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SOP Title:
Author: J G Davis
Document Control
The Master Copy of the Quality Manual and SOPs 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If this SOP appears inadequate or outdated it is the responsibility of all staff to bring this to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
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
6.1
6.2
6.3
6.4
6.5
Subject
Page
Issue No:1.0
Page 1 of 8
2
2
2
2
2
3
3
3
4
4
4
5
5
5
SOP Title:
Revision History
Managerial Approval
5
6
2.0 Background
2.1
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
3.0 Definitions
Refer to:
Rules and Guidances 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
Issue No:1.0
risk
CA2
Page 2 of 8
SOP Title:
6.0 Procedure
6.1
Non-sterile gloves are worn out side of the aseptic clean room
environment for tasks that include:
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
6.2.4
Tuck coat cuffs under the cuff of the gloves to ensure that there is no
skin exposed.
Issue No:1.0
Page 3 of 8
SOP Title:
6.3
6.4
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
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.
6.5
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
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
6.5.4
Issue No:1.0
Page 4 of 8
SOP Title:
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 members
assessment for procedure
carry out processing will undergo a gown up validation. Part of
this validation tests the operators ability to clean their hands
and put on sterile gloves without contaminating them. The
operator must pass Process Qualification Protocol BMTUSCIL 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
Training/Competency
Assessment
8.0
References
8.1.Rules and Guidances for Pharmaceutical Manufacturers and Distributors 2002
Sixth edition ISBN 011 322559
8.2.Joint Accreditation Council of ISCT/EBMT Europe (JACIE)
8.3 SOPs
9.0
BMTU.SCIL
List of Appendices
Appendix 1
Appendix 2.
10.0
Revision history
Issue
1.0
Change
JACIE format working in new facility
Issue No:1.0
Page 5 of 8
SOP Title:
Managerial Approval:
Name Printed
Signature
J Davis
John David
Reviewers
A. Rahemtulla
Amin Rahemtulla
K Patel
Kirtash Patel
Issue No:1.0
Title
Date
SCI Laboratory
Director
09 Feb 06
SCI Medical
Director
13/02/06
QA Mgr
14.Feb.06
Page 6 of 8
Not Missed
Less frequently missed
Most frequently missed
BACK
FRONT
Issue No:1.0
Page 7 of 8
Trainee:____________________________________________Trainer:_________________________________Date:_________________
The following table constitutes the Record Training - Training Status and Competency, in this procedure, for the personnel detailed below.
Date
Training
Started
Trainee
Name
Trainee
Signature
Date
Training
Completed
Supervisor /
Trainers
Signature
Supervisor / Trainer
to sign, if Trainee is
Competent in SOP.
This completed Record Training & Competency Assessment form must be forwarded to the QA Manager for archiving, by the trainer.
SOP No:BMTU-SCIL 152
Issue No:1.0
Page 8 of 8