1.0 PURPOSE
To design a
Standard Operating Procedure that describes the use and maintenance of the cage
changing station that offers the benefits of vertical HEPA filtered airflow for
product protection on the work surface.
2.0
SCOPE
This Standard
Operating Procedure (SOP) is applicable for the operation, and maintenance of the cage
changing station for cage wash and animal care personnel at the animal house facility (AHF).
3.0
RESPONSIBILITY
3.1 It is the responsibility of the
facility manager to ensure that all portable equipment is appropriately
cleaned, and maintained in good working order.
3.2 It is the responsibility of the
facility manager to ensure that all animal care staff is adequately trained and
experienced in the use of the cage changing station.
3.3 It is the responsibility of the
animal care staff using a cage changing station to read and understand the
instruction manual and this SOP prior to equipment use.
4.0
DISTRIBUTION
4.1 The Quality Assurance department is responsible to keep SOP ‘Master Copy’ approved through the Quality Manager.
4.2
The copy of ‘Control Copy’ of
SOP is being distributed in the AHF department and placed near related Equipment/
Instrument as Display Copy.
5.0
DEFINITION(S)
5.1
Definition(s)
5.1.1 Cage changing station offers
the benefits of vertical HEPA filtered airflow for product protection on the
work surface.
6.0 ABBREVIATION(S)
6.1 Abbreviations
6.1.1
SOP : Standard Operating Procedure
6.1.2
AHF : Animal House Facility
6.1.3
AHI : Animal House Instrument
6.1.4
PPEs : Personal Protective Equipment
6.1.5
HEPA :High Efficiency Particulate Air
7.0
PROCEDURE
7.1.1 The blower and lights shall be
turned and allow the blower to operate for a minimum of 10 minutes before
manipulations are begun in the cabinet.
7.1.2
Essential items/supplies shall
only be allowed in the workstation.
7.1.3 Cabinet’s interior surface
shall be decontaminated by wiping with a chemical disinfectant prior to
commencing work. Chlorinated or halogen-based cleaners shall not be used unless
followed by a final wipe/rinse with 70% alcohol.
7.1.4
To reduce airflow disruptions:
7.1.5
Movements in and out of the
work area shall be minimal.
7.1.6
Activity in the room, including
opening and closing doors shall be minimal.
7.1.7 The following completion of all
work, the station shall allow for 2-3 minute without activity to purge the
unit.
7.1.8
The cleaning/decontamination of
the interior surfaces shall be repeated after the removal of all work materials by
wiping with a chemical disinfectant.
7.1.9
The blowers and lights shall be
turned off. The cabinet shall not be used as a depository for excess laboratory
equipment during periods of non-operation.
7.2
Maintenance
7.2.1 Inspect the condition of the unit and
electrical cord/plug to ensure safe operation. Equipment determined to be
unsafe shall be removed from service immediately.
7.2.2 The station’s interior consists
of both powder coat urethane and type 304 stainless steel surfaces. Chlorinated
or halogen-based cleaners shall not be used unless followed by a final
wipe/rinse with 70% alcohol.
7.2.3 The exterior surface shall be easily clean with alcohol followed by any mild household detergent.
7.2.4
The exhaust pre-filter mesh
netting shall be checked daily and cleaned as often as necessary, but at least
weekly.
7.2.5
The supply and exhaust
pre-filter(s) shall be checked weekly and cleaned/changed as often as needed.
7.2.6 HEPA filters shall be replaced
by qualified personnel when airflow velocity cannot be maintained.
7.2.7 Castors shall be checked yearly
(older units have castors that screw onto the base these may loosen over time and
eventually snap off).
7.2.8
Certification shall be
performed on a triennial basis by qualified personnel and shall include:
7.2.9
Verifying pre-filter and HEPA
filter integrity.
7.2.9.1
Measuring down flow velocity.
7.2.9.2
Checking exhaust motor/blower
function.
7.2.10
Cleaning, sanitization & filter replacement
7.2.10.1
Unit work surface and
pre-filters shall be thoroughly cleaned and sanitized at least weekly.
7.2.10.2
With the fan running, the work
surface shall be cleaned with Oxivir Tb or Sporicidin wipes while wearing
gloves, lab coats, and sleeves.
7.2.10.3
Lift the work surface and wipe
the sides, underside, top & bottom of the stainless steel pre-filter cover, and
bottom area of changing station. Use as many Oxivir Tb or Sporicidin wipes as
necessary. Work surfaces that are extremely dirty shall be removed to cage wash
for sanitation.
7.2.10.4
Units may contain two black
foam filters, stacked, 1 coarse and 1 fine, or a single disposable white fiber
filter.
7.2.10.5 Exhaust pre-filters shall be
inspected weekly and cleaned/replaced when needed as described below
7.2.10.5.1
Turn Fan OFF.
7.2.10.5.2
Remove everything from the area
that could possibly fall into the fan blades/motor.
7.2.10.5.3
Spritz the surface of the filter with
Oxivir Tb or Sporicidin lightly.
7.2.10.5.4
Remove the filter from the housing.
7.2.10.5.5
Spritz underside of the filter with
Oxivir Tb or Sporicidin.
7.2.10.5.6
Place filter in plastic bag and
seal.
7.2.10.5.7
Foam filters are taken to cage
wash for sanitization.
7.2.10.5.8
Fiber filters are disposable
and are discarded.
7.2.10.6
Replace clean/new pre-filter(s)
in unit.
7.2.10.7
Replace cleaned work surface.
7.2.10.8
Weekly cleaning of the unit and
pre-filter inspection are noted on the Room Status Sheet.
8.0
PRECAUTIONS
8.1 All personal protective
equipment like apron, gloves, mask, head caps, and shoe cover should be worn
before using the instrument.
8.2
Clean the equipment with a dry
piece of robe or a lightly moistened one, Do not use organic solutions,
8.3
Never use abrasive products or
dissolvents.
8.4
Never pour water or liquids on
the equipment.
8.5
Once you have finished using
the equipment turn it off by using the main switch, clean, and check the equipment
so that it is in optimal conditions when you use it again.
9.0
REFERENCES
9.1
Reference
9.1.1
Refer to the manufacturer’s
manual for additional information
END OF THE DOCUMENT
You may like to read these links:
1. List of In-vivo laboratory Vendors (Capex)
2. List of SOPs and Documents for CPCSEA
3. List of All SOPs and Documents for Laboratory Instruments and Equipment
4. List of All SOPs and Documents for Animal House Facility
5. List of All SOPs and Documents for In-vivo Laboratory
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