Cleaning and sanitisation programmes are a key prerequisite to ensure the adoption of good manufacturing practice (GMP). Cleaning will not be effective unless it is fully supported by management. The role of management is to define the hygiene standards required and to communicate these effectively to staff, usually by means of a comprehensive cleaning schedule and associated task procedures. Management must demonstrate commitment by providing the appropriate means, that is, the equipment, the chemicals and the training for staff.
21.1 EU Regulation (EC) No. 852/2004 (as amended) on the hygiene of foodstuffs states that:
21.2 Cleaning procedures must not only be consistent with food hygiene legislation but also with the requirements of environmental and health and safety legislation (see Chapters 41 and 42), and cleaning and disinfection must be undertaken using procedures designed to minimise the risk of product contamination.
21.3 Cleaning schedules coordinate cleaning activities and are a means of information transfer between management and staff. They should be established for external areas, the premises itself and equipment, plant and services. They should also be established for transport vehicles in the distribution supply chain. Individuals who have the appropriate level of competence and knowledge to develop an effective cleaning and disinfection regime should design cleaning schedules and associated procedures. The site hygiene plan and associated cleaning schedules and cleaning procedures should be based on a risk assessment approach (see 21.7). Documentation such as cleaning schedules and associated task procedures must be clear and unambiguous. Consideration must be given to the language skills, numeracy and literacy of staff. Cleaning schedules and associated task procedures must state as appropriate:
21.4 Cleaning schedules may be designed to address daily, weekly, monthly, quarterly, six‐monthly and annual tasks separately or all on one format. Cleaning may be monitored by the quality control function as part of a routine site hygiene audit, or cleaning may be monitored instead as part of production procedures by a hygiene team leader or equivalent. Verification of cleaning will occur at a prescribed frequency and by defined competent individuals such as the quality control manager or designate, and will encompass a variety of activities, including auditing of records, visual audits of premises, review of swabbing results, microbiological testing of food products, customer complaint data etc. (see 21.12).
21.5 The cleaning schedule needs to ensure effective, economic cleaning. Equipment should be installed so as to facilitate effective cleaning. The practices used will vary with the size and type of manufacturing premises and number of staff involved. Cleaning schedules should be in place to ensure that external areas are kept clean and free from rubbish. Particular attention should be paid to waste storage areas. The cleaning requirements for chill and cold stores, road vehicles and shipping and air freight containers need to be considered. Cleaning schedules need to be developed with appropriate protocols to minimise the risk of product contamination and determine the effectiveness of cleaning.
The quality control manager or designate must determine a site hygiene plan, otherwise termed cleaning and disinfection protocol, that is appropriate to the business and the products manufactured, especially in terms of high‐ and low‐care requirements. Consideration should be given to the generation of aerosols that could contaminate nearby surfaces, packaging, ingredients or products. The control of allergenic materials and the disposal of cleaning equipment that may have come into contact with allergenic materials must also be considered.
The implementation of the cleaning schedule will only be effective if there are sufficient resources available in terms of time, trained personnel, suitable chemicals and cleaning equipment. Consideration should be given to the level of cleaning, for example routine cleaning at one level and then further deep cleaning programmes at designated intervals. Deep cleaning may need to be undertaken during periods of production shutdown and non‐production, and engineering and maintenance resources may also need to be programmed where equipment dismantling is required. If equipment is dismantled, appropriate controls should be in place to ensure that machine parts are not placed directly onto the floor. Controls include, but are not limited to, tables, designated racking and so forth. A hygiene clearance/sign back into production procedure should be in place for all cleaning tasks, but additional clearance procedures may be adopted following deep cleaning activities to ensure the risk of product contamination is minimised. The cleaning schedule and associated task procedures must be validated before implementation and monitored by staff to ensure they are sufficient to deliver the food safety objectives of the manufacturing organisation. Verification activities must take place over and above monitoring to demonstrate that the hygiene management system as a whole is functioning effectively (see 21.12).
21.6 The quality control manager should develop and validate a site hygiene plan and associated procedures for the site. The site hygiene plan should be reviewed at regular intervals to determine its appropriateness and effectiveness in ensuring a hygienic manufacturing site and minimising the risk of potential product contamination. The Food Standards Agency (FSA) publication E. coli O157 – Control of cross‐contamination: Guidance for food business operators and enforcement authorities (2014) stresses the importance of not only validating the hazard analysis critical control point (HACCP) plan, but also ensuring that disinfectants are purchased and used in compliance with validated dilution levels and contact times. The guidance states that the use of disinfectants or sanitisers that meet BS EN 1276:2009, BS EN 1650:2009 + A1:2013, BS EN 13704:2002 and BS EN 13697:2015 should be considered. In order to promote efficacy they must be applied to visibly clean surfaces and be used ‘strictly in accordance with the manufacturer’s instructions relating to proper dilution of the chemical, the effective temperature range and the necessary contact time. Since effective chemical disinfection can only be achieved on visibly clean surfaces, a cleaning stage is required first’. Validation of cleaning and disinfection processes is especially critical if dual use of equipment and machinery for slicing, mincing or vacuum packing of raw and ready‐to‐eat foods forms part of the manufacturing process. Where possible, there should be designated machinery to prevent this risk from occurring. Where this is not possible, effective disinfection is a key prerequisite to ensuring food safety. Validation of cleaning methods should also assess the potential for cross‐contamination by cleaning equipment. The guidance further requires that food business operators (FBOs) should ‘ensure that they are using the appropriate disinfectant products by confirming with their suppliers that the products they are using meet, as a minimum, the specifications of these standards. This information may also be obtained from the label of the product, or by contacting the manufacturer directly.’1 Records should be maintained of all validation and revalidation activities.
21.7 Risk assessment must be undertaken that is specific to the manufacturing unit to determine the level of cleaning and disinfection required. The site hygiene plan should be developed to address the following points as appropriate to the site and the type of product manufactured:
21.8 It is important that the quality control manager has sufficient understanding and is competent in the development of cleaning protocols. It is critical that she/he can distinguish between the different terminology and be aware of the potential issues if an incorrect type of chemical is used. All chemicals used in food environments should be food grade, non‐toxic, non‐corrosive and non‐perfumed, and should not cause tainting.
21.9 Care should be taken to avoid mixing of cleaning agents since their chemical nature may cause them to interact and could result in a health and safety hazard to staff working in the area.
21.10 Detergents are formulated to remove soil and dirt. Disinfection can be achieved by using:
Disinfectants or sanitisers should meet the requirements of the relevant BS EN Standards (see 21.6) 1276:2009 or BS EN 13697:2015 (see 21.6). Liquid hand wash that has disinfectant properties should conform to the requirements of the BS EN 1499:2013 standard. This information on disinfectants and sanitisers should be available on the label of the product, or may be obtained from the supplier or manufacturer. A sanitiser is a chemical that both cleans and disinfects. A sanitiser reduces the number of cleaning steps because it has both detergent and disinfectant properties and does not require an intermediary rinse. However, sanitisers are not effective on heavy soiling and can be expensive.
21.11 Food production systems, especially in dairies or drink manufacture, often have a number of bulk tanks, interconnecting pipework and pasteuriser systems. It would be impracticable to dismantle this system for cleaning and personnel entry into bulk tanks would not be safe, so the equipment is cleaned ‘in place’. Cleaning in place (CIP) allows equipment and pipework to be cleaned between processing runs. When designing a CIP system, the following factors are important:
A schematic plan should be available to demonstrate that the CIP system has been hygienically designed and validated (see 21.6), and a log of changes and subsequent revalidation is maintained. It is very important in the development of CIP cleaning systems that:
CIP systems must not only be validated, but also monitored and verified to ensure continued effectiveness. Activities that should be undertaken include analysis of rinse water and/or first product through the lines (which is sent to waste until approved as suitable for packing), usage data for cleaning chemicals and ATP bioluminescence testing.
21.12 The efficiency of cleaning and sanitisation should be checked and recorded at routine intervals by the quality control manager or designate. The frequency of checks should be based on risk assessment. The hygiene standards required should be defined. Mechanisms of monitoring and verification of the effectiveness of cleaning include:
The monitoring and verification of cleaning activities should be formally documented, records maintained, any trends analysed and, where required, corrective action implemented to improve cleaning and sanitisation practices. Follow‐up inspections should be undertaken to ensure that the corrective action has been implemented and is effective. These records should be maintained as part of the due diligence system.
21.13 The formation of biofilms is a major concern in food manufacturing environments. Biofilms are caused by micro‐organisms that adhere to each other and also to a surface. If biofilms form then this will reduce the efficacy of disinfection systems, especially as they can provide harbourage for pathogenic and spoilage organisms such as Salmonella spp. and Listeria monocytogenes. The type of biofilms formed will depend on the environment within the manufacturing unit in terms of the products manufactured and processed, and thus the nutrients and pH within the environment, and temperature. The risk of biofilm formation is greater in areas of the factory which are cleaned and/or dismantled at a lower frequency, e.g. in‐line filters or pipework joints and seals, and there is potential for sloughing from the biofilm into liquid if there is a change in flow rates and pressure. It is critical in the manufacturing environment to be aware of the potential for biofilm formation and to develop cleaning programmes and associated monitoring and verification that minimise the likelihood of biofilms occurring.
21.14 There must be controls in place to ensure safe and secure storage of cleaning and sanitisation chemicals when they are not in use. The quality control or hygiene manager, as appropriate, should develop procedures to ensure that:
21.15 Appropriate cleaning equipment must be used. It should be fit for purpose and not be a source of contamination in itself. Consideration should therefore be given to using non‐wooden equipment and/or equipment that is so coloured that a foreign object can be easily identified in the finished product, for example brush bristles. Cleaning equipment that is used in designated areas should be colour coded to prevent its use in another area, for example external equipment, internal machines, floor cleaning, internal factory, toilets and welfare areas. This is especially important in manufacturing units where there are designated high‐ and low‐care areas. A colour‐coded site plan may prove effective in communicating where equipment can be used. The use of mops, especially string mops, should be risk assessed to determine that they can be effectively cleaning and disinfected after use.
Cloths should be adequately controlled and be single issue where deemed appropriate within the hygiene risk assessment. Surfaces should be allowed to air‐dry, but if the task procedure requires that they must be wiped after cleaning, this must be with a single‐use cloth, a sanitising wipe or blue paper towel that is appropriately disposed of to prevent contamination. If an item is found to be incomplete, for example dustpan and plastic handle broom, then the brittle material control procedure should be implemented (see 19.36–19.42). If disposable single‐issue gloves are used by personnel during cleaning, they should be adequately controlled. The equipment should be cleaned and stored so as to minimise the potential for product contamination. Equipment should be allowed to air dry in designated racks.
3.143.22.23