The Environmental Manager of Pharma S.A. needs a solution to monitory and control the contamination in Pharmaceutical Cleanrooms.

Transcription

1 Story Summary The Environmental Manager of Pharma S.A. needs a solution to monitory and control the contamination in Pharmaceutical Cleanrooms. Storyline The Pharma S.A. is a pharmaceutical industry with many cleanrooms. A Cleanroom is an environment with a low level of environmental pollutants such as dust, airbornemicrobes, aerosol particles, and chemical vapors, where products are manufactured. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. The only way to control contamination is to control the total environment. Air flow rates and direction, pressurization, temperature, humidity and specialized filtration all need to be tightly controlled. This will be succeeded by measure the number of particles per cubic meter on a specified particle size at every cleanroom. There are three levels: warning, action and alarm limits. The Environmental Manager needs to be notified as soon as possible if there are problems with the cleanrooms. If the Environmental Manager could be alert if limits are approached in real time, he/she could take action quickly and minimize the impact at manufacture products. 1/7

2 Persona Environmental Manager About 35, married, 10 years of environmental experience. Being the person who ensures that the manufacture products are not contaminated. Very mobile, moving from building to building during day. I work with the Chief Production Engineer, Quality Assurance Manager and Quality Control Manager. Responsibilities Main Goals I am responsible for documented evidence which provides a high degree of assurance that the manufacturing process complies with EU guidelines about microbial contamination in pharmaceutical products. I am responsible to start the appropriate actions if contamination is occurred at any cleanroom. I enter a work order to Quality Assurance Manager to check the cleanrooms if problem arises to a cleanroom. I start clean procedures in a cleanroom if contamination is occurred. Needs I always need to find which cleanroom has a problem. It can become hard to locate. I need to know the inspection results of a cleanroom with problem. I need to know if samples are been taken from problematic cleanrooms. Real time monitoring in Pharmaceutical Cleanrooms. Better management of actual time spent only in cleanrooms which have problems. Pain Points Need to see daily which cleanroom has problem. Need to be informed automatically if limits of particles numbers is exceeds. 2/7

3 Point of View 3/7

4 User experience Journey ACTIONS MINDSET Products are been rejected because of microbial contamination. The means that some of cleanrooms are out of specification for particles numbers. Why cleanrooms has exceeded the warning limits? Helen informs Chief Production Engineer to stop production. Helen sends a work order to Quality Assurance Manager to check the cleanrooms. All cleanrooms should take a look. The QA Manager receives the work order and forwards it to his staff to check on the cleanrooms. Let s send Martin to check on all cleanrooms and to take samples for analysis. Martin receives a work order. He has to look up all cleanrooms and take samples from everywhere. He sends the samples to Quality control. Where are all the cleanrooms it in the factory? I don t even know which cleanroom might be causing the problem. The Quality Control Officer Jeff receives the samples and creates inspection lots for every cleanroom. The officer is executed the appropriate analysis. I have to create inspection lot for all cleanrooms to find which has the problem. The results of analysis are rejected only for Cleanroom 1. Helen is informed by the Jeff about results. She starts the clean process for the certain Cleanroom. Wooow this took forever to find which cleanroom has the problem and we lost lot money from stopping the entire production. FEELING TOUCH POINTS Product rejections. Work order request. Work order. Staff. Work order. Cleanroom. Inspection lots. . Quality control Equipment. Cleanroom. 4/7

5 Prototype Mockup With the IoT application Environmental Monitoring the Environmental Manager can monitor on-line all cleanrooms of the factory. In the first screen of application (Screen 1) there is the map of the factory where cleanrooms are displayed with the buttons with following colors: Green, the cleanroom is OK. Red, the cleanroom is NOT OK. Blue, the cleanroom is OUT OF ORDER. Screen 1 5/7

6 By click Cleanrooms List a screen with list of cleanrooms is displayed (Screen 2). Screen 2 The list has all cleanrooms code, their status and the number of particles which is measured on -line. If the number of particles are below limits are note with green color otherwise with red. By click each item of the table a screen with cleanroom attributes is display (Screen 3) for the cleanroom which is select. At the screen, besides cleanroom attributes, there are actions that user can make or made automatically (for example send information , send work Order, start clean process). Also there is a graph with the number of particles for the certain cleanroom across time period. In screen 3 user can been taken also by clicking the cleanroom button of the first screen at the factory map. At screen 2 and 3 there is a back button which it is taken to the previous screen. 6/7

7 Screen 3 Site: _S0 Category Manufacturing 7/7