MAN-015 Factory Cleaning Procedure

1. The General Rules and GMP Requirements

The rules and GMP requirements apply equally to Contract Cleaners and Operations staff.

All cleaners should undergo Induction conducted Sydco and be supervised while working in the Plant.

Clean uniforms, factory shoes and hats must be worn as applicable in the particular areas. (All cleaners working in the Production areas must be familiar with the requirements of SOP MAN-005)

Solutions, buckets, mops, etc., used for cleaning must be changed/renewed daily or whenever they become badly soiled, so as not to spread the soil.  This is to be done by the Cleaners during the cleaning process.

No food or drink can be taken into the factory.

Rubbish should be collected in either bins or bags and disposed of cleanly in the correct bins.  (Any filled product MUST go into the “FILLED PRODUCT” security disposal bin.  Other security waste to be placed into the “NON‑FILLED” security disposal bin.

Any tablets picked up from the floor are to be collected and placed in a container on the area Manager’s desk for reconciliation.  If a tablet that is currently being packed is picked up from the floor, place the tablet in the rejects floor bin and contact the area Manager.

Nothing should be picked up from the floor and returned to packing lines.

No container that comes in contact with product should be placed directly on the floor.

If Production is continuing in an area to be cleaned, advise the authorised person and work effectively in small areas, avoid creating large, wet, slippery areas.

Special cleaning should be arranged with the Production Managers preferably when sections of the plant are closed down.

All problems should be reported to the Cleaning Supervisor who will liaise with Cleaning Coordinator or Quality Assurance Manager.

All cleaning equipment and bulk solutions must be stored neatly in specific cleaners’ rooms.

The Cleaners’ rooms are to be kept in a neat, tidy, clean state.

2. Areas of the Plant and Hygiene Classes

2.1.             Critical areas – Environmental Grade A

Is the area at and around the point of manufacturing or production where contamination can gain direct access to the product or process. This is protected by localised laminar flow units and plastic curtains.  These areas are the most critical and should therefore be kept the cleanest.

Filling equipment is located in these areas and cleaned only by the Sterile operators.

2.2.             RED areas ‑ Environmental Grade B

The next most stringent requirements apply in ENVIRONMENTAL GRADE B areas ‑ Sterile Manufacture.

These rooms must be wet mopped and not polished, avoiding aeration of dust/particles, etc.  This work should preferably be carried out after Production has stopped, but should Production be in progress, approval MUST be obtained before commencing.

Cleaners must ‘scrub‑up’ and dress in Sterile uniforms.  Only adequately trained Cleaners are to enter ENVIRONMENTAL GRADE B areas, i.e. successful completion of Sterile Training

2.3.             YELLOW areas ‑ Environmental Grade C

Areas of product manufacture and or component preparation.

Liquid manufacture and Equipment preparation.

Component and Equipment Preparation. room.

NOTE:
Limited access to correctly dressed staff – (see SOP MAN-005) for these areas. Cleaning equipment is dedicated to these areas.  Only adequately trained cleaners are to enter Environmental Grade C areas.

2.4.             BLUE areas ‑ Environmental Grade D

Areas in which sealed product is handled.  Uniforms and hats are to be worn at all times ‑ (see SOP MAN-005) for these areas

2.5.             GREEN areas ‑  ENVIRONMENTAL GRADE E

There are many other areas not included in the Production Environmental Grades, which must be kept clean for sanitation and staff comfort.  Uniforms are not essential in these areas:

*   Warehouse/Stores

*   Plant Service areas  Environmental Grades E

*   Laboratories 

*   Change rooms and toilets

*   Canteen

*   Offices

*   Corridors

3. Degree of Cleaning

3.1.             Regular daily and weekly cleaning

All Sterile manufacturing and filling areas, Production and Packaging areas; Change rooms, Canteen, Offices, Laboratory, Corridors as outlined on Daily Cleaning Logs.  This cleaning covers mainly floors, walls, windows, sinks and rubbish removal.

3.2.             Accident/Spillage

Should a serious spillage or contamination occur, any Production staff may request urgent assistance in containing or removing this contamination.

3.3.             Special ‑ Building and/or Equipment maintenance

There are some sections of the Plant, which are cleaned on a periodic basis; on request; or after rebuilding or major maintenance, e.g. Duct-work; pipes/drains, lights; windows.

This work will be requested by the Cleaning Coordinator or  delegate  when a need is perceived and a practical time agreed.

Note     During special building or equipment installation activities, the Building Contractor or Project Manager will be responsible for protecting the plant, (floors, etc.) from the building debris.  They will also ensure it is moved off-site.

4 Cleaning Aids

4.1.             Buckets

There are three types of bucket systems used within Sydco.  These are the single, double bucket system and the triple bucket system.

4.1.1.       Single Buckets

These are roller wringer buckets. The buckets are colour coded to each environmental grade of the factory and are dedicated to these areas.  Green buckets for E areas, Blue for D and Yellow for C.

4.1.2.       Double and Triple bucket systems

This is a trolley holding two large buckets.  Over one bucket is suspended a mop squeezer, and this is considered the “dirty” bucket.  The other bucket, (“clean” bucket) accommodates the clean floor cleaning/disinfecting solution.  The buckets should be cleaned on a daily basis and the mop head and solution changed on a daily basis.  The mop should remain in the clean bucket when not in use.

These buckets are the only type that should be used within the sterile area and should be dedicated to that particular area of the cleanroom.

4.2.             Mops

Cotton mops with a plastic or anodised aluminium handle are used in the E, D and C areas and are also colour coded same as the mop buckets for their respective areas.

Cotton or natural fibre string mops should not be used within a sterile cleanroom.  An open cell hydrophilic mop head with a plastic or anodised aluminium handle should be used.  These should be dedicated solely to Sterile use on the floors, using a two-bucket system (one for wringing and one for rinsing).  The mops should be inspected daily by cleaning staff for any signs of shedding.  These should be processed daily, to obtain a guaranteed cleanliness level and sterilised before each use.

The mops are supplied by in a sterile state.  They are made of fabric and are very low in particulate and residue contamination.  They are used once and after use, the mop is put into a plastic bag and placed in the dirty Sterile garment basket on the ‘dirty’ side of the change room. They are then cleaned and returned to site, again in a sterile state, to the Sterile Garment Storage Room, located in the Work-In-Progress area of the Warehouse.

4.3.             Squeegees, Dustpans

Their use is necessary especially for broken glass, but not ideal as dust may be generated.

4.4.             Vacuum Cleaners

These are preferred for picking up dust from the floor or from containers.  Dry vacuums must be equipped with HEPA filtration and approved by the Cleaning Coordinator.

Wet vacuum cleaners (to cope with major spills) are available in the site in case of large liquid spills.

4.5.             Buffers, Waxers and Floor Polishers

Floors in Production BLUE areas, and Laboratory and Canteen areas to be sealed and then coated with Equinox Top Coat (see section 6.3 below), then polished by machine.  Spray bottles (Duraseal Auto Burnish) and nylon hand pads or stainless steel pads may be needed for ‘spots’.  Do not use IPA as this damages the finish.  These should not be used inside the Sterile Cleanrooms, as they generate particles, and are generally not HEPA or sterile filtered.

4.6.             Wipers

These are SINGLE‑USE cloths for wiping operations and are to be discarded after use.

Disposable wipes only are used throughout the Sterile rooms. Do not use the pre-sterilised wipes. All disposable wipes must be pre-processed e.g. autoclaved, to obtain a guaranteed cleanliness level and sterilised before use.

4.7.             Sterile Wipes

Sterile wipes are used in the Sterile areas only.

4.8.             Dust Control Mops

NOT to be used in YELLOW or RED areas.

They should be pushed in one direction only on dry floors.  They should not be lifted from the floor during the mopping operation.  When complete, they should be taken outside Hygiene areas and put into a plastic bag, and sent for washing by cleaner.  Clean mops are used daily in each area (Canteen; Laboratory; Warehouse; Production/Packaging).  Mops are colour-coded and must NOT be interchanged between areas to avoid cross-contamination.

5. Supply and Store Room

The Cleaner is responsible for the cleaning solutions, and pads for the polisher.  They are also responsible for issuing and maintaining supplies of consumables, i.e. single-use paper towels; liquid hand washing solution, etc., for use in Change rooms and toilets.

These cleaning aids are stored neatly in the Cleaner’s store.

Materials are supplied from these areas for cleaning each day.

All buckets are to be cleaned on a daily basis and placed in the correct areas for use next day.

The room and cleaning materials are to be maintained in a neat and tidy manner.

6. Cleaning Methods

6.1.             Production Areas, Office areas, Change rooms, Workshops, Laboratories, Stores, Canteens, plus the toilet facilities and the Cleaners’ Store, (see Table below).

Surface	Equipment & method	Solution (Brand)	Dilution, see note *
FLOORS Vinyl	Dust mop/wet mop/vacuum polish	“Neutral” detergent	80mL/10L
Concrete	Dust mop; spillages	“Neutral” detergent	80mL/10L
Tile (Quarry)	Wet mop	“Neutral” detergent	80mL/10L
Carpet	Vacuum.  Spots	“Scotchgard” (brand)cleaner	N/A
WALLS Vinyl	Scouring pad & squeegee/ disposable wipes	Target or Biogard (brand)	250mL/10L 225mL/15L
Painted	Disposable wipes & spot cleaning	Eclipse “Neutral” CL7	80mL/10L
Windows +        Sills	Disposable wipes wipe/disinfect Spot cleaning & cold water	70% IPA (Iso-propyl alcohol) “Neutral” detergent	No dilution 80mL/10L
Doors	Disposable wipes & spot cleaning	“Neutral” detergent	80mL/10L
OFFICES Desks	Disposable wipes & spot cleaning then wipe/disinfect	Spot cleaner, then 70%IPA	N/A no dilution
Office Chairs	Vacuum/wipe/dust	‑	–
Prodn Chairs	Wipe/disinfect	70% IPA	no dilution
Phones	Disposable wipes wipe/disinfect	70% IPA	no dilution
TOILETS/ CHANGEROOMSFloor	Sweep, then mop	Tutti – Frutti “Neutral” detergent	200mL/10L
Basins	Disposable wipes, scrub/clean/disinfect	Gumption, Ajax Spray ‘N’ Wipe 0brand) Sodium Hypochlorite	N/A N/A 2L/10L
Toilets       ) bowl/seat   ) Urinals       )	Disposable wipes, scrub/clean/disinfect. Stain removal	Creme cleanser Sodium Hypochlorite Ajax Bathroom Gel	N/A 2L/10L
Mirrors	Disposable wipes wipe clean & disinfect	70% IPA	no dilution
Lockers	Disposable wipes/dust control & spot cleaning	Eclipse “Neutral” CL7	80mL/10L
Showers	Disposable wipes/scrub/spot cleaning/disinfect	Sodium Hypochlorite	2L/10L
STAINLESS STEEL SURFACES	Disposable wipes wipe/disinfect/polish	70% IPA Shine-on cleaner	no dilution N/A
MOP HANDLES	Disposable wipes wipe/disinfect	“Neutral” detergent 70% IPA	80mL/10L no dilution
BUCKETS	Scouring pad scrub/disinfect	Target / Biogard/ 70% IPA	250mL/10L 225mL/15L no dilution
OPEN DRAIN Prod’n area	Disinfect, 50mL poured down drain	Sodium Hypochlorite	2L/10L

Note: “Neutral” detergent, “Sodium Hypochlorite” and “Tutti – Frutti” (flavour) is diluted using tap water.  “Neutral” detergent can be diluted 40mL/10L for very light conditions; 80mL/10L for light conditions.

Target is the preferred disinfectant, though Biogard may be used due to unavailability of Target. (See website for the brands)“Target” (brand) and “Biogard” (brand) are diluted using Distilled Water only (subject to availability).

Periodically, floors will be stripped, resealed, and polished.

70% IPA has an expiry date of one month and is displayed on the label on the bottle. It must not be used after the expiry date.

“CL7” (brand) may be used to degrease floors after hydraulic oil spills.  Usual sanitising methods must be used following the use of this chemical.

“Orange Solv” (brand) may be used to remove ink stains and tape marks from hard surfaces.

Cloudy Ammonia may be used to clean glass windows.

Turps may be used to clean glue from vinyl surfaces.

6.2.             Mop Cleaning Procedures – see SOP MAN-085

6.3.             Floor Sealing Procedures

6.3.1.       Duraseal Base Coat

After stripping floor, apply two thin coats.  First coat vertically and second coat horizontally.  Allow thirty minutes drying time between coats.

NOTE: You must then leave thirty (30) minutes after last base coat before applying the top coat. Do not buff polish between coats.

Equipment

1 x poly cotton mop with White handle

1 White wring bucket.

6.3.2.       Duraseal Auto Burnish

Spray floor one metre in front of buffing machine at intervals of 3 metres.  Using a fine mist, spray then buff directly over area you have just sprayed Auto Burnish.  Return to area you have just passed over and dry buff.

Equipment

1 Straight line buff
1 Trigger spray bottle with Auto Burnish

Chemical

Duraseal Auto Burnish
Dilution 20/1 48mL x 1L spray bottle.

6.3.3.       Equinox Top Coat & Duraseal Top Coat

After applying base coat, apply thin coats of Top Coat allowing ten minutes drying time between coats.  You must apply coats in a dragging motion.  Avoid lifting the mop.  Apply coats to floor until it becomes glazed.  Do not buff between coats and do not buff floor for twelve hours after applying last coat.

Equipment

1 poly cotton mop with White handle

1 White wring bucket.

7. Cleaning Procedures for Sterile Rooms

7.1.             Daily Schedule

General Areas
General areas are areas that surround the point of manufacture or production.  These are not termed as critical areas because they do not come in direct contact with the finished product.  Critical areas (EGA), are as mentioned earlier, cleaned by the Sterile Operators.

Floors
The floors in the Sterile areas need to be cleaned daily. The floor should be initially cleaned using an in-house vacuum system (where available) to remove glass, granulate or regrind.  Once the debris has been removed from the floor, a sterile solution of “Target” (brand) should be applied using a sterile mop, this should be applied liberally to the surface. (See Website for chemical brand names).

Trolleys
These should be designated to the sterile area only, these should be wiped down using disposable wipes.  Using 70% IPA, start from the top and work down.

Rubbish
Remove all rubbish at the end of each cleaning session, this will help prevent any cross-contamination.

7.2.             Weekly Schedule

General Areas

Walls
Using a WallWiprÔ (brand) wipe down the walls, working from the ceiling line down to the floor with Target 2.5% mixed with a sterile pre-filtered water solution.  Squeegee off any residue.

Ladders
Ladders need to be wiped with 70% IPA sprayed onto a disposable wiper, then wipe over the surface.

Return air vents
Wipe with 70% IPA

Cleaning as required

Ceilings
Ceilings should be wet wiped with a WallWiprÔ (brand) and Target (brand) 2.5% as per the walls procedure.  Squeegee off any residue.

7.3.             Cleaning Procedures for Sterile Airlocks.

7.3.1.       Daily Schedule

Due to the high activity of personnel travelling through this room, it requires cleaning at least as often as the manufacturing Cleanrooms.

Drains

Pour 50mL of undiluted “Target” into the drain of each sink and leave to soak.

Floors
Use the same procedure as Cleanroom floors

Rubbish
Same as General Areas

Disposable Sticky Mats
Disposable mats should be peeled off once contaminated or at least on a daily basis to prevent the migration of contamination into the Sterile room.

Weekly Schedule

Walls
Wipe down walls with a WallwiprÔ (brand) working from the ceiling line down to the floor, using Target mixed with a sterile pre-filtered water solution.  Using a squeegee, remove the excess solution.

Trolleys
Use the same process as Sterile Cleanrooms.

7.3.2.       Cleaning as required

Ceilings
These should then be wet wiped with a WallWiprÔ and 2.5% Target starting from the most critical part of the ceiling, (i.e. closest to Laminar/flow) and working to the less critical, (i.e. furthest from Laminar/flow).

SURFACE	EQUIPMENT and METHOD	SOLUTION	DILUTION
Floors	Wet mop	Target or Biogard (brands)	Target 250mL/10L Biogard 150mL/10L
Walls	Wet WallWiprÔ	Target (brand)	250mL/10L
Windows	Wipe with disposable wipes cloth. Squeegee	70% IPA Target	no dilution 250mL/10L
Doors, door jambs, window frames & stainless steel	Wipe with disposable wipes	70%IPA	no dilution
Trolleys	Wipe with disposable wipes	70%IPA	no dilution
Sinks and Drains	Sinks – wipe with disposable wipes. Drains – 50mL poured down drain	70%IPA Target	no dilution no dilution

Note: IPA has an expiry date of one month and is displayed on the label on the bottle.  It must not be used after the expiry date.

Target and Biogard (brands) are diluted using Distilled Water only.
Target is the preferred disinfectant, though Biogard may be used due to unavailability of Target.

7.4.             Rubbish Removal

At Sydco, several different classes of rubbish exist that must be disposed of separately by different means.

7.4.1.       Filled Product Security Waste

This type of waste is placed in specially labelled bins “Filled Product Security Waste“.  It is then placed in a yellow disposal bin held in the rubbish holding area for disposal by shredding.

CLEANERS are responsible for emptying these labelled bins from the Laboratory areas on a DAILY basis.

7.4.2.       Non‑Filled Product Security Waste

This type of waste includes empty product containers and product labels.  It is to be placed in the bins labelled “Security Waste“.  These bins are taken to the WIP area in the Warehouse for shredding.

CLEANERS are responsible for emptying these labelled bins from the Laboratory areas on a DAILY basis.

7.4.3.       General Waste

This type of waste collection includes most rubbish from Offices, floors, Cafeteria, etc.  It is to be bundled into plastic bags and placed in a disposal bin in the rubbish holding area.

Removal of this rubbish from the Laboratory, Offices and Canteen into the disposal bins is the responsibility of the CLEANERS.

Canteen rubbish is the responsibility of the Caterers and must not be taken through the Production area for disposal.

7.4.4.       Glass containers and broken glass

The items are to be kept SEPARATE from soft paper, etc. to avoid accidents, then placed into boxes and/or plastic bins before transferring to the general waste disposal bin.

CLEANERS are responsible for emptying these labelled bins from the Laboratory areas.

8. Tacky Mats

Tacky mats are to be changed by the Cleaners on a DAILY basis after cleaning has been completed.  If required in high use areas, the mat can be changed by Production or Laboratory staff in addition to the daily change.

9. Security of Building

Much of the cleaning is done outside normal hours.  While this allows free access to areas, it is important that buildings and offices are not left open when unattended.

External doors should be locked outside normal hours and NEVER chocked open.

All doors should be left in the same locked/unlocked state at the conclusion of cleaning as they were when the cleaner entered them.

10. Weekly Recording and Environmental Auditing

A Daily Cleaning Log, which is controlled by the Cleaning service, should be completed every day for all areas.  The details of the areas to be covered are outlined in the Daily Cleaning Logs.  The Log is checked and signed weekly by the Cleaning Site Manager and filed.  The Cleaning Services Coordinator signs off the Site Manager’s log and vice versa.

A monthly inspection of all contracted areas is conducted by the Cleaning Services Coordinator and recorded in the log at the beginning of each month.  The Site Manager also conducts a Quarterly Audit.  The records from this are kept by the Contract Cleaners and a copy is given to the Cleaning Services Coordinator or delegate.

Staff from the Laboratory check the environment and cleanliness throughout the Plant on a regular basis and report deficiencies to the Cleaning Services Coordinator or delegate, Quality Assurance Manager, or other relevant parties.

Note: Coloured area designation in “Daily Cleaning Log” refers to dress requirements while cleaning those areas.

 11. Summary of Changes

Version #	Revision History
MAN-015	New.