech Lab. BioPharm International.
[3] Turpin, J. 2003. Clearing the Air About the Latest Fume Hoods. Engineered Systems.


 

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