SOP - Clothing Requirements Inside The Factory
SOP - Clothing Requirements Inside The Factory
SOP - Clothing Requirements Inside The Factory
Manufacturing
Document no
MAN-005
Prepared by:
Date:
Supersedes:
Checked by:
Date:
Date Issued:
Approved by:
Date:
Review Date:
Document Owner
Operations Manager
Affected Parties
All Sydco Colleagues
Purpose
This SOP covers the clothing requirements needed in all Factory areas in Sydco. The different levels of
cleanliness must be maintained to minimise microbial and particle contamination.
Scope
It is the responsibility of each and every employee, contractor and visitor to follow this SOP. Clothing
restrictions apply at all times unless approval is given in writing by QA management to deviate for a specified
period.
Definition
Beard
A facial growth of more than 24hr prior to the start of your shift or first entry to the factory.
Environmental
Graded Areas
Related Documents
N/A
EHS Statement
Personal factory clothing must be changed on a daily basis for cleanliness and hygiene.
Safety Glasses and gloves must be worn when using IPA or solvent.
Table of Contents
1.
2.
3.
4.
5.
6.
7.
General.................................................................................................................................................... 1
Restrictions.............................................................................................................................................. 2
Environmental areas ............................................................................................................................... 3
Changing procedures.............................................................................................................................. 4
Procedures After Evacuation .................................................................................................................. 5
Ownership of Clothing............................................................................................................................. 6
Summery of Changes ............................................................................................................................. 6
Procedure
1.
General
Due to the nature of the work carried out in the factory as well as cleanliness requirements, a
minimum standard of protective clothing is required. More stringent protective clothing requirements
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3.
Environmental areas
3.1.
3.1.2.
Inspection areas
WIP area.
3.1.3.
3.2.
For Visitors, Navy Blue Visitors overalls placed on over street clothes:
If entering a Grade D area only, you may put the visitors overall on over street
clothes. That is if the visitor is only walking through the factory or not working
on a commissioned line.
All guests MUST remove any jewellery, and if it is not possible to remove a ring
then a glove must be worn to enter the factory.
Shoe covers must be worn over street shoes before entering the factory and a
beard cover (if applicable) and hair net.
3.2.2.
3.2.3.
Blue smocks/coveralls
No street clothes, which includes T-shirts, unless this is a clean one, worn as a
singlet.
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4.2.
4.3.
4.1.3.
While crossing to the other side of the room Wash your hands. Then cross to the
other side of the change room. This is known as the Clean side of the change
room.
4.1.4.
Open the half-length locker with the corresponding number to your personal locker,
and take out the uniform.
4.1.5.
If you have been sterile trained and validated, and are about to enter the Grade B
area from grade D, place on the Navy pants and White top, this is your Quick
change Grade D Factory uniform.
4.1.6.
Place on your designated Grade D safety shoes, or Blue shoe covers over personal
shoes if not issued with designated shoes.
4.1.7.
Put on White hairnet, (and beard net, if you have 24 hrs or more growth on face) and
enter factory via the door on the Clean side.
4.1.8.
Wait here for your host to collect you, (if you are new or a casual), otherwise go to
workstation.
Enter Grade C Airlock, wash hands, if hand basin is available in the area.
4.2.2.
Place on area specific Blue coat/coverall, (over the top of your Grade D uniform).
4.2.3.
4.2.4.
4.2.5.
4.3.1.
Summary table
Sterile Entry Training and validation of full surgical scrubbing procedure is required.
Graded Area
A/B Sterile preparation
and Filling
Activity Type
CRITICAL. Sterile filling, exposed product or
containers.
Clothing Requirement
Sterile garments
No makeup or jewellery.
C Preparation of
components for sterile
Less CRITICAL
Exposed components, non-sterile filling,
Solution & Filter Preparation., Equipment Prep.
D Packaging
CONTROLLED
Packaging no
components
Tablet Packaging
E Controlled Access
5.
exposed
product
and
After an evacuation of the factory all staff wearing Grade D factory clothing are to report to
the Shoe Cleaning Station. If staff did not use disposable Blue shoe covers when
evacuating, their shoes will need to be cleaned. First with a mild cleanser, to remove all
traces of dirt and grass and then sprayed with 70% IPA. Cleaned shoes must be carried (not
worn) to the clean side of the factory change rooms. Uniforms worn outside the building
during the evacuation must be put in the dirty clothes bins and fresh set worn to re-enter the
factory.
5.2.
After an evacuation, all staff wearing Grade B Sterile clothing must remove their
undergarments, sterile overshoes, hood and coverall and place in the factory change room
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