• Document: Cleanrooms. expertise you can rely on
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Cleanrooms – expertise you can rely on Design Construction Qualification Maintenance Project Management Validation Plan User Performance Plan Validation Plan Define Scope (VP) Requirements Qualification (PQ) Re-Qualification Summary Report Procure Budget Risk Assessment (URS) and CQ Develop Timelines Functional Operational Requirements Qualification (OQ) Change Control (FRS) and CQ Commissioning Design Installation and Qualification Preventive Specifications Qualification (IQ) (DDS) and CQ Maintenance Commissioning Engineering Runs Build Calibration FAT/SAT The ISPE general V-model Cleanrooms Elomatic has over 30 years’ experience in In order to achieve Good Manufacturing Prac- completing demanding cleanroom pro- tice (GMP) cleanrooms, Elomatic applies the Society for Pharmaceutical Engineering’s (ISPE) jects both domestically and abroad. Our guidelines, unless otherwise required by the experience covers all project kinds, sizes client. We are thoroughly familiar with GMP and their phases (CD, BD, DD, DR, DQ, C, regulations such as EU, FDA and WHO cGMP. IQ and OQ). Our intimate knowledge of For particle-based cleanliness, we mostly fol- processes and their GMP requirements low the ISO 14644 standard. Elomatic`s clean- make us the ideal partner for working room designers and project management nor- mally concentrate on the first five parts of the cleanroom solutions. standard. If the clients so desires, other stand- ards can also be followed. Cleanroom expertise you can rely on 2–3     Elomatic Services Cleanrooms The first five parts of the ISO 14644 standard family are of importance for cleanroom designers. EN-ISO 14644-1 Classification of Air Cleanliness EN-ISO 14644-2 Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1 EN-ISO 14644-3 Test Methods EN-ISO 14644-4 Design, construction and start-up EN-ISO 14644-5 Operations EN-ISO 14644-16 Code of practice for improving energy efficiency in cleanrooms and clean air devices (new standard part) ISPE tools and V-model User requirements – URS At Elomatic we make extensive use of tools The URS is arguably the most important docu- provided by ISPE to facilitate a clearer under- ment in the whole GMP project, as it defines standing of the application of

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