Cleanroom Technology Seminar 2013 SYDNEY 12TH NOVEMBER 2013 MELBOURNE 14TH NOVEMBER 2013

Kenelec Scientific invites all those who work in a cleanroom and process/manufacture sterile injectables, cell & tissue products, medical devices, radio-pharmaceuticals or compound sterile products, to attend this seminar. This seminar looks at the existing and emerging real-time monitoring technologies, primarily focusing on particle contamination in cleanroom and sterile environments.

Particulate contamination inside cleanrooms or clean air devices is a major concern to companies manufacturing or processing sterile products. The ability to make real-time informed decisions on the nature and concentration of particulate contamination greatly assists the Production or Quality Manager to assess the impact to product, allowing quicker, more informed decisions to be made based on real time data. More effective root cause analysis can be performed and the products integrity can be assessed just moments after the actual event thus eliminating expensive down-time and root cause analysis; CAPA’s which clog up the Quality Department’s resources.

By having an effective Environmental Monitoring Plan and system utilising real-time monitoring technologies, you are keeping up with regulatory expectations and also improving the quality of your products.

Recent updates to ISO 14644 Parts 1 & 2 ‘Cleanroom’s and Associated Controlled Environments’ and ISO14644-9 ‘Classification of Surface Cleanliness By Particle Concentration’ and the PIC/s guide all emphasise the need for real-time environmental monitoring concentrating on particle contamination.

To attend the seminar, please email or fax back to info@kenelec.com.au or 03 9873 0200.

For more information please contact Fiona on 1300 732 233 +61 3 9873 1022