Beste WahlIf you decide to use a cleanroom monitoring system, it must be qualified and subsequently maintained in a qualified state. We offer you a validated software solution and the qualification of our monitoring system, the calibration of temperature, humidity, differential pressure and air velocity sensors, as well as calibration of particle size and particle concentration. Thanks to our DDS sensor technology, the work causes minimal downtime to your cleanroom and is therefore as cost-effective as possible. A cleanroom is a specially equipped room that allows certain environmental parameters such as temperature, humidity, differential pressure, particle concentration and air velocity to be controlled within certain limits. Cleanrooms must be validated for the following reasons:

  • Ensuring that the design and Jenzept correspond to the intended application
  • To check the conformity with the requirements from the specification sheet
  • Ensure that concept and execution meet regulatory requirements and guidelines

 

  

Bestes ServiceAfter completion of the validation process, the cleanroom can be assigned to a specific cleanroom class in accordance with DIN ISO 14644-1. The qualification process usually passes through the following phases:

  • Design Qualification (DQ)
  • Risk analysis
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Monitoring

 

Design qualification (DQ)

The requirements specification defines certain minimum criteria which must be met by the planned implementation according to the requirements specification. Ideally, the planned realization will fully meet or exceed all requirements from the specifications, otherwise the underlying concept must be reconsidered. In the course of the DQ, the requirements specification and the functional specification are compared with each other and any deviations are highlighted.

Risk analysis

To identify any potential risk that could lead to a non-compliant or temporarily non-compliant cleanroom, a risk analysis must be performed. This is a detailed analysis of all possible failure options and their probability of occurrence. In the case that might not be detected during operation, appropriate adjustments or additions to the equipment must be made, or special procedures to cover these risks must be written.

Installation Qualification (IQ)

The purpose of this phase is to confirm that the installed components or the design is fully in accordance with the user requirements. Typically, this is demonstrated by completing an IQ test plan, a series of test points that are manually checked. Finally, the IQ protocol should not show any critical deviations, otherwise appropriate remedial action must be taken and the associated test points re-verified.

Operational Qualification (OQ)

The goal of this phase is to objectively prove that the built cleanroom is functional in accordance with the original design and therefore meets the user requirements. In practical terms, this involves a series of tests, which also take into account so-called "worst-case" scenarios, to ensure that the user requirements are met even under heavy load (people in the cleanroom, or frequent lock-in/lock-out, etc.). The result of this verification is again a report stating that the cleanroom is guaranteed to operate within the defined limits.

Performance Qualification (PQ)

The intended purpose of performance qualification is to demonstrate by objective evidence that the cleanroom operates permanently in accordance with user requirements, i.e. the environmental parameters such as temperature, humidity, differential pressure, particle concentration, etc. are always within the specified limits. In the event of an exceedance, an alarm is triggered and a corresponding error message is entered in the alarm log. This ensures that any limit exceedance is recorded and can be subsequently analyzed.

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Firm: Niotronic GmbH
Address: Am Eichengrund 1
  8045 Graz
Email: office@niotronic.com
Telephone: +43 316 698200
Opening Hours: Mon - Thu 09:00 till 16:30
  Fri 09:00 till 14:30

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NIOTRONIC MONITORING SOLUTIONS LTD.

Georgiou Griva Digeni 13B
CY-6030 Larnaca, Cyprus

Tel: +357 24 040908
Web: www.niotronic.com
Email: office@niotronic.com