MAN-005 Clothing Requirements Inside the Factory Area

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 apply in certain restricted factory areas.  We need to prevent any form of possible contamination being introduced into the factory environment.

NO EATING or storing of food will take place in part of inside the factory area.(This includes lollies and chewing gum)

Drinking water is supplied in some areas of the factory.  (The water must only be consumed at the water cooler and the cup placed into the rubbish provided.)  No other drink is allowed.

HANDS MUST BE WASHED before entering the factory, leaving the factory and after using the toilet.

NO MEDICATIONS (eg. tablets, sprays, eye drops, ointments, etc.) are to be taken into ANY Environmentally Graded area.  In extreme cases there might be a need, this will be evaluated on a case by case bases after first informing your Production Manager who will consult with HR and the Quality Manager.  If there is a need to use an eye drop preparation or take a medication you must not do this in your factory uniform.

NO personnel, including visitors are to wear or carry Lanyards that can be used for the holding of company identification cards in the Factory.

2. Restrictions

Restrictions apply to ALL environmentally graded areas of the factory. Anyone entering the factory must understand and comply with all the below restrictions before access is granted.

All employees must change in the factory change rooms.  Visitors and contractors MUST also enter the factory via the visitor change rooms provided.

Uniforms are to be changed everyday and a fresh, clean laundered one is to be used.

Arms and legs and feet must be covered at all times.

All closures on uniforms must be fastened to ensure that the product is protected from contamination.

Garments can be reused several times throughout one day, by being hung neatly on the clean side of the D Grade change room when changing to go on a break. And being placed in the soil bins provided at the end of your shift.

Clothing provided (including safety shoes) must only be worn in the factory.  Clothing must be changed before leaving the factory into an Environmental Grade E office, canteen, dirty workshop, etc.

Factory clothing (including safety shoes) is NOT to be worn when walking between Sydco sites.  Staff must change into their own street clothes and shoes.

Supplied garments and shoes must never be taken or worn home.

Safety shoes and appropriate garments are provided to all permanent employees and must be stored in “Clean Side” lockers. Which means these cloths and shoes can not be used at any time beyond the factory graded area

Shoe covers are to be worn over designated factory safety shoes when going to the toilet or using the hand basins.  Visitors, casual staff or staff waiting for designated factory shoes to be issued must also wear shoe covers over personal shoes – must be safety shoes if working on a process line.

NO JEWELLERY ALLOWED.  One sleeper earring in each ear of less than 2cm in diameter worn under a hair net is permissible also rings worn in pierced body parts fully covered by factory clothing.  Gold chains, bracelets, wedding bands, watches, leather or cloth bands etc. are NOT permitted.  All jewellery is to be placed in personal lockers.

NO MAKEUP ALLOWED.  Moisturisers, lip balm and other cosmetics that, when wiped off with a tissue, do not leave a residue on the tissue are permitted

Hairnets: MUST COVER ALL HAIR and the ears, and must be worn at all times in all environmental areas of the factory.  It may be necessary to wear two hairnets in order to cover all the hair.

Beard Covers MUST BE WORN at all times (if applicable) when entering all Environmentally Graded Areas of the factory.

Underwear including singlet tops, collarless style T-shirts, which are worn as undergarments only, i.e. Not worn as an outside garment to work, are permitted to be worn in all Environmental Grade D and C areas.

Fingernails are not to be above the top of fingers, (“netball rule”), and no nail polish or false fingernails to be worn.  Nail polish remover is supplied near all female change room if necessary.

Exception: Nail hardener is permitted if required to protect flaking nails.  If this is the case, this must be reported to your area Manager to inform the Quality Manager.

Disposable aprons and sleeve covers must be worn when handling printing inks, when there is any risk of staining or damaging factory clothing, these are stored in the Solvent room.

3. Environmental areas

3.1.             Environmental D grade area

3.1.1.       Environmental Grade D areas include

Product Packing lines

Inspection areas

Clean side of change rooms

Corridors throughout factory

WIP area.

3.1.2.       Environmental Grade D “Quick Change” uniform consists of:

All above restrictions

Undergarments, if entering to gain access to B-Grade area:

Navy Blue pants.

White collared, full length sleeved throwover.

Designated factory safety shoes

For Visitors, Navy Blue “Visitors’’ overalls placed on over street clothes:

3.1.3.       For Visitors and occasional entry staff:

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.

If visitors are to be working on the line, (inside a commissioned Production Bay) or with machinery that is in direct contact with the making of a saleable product, they must have removed their street clothes and have on safety shoes.

3.2.             Environmental Grade C and (Restricted access)

3.2.1.       Environmental Grade C areas include:

Sterile Air Lock

Component or Equipment Preparation rooms

Sampling and Dispensing booths

3.2.2.       In addition to all above, Environmental Grade C clothing includes:

All above restrictions and Grade D uniform

Blue smocks/coveralls

Shoe covers over Factory safety shoes, or designated Grade C shoes.

No street clothes, which includes T-shirts, unless this is a clean one, worn as a singlet.

3.2.3.       For Visitors and occasional entry staff:

If entry to a Grade C area is required, you must remove your street clothes, store in allocated locker before fitting coveralls and entering the factory.

When entering a Grade C area, an additional set of shoe covers must be worn.

3.2.4.       Staff whose normal work area is an Environmental Grade C area can be issued with 5 White Lab. coats and/or a second pair of shoes, which are to be designated for Grade C.  These employees must put on their White Lab. coat, and change to their designated Grade D shoes, (or wear shoe covers over their Grade C shoes) when outside their area.  White Lab. coats must be changed at least twice per week.

3.2.5.       Solution Preparation staffs are NOT required to wear White Lab. coats over the Grade D clothing.

3.2.6.       Double lockers or racks are provided in Environmental Grade C Airlocks to store Blue smocks or coveralls and shoe covers, and to place White Lab coats.  Staff with two pairs of factory shoes (one for Grade D, and one for Grade C) will store their second pair here.

3.3.             Environmental Grade B (Authorised and Validated Staff only)

3.3.1.       Grade B areas include Sterile Preparation Areas.

3.3.2.       Environmental Grade B uniforms consists of:

Approved undergarments

Sterile hood

Sterile surgical mask

Sterile coverall

Grade B designated safety shoes

Sterile overshoes

Sterile gloves

Safety glasses

3.4.             Environmental Grade A (Completely Restricted)

3.4.1.       Automated Sterile filling Areas.

3.5.             Stores Areas

Company‑supplied clothes and safety shoes must be worn.

3.6.             Laboratories

Site will supply uniforms and Lab. coats for both Grade E area work and normal factory clothing of which all restrictions apply.

3.6.1.       Eye protection, (i.e. glasses) must be worn in designated areas or for certain designated tasks while in Analytical Laboratories.

3.6.2.       For Visitors: A supply of spare safety glasses is available in a basket at the doors to the Analytical Laboratories.

3.7.             Engineering staff

Sydco will supply clothes for both Grade E area work and normal factory clothing of which all restrictions apply.

3.7.1.       Eye protection, (i.e. glasses) must be worn in designated areas while in any of the “Dirty” Workshops.

3.7.2.       For Visitors:  A supply of spare safety glasses is available in a basket at the doors to the “Dirty” Workshops.

4. Changing procedures

4.1.             To enter an Environmental Grade D area (Factory Clothing)

4.1.1.       Enter locker bay allocated.  This is the “Dirty Side” of the change room (Grade E).

4.1.2.       Remove all outer personal clothing, jewellery and shoes, leaving on your underwear and socks, and place all belongings in full-length personal locker allocated.  Lock the locker and take the key.  If only entering the Grade D.

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.

4.2.             To enter an Environmental Grade C area (Restricted access)

4.2.1.       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.       Place on area-specific shoe covers provided.

4.2.4.       Put on gloves if required.  (See signs in change area.)

4.2.5.       Enter the Grade C area.

4.3.             Environmental Grade B (Authorised and Validated Staff only)

4.3.1.       “Sterile Entry Training” and validation of full surgical scrubbing procedure is required.

Summary table

Graded Area	Activity Type	Clothing Requirement
A/B Sterile preparation and Filling	CRITICAL. Sterile filling, exposed product or containers.	Sterile garments No makeup or jewellery.
C – Preparation of components for sterile	Less CRITICAL Exposed components, non-sterile filling, Solution & Filter Preparation., Equipment Prep.	Factory clothing + Blue coats &/or Blue coveralls & shoe covers No makeup or jewellery.
D – Packaging	CONTROLLED Packaging – no exposed product and components Tablet Packaging	Factory clothing and shoes, hair nets, beard covers No makeup or jewellery, sleepers only.
E – Controlled Access	Controlled access Office, Warehouse and Laboratories	Warehouse uniform, laboratory uniforms and Lab. coats

5. Procedures After Evacuation

5.1.             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 undergarment soiled clothing bin.  These items must not be taken back through the factory to be placed in the usual sterile change room soil bin.  A fresh set of undergarments must be worn with a fresh Grade D uniform when re-entering the factory.  Sterile safety shoes must be covered with shoe covers and worn to the sterile change room to collect your D-Grade shoes.  You must then spray your sterile shoes with IPA before using them in Sterile again.  The Grade D uniform left in the sterile change room must be sent for laundering.  These can be put into the sterile change room soiled bin.

6. Ownership of Clothing

All clothing remains the property of the site and must be returned on termination.
Clothing must not leave Sydco premises without permission of the Facilities Services Manager.

7. Summary of Changes

Version #	Revision History
MAN-005	New