Clean Room & Hospital HVAC Systems Validation

Clean Room & Hospital HVAC Systems Validation

Clean Rooms; Airborne particulate dispersion is constantly under control by measurements, built and used to minimize particulate inlet, particulate proliferation and particulate housing, as well as temperature, humidity, pressure, air flow lines, etc. private rooms where other variables are kept under proper control.

Clean room systems today, Human Health Activities, Health Industry, Biomedical Industry, Pharmaceutical industry, Veterinary Medicine, Food industry, Chemical industry, Semiconductor industry, Conductive industry, Electronic Industry, Optical Production Industry, Aerospace and Defense Industry, Biotechnology etc. are among the priority requirements in many areas.

HVAC performance tests cannot be considered as Clean Room Validation alone. HVAC performance tests are part of the testing and examination procedures carried out within the scope of Clean Room Validation within the framework of PQ (Performance Qualification). However, Clean Room Validation has a wide range of content including evaluation studies such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operating Qualification) and PQ (Performance Qualification).

Validation means “VERIFICATION” and includes verification of all stages (design, installation, commissioning, functional features, operation, performance, maintenance&operation, personnel training, etc.) until the design stage reaches the final conclusion in order to fulfill user requests.

The basic error dropped by non-professional teams during the establishment of hvac system to qualified areas such as Clean Room and Hospital sterile areas is that performance tests are perceived as Clean Room Validation. If the basic verification phases mentioned above of hvac systems are not carried out, the success of a newly established ventilation system performance tests is often repeatable and does not mean that successful results will be achieved continuously throughout the year.

  • SERVICE TESTS Calculation of Air Debisi, Air Speed and Air Change Numbers
    HEPA Filter Sealing Test (DOP Test)
    Content Leak Test
    Measuring Pressure Difference
    Temperature and Humidity Measurement
    Particle Measurement / Census
    Decontamination Test

TS EN ISO/IEC 17020: 2012 Compliance Assessment-Terms for The Operation of Various Types of Inspection Agencies

TS EN ISO 14644-1: 2001 Clean Rooms and Controlled Environments With These Rooms Part 1- Classification of Air Cleaning

TS EN ISO 14644-2: 2006 Trial and Monitoring Requirements for Continuous Compliance Testing for Clean Rooms and Controlled Environments Section 2: ISO 14644-1

TS EN ISO 14644-3: 2006 Clean Rooms and Controlled Environments Section 3- Experimental Methods

IEST-RP-CC006.3: 2004 Testing Cleanrooms

IEST-RP-CC034.3: 2009 Hepa and Ulpa Filter Leak Test

VDI 2083-Part 3: 2005 Cleanroom Technology Metrology and Test Methods

Eudralex Volume 4: 2008 Medicinal Product for Human and Veterinary Use Annex 1

FDA c GMP: 2004 Sterile Drug Products Produced by Aseptic Processing

DIN 1946-4: 2008 Ventilation and Conditioning-Part 4: VAC Systems in buildings and rooms used in the health care sector

T.C. Ministry of Health Regulation of Private Hospitals

T.C. Ministry of Health Inpatient Health Facilities, Intensive Care Services Implementation Procedures and Principles Of Notification

T.C. Ministry of Health Service Quality Standards