Sectors

under construction...

Download

• Analisi del rischio: un esempio applicativo al settore farmaceutico della Fault Tree Analysis
• Note informative sulla nuova Linea Guida AFI: l’Analisi del Rischio e le sue applicazioni nel settore farmaceutico
• Il nuovo Annex 1 dell’EU GMP e la ISO 14644-1/2. Come si controlla, forse, il particolato aeroportato in una cleanroom farmaceutica
• Impianti HVAC a contaminazione controllata per i reparti operatori alla luce della nuova guida ISPESL
• Isolatori per linee di imbottigliamento bevande
• La gestione delle deviazioni nella produzione dei farmaci
• Misure in cleanroom: l’influenza della aerodinamica interna sulla affidabilità dei dati di certificazione
• Teoria e pratica della misura del Recovery Time secondo ISO 14644/3 - 1° parte - Modello a due flussi
• Analysis of airborne contamination distribution in mixed flow cleanroom and consequences in the control techniques

Who we are

Lesatec was established in 1996 by Leonello Sabatini, present President and Technical Director.

Since the beginning the structure created was able to answer the requests of companies of contamination control systems sector.

Lesatec headquarter is in Opera, near Milan, where in just one location are developed all activities, technical, commercial and administrative.

Services offered are:

• Design, building and supply of Cleanrooms and contamination controlled environments with applications that comply  with laws and line-guides of the specific sector
• Design, building and supply of  HVAC Systems for of Cleanrooms and contamination controlled environments
• Design, building and supply of Contamination Control Equipments
• Cleanrooms and contamination controlled environments qualification
• Consulting for protocols drafting and execution
• Clean Rooms, Contamination control equipments and HVAC Systems maintenance
• Clean Rooms and departments revamping
• Works direction
• Building of turn key plants

Services

The range of products offered by Lesatec in contamination control field is completed by the following services:

• Cleanrooms and Clean Environments design...
• Contamination controlled environments qualification...
• Existing Clean Rooms check up...
• Clean rooms revamping...
• IQ/OQ protocols drawing up and execution
• Training courses for Clean Room operators
• Clean Rooms and HVAC systems maintenance
• Works direction