MICLAB-005 Entry Procedure for Sterile Filling Areas

A.      Procedure For Entry To Sterile Filling Areas

1. Prerequisites:

1.1.         General 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 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 office area, canteen, dirty workshop, etc.

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

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

A personal “Dirty Side” locker should be provided is where all personal items MUST be stored (including shoes).  No supplied factory uniforms are to be stored in this locker.

The “Clean Side” locker should be provided for supplied uniforms and shoes only. NO personal items – of any kind – are to be stored there.

Safety shoes are provided to all employees and must be stored in “Clean Side” locker.

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 jewelry is to be placed in personal lockers.

NO MAKEUP ALLOWED. Moisturizers, lip balm and other cosmetics that, when wiped off with a tissue, do not leave a residue on the tissue are permitted.  Make-up removing wipes are to be supplied.

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.

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 should be supplied.

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.

1.2.         Clothing Restrictions for Sterile Areas

Sterile Filling (high grade) Environmental (Authorized and Validated Staff only). Entry into this area should be managed by the Microlab team. Higher Environmental Grade uniforms consists of: Company approved and provided undergarments Sterile hood Sterile surgical mask Sterile coverall Sterile designated safety shoes Sterile overshoes Sterile gloves Safety glasses.

Sterile Preparation (medium grade) Environmental (Authorized and Validated Staff only). Entry into this area should be managed by the Microlab team. This environmental grade area include: Sterile Area Scrub Prep. Rooms Sterile Air Lock Component or Equipment Prep. rooms Dispensing booths Sterile Solution Preparation rooms. Medium Environmental Grade uniforms consists of: Blue smocks/coveralls Shoe covers over Factory safety shoes, or designated shoes. No street clothes, which includes T-shirts, unless this is a clean one, worn as a singlet.

1.3.         Surplus dirt and grease etc. to be removed from hands before entering the Sterile scrub room.

1.4.         Covered by a current validation Form 655.

2. Upon entry into the Sterile scrub change room

2.1.         All outer clothing is to be removed including shoes and socks down to approved undergarments, which must be worn; all this is to be placed onto racks on the “dirty” side of the dividing seat.  Remove any band-aids from small, uninfected cuts and discard into rubbish bin.

2.2.         If necessary, use a new clean hairnet that must be put on before crossing the barrier.  The hairnet is to be worn under the hood and ensure all hair and ears are covered.

2.3.         Reach for a pair of sterilized socks and put these on at the dividing seat before placing feet on the floor on the “clean” side of the barrier.

2.4.         Slip on dedicated Sterile safety shoes.  Do not touch the shoes with your hands.

WASH hands – HIBICLENS (brand) OR MICROSHIELD (brand) can be used.

NOTE: 60 seconds Contact time is of vital importance to reduce bioburden during scrub-up procedure.

2.5.         Proceed to the sink with wrapped nailbrush and wet hands and forearms and lather thoroughly with Hibiclens or Microshield-T, paying particular attention to the area between the fingers.  Leave lather on while unwrapping the nailbrush, adding Hibiclens or Microshield to brush and cleansing nails – contact time of lather must be a minimum of 60 seconds.  Discard nailbrush into rubbish bin after use.  Then rinse well allowing the water to flow from the fingers towards the elbow.

NOTE: The taps must be turned ON and OFF by using the ELBOWS or sensing device as appropriate.  The Hibiclens and Microshield dispensers must be activated using the forearm and not the hand.

3. Dry

Dab dry hands and arms with a sterile wipe, working from the elbows towards the fingers.  When drying hands, use a clean sterile wipe.  Discard the wipe in the rubbish bin.

4. Hood on

Undo a packet containing a sterilized hood and put on the hood and then the facemask in that order.  Make sure that the ties are securely tied.

5.            Repeat wash for hands and arms – leaving Hibiclens or Microshield solution again in contact with the skin for a minimum contact time of 60 seconds.

6.            Dry: Rinse off and dab dry hands with a sterile wipe.

7.            Dress – jumpsuit and overshoes

Peel open a packet containing a sterilized jump suit (sizes are labelled on packet) and climb in ensuring that the sleeves and body do not touch the floor.  Tuck flaps of hood into top of suit without touching the external surface. Sterile uniform needs to be changed every three hours.

8.            If you have any uninfected small cuts on hands, put on fresh band aids.

9.            Peel open a packet containing a pair of sterilized overshoes.  Ensuring different categories of trapped overshoes are being used in Plastic Sterile areas and in Glass Sterile Area due to difference in surface slipperiness.

10.         Carefully put on overshoes touching only the inside of the material and pull up loosely to the knees.  Clip the strap of the overshoe across the foot touching as little of the strap and clip as possible.

11.         Gloves and complete knee strap clips from OVERSHOES.  Pull on sterilized gloves.

11.1.      Take left or right glove and holding the folded‑over inner section, insert fingers of left or right hand.

11.2.      Pull glove up onto middle of hand.

11.3.      Repeat with left or right glove.

11.4.      Fold‑over top section of glove.

11.5.      Clip the straps at the knee of the overshoes with gloved hands taking care not to touch the outside material of the overshoe.
NOTE: Sterile overshoes are used per shift only.

12.         Apply Hexifoam to the outer surface of the gloves

YOU ARE NOW READY TO ENTER THE STERILE AREA.

NOTE
Thin rubber gloves are worn throughout Sterile to minimize bacterial and particulate contamination.  Their use is not an answer to all microbial contamination problems, but an aid to quality production.  Regular use of IPA or Hexifoam is essential for the maintenance of cleanliness and sterility, etc.

Gloves are to be sprayed regularly with 70% IPA – approximately every 10 minutes, before entering any Laminar Air Flow area and before and after handling equipment.

12.1.      Gloves must be replaced:

a. On re-entering Sterile after a break.

b. If the glove is holed, soiled or having touched any dirty area, e.g. floor.

c. If additional comfort is required.

d. After conducting a ‘glove print’ for the Microbiology Laboratory.

Along with clothing after Breakdown Maintenance (see Section D.).

NOTE:
Gloves and mask must be replaced if the operator sneezes in the Sterile room.

13.         Safety Glasses

13.1.      Dedicated safety glasses are to be left in the Sterile scrub rooms and NOT worn outside the Sterile areas.

13.2.      For occasional entry, personal prescription glasses may be used, but these are to be swabbed down with sterile 70% IPA and wiped with a sterile, lint-free wipe before entry.

14.         Personnel Monitoring (see MICLAB 095)

14.1.      Operator’s Clothing – Personnel exiting the Sterile areas are to monitor their clothing using contact plates supplied by the Micro Lab.  These plates are to have person’s name, area to be sampled and date written on the base of the plate.  The areas to be sampled are the hood, sleeve and the chest part of the uniform as was demonstrated during Sterile training.

14.2.      Glove Prints – Sterile areas are to conduct glove prints onto sterile Agar plates as per the method demonstrated during the training sessions.

14.3.      All equipment to be used for personnel monitoring is sterile and the correct aseptic technique must be used to gain valid information.

B.      Procedure For Leaving Sterile Areas

Overshoes are to be changed on a daily basis and not on a per entry basis as are gowns and hoods.

If you are to re-enter the Sterile area again on that day the procedure for preparing the overshoes for exit and re-entry is as follows:

Carefully roll down the leg part of the overshoe exposing the inside while you are still wearing gloves.  Slip out the foot and shoe and place the overshoes on the shelf or bench provided.  The overshoes and the safety shoes may be removed together if this is preferred provided the foot can be slipped into both after the next gowning. This procedure cannot be carried out in Glass Sterile due to glass fragments being carried into the change room on the soles of overshoes.

Remove jumpsuit, hood, mask, gloves and socks and place into used clothing and rubbish bins respectively.

GENERAL

Should you suffer any minor cuts while working in the Sterile areas immediately leave the Sterile areas to receive First Aid.  If the cut is small and bleeding stops, you may re-enter the Sterile areas provided a clean band aid is applied to the cut on each entry and surgical rubber gloves are worn over the band aid.

You may continue working in the Sterile areas on this basis, provided the cut does not become infected.  If this occurs you must not enter the Sterile areas until you have been cleared to do so by your Area Manager.

C.      Procedure For Changing Clothing After Clothing Has Touched The Floor Both During Maintenance or Normal Operation of The Machines In All Sterile Areas

NOTE
If any part of the sterile jumpsuit touches the floor during manufacturing in a Sterile area it will pick up particles and microbiological contamination.

The following procedure must be followed after any part of the jumpsuit comes into contact with the floor during manufacturing:

If any part of the jumpsuit touches the floor and providing all necessary work has been completed then the jumpsuit and gloves must be changed in the sterile scrub room and the uniform placed in the dirty clothing bin.

The following procedure must be followed after any part of the jumpsuit comes in contact with the floor during maintenance.
If any part of the jumpsuit touches the floor and providing all necessary work has been completed, then the jumpsuit and gloves must be changed in the sterile scrub room immediately without entry to any other sterile filling areas and the uniform placed in the dirty clothing bin.

“THIS MUST BE DONE BEFORE THE DIRTY UNIFORM IS WORN NEAR ANY STERILE EQUIPMENT ‑ FURNITURE, Laminar Flow curtain, WALLS and MACHINERY.”

“Checklist For Procedure For Entry Into Sterile”.

This Checklist (Form 650) is to be used as a guide when assessing the Entry Procedure of employees who have had training in Sterile Entry Procedures.

The checklist will be used as one of the training tools for new employees plus it will also be used to monitor Operator performance and attention to detail, on a periodic basis, for every person who works in Sterile.

The “Participant” and the “Observer” will be selected by the Production Manager and the records will be assessed and acted upon by the Production Manager.

NOTE:

Entry to any Sterile areas is NOT PERMITTED to personnel who have NOT been successfully validated according to MICLAB 010.

Summary of Changes

Version #	Revision History
MICLAB 005	New