SOP Title: Hand cleaning and gloving procedure

SOP Type: Procedure

Hammersmith Hospitals NHS Trust

Department of Haematology
Quality Management Policy and Procedures

Purpose: In order to instruct the staff working within the Processing Dept. on hand
cleaning techniques and how to put on gloves to carry out designated tasks as
detailed in specific SOP’s.

Scope: Applies to all Laboratory staff required to work in environmentally controlled area

Departmental Responsibility: SCI Lab Date Effective: 28.Feb.06

Author: J G Davis Review Date: 27.Feb.07

Document Control
The Master Copy of the Quality Manual and SOP’s will be filed in the Quality Management
Office. Controlled copies are numbered and stamped “Controlled Copy” in red ink.
Any copies without this red stamp are uncontrolled and should be destroyed.

If this SOP appears inadequate or outdated it is the responsibility of all staff to bring this to
the attention of their Supervisor immediately.

Training Record
The training record for this SOP is filed with the master copy of the SOP in the Quality
Management Office.

Security Statement
This SOP is the intellectual property of the BMT Unit within the Division of Clinical
Haematology at the Hammersmith Hospital NHS Trust and as such, must not be circulated
outside of the Trust without written approval from the Quality Assurance Manager and the
Author of this procedure.
_________________________________________________________________________

Contents
Section Subject
Page

1.0 Personnel & Responsibilities 2

2.0 Background 2
3.0 Definitions 2
4.0 Health & Safety 2
5.0 Equipment/Documentation 2
6.0 Procedure 3
6.1 Use of hand gel or rub to clean hands 3
6.2 Putting on non-sterile gloves 3
6.3 Putting on vinyl gloves 4
6.4 Gloving requirements when working in clean rooms 4
6.5 Cleaning of gloved hands –
alcohol wipes and alcohol solution. 4
7.0 Training and Competency Assessment 5
8.0 References 5
9.0 List of Appendices 5

SOP No:BMTU-SCIL 152 Issue No:1.0 Page 1 of 8

SOP Title: Hand cleaning and gloving procedure

SOP Type: Procedure

10.0 Revision History 5

11.0 Managerial Approval 6

1.0 Personnel & Responsibilities

1.1 The basic procedure must only be carried out by qualified Biomedical
Scientists, Clinical Scientists and other staff who have been properly trained
in the procedure and are deemed to be competent. Training must be in
compliance with the training record accompanying the SOP.

2.0 Background

2.1 Minimising the risk of hands as a source of contamination

2.1.1 Staff working within environmentally controlled areas MUST maintain

a high level of personal hygiene. Effective hand cleansing is of
paramount importance when working within the grade B areas.
Ineffective hand cleaning when working within a practical ‘hands on’
environment could potentially cause contamination of a clinical
harvest which could pose a serious risk to patients receiving HPC and
other cell products from the laboratory.

2.1.2 Staff within the unit MUST wear gloves to carry out specific tasks as
outlined in specific standard operating procedures. This ensures that
the risk of contaminating the compounded product is reduced.

2.1.3 Staff MUST also wear gloves to protect themselves against known
and unknown biohazards and cryoprotectant substances.

3.0 Definitions

Refer to:
Rules and Guidance’s for Pharmaceutical Manufacturers and Distributors 2002
Sixth edition ISBN 011 322559

4.0 Health & Safety

All staff must follow safe practice for dealing with biological materials as stated in the
Hammersmith Hospitals NHS Trust Infection Control Policy, Section 2:Universal Infection
Control including Safe Handling and Disposal of Sharps, Sharps Injuries and Exposure to
Blood and Body Fluids, Spillages and Waste. All human derived products should be
treated as a potential biohazard.

Alcohol solutions should be used in well-ventilated environments and staff must avoid
inhalation of vapour (refer to departmental COSHH assessment)
Staff with latex allergies must wear latex free gloves at all times.

5.0 Equipment/Documentation

5.1 Equipment COSHH assessment risk

70% IMS spray CA2 L

SOP No:BMTU-SCIL 152 Issue No:1.0 Page 2 of 8

SOP Title: Hand cleaning and gloving procedure

SOP Type: Procedure

Klergel 70 Alcohol hand gel

Low lint IMS impregnated wipes
Sterile IMS wipes
Sterile individually wrapped vinyl gloves
Non-sterile boxed gloves
6.0 Procedure

6.1 Use of hand gel or rub to clean hands

6.1.1 Ensure that the hand rub/gel bottle is in date

6.1.2 Ensure that the lock cap has been removed this allows the pump
dispenser to be used.
6.1.3 Ensure that there is sufficient hand rub/gel in the container to allow
hand cleaning to take place.
6.1.4 Dispense a small amount of hand rub /gel to the palm of one hand by
pressing down on the pump dispenser.
6.1.5 Put your hands together and proceed to rub the hand gel/rub into both
hands. Pay particular attention to the following areas

• Fingernails
• Back of hands
• Wrists
• Between webs of fingers
•Thumb

Refer to appendix 1 for diagram.

6.1.6 Allow hands to dry, this should take approximately 60 seconds.

6.2 Putting on non-sterile gloves

6.2.1 Non-sterile gloves are worn out side of the aseptic clean room
environment for tasks that include:

• All cleaning duties

• Working in Grade C support areas
• All spraying in duties (corridor to support room transfer
lobbies, support room to clean room lobbies)
• Working in the QA laboratory preparing when handling
biological samples.

Gloves must be changed before staff move on to new task as to

prevent cross contamination between products. If gloves become
damaged they must be changed at immediately.

6.2.2 Select the appropriate size gloves to fit your hands comfortably from
the box of non-sterile gloves located in the appropriate area(s) for the
task(s) that are to be undertaken.

6.2.3 Pull gloves onto hands

6.2.4 Tuck coat cuffs under the cuff of the gloves to ensure that there is no
skin exposed.

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SOP Title: Hand cleaning and gloving procedure

SOP Type: Procedure

6.3 Putting on vinyl gloves

6.3.1 Vinyl gloves are used to gown up in. Clean the gowning gloves with
alcohol wipes and solution.
.
6.3.1 Within the changing room, select the most appropriate gloves to fit
your hands, (one size larger than normal) peel open the outer
packaging of the gloves. Discard this packaging.

6.3.2 Unfold the paper housing of the sterile gloves.

6.3.3 Put on the first glove touching only the folded back part of the glove
with ungloved hand.

6.3.4 Put on the second glove. Do not touch the outside surface of the
gloves with ungloved hands.

6.3.5 Following gowning up tuck cuffs of suit into the cuff of the gloves to
ensure that all skin is covered.

6.4 Gloving requirements when working in clean rooms

6.4.1 Sterile gloves are used when working on HPC and other products for
clinical use. They are only sterile whilst within the packaging.
Operators must not use sterile gloves that have had their packaging
removed or damaged in any way. If gloves become damaged they
must be changed at immediately.
Sterile gloves MUST be worn at all times when working in Aseptic
Rooms

6.5 Cleaning of gloved hands - alcohol wipes and alcohol solution.

6.5.1 Staff must ensure that prior to commencing the following task(s) they
clean their gloved hands.
• Spraying in
• Cleaning transfer hatches
• Working within clean rooms.

6.5.2 Select a wad of alcohol wipes and wipe each hand. Pay particular
attention to the following areas:

• Back of hands
• Wrists
• Between webs of fingers
• Thumb

6.5.3 Spray each hand with a fine mist of alcohol solution.

6.5.4 Allow hands to dry (alcohol'

s disinfection process works by
evaporation).

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SOP Title: Hand cleaning and gloving procedure

SOP Type: Procedure

6.5.5 Visually ensure that your hands have dried before proceeding.

7.0 Training and Competency Assessment

Type of Training Staff require demonstration of hand cleaning and gloving
procedure appropriate to the areas to be worked in.
Satisfactory observation of trainee gowning up.
Method of competency By demonstration and performance validation. Staff member’s
assessment for “procedure” carry out processing will undergo a gown up validation. Part of
this validation tests the operator’s ability to clean their hands
and put on sterile gloves without contaminating them. The
operator must pass Process Qualification Protocol BMTU-
SCIL – 149 PQ gowning procedures before being permitted
into Cellular Therapy Suites 1 and 2.
List Staff required for Training All staff engaged in processing.
and Competency Assessment
Who is to perform this training Laboratory Director, Head of Processing Dept, Head of Quality
Dept.

Evidence Log of Complete the Training Record (Appendix 2)

Training/Competency
Assessment

8.0 References

8.1.Rules and Guidance’s for Pharmaceutical Manufacturers and Distributors 2002

Sixth edition ISBN 011 322559

8.2.Joint Accreditation Council of ISCT/EBMT Europe (JACIE)

8.3 SOPs
BMTU.SCIL 149 PQ gowning procedures

9.0 List of Appendices

Appendix 1 Use of hand gel or rub to clean hands

Appendix 2. Training Record..

10.0 Revision history

Issue Change
1.0 JACIE format – working in new facility

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SOP Title: Hand cleaning and gloving procedure

SOP Type: Procedure

10.0 Managerial Approval:

Name Printed Signature Title Date

Author:
SCI Laboratory
J Davis John David
Director
09 Feb 06
Reviewers
SCI Medical
13/02/06
A. Rahemtulla Amin Rahemtulla Director
QA Mgr 14.Feb.06
K Patel Kirtash Patel

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SOP Title Hand cleaning and gloving procedure

SOP Type: Procedure

Appendix 1 - Use of hand gel or rub to clean hands

HAND WASHING TECNIQUES

Not Missed

Less frequently missed

Most frequently missed

BACK

FRONT

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SOP Title Hand cleaning and gloving procedure

SOP Type: Procedure

Appendix 3 – Training Record and Competency Assessment

SOP No:__BMTU- SCIL 152_____Version: ____1.0____SOP Type: Procedure

SOP Title: : Hand cleaning and gloving procedure

Trainee:____________________________________________Trainer:_________________________________Date:_________________

The following table constitutes the Record Training - Training Status and Competency, in this procedure, for the personnel detailed below.

Date Trainee Trainee Date Supervisor / Supervisor / Trainer Competency Assessment Method.
Training Name Signature Training Trainers to sign, if Trainee is
Started Completed Signature Competent in SOP.

This completed Record Training & Competency Assessment form must be forwarded to the QA Manager for archiving, by the trainer.

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