soloLAB bench-top isolator from Solo Containment Ltd flexible film containment

1. OPERATION
MAINTENANCE AND
BUILD MANUAL
soloLAB bench-top isolator
flexible film containment
Ref: soloLABOM19All information copyright Solo Containment Ltd.

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3. 1. FOREWORD 2
3
4
4
6
6
8
2. PRE-USE CHECKS
2.1 Visual check
3. CLEANING AND MAINTENANCE
3.1 Maintenance of your soloLAB
3.2 Internal and external cleaning
4. ASSEMBLY OF SOLOLAB AND SOLOLAB X
4.1 General assembly
4.2 soloLAB X additional setup
4.3 Operating the soloLAB with nitrogen
C O N T E N T S
5. MATERIAL TRANSFER PROCEDURE 9
6. GLOVE FITTING PROCEDURE 10
7. GLOVE SAFE CHANGE PROCEDURE 11
8. UTILITY SLEEVE 13

4. 02
FOREWORD1.
The soloLAB flexible enclosure has been designed and manufactured to
provide a physical barrier between operator and contents, providing both
the environment and operator protection from contamination. The
strategically positioned glove sleeves give access to the contained
contents and process.
While the system has been designed and installed to protect the user, the
system alone can not guarantee the safety of the user. However, provided
the system is operated as it is intended and the following simple
procedures, checks and recommendations are followed, the containment
system will provide a safe working environment.
Prior to commencing work, the following procedures should be read. Should
you have any questions, please contact your supervisor in the first
instance, or if necessary contact:
Solo Containment Ltd
Unit 3 Bramhall Moor Technology Park
Pepper Road
Hazel Grove
Stockport
SK7 5BW
+44(0)161 358 2233
mail@solocontainment.com
All information copyright Solo Containment Ltd.

5. 2. PRE-USE CHECKS
To ensure that the soloLAB flexible film enclosure operates correctly,
follow this simple procedure.
2.1 Visual Check
Before you start using the soloLAB flexible enclosure, visually check it for
damage paying particular attention to the gloves and glove sleeves,
checking for holes or tears.
Any damage must be reported to your supervisor. Any significant damage
around the canopy could make the flexible enclosure UNSAFE to use. Minor
damage can be patched without compromising the safety of the
containment device.
Check the gloves are in good condition. If in doubt, change the suspect
glove(s) prior to commencing work. Damaged gloves may allow active
materials to leak and compromise the containment provided by the unit.
Check gloves are sealed within the grooved glove ring and that the
securing o-rings are in position.
Check that the unit has been decontaminated following the last period of
activity. If everything is ok, you are ready to use the soloLAB.
Decontamination of the gloves and sleeves are essential at the
end of each day.
03
All information copyright Solo Containment Ltd.

6. 3. MAINTENANCE AND CLEANING
3.1 Maintenance of your soloLAB
See 2.1 for visual checks of the soloLAB. If everything is ok following these
checks, you are ready to use the flexible isolator.
The flexible isolator must be maintained in accordance with the relevant national
Health and Safety legislation for your industry, in addition to your own internal
company standards for the materials being handled.
We recommend that at least an annual maintenance check of the HEPA filter to
ensure continued protection of the users and the wider environment.
3.2 Internal and external cleaning
It is an important safety consideration that this type of device can only provide
assured containment if the inner surfaces and the items contained within are
cleaned regularly. This is of paramount importance to ensure that a buildup of
active material does not become a latent hazard for subsequent use and during
the decommissioning of the isolator.
Appropriate personal protective equipment (PPE) should be used when handling
the contaminated gloves, seals and HEPA filter during the service activity and
subsequent disposal.
For cleaning, we recommend low linting IPA wipes or non-shedding textile wipes
with 70% IPA spray bottles. Alternatively, a diluted detergent with high quality
water (demineralised) will act as a wetting agent. Upon request, sample
swatches of film can be provided for testing.
Solvents or any flammable liquids are not recommended as cleaning agents. The
filters used in this device are not suitable for use with solvents or vapours.
The use of dry wiping of the isolator should be minimised as mechanical abrasion
of the surface may reduce the optical qualities of the material and can result in
powder residues being attracted and adhering to the roughened surface more
readily.
04
All information copyright Solo Containment Ltd.

7. 05
05
4. ASSEMBLY OF SOLOLAB AND
SOLOLAB X
4.1 General assembly
A qualified and competent person should carry out all servicing and maintenance.
Place the soloLAB bag on worktop and unzip.
Remove soloLAB and blue mat from the carry bag.
The soloLAB can also be removed from its clear bag.
Once the soloLAB is out of its clear bag it will start to
open up. To help speed up this process the gas tight
zip door can be opened. Opening the door will aid with
the additional assembly for the soloLAB X.
With the soloLAB fully open it needs to be secured to
the bench. This is done using the cords that hang from
the rear of the soloLAB. These are to be pulled under
the working level and then tied to the eyelets at the
front of the isolator. At this point, the soloLAB is now
ready for use, unless it is being purged with nitrogen.
All information copyright Solo Containment Ltd.

8. 06
4.2 soloLAB X additional setup
Locate and open the
Sundström fan unit and filter
case. The fan with filters
should be removed and the
filters unscrewed from the
fan.
The white spacers can now be screwed into the filter locations. This should be
carried out for both sides. The fan unit is now ready to be connected to the
isolator.
The filters can both be placed into the isolator
and rear blanking panel removed, as shown
below. This will allow the filter to be fitted to the
fan unit.
All information copyright Solo Containment Ltd.

9. 07
To install the filters,
first push the threaded
end through the
enclosure film. This will
be a fight fit. Repeat
for both filters.
The fan unit can be offered up to the filters and each one screwed into the
white spacers. Once installed the soloLAB X zip door should be closed up and
the fan unit can be turned on.
When the fan unit is on, it will light up
green.
The soloLAB X runs at negative
pressure so the enclosure will
naturally compress slightly when the
fan is on.
All information copyright Solo Containment Ltd.

10. 08
If the soloLAB is being operated
with nitrogen, the gas line will need
to be installed via the utility sleeve.
For details on using the utility
sleeve, please see section 8.
4.3 Operating the soloLAB with nitrogen
The sleeve on the filter should be
opened ready for the soloLAB to
be purged with nitrogen.
A gas detector must be used
during nitrogen operation.
The soloLAB must be
connected to, or have a
local exhaust running to
extract the nitrogen during the
purge and then during the
operation of the isolator.
All information copyright Solo Containment Ltd.

11. 09
5. MATERIAL TRANSFER
PROCEDURE
For removal of contaminated laboratory apparatus it is recommended that all
items of test equipment should be removed following this procedure.
Ensure clean down materials are installed into the soloLAB prior to use.
Clean down all isolator internal surfaces via the glove ports.
Fully decontaminate test equipment with wipes and sprays, also via the
glove ports.
Over bag the items for removal - still via the glove ports.
A second decontamination of the bag should be carried out, especially
the base and rear side.
If possible, swab the clean off bag and have a 'clean certificate'
generated after HPLC or similar trace contamination testing.
As the HEPA filters may contain API material, please seal the filters
with a suitable over bag before opening the enclosure frontal zipper.
It is now safe to open the access zipper and remove the items.
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2.
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4.
5.
6.
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All information copyright Solo Containment Ltd.

12. 10
6. GLOVE FITTING PROCEDURE
Glove sleeve in withdrawn state with the cuff fitted
to sleeve via encapsulated o-ring.
Glove mounted to the cuff.
To do this, position the glove thumb at the top of
the opening and position the bead of the glove
into the furthest grove of the cuff.
Fit an o-ring to the first groove to retain the glove
onto the cuff.
Glove sleeve inverted. This is where it is pushed into
the enclosure.
Glove fitted and sleeve in normal operating position.
All information copyright Solo Containment Ltd.

13. 11
7. GLOVE SAFE CHANGE
PROCEDURE
The changing of any glove is a process that requires practice.
The rate at which gloves are changed is not an exact science and as such, all
gloves should be visually inspected prior to and during the use of the isolator. If
in any doubt, change the gloves using the following procedure.
Withdraw the damaged glove into the sleeve and pull
the sleeve out of the enclosure.
Fully withdraw the glove and cuff assembly to expose
the glove bead and o-ring.
Carefully remove the o-ring and move the glove into
the first groove.
O-ring fully removed with glove still in place.
Position the replacement glove (with the thumb at the
top) inside the existing glove.
All information copyright Solo Containment Ltd.

14. 12
Fit the new glove onto the second groove (existing
glove will still be connected to the cuff). Working
through the new glove, carefully peel the original
glove off the cuff.
Withdraw the sleeve from the enclosure and fit an
o-ring into the first groove. Return the sleeve to the
normal operating position.
All information copyright Solo Containment Ltd.

15. 13
8. UTILITY SLEEVE
All information copyright Solo Containment Ltd.
Cut the corner of the sealed utility sleeve
to leave a small hole.
Push the tube and / or cable through the
hole until it is in the correct position.
Roll the end of the utility around the tube
so that it is tight and place a cable-tie
about 25mm from the end to secure the
sleeve in place.
Wrap the end of the sleeve with a strip of
tape to seal.

16. Ref: soloLABOM19All information copyright Solo Containment Ltd.
Solo Containment Ltd
Unit 3, Bramhall Moor Technology Park
Pepper Road
Hazel Grove
Stockport
SK7 5BW
0161 358 2233
www.solocontainment.com