Cleanroom Performance Qualification Test Instruction And Its Annexes

Alper Sarı
TURKAK ISO 17021 Teknik Uzmanı
Summary
Performance Qualification tests of cleanrooms performed on the basis of the ISO 14644 standard can be seen in this instruction. The instruction is not only limited to the ISO 14644 standard, but also makes use of other standards in terms of the way the tests are carried out and the acceptance criteria. In the instruction there are explanations about - Measurement of Air Flow, Air Flow Rate, Air Change Number and Air Uniformity, - Measurement of Pressure Differences, - HEPA and ULPA Filter Integrity Test, - Particle Counting and Classification of Cleanroom Air Cleanliness by Particle Concentration, - Determination of Recovery Time, - Temperature and Humidity Measurement, - Visualization Test of Air Flow Characteristics. It is included in the Performance Qualification Protocol and Report as well as the Data Entry Forms for the above tests.
Language
English
Existing Standards
ISO 14644-1, ISO 14644-2, ISO 14644-3, IEST-RP-CC034.4, Eudralex Volume 4, FDA cGMP
Types
Talimat, Form, Protokol, Rapor
Tags
temizoda, validasyon, kalifikasyon, PQ, partikül sayımı, hijyenik alan, kontaminasyon
Attached Files
Annex-1 Cleanroom Performance Qualification Protocol.docx
Annex-2 Data Entry Form of Cleanroom Performance Qualification Pre-Inspection.docx
Annex-3 Measurement Data Entry Form Of Cleanroom (LAF) Air Flow Rate And Uniformity.docx
Annex-4 Measurement Data Entry Form Of Turbulent Cleanroom Air Flow Rate And Air Volume.docx
Annex-5 Measurement Data Entry Form Of Pressure Difference And Air Direction Between Areas.docx
Annex-6 Test Data Entry Form of Cleanroom HEPA _ ULPA Filter Integrity With DPC Method.docx
Annex-7 Test Data Entry Form Of HEPA _ ULPA Filter Integrity Print-Outs.docx
Annex-8 Test Data Entry Form Of HEPA _ ULPA Filter Integrity With Photometer Of Cleanroom.docx
Annex-9 Test Data Entry Form Of Cleanroom Particle Counting and Classification.docx
Annex-10 Test Data Entry Form of Particle Counting Print-Outs Of Cleanroom.docx
Annex-11 Data Entry Form of Recovery Time Determination of Cleanroom.docx
Annex-12 Data Entry Form of Recovery Time Determination Print-Outs of Cleanroom.docx
Annex-13 Measurement Data Entry Form of Temperature And Humidity of Cleanroom.docx
Annex-14 Data Entry Form of Air Flow Visualization Of Cleanroom.docx
Annex-15 Cleanroom Performance Qualification Report.docx
Cleanroom Performance Qualification Test Instruction.docx