BIOTECHNOLOGY CASE STUDY


Applications Consulting / 1 Day
November 2020

A manufacturer of cell counters, image cytometers, and reagents requested an on-site visit from our Applications Consulting Team to recommend improvements to current standard operating procedures (SOP’s), safe workstation setup, test system operation, and test verification. The client’s products are used in various applications including automatic cell counting, image-based cytometry for cell analysis, and toxicology studies. Testing requirements fall under the test and measurement industry per the IEC 61010 test standard. Currently the client uses the old HYAMP® III model 3130 and Hypot® III model 3765 system for their production testing. The group consisted of three Operators/Technicians and three Engineers.

Consulting Visit

The day started with reviewing their existing test procedure (SOP’s). The client operates the test system manually and collects test data by watching the screen of the test instruments and writing it down on their test sheets, unfortunately this can lead to mistakes while recording the data. Implementation of software control and digital data capturing was recommended; in addition to other suggestions to reduce the amount of operator intervention and redundant test steps. Our team showed the group how to wire the test system and how to program test routines. It was suggested that they keep their verification test routines separate from their actual test files for production testing, to avoid any confusion and operator error. Next, we simulated all possible failures and error messages that can appear during testing. With each error message we explained in detail the necessary tips for troubleshooting. We also discussed personal protective equipment that can be utilized as a part of their safe workstation. The client currently utilizes an insulation mat, emergency stop switch (E-Stop switch), and HV warning signs. They plan to dedicate an area for their test station where they will install signal tower lights and a 10-foot boundary around their work area.

KEY POINTS

  • SOP/test procedure improvements
  • Setup and programming of test equipment
  • Test system operation
  • Daily verification method (TVB-2)
  • Train operators and staff with safe workstation practices
  • Understanding error messages
  • Troubleshooting tactics

Consulting Notes

At the end of our training, the group felt confident in using their test system and being able to do base level troubleshooting in the event of a testing failure. The client mentioned they were able to make serious advances to their SOP’s and improvements to streamline their testing protocol. The client was highly appreciative of our willingness to provide on-site support during these uncertain times.