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Validations area is the added value of our services. Every project ends with validation thereof to give quality assurance in all its dimensions.
The commissioning of a plant, the renovation of a sector, the addition of new equipment, repairs, modifications and replacements are subject to validation; integration is the process of building the quality of any type of plant. In KLARIOS SRL, we provide efficient and effective methodology, documented programs that meet the requirements defined in the quality guidelines for each particular market.
We apply the guidelines set by the ISPE for the commissioning of equipment and systems and process validation and qualification of equipment.
SYSTEM'S VALIDATION – EQUIPMENT QUALIFICATION
Qualification of clean rooms and terminal HEPA filter units.
Validation of HVAC systems.
Validation nitrogen generation systems, compressed air and high pressure gases.
Validation of water generation plants and FWI PWI.
Handlers units and air handling, dust extraction systems, Laminar Flow, biosafety cabinets, Isolators, hoods, Cleanroom and local air classified.
(*) Note: Our technical department develops supporting documentation to the extent consistent with its objective of quality: IQ / OQ / PQ / REPORTS.
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- Integrity Check tightness of HEPA filters and terminals
- 2
- Checking drive speeds in different outfits and trials
- 3
- Verification of air flow laminarity in terminal HEPA (laminar flows, Grade A rooms, etc.)
- 4
- Verification flow
- 5
- Check and adjust the pressures between locals
- 6
- Air check directionality
- 7
- Verification of trace levels of hydrocarbons in lines high pressure gas
- 8
- Verification lines dewpoint high pressure gas
- 9
- Verification and adjustment of environmental variables: temperature, humidity, lighting and sound
- 10
- Classification of air cleanliness according to ISO 144644 - ANMAT 2819/2004 - EU – GMP Volume 4 - Annex 1: 2008
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- Recovery tests classes
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