Validation of mixing tanks and fermenters
INTRODUCTION
Mixing tanks and fermenters play an important role in the medical and pharmaceutical sector. To demonstrate that the decontamination processes in your mixing tanks and fermenters are running correctly, you should have these devices validated periodically. Bureau Veritas can carry out this validation accurately on your behalf.
Bureau Veritas' Validation & Monitoring department was established in 1985 from Krachtwertuigen (Kwant) and later KW2. Due to our extensive experience involving process validations, you are assured of a professionally executed procedure. And with our team of ten highly skilled validation technicians, we can plan flexibly.
MAIN SCOPE
We validate mixing tanks and fermenters in the medical sector and pharmaceutical industry when required or desired.
STANDARD CONTENT
The ISO17665-1 standards and/or the Dutch Directive R6107 apply in the validation of mixing tanks and fermenters.
VALIDATION PROCESS
What does the validation process look like? First, we draw up an audit plan with you as a client/user. Important focus points included in this plan:
- the applicable standard
- the type of device (make, type, age, status, size etc.)
- load bearing
- the processes.
In consultation with you, we also determine at this stage when the validation takes place.
Our validation technician conducts measurements during the decontamination process and assesses the measurement results according to the applicable standards. Afterwards, the technician will discuss the results with you, and you will receive a preliminary assessment. Within twenty working days, you will receive a final report with all findings and conclusions.
ACCREDITATION
Bureau Veritas' Validation & Monitoring department is accredited as an ISO/IEC17020 type A inspection body. This means the validation we perform is completely independent. In addition, our validations are periodically assessed by the Dutch Accreditation Council (RvA - Raad voor Accreditatie) and by various certification bodies. On the RvA website, you will find the scope of the work areas for which we are accredited.
ADDITIONAL STANDARDS
Instead of the default standards, a client can also opt for its own validation plan, which deviates or goes beyond the applicable standards. A review condition is that the plan refers to those standards, or that the assessment requirements have been fully recorded.