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QUALIFICATION OF DEPARTMENTS WITH CONTROLLED CONTAMINATION AND THERMAL MAPPING

 

The thermal mapping of warehouses and material storage areas along the entire production and distribution chain is complicated by the heterogeneity of the environments and conditions (just think of the transporters). The qualification of production premises or laboratory with controlled contamination requires specialized and multidisciplinary skills, considering the intervention of microbiologists. On both fronts, Adeodata stands out for a structured approach based on competence, experience, continuous updating and a solid organization, which guarantee an approach that is always in line with regulatory requirements.

If it is in fact relatively easy to reuse a validation protocol for a room or an equipment, it is not certain that this is aligned with the requirements of the new versions of rules and standards that are issued:

    • 2009 EN 1822-1 (UNI EN 1822-1: 2010), High efficiency air filters (EPA, HEPA and ULPA). Part-1 Classification, performance testing, marking;
    • WHO, Technical Report Series No. 961, 2011. ANNEX 9: Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products;
    • 2015 ISO 14644-1, Cleanrooms and associated controlled environments. Part-1 Classification of air cleanliness by particle concentration;
    • 2015 ISO 14644-2, Cleanrooms and associated controlled environments. Part-2 Monitoring provide evidence of cleanroom performance related to air cleanliness by particle concentration.

 

Competence and experience:

Right here Adeodata makes the difference. Adeodata established the figure of the SME - Subject Matter Expert, a person dedicated to:

    • study the regulations (and related updates);
    • update internal standards, also in light of the experiences on the latest generation of qualified equipment;
    • instruct all consultants on these standards.

The figure of the SME for Adeodata is the basis of the quality system procedures, certified ISO 9001: 2015.

 

 

Instruments:

The Adeodata equipment and related software are used in compliance with the Data Integrity requirements, have been validated and are periodically calibrated.

 

>> Discover our instruments

Adeodata S.r.l.
Via E. Mattei, 2

22070 Bregnano (CO)

 

 

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