SCGT - Gowning for Entry
into GCMF Cleanrooms
1
Purpose
To describe the aseptic gowning procedure for entry into the Gene and Cell Medicine Facility (GCMF)
Cleanrooms. This procedure aids in reducing the risk of product contamination with bacteria and/or
particles. Please note the procedure for gowning in hospital blues for entering the GCMF workroom is
covered by RE-KRI-S001 (Entry and Exit of Personnel into the Gene and Cell Medicine Facility).
2
Responsibilities
Position
Director of GCMF
Production Manager
Operators
Quality Officer
Responsibilities
Authorise this procedure
To review and update this procedure in line with current practice.
Supervise the training of users of the facility and ensure that the
procedure is adhered to.
To follow this procedure
To train new users of the facility in this procedure
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Equipment & Supplies
 2 pairs Cleanroom gloves (powder-free)
 Sterile 70% Alcohol Spray
 Sterile Cleanroom hood
 Sterile Cleanroom coverall
 Sterile Cleanroom overshoes
 Face Mask
 Safety eyewear
 Sterile waste bag
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References
4.1 RE-KRI-S001 (Entry and exit of personnel into the Gene & Cell Medicine Facility)
4.2 RE-KRI-S002 (Trafficking and Storage of Materials in the GCMF)
4.3 RE-KRI-S003 (Entry and Exit of Personnel into the Cleanrooms)
4.4 RE-SYS-S012 (Validation of Aseptic Gowning Procedures)
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Additional information
5.1 Precautions
5.1.1 Only authorised, trained and validated personnel may enter a cleanroom unescorted.
5.1.2 Eating, drinking or smoking is not permitted in the cleanrooms. Personal items (including
jewellery) must not be brought into the cleanrooms. Nail polish or acrylic nails should not
be used.
5.1.3 Staff members infected with an infectious disease should not be engaged in production.
Any open lesions on exposed surfaces of the body must be covered with adhesive protective
film. All staff must be immunised against hepatitis B and tetanus prior to commencement in
production areas. All staff engaged in production are subject to Sydney West Area Health
Service health policies.
5.1.4 Individuals who are ill, e.g. with a cold, flu symptoms, stomach disorder, open lesions or
any type of skin disorders e.g. eczema or sunburn, should report to the Production Manager
who will determine if the individual may enter the GCMF Facility.
5.1.5 The hospital blues need to be in an acceptable condition, if any tears or soiling have been
identified, immediately dispose of the garment into the linen trolley and obtain a new
garment.
RE-KRI-S004 Version 2
Active:
Documents not printed on controlled paper are valid for the print date only
CONFIDENTIAL
Page 1 of 4
Author: R.Singh/V.Terpos
SCGT - Gowning for Entry
into GCMF Cleanrooms
5.1.6
5.1.7
6
No person is permitted to enter the clean room unless they are correctly attired.
Keep hands away from face whilst in the cleanrooms.
Procedure
6.1 STEP 1 – Entry into Airlock
6.1.1 Follow Section 6.1 in RE-KRI-S003 (Entry and Exit of Personnel into the GCMF
Cleanrooms) for trafficking of the garments into the required Airlock.
6.1.2 Remove latex gloves, apply a couple of squirts of Antiseptic hand rub and gently spread
over the palm and massage in-between fingers, nails and wrists. Allow to air dry.
6.2 STEP 2 – Putting on 1st Pair of Gloves
6.2.1 Peel open the packet of sterile cleanroom gloves and fold out to expose the folded cuff area
of the gloves.
6.2.2 Put on the first glove by inserting the fingers into the glove and pulling on the folded cuff
area to cover the palm, ensuring that only the inside of the cuff is touched. Repeat with the
second glove.
6.2.3 With gloved fingers, fold the gloves over the arms, pulling them up over the wrists and
forearms, ensuring that the gloves remain sterile.
6.2.4 Spray gloved hands and wrists with sterile 70% alcohol spray and allow to air dry.
6.3 STEP 3 – Putting on Hood
6.3.1 Open the packet containing the sterile hood ensuring that the contents remain sterile.
6.3.2 With care and only touching the inside of the hood, turn the hood inside out and place on
the head, ensuring that all the head is covered and no bouffant cap is exposed.
6.3.3 Fasten the hood around the neck by clipping together the buttons under the chin.
6.3.4 Being careful not to touch the outside surfaces, adjust the hood to cover all of the head. If
required use a sterile wipe to adjust the hood.
6.4 STEP 4 – Putting on Mask
6.4.1 Put on the face mask and by touching as minimal area as possible tie on the mask. If
required adjust the mask across the bridge of nose using a sterile wipe, making sure it fits
snugly.
6.5 STEP 5 – Putting on Safety Eyewear
6.5.1 Spray, wipe (air dry if required) and put on safety eyewear. Dedicated safety glasses should
remain on the clean side of the airlock and should not be removed.
6.5.2 Spray gloved hands and wrists with sterile 70% alcohol spray and allow to air dry.
6.6 STEP 6 – Putting on Coveralls
6.6.1 Open packet containing sterile coveralls, ensuring contents remain sterile.
6.6.2 Place garment on trolley, label down, with the neck line away from you.
6.6.3 Unfold left and right sides of coverall.
6.6.4 Taking the top folded edge of the coverall unfold it towards you until it is lying flat to
reveal the full length of the zipper and the openings for each leg along the bottom edge.
6.6.5 Keeping the coverall lying flat on the trolley, take hold of the upper edge of each leg
opening and gather a handful of the garment in each hand, to catch up the legs of the
coverall (folded inside).
6.6.6 Continue to gather the garment in this way so that when the coverall is held up (to step into)
it does not touch the floor.
6.6.7 Lifting the coverall off the trolley, hold it in front of you and step into one leg at a time,
slowly releasing the gathered fabric to allow each foot to push through.
6.6.8 Take care not to allow the arms of the coverall (folded inside) to touch the floor.
RE-KRI-S004 Version 2
Active:
Documents not printed on controlled paper are valid for the print date only
CONFIDENTIAL
Page 2 of 4
Author: R.Singh/V.Terpos
SCGT - Gowning for Entry
into GCMF Cleanrooms
6.6.9 Pull the coverall up to waist height, taking care not to touch the outer side of the coverall.
6.6.10 Slip hands into sleeves, one at a time and then slip the remainder of the coverall over the
shoulders.
6.6.11 Check that the hood skirt is completely inside the collar of the coverall and fasten the
coverall with the zipper.
6.6.12 Spray gloved hands and wrists with sterile 70% alcohol spray and allow to air dry.
6.7 STEP 7 – Putting on Overshoes
6.7.1 Open the packet containing the overshoes, ensuring they remain sterile.
6.7.2 Sit on the seat with both feet on the grey flooring. Starting with the foot closest to the blue
flooring, put on the first overshoe carefully ensuring that only the inside of the overshoe is
touched. Adjust and secure the buckles touching the outside as little as possible and place
foot on the blue flooring.
6.7.3 Repeat with second foot.
6.8 STEP 8 – Putting on 2nd Pair of Gloves
6.8.1 Obtain the second pair of gloves from the pass-through hatch. Peel open the packet of
sterile cleanroom gloves and fold out to expose the folded cuff area of the gloves.
6.8.2 Put on the first glove by inserting the fingers into the glove and pulling on the folded cuff
area to cover the palm, ensuring that only the inside of the cuff is touched. Repeat with the
second glove.
6.8.3 With gloved fingers, fold the gloves over the sleeve cuffs of the sterile garment, pulling
them up around the wrists and forearms.
6.8.4 Spray gloved hands and wrists with sterile 70% alcohol spray and allow to air dry.
6.9 STEP 9 – Entry into Cleanrooms
6.9.1 Check appearance in the mirror, to ensure integrity of all garments.
6.9.2 Spray gloved hands and wrists with sterile 70% alcohol spray and allow to air dry.
6.9.3 Complete trafficking of materials as described in RE-KRI-S002.
6.10 STEP 10 – Exiting of Cleanrooms
6.10.1 Ensure that glove print plates were conducted prior to leaving the BSC workspace.
6.10.2 Conduct Personnel Monitoring (hood, chest and sleeve plates) on the clean side of the
airlock.
6.10.3 Remove sterile garments in the Workroom and dispose of them in the workroom linen
trolley.
6.10.4 Exit the GCMF facility as described in RE-KRI-S001 - Section 6.2.
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Points of Consideration
7.1 Gloves must be replaced if there is a hole in the 2nd pair (top pair) of gloves or both gloves.
7.2 Ensure extra stock of gloves and masks are easily accessible when processing.
7.3 If you sneeze whilst in the cleanrooms, you must exit the cleanroom as soon as able and exit into
the airlock, where you will replace your mask and 2nd pair (top pair) of gloves. Gloves must be
sprayed with 70% alcohol spray prior to re-entry into the cleanrooms.
7.4 Gloves should be frequently sprayed with 70% alcohol whilst in the cleanrooms.
7.5 Should you suffer any open wound injuries while working in the cleanrooms immediately leave
the room to receive First Aid. If the cut is small and the bleeding has stopped, you may re-enter
the cleanroom provided a clean Band-Aid is applied to the cut and sterile gloves are worn over the
Band-Aid. You may continue working in the cleanrooms provided the cut does not become
infected. If this occurs you must not enter the cleanrooms until the infection has or you have been
cleared to do so by your Production Manager.
RE-KRI-S004 Version 2
Active:
Documents not printed on controlled paper are valid for the print date only
CONFIDENTIAL
Page 3 of 4
Author: R.Singh/V.Terpos
SCGT - Gowning for Entry
into GCMF Cleanrooms
8
Changes to previous version
Version
1 to 2
Summary of change
Update of logo
9
Appendices
10
End of document
RE-KRI-S004 Version 2
Active:
Documents not printed on controlled paper are valid for the print date only
CONFIDENTIAL
Page 4 of 4
Author: R.Singh/V.Terpos