Obtaining the accordance to current regulation

July 29, 2022


Obtaining the accordance to current regulation

Particle counters, photometers, hot and cold smoke generators, anemometers and pressure gauges




Commissioning & Qualification



The client company was running a contract with a poorly prepared and updated supplier on the procedures which were created ad hoc for the management of its machinery. This preparation was necessary to produce drugs in a sterile environment. Poor and worthless training have therefore been the main causes of a few serious technical problems. There was even a harmful dripping that forced the costumer to block the line and ultimately ended up with a complete loss of turnover and operations.


In order to eradicate the technical issues and fully tackle the emergency, the customer asked JSB for support. The action was primarily focused on two verification phases: the first took place on the integrity of HEPA filters in a sterile environment, while the second on differentials and on pressure.


JSB assembled a dedicated team to be focused solely on the company which, even before starting, was trained to achieve compliance with the customer's tailor-made procedures. The adaptability of our working group led to the achievement of the tasks.


In the verification session, a total of 200 filters were tested on 2 different production lines, both including isolators, rabs and grade A B and C areas. All the tests reached positive results and no adverse events were detected during the verification period. The resolution of the problem brought back the client to a profit equal to 30,000 euros per year.