Clean Room Validation Equipment
Clean Room validation equipment is the basic device for providing validation services.
Sugold We supply all necessary equipment and instruments for the fulfillment of these services representative with Turkey.
In addition, it is one of our services we provide in biomedical metrology activities within our institution.
Our institution; It successfully carries out clean room validation services in all medical and sterile industrial clean rooms, units such as Operating Room, General, Surgical and Cardio Intensive Care and Baby Intensive Care in healthcare institutions.
Within the scope of Clean Room Validation Services;
⇒ Room class assignment
⇒ Point-based particle counting
⇒ Flow Measurements (Arrival and Exit)
⇒ Air cycle coefficient calculation
⇒ Hepa filter leak and leak test (Integrity test or DOP test)
⇒ Room and outdoor differential pressures
⇒ Dekontaminasyon Testi (Aerosol kirletme ve arındırma performansı testi)
⇒ In-room Airflow visualization test
CLEAN ROOM DESCRIPTION:
Products, tools, equipment and people; According to internationally accepted cleaning standards (DIN 1946/4 and / or ISO-14644), temperature, humidity, pressure, noise level and to protect them from dead particles such as dust, particles, waste anesthetic gas and bad odors or living particles such as microbes, microorganisms and hygienic environment with air movement within certain dimensions is called clean room.
The main purpose of the clean room is to obtain a fresh air environment according to internationally accepted cleaning standards, then to provide all conditions that require the technological environment related to the process and keep it under control.
While designing the clean room, the importance of temperature, humidity, pressure, test-noise level and air movement are determined according to the purpose of use and selection criteria are created. Therefore, all factors must be taken into account in construction, manufacturing and operation.
General Scope of Clean Room Technology:
⇒ Protection of products against contamination.
⇒ Protection of the environment against pollution.
⇒ Protection of people against the environment.
⇒ Protection of people against germs released from humans.
⇒Protection of the environment from Products.
⇒ Protection of the environment against germs released from humans.
Industrial sites such as sanitary-producing health and food are still subject to huge costs through in situ filter test failures that may result from poor testing and poor application, and thus filter leakage. Using the correct test method and providing all the necessary hardware for regular testing will provide a way to reduce the test failure rate.
In general, the filter or filter casing is held responsible for these leaks and solutions can be produced by seeing these problems with good tests.
The definition of a clean room can be determined by the applied “standard” and ultimately the quality requirement of the sector. The pharmaceutical and electronics industries have a set of counter standards for the auditing and validation of a clean room (validation):
⇒ Industrial Areas: Failure of transactions that are covered by ISO EN14644-1 and 2 and normally within the company standards, and are not against the law.
⇒ Medicines and hospitals – ISO EN14644-1 to standards 8.
⇒ In addition, the pharmaceutical industry has been legalized to ensure that high standards are maintained.
TS EN ISO 14644 Standard Definitions:
Part 1: Classification of air purification
Part 2: Features for testing and monitoring to prove continuous compliance with ISO 14644-1
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 6: Vocabulary
Part 7: Separating devices (fresh air hoods, glove boxes, insulators and mini environments)
Part 8: Classification of airborne molecular contamination.
HEPA filters can filter 100% of airborne particles above 5µm. It is less efficient under this and typically extracts 95% to 99.9995% in the particle size range of 0.15 µm to 0.25 µm. The degree of filter selected for the application determines the overall filtration ability.
Failure or improper application of the HEPA filter will lead to degradation of fresh air. Thus, by testing the HEPA filter to determine that it filters, we can guarantee that the air we deliver to the clean room is particle-free for the selected filter quality.
When the HEPA filter is tested in place and there is no leakage, we can make sure that we supply fresh air to the clean room location. Installed HEPA filters require regular testing to ensure there are no leaks. A good, leak-free HEPA filter can provide fresh air for many years, but a leak from damaging the filter is a concern.
The main reasons for testing the filter are:
1. Qualification – setup test.
⇒ Compliance with order and installation specification
⇒ Verify the quality of the purchased product
2. Periodic testing for leaks
⇒ In situ test – test to determine that the filter is still working well over time?
3. Health and safety requirements.
To overcome the need to test HEPA filters individually, it is often necessary to prove that the particle count according to EN 13644-1, the part does not contain particles and meets the standard according to Part 1. This does not prove that HEPA filters are leak-proof. . In general, particle counting is performed without processes or personnel available. So there are few or few particles to count. Very few clean rooms were found that did not pass the particle counting test.
The risk of a leaking HEPA filter is real, and data revealing that there is a correlation between increasing micro-biological numbers and leaking HEPA filters. The biggest risk in the facility is when it is operating. Meanwhile, filters remove particles from human and process origin.