PVS

PVS, established in 2013, operates in consulting services, validation, qualification and calibration “on field” of critics process instruments. Since 2017 it has had an operational unit dedicated to validation and technical assistance of total organic carbon analyzers (TOC) intended for ultra-pure water (WFI / PW) for  pharmaceutical and electronic use.

info

registered office

Via Varese 6/B, 20037 Paderno Dugnano (MI)

headquarters

Via Varese 6/B, 20037 Paderno Dugnano (MI)

Services

From the aggregation of heterogeneous experiences and skills was born, in 2013, PVS srl: a flexible and dynamic reality, capable of easily adapting to the needs of the various interlocutors and all the players in the reference market. Thanks to the consolidation and positive interaction with major national and international pharmaceutical groups, new professional figures have gradually been added to our team.

Our activities range from consultancy to GxP validation and qualification services. With the inclusion of specific professionals roles, we also provide consulting, assistance and validation services for total organic carbon (TOC) analyzers used for the measurement of the parameter in waters for pharmaceutical and electronic use, or for special applications.

QUALIFICATION OF EQUIPMENTS AND PLANTS

The qualification activities range from laboratory equipment (refrigerators, freezers, hoods, incubators, autoclaves, climatic chambers…) to production equipment of all types (isolators, glove boxes, passboxes, hoods, autoclaves, ovens, freeze dryers, filling, tablet presses, packaging machines, turboemulsifiers, reactors, fermenters, filters, preparers…) up to plants and utilities (HVAC / cleanroom systems, PW, WFI, nitrogen and compressed air…).

CALIBRATION ACTIVITIES OF THE “ON SITE” INSTRUMENTATION

We develop instrumentation calibration plans by defining, through dedicated analysis processes, the levels of “criticality” and therefore the verification periodicity. Our activities are typically carried out at the customer sites with the aid of the verification instrumentation subjected to periodic checks at the ACCREDIA centers.

THERMAL AND THERMO-HYGROMETRIC MAPPING

Thanks to the aid of dedicated instrumentation (dataloggers, acquirers equipped with thermocouples) we develop the most varied thermal or thermo-hygrometric mapping activities, operating both on equipments and on warehouses and climatic cells or stability chambers.

VALIDATION OF COMPUTERIZED SYSTEMS

The activities are focused on the validation of the computerized systems typically present within the production environment and the systems serving the plant (MES, DCS, SCADA).

SOFTWARE SELECTION

We support companies in the search and selection of software application suppliers dedicated to the world of automation within the relevant sectors, with particular expertise in DCS, SCADA and MES solutions.

RISK ASSESSMENT

PVS, for all reference sectors, is able to develop Risk Assessment activities (ICH Q9) with the use of different methodologies, integrating where necessary tools for the preventive mapping of processes. The Risk Assessment activity is the “cornerstone” in order to mitigate critical issues, control processes and ensure the best quality of the “product”.

GAP ANALYSIS & ACTION PLAN

We develop GAP Analysis processes independently or by integrating ourselves into the customer’s structure, subsequently if required we develop dedicated Action Plans with identification of the actions to be taken by defining priorities based on the criticality of the GAPs found.

ADVICE, ASSISTANCE AND VALIDATION ON TOTAL ORGANIC CARBON (TOC) ANALYZERS

Thanks to the introduction of specific skills, since the end of 2016 we have been operating in the area of activities related to total organic carbon (TOC) analyzers used in the pharmaceutical and semi-conductor sectors for the measurement of the parameter in pure and ultra-pure water (PW / WFI / FROM). We are able to assist customers in selecting the TOC analyzer most responsive to the application of interest, also evaluating its positioning and the problems of interfacing with automation systems. We directly provide technical assistance, validation and revalidation activities for Sievers branded TOC analyzers.

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products

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PVS Collirio

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PVS Compresse

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PVS Siringa

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PVS Formula

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