MAN-010 Cleaning Responsibilities and Methods for Employees

1. A high standard of cleanliness involves:

1.1.             Staff attending to their own personal hygiene.

1.2.             Staff correctly dressed in clean uniforms with access to well equipped rest rooms.

1.3.             Documented methods of cleaning of specific machines, areas and equipment.

1.4.             Prompt action to mop‑up spillage and prevent spread of contamination.

1.5.             Regular (at least daily) removal of rubbish and materials for recycling.

1.6.             Daily, effective back‑up, and cleaning by Contract Cleaners. (See SOP EHS-020)

1.7.             Supply of fresh and satisfactory cleaning aids, mops, solutions, wipes, etc.

2. Degrees of cleaning

2.1.             Partial Cleaning ‑ applies when the batch is to be followed immediately by a second batch of the same product.  This entails removing any product, dust, spills, broken glass, coded materials, unused components, baskets and trays from all working surfaces and above, of the machine and/or line, floor and surroundings.

2.2.             Overnight Cleaning (Daily) ‑ applies when a batch is part‑filled or packed and work is to continue next morning.  Remove any spilt product, wipe the working surfaces, wet mop surrounding floor area and cover the product and components to prevent contamination and/or interference.

2.3.             Sanitising ‑ applies when equipment is to be cleansed of all traces of product.  This involves washing with a suitable solvent, rinsing and drying.  To prevent contamination, parts must be stored carefully i.e. inverted on racks, in bags, in cupboards, etc.

2.4.             Sterilising ‑ applies to equipment which is rendered free of living organisms by firstly sanitising, followed by treatment in an Autoclave, Dry Heat Tunnel, or Ethylene Oxide Steriliser.

3. Cleaning Aids

3.1.             The “two‑bucket mop system”

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 solution. The mop head and solution is changed on a daily basis, and the mop should remain in the clean bucket when not in use.

Several of these bucket mop trolleys are available throughout the factory and they should remain dedicated to the particular areas.

3.2.             Dustpans

Their use is necessary especially for spilt glass, but not ideal as dust may be generated.  Squeegees are used in place of brooms.

3.3.             Vacuum Cleaners with HEPA filters

These are preferred for picking up dust from the floor or from containers. Compressed air hoses are to be used only in specific areas where access to cleaning is difficult as it may spread contamination e.g. inside blister packers.  Safety glasses must be worn when using compressed air.

3.4.             ‘One Touch’ disposables Wipes

These are SINGLE‑USE cloths for wiping operations and are to be discarded after use.
Sterilised Wipes are used in Sterile areas.

3.5.             Lint‑free Absorbent Wipers

These are available in Sterile for wiping around vessels and filling equipment and avoiding contamination with fibres.

3.6.             Other devices

Nylon scouring pads ‑ NOT steel wool

Bottle brushes

Plastic scrubbing brushes

“Tacky” mats

“Purity” wipes (lint free disposable)

4. Solutions to be used for cleaning

4.1.             General-purpose detergent/bactericide used in mop buckets and for general disinfection.

4.2.             70% IPA – Filtered Isopropyl alcohol (IPA).  Used for cleaning/sanitising of working surfaces of machines and for spraying items in airlocks, in transit to sterile areas.
This solution is also sprayed onto gloved hands to sanitise them after touching walls, equipment, etc., inside sterile areas.

4.3.             Distilled Water – Freshly collected. For rinsing glassware and tubing; also removing spilt, dried product from machines.

4.4.             Antiseptic hand cleaning solutions.

4.5.             Other – Ink Solvent  or thinner for ink removal.

NOTE:   Normal Detergents are NOT used in the Factory as traces are difficult to remove from equipment.  ONLY NEUTRAL DETERGENTS MAY BE USED.

5. Rubbish Removal

Rubbish is segregated and disposed of in different ways.  It is to be removed from the factory area on at least a daily basis.

5.1.             Filled Product Security rubbish ‑ this type of waste is placed in specially labelled YELLOW bins “Filled Product Security Waste”.  These bins are placed at the WIP airlocks for Warehouse staff to remove.

5.2.             Non‑Filled Product Security Waste ‑ this type of waste includes empty product containers and product labels.  It is to be placed in the GREY/GREEN bins labelled “Non-Filled Security Waste”.  These bins are placed at the WIP airlocks for Warehouse staff to remove.

5.3.             Plastic waste – Plastic wastes are to be put in the ORANGE bins. These bins are placed at the WIP airlocks for Warehouse staff to remove.

5.4.             General Waste ‑ such as paper and cartons that cannot be recycled is placed in BLUE bins. These bins are placed at the WIP airlocks for Warehouse staff to remove.

5.5.             Solvent soaked waste – such as One Touch disposables or anything soaked in solvent or IPA are to be placed in the RED bins. These bins are placed at the WIP airlocks for Warehouse staff to remove.

5.6.             Glass Containers and broken glass ‑ are to be kept SEPARATE from soft paper, etc., to avoid accidents, and then placed into boxes and/or plastic bins before transferring to the General Waste disposal bin.

5.7.             Contaminated Waste – is waste from the Analytical lab that can consist of used, filled and open product. All Biological waste can be put in these bins. These are yellow bins with red lids and are provided by the Hazardous Waste Contractor.

6. Change Rooms, Rest Rooms, Toilets

Change rooms, rest rooms and toilets are situated adjacent to the production areas.

These are maintained by the Contract cleaners, and equipped with liquid soap and hand towels.

Change rooms are to be kept neat and tidy with:

All rubbish, used hats and shoe covers, deposited in the bins provided.

Coat-hangers placed on dedicated frames.

Any food to be stored in Personal Side locker only or in Canteen.

Shoes are to be stowed in shoe locker or neatly on racks provided.

Hand washing is required before and after meal breaks and after visiting the toilet.

NOTE: Many products contain potent actives and careful washing of hands is required to avoid contamination of food.

7. Colour‑Coded Environmental Grades

The Environment Grade system:

GREEN areas (Grade E)	Laboratory/Warehouse/Office	Controlled Access areas
BLUE areas (Grade D)	Packaging	No exposed product or components
YELLOW areas (Grade C)	Manufacturing or Component and Equipment Preparation areas	Exposed components and non-sterile product preparation.
RED areas (Grade B)	Sterile filling	Most critical

This system minimises the movement of people and materials between different areas.  The environmental Grading System, strict uniform requirements and adherence to all procedures as outlined in SOPs, help attain and maintain a high level of cleanliness to meet the Quality requirements.

8. Pest Sightings

If a pest is sighted within manufacturing building, there are three types of reporting.

1. Contact the Cleaning Services Personnel detailing: time, date and the exact where about of the sighting and if the pest has been removed.
2. Raise a Deviation Report (DR QMS-035) detailing the event. This is used primarily within production areas. These details are logged on to Form-135 and passed on to the Pest Contractors and actioned at a monthly service.

9. Summary of Changes

Version #	Revision History
MAN-010	New