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Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 37 hence, it is predicted there would potentially be mul- tiple distributions, as noted in Figures 7–9. It is reasonable to assume from multiple analy- ses of reference materials over the range of particle sizes obtained for the samples, the resolution of the system is 5–8%. This suggests the differences ob- served as a result of the particle morphology were real; however, the differences observed as a result of the vortexer model were well below 5–8% and were most likely not statistically significant. References 1. C. Hare, M. Ghadiri, Chemical Engineering Science, 125, 7, 13-19 (2015) 2. IUPAC, Compendium of Chemical Terminology, 2nd ed. (the "Gold Book"), compiled by A. D. McNaught and A. Wilkinson. (Blackwell Scientific Publications, Oxford 1997). XML on-line corrected version: http://goldbook.iupac.org (2006-) created by M. Nic, J. Jirat, B. Kosata; updates compiled by A. Jenkins. ISBN 0-9678550-9-8. https://doi.org/10.1351/goldbook. 3. USP, USP <941>, "Characterization of Crystalline and Partially Crystalline Solids by X-Ray Powder Diffraction," USP 41-NF 36. 4. USP, USP <776>, "Optical Microscopy," USP 41-NF-36. 5. R. E. Gordon and S. L. Amin, "Crystallization of Ibuprofen" US Patent 4.476.248, 1982. 6. V Elango, et al., "Method for Producing Ibuprofen," US Patent 4,981,995, 1987. 7. E.T. White, A. Rashid, International Journal of Pharmaceutical Research and Innovation, Vol. 8, 2015, 29-33. 8. F. Yang, S. Zhou, Chem. Biochem. Eng. Q., 29 (3) 395–403 (2015). 9. D. Rajavathsavai, A. Khapre, B. Munshi, World Academy of Sci- ence, Engineering and Technology International Journal of Chemi- cal and Molecular Engineering, 8 (12) 2014. 10. B. Launder, S. Poncet, E. Serre, Annual Review of Fluid Mechan- ics, Annual Reviews, 2010, 42 (1), pp.229-248. PT Tackling operational issues in the lab Successful laboratory operations are dependent on the synergy between technologies, practices, and team culture in the lab. This synergy often requires an optimized approach toward handling operational issues both when and before they arise. Pharmaceutical Technology spoke with Katie Schlipp, executive director of Analytical Services at Avista Pharma Solutions, about what it takes to optimize the way operational issues are handled in the lab. PharmTech: What are some common operational issues experienced in today's lab? Schlipp: From an analytical perspective in a multifunctional contract laboratory, there is a high variability in studies ranging from early development to routine commercial release. It is critical to ensure there are streamline processes in place that operate with a 'real lean' approach. Processes should be evaluated to eliminate complexity and ensure there are no unnecessary steps that impede the progress of workflows, regardless of work types. Processes must be carefully constructed with flexibility for irregular types of programs while being controlled and robust to ensure work is conducted at a high level of quality and integrity to support all GMP analytical work. PharmTech: What are some considerations that should be made when approaching an operational issue in the lab? Schlipp: Consider all the facts. Allow several team members to assess the data and have an open discussion around the opportunities to resolve the issue. Not one person has all the right answers, but collectively as a team, the best ideas and solutions can come to light. PharmTech: What kinds of organizational strategies should be used to help minimize operational problems? Schlipp: A strong organizational structure is key in a high- growth contract development and manufacturing organization. The span of the work and various work types need to be functionally organized, and each function should have a process- driven approach that considers upstream and downstream activities as well as their interdependencies. PharmTech: What kind of lab 'team culture' should be maintained to ensure quality and accuracy, and what can individual team members do to uphold this culture? Schlipp: It must be a 'one team' culture. Teams should work toward the same goal of finding the most efficient path to success, with each member working with an 'owner's mindset' to find that path. PharmTech: What are some effective preventive approaches to tackling operational issues? Schlipp: Frequently hiring new staf f members gives the benefit of fresh eyes and new perspectives. We all look through different lenses, and different perspectives allow us to consider all angles in the process. Employees should be encouraged and empowered to improve the processes and help minimize the risk of operational issues. Keeping close and listening to those working at the front lines to understand the challenges and opportunities helps divert any near misses. This is a proactive approach to keep operations running smoothly. —Amber Lowry