8.1.2 Where high-risk areas are part of the manufacturing site, there shall be physical segregation between these areas and other parts of the site. Segregation shall take into account the flow of product, the nature of the materials (including packaging)
The location of transfer points shall not compromise the segregation between high-risk areas and other areas of the factory. Practices shall be in place to minimise the risk of product contamination (e.g. the disinfection of materials on entry).
Where high-care areas are part of the manufacturing site, there should be physical segregation between these areas and otherparts of the site. Segregation shall take into account the flow of product, the nature of materials (including packaging)
Where physical barriers are not in place, the site shall have undertaken a documented risk assessment of the potential for cross-contamination, and effective, validated processes shall be in place to protect products from contamination.
the raw materials and products
the flow of raw materials, packaging, products, equipment, personnel and waste
the provision and location of utilities (including drains).
8.2.1 Where sites include high-risk or high-care facilities, there shall be a map of the drains for these areas which shows the direction of flow and the location of any equipment fitted to prevent the back-up of waste water. The flow from drains shall no
8.2.2 High-risk areas shall be supplied with sufficient changes of filtered air. The filter specification usedand frequency of air changes shall be documented, based on a risk assessment that takes into account the source of the air and the requirement to
8.3.1 Maintenance activities undertaken in high-risk and high-care areas shall respect the segregation requirements of the area. Wherever possible, tools and equipment shall be dedicated for use in that area and retained in the same
8.3.2 Where equipment is removed from the high-risk or high-care area, the site shall have a procedure to ensure the cleanliness and removal of contamination hazards before being accepted back into the area.
visually distinctive and dedicated for use in that area
have specific procedures (e.g.a full clean) to ensure that their use does not result in contamination.
8.4.1 Where an operation includes a high-risk or high-care area, personnel shall enter via aspecially designated changing facility at the entrance to the area. The changing facilities shall incorporate the following:
protective clothing that is visually distinct from that worn in other areas and which shall not be worn outside the are
hand-washing routine during the changing procedure to prevent contamination of the clean clothing (i.e. hand-washing after hair covering and footwear have been put on, but before handling clean protective clothing)
prior to entry for high-risk areas
on entry for high-care areas
dedicated site footwear that is provided by the site and which shall not be worn outside the factory
(such as a barrier or bench system) or by the use of controlled and managed boot-wash facilities where these demonstrably provide an effective control of footwear to prevent the introduction of pathogens into the area.
A programme of environmental monitoring shall be used to assess theeffectiveness of footwear controls.
responsibility for cleaning
method of cleaning, including dismantling equipment for cleaning purposes where required
cleaning chemicals and concentrations
cleaning materials to be used
cleaning records and responsibility for verification.
The site shall define the corrective action to be taken when monitored results are outside of the acceptable limits.
This shall include the risk from cleaning chemical residues on food contact surfaces.
8.5.3 Equipment used for cleaning in high-care and high-risk areas shall be visually distinctive and dedicated for use in that area
8.6.1 Waste disposal systems shall ensure that the risk of contamination of products is minimised through the control of potential cross-contamination.
Risk assessment shall consider the movement and flow of waste and waste containers. For example, waste bins should be dedicated to either high-risk or high-care areas and not be moved between different production risk zones.
adequate segregation between dirty and cleaned clothes
adequate segregation between clothes for high-risk, high-care and low-risk areas etc
effective cleaning of the protective clothing
commercial sterilisation of the protective clothing following the washing and drying process
protection of the cleaned clothes from contamination until use (e.g. by the use of covers or bags).
8.7.2 Where protective clothing for high-care or high-risk areas is cleaned by a contracted or in-house laundry, the laundry shall be audited either directly or by a third party. The frequency of these audits shall be based on risk.
8.7.3 Protective clothing for use in high-risk and high-care areas shall be changed at an appropriate frequency based on risk, and at a minimum daily
