PROTOCOL OF

RATING

SECURITY CABIN
BIOLOGICAL CLASS II
BRAND: BIOBASE
MODEL: 11231BBC86
SERIE:BSC31A1909906A

COMPREHENSIVE HEALTH SERVICE CENTER RAY LAB EIRL

COVID DIAGNOSTIC REAGENTS LABORATORY
ITINERANT

Av. Luis Gonzales No. 642. Cercado

Chiclayo - Lambayeque
March 2021
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DATOS DE LA EMPRESA:

COMPREHENSIVE HEALTH SERVICE CENTER RAY LAB EIRL

NAME

AREA ALICUOTING LABORATORY

ADDRESS AV. LUIS GONZALES N° 642, CERCADO.

CITY CHICLAYO - LAMBAYEQUE

PHONE (074) 755723

DATE OF
09 DE AGOSTO DEL 2021 FECHA RECALIFICACION: AGOSTO DEL 2022
RATING

TESTS DEVELOPED BY:

EQUIBIO J&J EIRL

NAME

ADDRESS ANA PASSAGE A. LOT 7

CITY MY PERU, CALLAO - CALLAO

(01) 6937345
TELEPHONE

PREPARED BY: ANGIE CÓRDOVA SIGNATURE

ERICK NUÑEZ SIGNATURE

REVIEWED BY:

JAIME CORDOVA SIGNATURE

APPROVED BY:

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 TABLE OF CONTENTS

[Link]

2. SCOPE

3. DESCRIPTION AND CLASSIFICATION OF THE BIOSECURITY CABINET

4. MEASUREMENT EQUIPMENT TO BE USED IN THE RATING OF THE FLOW CABINET

LAMINAR HORIZONTAL

5. DISTRIBUTION OF THE HEPA FILTER

6. TESTS TO BE PERFORMED AND METHODOLOGY

6.1 Installation Evaluation Tests in the Workplace

6.2 HEPA Filter Integrity Test. Admission and Escape

6.3 Airflow Test (Velocity) Downward

6.4 Incoming Air Flow (Speed) Test

6.5 Airflow Direction and Visualization Test (Smoke Test)

6.6 Non-Viable Particle Count Test

6.7 Voltage Test in the Work Area

6.8 Ultraviolet Radiation Test.

6.9 Lighting Level Test

6.10 Noise Test

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1.- OBJECTIVE
The purpose of this protocol is to determine the tests and define their methodology.
develop, to carry out the qualification of the Biosafety Cabinet Brand: BIOBASE,
Modelo: 11231BBC86, Serie: BSC31A20102050; ubicada en el laboratorio de ALICUOTADO,
from the comprehensive health services center RAY LAB, at the client's request.

2.- SCOPE
The current qualification protocol applies to the Biosafety Cabinet Brand:
BIOBASE, Model: 11231BBC86, Series: BSC31A1909906A.
The Biosafety cabinets are equipment designed to ensure the absence of contamination.
of the products or samples that are handled inside it. They consist of high filters
efficiency (HEPA) and allow for a designated area of clean and sterile air.
They present two main characteristics: Speed and Laminarity.
The speed of the air ensures that the particles are carried away, while the
Air laminarity ensures that there is no turbulence.

3.- DESCRIPTION AND CLASSIFICATION OF THE BIOSAFETY CABINET

The biosafety cabinet is described and classified according to the table:

BRAND: BIOBASE
MODEL: 11231BBC86
SERIES: BSC31A1909906A
CLASSIFICATION: ISO 5 (GRADE A)

4.- MEASURING EQUIPMENT TO BE USED IN THE RATING OF THE FLOW CABIN

LAMINAR HORIZONTAL

BRAND MODEL SERIAL NUMBER USE

TEAM

Anemometer ALNOR TSI AVM-430-A AVM431107001 Air Flow

Counter of KANOMAX 3910 430404 Non-Viable Particles
Particles
Filter Integrity
Photometer TEC Services PH-5 3093
HEPA
SPER Ultraviolet Radiation
Radiometer 850010C 072754
SCIENTIFIC

Lux meter BENETECH GM1020 2341164 Lighting

SPER Sound
Sound level meter 072755
SCIENTIFIC

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5. DISTRIBUTION OF HEPA FILTERS INLET AND OUTLET

61 cm

61 cm

61 cm

30.5 cm

6.- TESTS TO BE CARRIED OUT AND METHODOLOGY (GENERAL REFERENCE ISO 14664-3)

6.1. INSTALLATION EVALUATION TESTS IN THE WORKPLACE

Before carrying out the measurements in the certification process, an evaluation is necessary.
from the installation of a biosafety cabin. It is recommended to maintain an ideal distance
from the cabin with the back wall, side walls, and ceiling of 30 cm. In case it is not
feasible, the minimum recommended is 10 cm separation from the back of the cabin
and the wall; for the side part of the cabin, it should have a minimum separation of
5 cm; for the top of the cabin this should have a minimum distance of 20 to the ceiling
cm.
Acceptance criterion. The cabin must be located outside the traffic pattern of
people and away from the drafts of the door of the clean area.

6.2. HEPA FILTER INTEGRITY TEST

The integrity test of HEPA filters is performed with the photometer and consists of the
Generation of aerosol Emery 3004 P.A.O (POLY-ALPHA OLEFIN) in cold, which is injected
before the filter, where air is injected into the work area to later,
the corresponding accessory of the photometer to perform a full sweep of the surface
filtering, of the frame and its packaging, verifying that there are no leaks.
When leaks are detected, they should be sealed with silicone (anti-mold) until obtaining the
total integrity of the filter, which is verified by subsequent sweeps with the photometer.

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 The evaluated filters are listed in Table No. 01 and the reading results are detailed
in the grading report.

Tabla N° [Link]ón de Filtros HEPA, Tamaño y Ubicación

No. LOCATION TAMAÑO (pulgadas) QUANTITY

1 Biosafety cabinet (HEPA FILTER INLET) 24” x 24” x 3” 1

2 Biosafety cabin (HEPA FILTER ESCAPE) 24” x 12” x 3” 1

Acceptance Criteria:
a. ISO 14644-3 (B.6.2.7):
The permissible leaks are those that produce a reading higher than 10–4 (0.01%) in the
upstream test aerosol concentration. Criteria can be agreed upon
alternative acceptance between client and supplier.
b. NEBB (National Environmental Balancing Bureau):
No leak greater than 0.01% should be detected with the photometer. If detected
Leaks should be sealed with silicone. The sealed leaks should not exceed 5% of
the exposed surface of the filter.
c. ISO 14644-3 (B.6.6):
The repair of a leak should only be acceptable by agreement between the client.
and supplier. The repair method should take into account all the
instructions from the manufacturer or the customer.
All leaks found in the filters, the joint, or the structure should be repaired.
support.
The repair of the filter or the support structure can be carried out using
agreed procedures between the client and the supplier.
After having completed the repair and after having left an interval of
convenient time for curing, the place of the leak should be swept again
following the defined procedures.

Considering that ISO 14644-3 does not provide a specific value for leaks, EQUIBIO J&J
E.I.R.L. suggests taking as a reference value; prior agreement with the client; the
NEBB recommendation that the values of blocked leaks cannot
exceed 5.0% of the exposed surface area of the filter.

6.3. DOWNWARD AIR FLOW TEST (SPEED)

The anemometer must have a resolution of 0.01 m/s and an accuracy of 0.015
m/s, your sensor is of the "wire" type.
To take accurate measurements, the speed sensor must remain rigid.
until the instrument stabilizes in its reading, the stiffness is obtained using
a universal support with its respective clamp, this process is repeated on all the
points taken.

Regarding the amount of data to take, this depends on the size of the table.
work. Where the minimum to consider is to divide the distance from the part into 3 parts
rear of the cabin towards the front. About the distance between the walls
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 lateral and rear parts of the cabins, the minimum to consider is to divide this
distance in 8 parts.

Acceptance criteria.
The average speed cannot be less than 0.31 m/s and no individual measurement
it can vary +/- 20% of the average
Reference. NFS 49 Standard. Annex F–F4

6.4. INCOMING AIR FLOW VELOCITY TEST

Utilizando un anemómetro calibrado en el exterior de la cabina y con la ventana
restricted to 7.6 cm. Six measurements are taken at a distance of 12.7 cm each in a
regular pattern across the front of the cabin.

Acceptance criteria: The average speed cannot be less than 0.51 m/s and
ninguna medida individual puede variar ± 20% del promedio.

NOTE. The average of the readings is multiplied by the conversion factor (Factor
the conversion is 0.53)

Reference. Standard NFS 49. Annex F–F2

6.5. AIRFLOW DIRECTION AND VISUALIZATION TEST (SMOKE TEST)

The purpose of the essay on airflow direction and its visualization is to confirm
that the direction of airflow and its uniformity comply with the
specifications relating to design and operating conditions and, in case
if necessary, with the special and temporary characteristics of the airflow
in the installation.
With the help of a smoke generator, the airflow and directionality will be evaluated.
entry to the cabin, on the central line of the work surface.
A smoke generator will be used that is not too powerful, but enough for
observe the direction of the flows in the cabin.

Acceptance Criteria. The air patterns seen with the smoke must have a
constant, smooth, and unobstructed vertical direction during its trajectory.

6.6. TEST FOR NON-VIABLE PARTICLE COUNT

This test allows calculating the concentrations of particles contained in the
air inside the cabin, with a distribution of sizes whose minimum size
The particle size ranges from 0.1 µm to 5 µm.
The calculated concentrations determine the air classification inside the
cabin, which must correspond to the established requirements in the
ISO 14644-1 Standard Part 1 - 'Classification of Air Cleanliness - Cleanrooms and'
Associated Controlled Environments.

To do this, with the help of the particle counter, the classification will be verified.
from the cleaning of non-viable particles inside the biosafety cabinet, in

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conditions "AT REST". Its measuring probe is placed inside the cabin,
at a height of about 30 cm from the work area and at the indicated points in the
grade report.

Table No. 02. ISO Class of Air Cleanliness Through

la Concentración de Partículas (Norma ISO 14644-1)

According to WHO Report 45 (Annex 6, Number 4.6), clean areas

intended for the manufacture of sterile parenteral preparations are classified
according to the required characteristics of the air, in grades A, B, C, and D (See Table 03).

Table No. 03. Air Classification System in the

Manufacturing of Sterile Products

To determine the sampling points for particle counting, one takes into account
consideration of the sampling location table in relation to the area
from the cleanroom, from the ISO 14644-1 standard (A.4 - Establishment of the
Sample Collection Locations). (See Table 04).

Table No. 04. Sampling Locations in Relation

with the Clean Room Area

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According to the ISO 14644-1 standard (A.4.4), the sample volume at each location will be at least
of two (2) liters, with a minimum sampling time at each point of one (1) minute.

Acceptance Criteria. According to Table No. 02 and for the class

corresponding to the biosafety cabinet, the quantities of particles to
to comply will be: Less than 3,520 particles/m3, for particles ≥ 0.5µm and 29
particles/m3, for particles ≥ 5µm.

6.7. VOLTAGE TESTS IN WORK AREA

With this test, we demonstrate that the voltage is stable in the work area.
that the input voltage to the cabin is lower than the voltage in the area.

6.8. ULTRAVIOLET RADIATION TEST

Using a radiometer in the work area, the radiation level is measured five
minutes after the UV lamp has been turned on.

Acceptance Criteria: The radiated energy must not be less than 40 µW/cm2
253.7 nanometers.

6.9. LIGHTING LEVEL TEST

This test involves measuring the intensity of white light at the workstation.
from the cabin, in order to reduce the operator's level of fatigue.
For this purpose, a lux meter is used that has 3 measurement ranges: from 0 to 1999

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 lux, from 2000 to 19999 lux and from 20000 to 100000 lux; its resolutions are: 1 lux, 10
100 lux; and its accuracies are: (5% + 2).
A central line is drawn along the cabin, between the side walls. It
three evaluation points are taken, two of them 15 cm from the side walls and the
third to the center.

Acceptance Criteria. The average light reading must be at least 800 lux.
(74 foot candles), according to manufacturer's specifications.

6.10. NOISE TEST

This test consists of measuring the sound intensity generated by the cabin, the
it should be within permissible limits that reduce the level of fatigue of
operator.
A sound level meter is used which has a minimum accuracy of ± 1 dB, resolution
from 1 dB and a minimum range of at least 50 to 100 dB.
The tests are conducted by placing the sensor outside the cabin, about 30 cm away and
about 38 cm taking the surface of the table as a reference
cabin work.

Acceptance Criteria. The noise level must be less than or equal to 72 dBA, if the
the environmental level is not higher than 55 dBA (Source: IEST-RP-CC002.0 Section
6.11)

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