![\"Building](\"https:\/\/www.weidmann-medical.com\/wp-content\/uploads\/2265905_EmployeeSpotlight_1200x600-V2_051324.jpg\")
<\/h1>\n<\/h1>\nThis part of the interview covers the timeline and challenges faced while constructing the new clean room in Mexico for the new project. Jos\u00e9 elaborates on\u00a0<\/span>the process of<\/span>\u00a0meeting quality requirements according to ISO 13485 and the certification process. He also discusses the involvement of the Swiss team and the smooth execution of the project.<\/span><\/p>\n <\/p>\n Viola Frey<\/span><\/strong><\/p>\n Is the project in Mexico\u00a0<\/span>basically<\/span>\u00a0a twin of the Rapperswil project?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n That’s correct.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n How long did\u00a0<\/span>it take you to<\/span>\u00a0build the clean room, from planning to finishing it?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n We started in March 2023 this year and finished in August 2023.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n So that’s pretty quick<\/span>, isn’t it?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n Yes, indeed, it took about six months and was an impressive project building construction.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n How was the project set up for the new clean room?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n We had a project leader from Mexico, Lourdes Labastida, our project manager. From the Swiss side, Roger Wolf from the technical department supported us. I was responsible for all quality issues.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n What were the main challenges in meeting all quality requirements according to ISO 13485?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n The real challenge from a quality perspective is demonstrating that once the new clean room is built and completed, it will\u00a0<\/span>be classified<\/span>\u00a0according to ISO 13485:2016. So, in that sense, we achieved our initial clean room certification from an external company that was in charge of a series of tests performed to show that it was operating at its required class.<\/span><\/p>\n The certification process checks the following parameters: temperature, humidity, pressure, and degree of purity (suspended dust in one cubic meter of air). It also checks whether the contamination class, air velocity, pressure, and flow rate comply with the project requirements.<\/span><\/p>\n From my perspective, this<\/span>\u00a0was the biggest challenge in building the new clean room, as quality is Weidmann’s top priority.<\/span>\u00a0Our unwavering commitment guarantees that every product is crafted to precise specifications, prioritizing patient care throughout the process.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n So, did this external company\u00a0<\/span>that was<\/span>\u00a0checking all those parameters issue official documentation to verify the clean room’s proper functioning?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n Yes, the documentation issued ensures that our new clean room complies with ISO and current Good Manufacturing Practices (cGMP) standards.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n It was a very quick project, but were there any difficulties along the way when you thought there would be delays, or were there any unexpected challenges in building the clean room?<\/span><\/p>\n Jos\u00e9 Fuentes<\/span><\/strong><\/p>\n I have to say that it<\/span>\u00a0was\u00a0<\/span>really impressive<\/span>\u00a0since everything within this particular project was according to the timeline.<\/span><\/p>\n We didn’t have any real problems from a quality point of view because we were able to separate the new clean room construction from the current series production, which meant that they didn’t interfere with each other, e.g., the warehouse, material flow, packaging materials, or finished goods. That made it easier to manage and allowed us to meet the schedule.\u00a0<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n What do you think made the project so smooth?<\/span><\/p>\n Jos\u00e9 Fuentes\u00a0<\/span><\/strong><\/p>\n It was also\u00a0<\/span>very important<\/span>\u00a0for us to have the support of the Swiss team at all times. To accomplish this task, we received\u00a0<\/span>a lot of<\/span>\u00a0feedback from the quality department and the project manager responsible for the project in Switzerland.<\/span><\/p>\n Viola Frey<\/span><\/strong><\/p>\n Thank you for your time today. I look forward to our next catch-up about sustainability considerations for the clean room and\u00a0<\/span>future<\/span>\u00a0plans.<\/span><\/p>\n Read the third installment of this interview series here <\/a>and the first part here<\/a>.<\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" An Interview with Jos\u00e9 Fuentes Part 2 – Building the Clean Room This part of the interview covers the timeline and challenges faced while constructing the new clean room in Mexico for the new project. Jos\u00e9 elaborates on\u00a0the process of\u00a0meeting quality requirements according to ISO 13485 and the certification process. He also discusses the involvement […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-7393","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\n\n