CLEAN ROOM MEASUREMENTS
Clean room measurements are special rooms where the particle concentration in the air is constantly controlled by measurements, built and used in a way that minimizes particle entry, proliferation and accommodation, and where other variables such as temperature, humidity, pressure, and air flow lines are kept under control. Clean room measurements and systems are among the priority requirements in many fields such as Human Health Activities, Health Industry, Biomedical Industry, Pharmaceutical Industry, Veterinary Industry, Food Industry, Chemical Industry, Semiconductor Industry, Electronics Industry, Optical Manufacturing Industry, Aerospace and Defense Industry and Biotechnology.
HVAC performance tests alone cannot be considered validation of cleanroom measurements. HVAC performance tests take place within the framework of PQ (Performance Qualification), which is part of the testing and inspection processes carried out within the scope of validation of room measurements. Whereas, Cleanroom Validation has an extremely comprehensive content that includes evaluation studies such as DQ (Design Qualification), IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification).
Validation means “VERIFICATION”. It includes the verification of all stages (design, installation, commissioning, functional features, operation, performance, maintenance & operation, personnel training) from the design stage to the final result so that the system to be installed can fulfill the user’s requests.
The main mistake made by non-professional teams during the installation of the HVAC system in qualified areas such as Clean Room measurements and Hospital sterile areas is that performance tests are perceived as clean room measurements. If the above-mentioned basic verification steps of the HVAC systems are not performed, the successful passing of the Performance tests of the newly installed ventilation system is often repeatable and does not mean that successful results will be obtained continuously throughout the year.
IMPORTANT RULES FOR CLEANROOM MEASUREMENT PROCEDURES
Depending on where clean rooms are used, there are different regulations, legal requirements and separate rules for qualification and operation. There are also general and ground rules for cleanrooms and connected cleanroom areas.
International Cleanroom Tests DIN EN ISO 14644:
The basic internationally valid norm for cleanrooms and connected cleanroom areas is DIN EN ISO 14644.
While Chapter 1 deals with the classification of air purity based on particle concentration,
Part 2 deals with the testing and follow-up specifications required to ensure continued compliance with DIN EN ISO 14644-1. As for measuring devices and measurements in clean rooms,
Part 3, the test methods, applies. This part of DIN EN ISO 14644 consists of test procedures used to characterize clean rooms and are defined and specified in other parts of DIN EN ISO 14644.
Clean air measurement tests are created in two types, low turbulent flow and normal turbulent flow, for clean room and clean areas. Three operational states are considered: ready (“installed”), not running (“standby”), production (“running”). In some tests, many different procedures and devices have been defined so that different types of use can be taken into account.
Germany: VDI 2083 Part 3 Cleanroom Technology – Measurement science and test methods: In Germany, VDI 2083 Part 3 applies in addition to the international ISO 14644. This guide defines measurement methods for cleanrooms that can be applied during handover, new facility qualification, routine checks, and continuous monitoring.
National regulations in USA and Japan: American IEST (Environmental Science and Technology Institute) has established its own regulation in recommended practice IEST-RP-CC006.3. In Japan, the Japanese Industry Standard “JIS B 9917-3:2009: Clean rooms and related controlled environments- Part 3: Test methods” applies. In both cases, the goal is to fulfill the cleanroom measurements and qualifications in detail according to the requirements applicable in these countries.
Laminar flow cabinets and sterile production in the pharmaceutical industry: In addition, there are special applications that must comply with specific norms. In accordance with DIN EN 12469, laminar flow cabinets used in microbiological and biotechnical studies must have suitable ventilation systems to protect both the persons to be worked on and the work object. EU-GMP Guidelines, Annex 1 applies to sterile production in medical clean rooms. This chapter establishes a legal framework for the classification and operation of cleanrooms.
VENTILATION IN CLEAN ROOMS
Its functions are temperature and humidity control, control of microorganism and particle numbers, pressure control and control of waste and toxic gases. HEPA filters (high efficiency particulate arresting) are used to collect and purify airborne particles. In general, there are different types according to their quality. Filters called true HEPA can collect up to 90 percent of airborne particles up to 0.3 μm in size. Normal HEPA filters, on the other hand, are slightly below this rate.
It is necessary to test whether an area used as a clean room has the limit values specified in the standards and whether it maintains this situation. The basic standard in this regard is TS EN ISO 14644 Clean rooms and their related controlled environments.
During environmental testing studies, current legal regulations and relevant standards published by many domestic and foreign organizations are taken into account. In line with the needs of the enterprises, our organization also carries out clean room tests within the framework of environmental tests.
EXPLANATIONS OF THE TESTS PERFORMED WITHIN THE CLEAN ROOM MEASUREMENTS SERVICE
Calculation of Air Flow, Air Velocity and Air Exchange Numbers: The purpose of these tests is to determine the air flow rates and uniformities in clean rooms and clean spaces, and the air flow rates provided. With this test, the flow of air provided in Clean rooms without one-way air flow and the distribution of air velocity in Clean rooms with one-way air flow are calculated. Generally, air velocity or air flow is measured and the results of these measurements are recorded in the form of average velocity, average air flow or total air exchange. Total airflow is used to calculate the number of air changes (air changes per hour) in Cleanrooms without one-way airflow. Air velocity is calculated by measuring in Clean rooms with unidirectional air flow. Measurement of Air Flow, Air Velocity and Uniformity test is carried out in accordance with ISO 14644-3:2005, EU Guidelines to GMP:2015.
Clean Room Measurements in Hospitals:
Clean Room Measurements in Production:
As mentioned above, inspections and reporting procedures of regions where air quality is important are carried out by our company as a third-party independent institution within the scope of our accredited services. The clean room inspections are carried out in the form of reporting a wide range of measurements and controls according to ISO/EN14644 and FDA regulations by evaluating customer criteria. Reporting by determining ISO Class only according to particle measurement values applied by non-accredited companies is not an adequate Validation Inspection. In the inspections made by our company, the Clean Area and LAF Cabins are reported by performing the inspection procedures according to the control parameters that can be determined in the following scopes or according to the customer needs.
Clean Room Measurements Reference Standards;
TS EN ISO 14644-1 Clean Rooms and Related Controlled Environments
Part 1: Classification of Air Cleanliness by Particle Concentration TS EN ISO 14644-2 Clean Rooms and Related Controlled Environments-
Part 2: Documentation Monitoring of Clean Room Performance Related to Air Cleaning with Particle Concentration TS EN ISO 14644-3 Clean Rooms and Their Related Controlled Environments
Bölüm 3: Deney Metotları DIN 1946-4 Ventilation and Air Conditioning Part 4: VAC Systems in Buildings and Rooms used in the health care sector
Eudralex Volume4 Annex1 : EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Manufacture of Sterile Medicinal Products