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Applying Lean Tools to Chemical Process Development

Lean tools are engineering evaluation techniques that can be integrated into chemical process development labs in order to reduce different types of waste

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Lean tools are engineering evaluation techniques that can be integrated into chemical process development labs in order to reduce different types of waste.1 One of these tools is an online pull or kanban (scheduling) system that allows lab managers to create a list of requests. Failure mode and effects analysis (FMEA) can also be applied to reduce hazards while allowing flexibility in the layout of materials and equipment for developing chemical processes.

Types of waste

Examples of the types of waste and hazards in chemical process labs are: (1) waiting for supplies and chemicals and instrument calibration by a manufacturer; (2) correcting laboratory procedures when they are not within instrument calibration; (3) increased workload for analytical instruments; (4) waiting for online orders from vendors; (5) transporting chemical reagents, samples, and waste through the labs; (6) searching for items not properly labeled in storage cabinets; (7) overproduction of waste without storage containers and secondary containers for spills from overfilled containers; and (8) underutilized staff due to lack of training. Table 1 presents the action items for each type of waste and identifies which lean tools can be applied to each scenario.

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Type of wasteScenarioLean ToolAction Items
Reduce DefectsChemical supplies do not meet chemical specificationsQuality at the SourceCreate a list of suppliers who meet chemical specifications according to lot numbers and certificate of analysis prior to purchasing
OverproductionOverproduction of hazardous waste without any storage containers and secondary containers to prevent spillingPull SystemRequest for waste containers when chemicals and lab supplies are ordered for experiments and pilot-plant projects
Waiting
  • Waiting for supplies and chemicals to arrive
  • Waiting for calibration of an instrument by the manufacturer
Pull System
  • Create an inventory of supplies from similar projects
  • Order supplies and chemicals when they are 75% consumed from the list of suppliers with chemical specifications
  • Allocation of the number of samples tested on an instrument allows the project leader to be aware of the funds needed for chemical analysis and the routine calibration and preventive maintenance needed
 Overprocessing or increased workload on analytical instrumentsPull System 5S
  • Online reservation system for scheduling use of instruments
  • Preventive maintenance according to SOPs or prior documentation of its use by other operators in logbooks
  • Logbooks would indicate the time for maintenance based on the lifetime and recommendations from the SOPs or user’s manual
TransportationConveyance of chemical reagents, samples, and waste through the lab to reduce exposureValue Stream MappingLayout of the laboratory or pilot-plant for ease of processing in an equipment, sampling beside the instrument, storage of samples, and disposal of waste
Reduce MotionWasted motion due to searching for items in the laboratories5SStorage cabinets and chemical containers should be properly labeled
Under Utilized EmployeesPart-time student workers waiting for tasks and work assignmentsTraining and Motivation
  • Training for new skills that are in demand by prospective employees
  • Motivating them to learn by assigning tasks that apply science and engineering principles from their coursework
  • Recognition in meetings and giving credit in presentations

Lean tools

Quality at the source can identify suppliers that can list certificates of analysis of their batches of reagents on their purity, efficacy, and type of chemical test used to determine their chemical composition.

The pull system can be used for addressing issues of overproduction of waste, waiting for supplies and instrument calibration, and reducing inventory. For example, an online laboratory request form can be a pull system platform. A laboratory manager can use the pull system to learn the immediate needs versus the most frequent needs of workers. An online form gathers the requests from staff in predetermined categories. The form also asks users when they need it (whether one to two days, one week, or one month) in order for the lab manager to prioritize tasks and delegate them to the staff. This online Google form compiles the information on a spreadsheet that the department head, staff, faculty, and student workers can access to get the tasks done according to their job descriptions and responsibilities. Data from each category gathered from a research facility from the pull system can be shown on a Pareto diagram as a basis for making decisions about the allocation of people, time, and budget. For example, a series of Pareto diagrams over a 12-month period from a biomaterials academicindustry consortia lab identified that facility improvements are the most requested and comprise 30 percent to 40 percent of the online requests. Facility improvements include repairs, requests for compliance with university regulations, or project-sponsored specifications. These diagrams also showed that the top 80 percent of the requests involved research activities of new hires who create materials or install instruments in experiments with potential economic benefit as value-added products.

The Pareto diagram data from the pull system can be reinforced with Gemba Kaizen or management by wandering around (MBWA). “Adopting MBWA as a participatory management style encourages employees to ask questions by making managers available to employees in casual discussions.”2 MBWA also reinforces continuous improvement of the safety, efficiency, and productivity of the laboratory.

The 5S methodology in laboratory management involves the following practices: sort, sweep, straighten, shine, and sustain. It involves sorting chemical reagents (acids, bases, solid, liquids, waste) into different storage containers; sweeping any spilled items or disposing of hazardous chemical waste in appropriately labeled containers for routine pickup; straightening the glassware, plasticware, and instruments in place; shining the laboratory workplace by removing clutter, wiping spills, and routine cleaning; and sustaining the operation by training workers to use online standard operating procedures, instrument users’ manuals, and experimental procedures (SOPs). The 5S approach reduces searching for items in the laboratory by labeling storage cabinets and chemical containers, reduces hazards and inefficiencies by routine cleaning and straightening.

Underutilized student workers can be motivated to learn by assigning them tasks that apply science and engineering principles from their coursework and recognizing them in research group meetings, on posters, and in presentations. Hiring part-time workers could enable important laboratory management work to be done less expensively.2 Standard operating procedures can facilitate the learning process and prevent nonvalue Gemba Kaizen–added steps in worker’s activities.

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Value stream mapping provides a layout of processing equipment placed beside sample testing instruments and for disposal of waste. A layout for process development can also reduce trips and falls. However, when the process is being developed and there are changes in the setup, moving different experimental setups or modules should be allowed. Flexibility of the equipment and workbenches reduces motion. Hence, the proposed process should involve a process map to reduce motion but allow flexibility to add or remove parts when improving the process. For example, biopharmaceutical process development laboratories utilize single use flexible systems for scale-up of disposable bioreactors, filtration membranes, and chromatography systems to reduce waste in workflows.3

Occupational hazards in research and teaching labs that might affect the health and safety of researchers and students include chemical, physical, electrical, and mechanical risk factor.4 To reduce these to an acceptable level and control routine inspection, corrective and preventive actions, group trainings, and to identify potential hazards in the scale-up of a chemical process, FMEA can be used as an assessment tool. FMEA ranks the different instruments, chemical storage, and workbenches in terms of their severity (S), occurrence (O), and detectability (D). The severity score is set according to the Hazardous Materials Identification System and material safety data sheets found in the occupational safety database. Occurrence and detectability scores are gathered by biased visual inspections. The sums of the scores are posted online for faster data collection and ranking. For example, from FMEA scores in a bioenergy process analytics laboratory, the top three risks identified were: (1) possible explosions due to the flammable gases (methane, hydrogen, propane) in high-pressure tanks, (2) contact of the metal tanks with live electrical parts, and (3) sharp cuts when capping used syringes and disposing of them in sharps containers, or broken glass from disposable broken glass pipets or broken glass containers. From this FMEA, safety measures involve installing an emergency poweroff switch, gas monitoring using a pressure relief device, an emergency gas-off switch, exhaust flow monitoring, and having a ventilated enclosure, gas cabinet, and fume hood. Laboratory managers can identify the top risks for allocating time, money, and personnel to prevent violations of university or government laboratory regulations. However, chemical process safety risk mitigation involves cost as a constraint.

Acknowledgements

Barbara White is acknowledged for sharing data from the online laboratory request for laboratory management of her biomaterials academic-industry research consortium facility at North Carolina State University. William Holmes and Emmanuel Revellame are acknowledged for sharing their experience from their bioenergy process development projects at the Energy Institute of the University of Louisiana at Lafayette and the Mississippi State University Department of Chemical Engineering, respectively. Carl Breuning is acknowledged for sharing his experience in biopharmaceutical process development.

Jim Lee reviewed and gave feedback on this work as a requirement in ENGR 640, Lean Six Sigma, a course offered at the College of Engineering at the University of Louisiana at Lafayette.

References

1. Speziale, R. Logjam, Bottleneck, Pinch-Point: The Efficiency Drain for the Modern Laboratory. Lab Manager magazine, January 31, 2007. https://www.labmanager.com/business-management/logjam-bottleneck-pinch-point-the-efficiency-drain-for-the-modern-laboratory-21205 

2. Borchardt, J. K. Top 10 Management Skills You Need. Lab Manager magazine. October 4, 2011. https://www.labmanager.com/leadership-and-staffing/top-10-management-skills-you-need-18128 

3. Sinclair, A. and M. Monge. Disposables Open Up Possibilities in Facility Design. Biopharm International, August 1, 2008, Volume 21, Issue 8. http://www.biopharminternational.com/disposables-open-possibilities-facility-design?id=&sk=&date=&%0A%09%09%09&pageID=2

4. Ozdemir, Y., Gul, M., Celik, E., 2017. Assessment of occupational hazards and associated risks in fuzzy environment: A case study of a university chemical laboratory. Hum. Ecol. Risk Assess: An Int. Jour., Volume 23, 2017, 895–924. https://doi.org/10.1080/10807039.2017.1292844

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