UNE 171340 Normative. Validation and qualification of atmosphere controlled Rooms in Hospitals

Using particle counter

HEPA Filter Validation Trial using a particle Counter

REFERENCE DOCUMENTS - UNE-EN ISO 14644-3:2006 Norm. Clean rooms and controlled annexed premises. Part 3 : Trial methods.
- Section 10.2. technical acceptance tests of the UNE 100713 Norm. Air conditioning installations in hospitals.
TRIAL OBJECTIVE To confirm that the terminal filtration system is correctly installed, verifying the absence of leaks derived from the installation, that the filter is damage and leak free in the filter media and in its support frame.
PARAMETERS TO BE DETERMINED N° of particles of 0.3 µm.
APPARATUS TO BE EMPLOYED Particle counter, with a device to indicate and register the number and size of the particles in the total concentration and with a suitable system with which to take samples.
STABILISATION Discart the 1st measurement
Preparation of trial objetives Ensure that the air conditioning equipment is working. The room must be clean and in conditions for use. The filters must be reachable and without the presence of diffusors.
Prior controls Register filter change, which will contain the date fitted. HEPA filter certificate.
Preparation of equipment (adjustments and verifications) Check that the equipment is within the calibration validity period.
Trial operations Through stationary measurements at the sealing joins and in two central points of the filter, with a standard flow rate sample of 2.81/m. at a distance inferior to 20 - 30 111111 from the filter.
Register method: Observations, results Note down the equipment code. Note down the tecnician who took the measurement and the date it is taken on.
Data that must be registered-calculation method The data will be presented on a list and will be related to the identification of the filter subjected to the sampling. The number of particles by size from 0,3 µm will be recorded. 
Presentation of the results in the report Identification of the COMPLIANT filters. when the number of particles is less than the real number of particles that defines the admissible leak, according to the class of filter and in the absense of particles, the filter is VALID.
Criteria for results evaluation NON-COMPLIANCE is considered to be when the appearance of particles is observed behind the filtering material and in the sealing join in a number superior to the particle limit established in accordance with UE-EN ISO 14644-3 for sizes of 0,3 µm 

Using DOP test

HEPA Filter Validation Trial using a particle Counter


- UNE-EN ISO 14644-3:2006 Norm. Clear rooms and controlled annexed premises. Part-3: Trial methods.
- IEST-RP-CC006.2. IEST-RP-CC034.1. guideline ofsterile drug products proceeded by aseptic processing (FDA).

FIELD OF APPLICATION HEPA/ULPA filters in the air treatment systems in controlled zones.
TRIAL OBJECTIVE To confirm that the absolute filters are correctly installed and verify that no fissures or breakages have been caused to them during installation or due to their continuous use.
PARAMETERS TO BE DETERMINED Verify the absense of leak that can affect the integrity of the filters and air quality and efficiency.
- Cold Generator: This generator will be used to 20 PSI. in order to achieve an aerosol concentration of at least 20 ug/l, in equipment that has a supply air flow rate of up to 3 000 m '~1.
- Hot Generator: This generator will be used in order to achieve a concentration of at least 20 ~gI1. in equipment that has a supply air flow rate with the following interval: 3 000 m llh - 100000 m l/h.
- Photometer detector.
- Oil.
Preparation of trial objectives

An entrance for the aerosol will be identified in the filtration box and the possibility of carrying out leak detection on the filter's entire surface on the discharge side will be verified. If it is not possible to carry out a scan of the entire filter surface the possibility will be studied as to whether to make a record in order to carry out the test or determine taking a photometric reading at the air outlet after the filter with the aim of taking a sample of filtered air and therefore check the aerosol concentration after the filter.

If these are room terminal filters then the diffusor grille should be dismounted before carrying out the trial.

Prior controls Check that the HVAC system or the ventilation equipment work correctly.
Preparation of equipment (adjustments and verifications)  The equipment used whilst carrying out the trial must have valid calibration plan in which, as a general rule for all equipment, the established calibration validity period is one year ± I month, considering this month as the maximum period in order to carry out the equipment shipment arrangements to the authorised calibration entity.
Trial operations

At the start of the trial, carry out a 100% internal calibration of the photometer detector.
Inject aerosol into the air current before the filter, choosing the aerosol injection point according to this order of preference:
- The climate control that supplies air to the filter. whenever possible the pre-filters must be removed.
- In the filtration box outlet.
- The room's return-air in which the filter is located, ensuring that the return-air corresponds to the same climate control unit that drives air to the installation or equipment.
- Carry out a measurement at the Upstream outlet (before the filter) to check the existing aerosol concentration.
If the detected value is between 20% and 30% do net make any adjustments.
If the value detected is superior to 30, regulate the generator so that it generates less aerosol until reaching a value of between 20% and 30%.
If the value detected is inferior to 2, then regulate the generator so that it generates more aerosol until the detected value runs between 20% and 30%.
The periphery of the filter and the filter media will be explored at a velocity not superior to 5 cm/sand at a distance of between 2.5 cm and 5 cm. from the filtering surface, checking whether it complies or not with the acceptance criteria.
If a leak is detected then the detector will be 100% adjusted to value obtained in the upstream measurement, meaning that the P1-100 value will be reduced manually until the obtained value (between 20 µg/l and 30 µg/l) . And the detector will be recalibrated to determine the exact leak percentatge.

Register method: Observations, results  The filters and/or equipment for each room will be identified in the corresponding data sheet in the following way:
- Their location.
- Individualised numbering for each filter. It can be a number provided by the user (internal code) or they can be identified with an Fvxx code (where xx is a numerical sequence).
Presentación de resultados en el informe  The results obtained from the trial carried out will be registered as indicated hereafter in the corresponding data sheet: COMPLIANCE
Presentation of the results in the report   The concentration read on the clean side of the filter, for concentrations of between 20 µg/l and 30 µg/l (100% detector adjustment), must not be superior to 0,01% of the concentration detected before the filter for filters of H-14, H-13 AND H-12 (filtration efficiency of at least 95,95%).
For H-11 filters ( 99.90% efficiency) the concentration read on the clean side of the filter must be ≤ 0.1% of the one previously detected.
Lastly, for H-10 filters ( 95% efficiency). the concentration detected on the clean side of the filter must be ≤ 5% of the previously read one.