Some our projects in pharmaceutical plant validation performed in Bulgaria, Western Europe, Mediterranean and Scandinavia ✓


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Fluid bed dryer validation
Glatt fluid bed dryer validation. Prepared documents: URS, FS, DS, QPP, IQOQ, PQ and QRS. Performed all IQOQ tests and issued a final report.

ATEX equipment

Qualification of clean rooms and ATEX equipment related to fluid bed dryers and coating pans. Validation of the control system.

HVAC & BMS qualification

BMS, HVAC and dust collectors qualification. Prepared: Functional Specification FS, Validation Plan VP, IQOQ protocols, Performance Qualification PQ protocol, Qualification report QSR. All HEPA filter certificates attached, all calibration certificates attached too. Performed IQ, OQ and PQ tests and deviations are closed successfully.

Validation documents set

Validation set of documents including FS, URS, QPP, IQOQ, DQ, PQ and QSR. All documents are prepared bilingual - in Bulgarian and in English. All tests done, all equipment certificates are atatched, deviations has been closed and project has finished with QSR.

WinCC system validation

Qualification of a control system consists an operator station, PLC controllers and WinCC software. The system serves coating pans and dryers. Performed Validation Plan VP and all other protocols needed to start and finish the qualification. Final qualification report is issued.

 

Low humidity control and system's validation.

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