Equipment cleaning procedure in non sterile facility

  • Published on: Oct 27, 2017

This procedure defines and controls aspects that support the non-sterile manufacturing activities of storage, dispensing, formulation and filling – regarding equipment cleaning. Implementation of this program will aid in limiting the potential for cross-contamination and also provide a mechanism for reviewing the cleaning process.

In scope of this procedure are general housekeeping, responsibilities, approved cleaning agents, frequency, spills, waste handling and room disqualification and re-instatement.

Areas that this applies to at the Non-sterile facility are: warehouse / storage, dispensing booths, formulation areas, dispensing areas, filling suites and offices.

Out of scope is detergent residual limit confirmation of vessels and tanks after cleaning and before use in manufacturing activities. Validation work is required to demonstrate that the cleaning process is effective and detergent residues have reached an appropriate level for manufacturing to commence. Limits will be defined in the validated protocol as to which standard they have been defined from.

To ensure compliance with this procedure all staff have a responsibility to varying aspects in this procedure. Supervisors are responsible for ensuring compliance to this and associated procedures for their areas. The Site head is responsible to review aspects of this procedure at defined points for compliance to this procedure.

All Operators are required to comply to follow the requirements as specified in this Standard Operating procedure.

The Non-sterile site management must ensure adherence and compliance to this procedure.

General Facility and Waste

All areas of the Non-sterile facility are to be kept in a clean and orderly condition. Doors (including roller doors) must be kept shut, when not in use, to minimise ingress of dirt, pests and rodents as well as minimise the potential of cross contamination. Upon entry to the manufacturing facility, operators are required to wear scrubs, hair nets, beard snoods, glasses, and factory shoes. General waste material generated must be placed into bins marked waste (no material is allowed to be stored on the floor). Waste bins located in each area must be emptied as they become full or at the end of each shift. 

Frequency and Types of Cleaning

Frequency for cleaning (daily, weekly, and monthly) has been based on the direct environment and equipment that supports the manufacturing process. Manufacturing areas must be cleaned before and after use. The office must be cleaned weekly at a minimum, the warehouse floor is required to be vacuum scrubbed weekly or more frequently as required. Equipment must be cleaned after use and verified to be clean before use.

Types of cleaning may involve: vacuuming, sweeping, wiping and washing.

All cleaning activities must be documented in the cleaning log.

Technique employed for cleaning is working from an area which is classed as cleanier to dirtiest. For eample, when cleaning the ceiling, one should clean from back to front and for walls from top to bottom.

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Approved Cleaning Agents

The preparation of approved cleaning agents must be recorded on the cleaning logs. Detergent “working” solutions are as follows:

1. Detergent or Agent: Antifoam Emulsion Cleaner

          Preparation: Use undiluted

          Area of use: Used in cleaning of vats associated with antifoam products

          Expiry: 1 week

2. Detergent or Agent: Aquatron (alternative to Hydo-Delv F-56)

          Preparation: 1 part :2 parts water.  Spray lightly / agitate. Leave 2 minutes. Rinse.

          Area of use: Oily Surfaces

          Expiry: 1 day

3. Detergent or Agent: Chlorine Solution

          Preparation: 1 part 10% Chlorine to 9 parts water.

          Area of use: Cleaning of Mop heads

          Expiry: 1 day

4. Detergent or Agent: Black and Gold Laundry Detergent

          Preparation: 1 cup of detergent per 5 Liters of water.

          Area of use: Oily Surfaces

          Expiry: 1 week

5. Detergent or Agent: Cold Power Laundry Detergent

          Preparation: 1 cup of detergent per 5 Liters of water.

          Area of use: Oily Surfaces

          Expiry: 1 week

6. Detergent or Agent: Hydro-Delv F-155. “Pink Solution”

          Preparation: 1 part:9 part water. Apply solution. Rinse off with water. Mop/wipe off.

          Area of use: Portable Manufacturing Vessels

          Expiry: 1 day

7. Detergent or Agent: Hydro-Delv F-56 “Black Solution”

          Preparation: 1 part:9 part water. Apply solution. Rinse off with water. Mop/wipe off.

          Area of use: Oily surfaces

          Expiry: 1 day

8. Detergent or Agent: Hydrosolv (alternative to Hydo-Delv F-155)”

          Preparation: 1 part:9 part water. Apply solution. Rinse off with water. Mop/wipe off.

          Area of use: Portable Manufacturing Vessels

          Expiry: 1 day

9. Detergent or Agent: Wonder Clean

          Preparation: Use undiluted.

          Area of use: Benches, walls and tables

          Expiry: 1 month

10. Detergent or Agent: Glass Cleaner

          Preparation: Use undiluted.

          Area of use: Windows

          Expiry: 1 month

11. Detergent or Agent: 70% Ethanol

          Preparation: 7 parts Ethanol to 3 parts water.

          Area of use: Outside of vessels, benches, windows,

          Expiry: 1 week

If a “working” solution is prepared by decanting from a concentrated drum, a new clean dry container must be used each time for each decant. If the detergent “working “solution differs to that of the manufacturer, consult with supervisor before formulation of “working” solution. Document any change to listed instructions with appropriate authorization on the working document is required. Update master instruction as per approved procedures.

Cleaning Equipment

Cleaning equipment typically used includes:

    • Personal Protective Equipment (Gloves, Masks, Googles / Glasses, aprons, etc)
    • Plastic Bags
    • Vacuum Cleaner fitted with HEPA filtraion
    • Yellow bucket for cleaning floors of areas
    • Mop (clean and dry mop head)
    • Squzee and blue bucket for cleaning of walls and cabinets only
    • Clean Wipe

Any cleaning equipment that is required for specific areas must be labelled as such. Operators should ensure that any cleaning equipment used to complete routine tasks are clean and dry before use.

Spills

Any chemical or biological spill that occurs during routine steps of manufacture or as an operator notices in any area of the Non-sterile facility, must be cleaned up immediately using the necessary cleaning equiment, approved cleaning solution and appropriate personnel protective equipment. The event of cleaning must be recorded in the appropriate log, defining the approved cleaning solution and strength.

Room Disqualification / Reinstatement

Where the manufacturing area has been taken out of service for major repairs, area modifications, floods or any other atypical event, the room must be re-cleaned and approved for use again through a formal process.

Facility Cleaning Procedure

– Update the status board to reflect “cleaning in progress”.

– Complete a line clearance of the area to ensure all materials have been removed.

– In the wash bay prepare the detergent “working” solution (water and black or pink detergent) in a clean dry rectangular bucket for walls and yellow for floors.

– Take cleaning equipment and solutions to the area designated to be cleaned.

– Vacuum the floor with a vacuum cleaner fitted with a HEPA filter.

– Dip one squeegee into the rectangular “working” solution bucket. Use a slow smooth motion to wipe across the ceiling from back to front. Overlap the previous stroke and repeat until all surfaces of the ceiling have had working solution applied.

– For the walls, use a slow smooth motion to wipe down the wall from top to bottom. Overlap the previous stroke and repeat until all surfaces of the wall have had working solution applied.

– Wipe all surfaces of fixtures, trolleys, extraction units, cabinets and table tops with 70% ethanol and wipe dry with a wipe.

– Mop the floor from back to front in a slow smooth motion, using the detergent “working” solution from the yellow bucket.

– Wipe roller doors and curtains with detergent ”working” solution from the rectangular bucket, then wipe over with a clean wipe, moisten with water only to remove detergent residue, then spray with 70% ethanol and wipe dry using a clean wipe.

– Clean glass fixtures such as windows with a clean wipe and Glass Cleaner.

– Using a wipe, moisten with detergent solution from the rectangular bucket and wipe over stair railings.

– Using a blue floor mop/bucket and a fresh cleaning solution to mop the hall and stairs adjacent to the area being cleaned.

– Wipe down return air grills and ledges.

– Rinse the mop bucket and mop head with clean warm potable water after use. Hang the mop head in the designated area in the washbay to dry. Place the bucket inverted on a stainless steal rack.

– Empty the vacuum filter bag and replace with a new bag.

– Fill in the cleaning Log book, complete a cleaning status card and apply to equipment appropriately and record on the status board that the area is clean (complete date field).

Equipment Cleaning Procedure

– Move all equipment (except fixed vessels) that requiring cleaning to the wash bay. Ensure any vessels have a “cleaning in progress” tag applied.

– Identify which detergent is required to be used to clean equipment based upon product formulation (eg. Oily surfaces require Hydro-Delv F-56

– “Black Solution” or Aquatron) – refer to section 7 for full list of approved detergents.

– In the wash bay prepare the detergent “working” solution. 

– On the internal surfaces of the equipment, apply an appropriate quantity of detergent “working” solution.

– Scrub the internal surfaces systematically ensuring all surfaces have come into contact with the detergent “working” solution. Scrub surfaces until visually all material has been removed.

– Rinse internal surfaces with purified / process or potable water until no sign of detergent residual is apparent.

– Wipe all external surfaces of the equipment with 70% ethanol and wipe dry with a wipe.

– Rinse the brushes / mop used during cleaning with warm water and hang up to dry in the wash bay. Place any buckets used during the process inverted on a stainless steal rack.

– Remove the “cleaning in progress” tag and complete a cleaning status card and attach to the equipment in an appropriate manner.

– Return equipment to staging area and to portable vessels apply a cover on ports and over the top of the vessel to reduce dust ingress once dry or free from moisture.

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