15. Risk-based facilities
Ambient high-care facilities
What controls are needed for an ambient high-care product
Ambient high-care
This article covers the requirements defined in the standards, for processing of ambient high-care products.
The standards
This article is written to meet the following standards:
BRCGS Food Safety Issue 9 | 8.1.4 Ambient high-care |
BRCGS Packaging Issue 6 | Not applicable |
BRCGS Agents & Brokers Issue 3 | Not applicable |
BRCGS Storage & Distribution Issue 4 | Not applicable |
FSSC22000 Version 5.1 | No specific clauses |
IFS Food Version 7 | No specific clauses |
SQF Edition 9 | No specific clauses |
The requirements
Ambient high-care controls
The controls defined in the procedure must be determined by the risk assessment, but should include consideration of:
- Segregation requirements.
- Process flow.
- Fabrication.
- Air quality.
- People movement.
- Transfer points.
- Equipment and tools.
If you’d like to learn more about the risk assessment to determine zones, please read our article Defining risk-based zones.
Segregation
Ambient high care areas must be segregated from other designated areas, but they do not need to be physically segregated with walls. Floor marking is sufficient.
Anything entering the segregated area must be decontaminated to ensure that pathogenic contamination is not transferred into the area as well, this includes:
- Equipment and tools.
- People.
- Air and utilities.
- Materials and product.
Fabrication
The design of fabrication and equipment in the area, must not pose a risk of contamination.
Air and utilities
Where there is a physically segregated ambient high-care zone, which would benefit from controlled air, decontamination of the air used may be considered, using:
- Filters.
- Water treatments.
Where segregation is not physical improved air quality is not necessary, as it wouldn’t add any value.
People movement
Decontamination of people, require personal hygiene and protective clothing controls. Access to the area must only be accessible through the changing facilities.
Transfer points
Materials and products are transferred into the zone, either:
- Through a hole in the wall.
- Using equipment which travels from low risk to the ambient high-care zone.
Where travelling equipment is used, decontamination should occur during travel into ambient high care. Where a hole in the wall is used, a decontamination process should be applied just before or during transfer through the hole in the wall.
All raw ingredients and products that are transferred into the zone, must be decontaminated to reduce contamination. The target pathogen and the level of reduction required, must be defined. The method used to achieve the reduction must be validated.
Controls must ensure that raw ingredients do not contaminate cooked (decontaminated) ingredients, during transfer into the zone.
Equipment and tools
Equipment and tools should be dedicated to the area, so that they don’t need to be moved.
However, where equipment and tools cannot be dedicated, or where equipment needs to be taken out of the ambient high-care zone (e.g. for maintenance) there must be a procedure, which details how it must be cleaned and disinfected, prior to re-entry. In this instance, there must be a designated transfer point to allow for cleaning immediately prior to transfer. Records of the cleaning, transfer and acceptance back into the area must be retained.
Portable equipment which is dedicated to ambient high-care zones, must be:
- Visually distinctive.
- Or, must coded so that it can be cleaned and recorded prior to entry.
Maintenance, engineers and contractors must also follow these rules.
Waste
The route of disposal of waste must be controlled so that they do not contaminate product, including:
- Waste materials.
- Drainage waste.
- Extracted air.
Drains must flow away from ambient high-care zones.
Ambient high-care explained
The purpose of ambient high-care is to prevent pathogenic cross-contamination in products which are not chilled.
BRCGS state that the definition of ambient high care is “An ambient area designed to a high standard where practices relating to personnel, ingredients, equipment, packaging and environment aim to minimise potential product contamination by pathogenic micro-organisms”
Ambient high-care products include:
- Nuts
- Seeds
- Cocoa beans
All of the above would be at risk from Salmonella contamination – as this pathogen is known to be present in raw nuts, seeds and beans. So, there’s a risk of Salmonella from the raw materials and contaminated ready-to-eat materials.
But not all nut, seed and cocoa bean processing needs to have an ambient high-care area. The key is whether you handle raw materials as well as treated materials.
For example: A site that purchases roasted nuts and blends and packs them, wouldn’t need an ambient high-care area – as there’s no risk of microbial cross-contamination from raw to ready-to-eat. This is because they already buy roasted nuts, so the Salmonella hazard has already been removed through heat treatment.
However, if a site was to purchase raw nuts and then roast, blend and pack them – then there would be a risk of Salmonella from the raw nuts, contaminating the roasted nuts. And therefore, an ambient high-care area would be needed.
BRCGS Food Safety Issue 9
The interpretation of clause 8.1.4 has been updated to state that, cleaning procedures and environmental monitoring must be specifically considered, for the ambient high-care zones.
If you have an ambient high-care zone, this means that you must check to make sure that you have separate and specific cleaning procedures for the zone. You must also ensure that the zone is covered by relevant environmental monitoring.
Risk-based zones have now been referenced in clause 2.2.1. This means that if you have an ambient high-care zone, that you must review your prerequisite procedures for these specific controls. The procedures must be either separate completely, or the information related specifically to the ambient high-care zone must be clear. Anyone using the procedure must be able to easily identify which controls in the procedures relate to which type of risk-based zone.
Hi Kassy,
Thank you for this article.
*Would like to check with you whether the following scenario is appropriate:
-our factory has only low risk zones and one ambient high care (AHC) zone, apart from enclosed product areas
-all staff enters (all zones) production area through one common changing room & the order of protective clothing control is as follows: they change into company t-shirt, put on face mask, put on hairnet (so that they don’t need to fiddle with the hairnet when looping the mask to ears), put on boots, then wash and dry hands
-then the AHC zone staff proceeds to an area just outside the AHC zone that is cordoned off using mobile barriers for demarcation; they first clean their boots with a boots scrubbing equipment, then sanitise their boots with a boots sanitising equipment (no contact with their hands), they then put on a disposable overall over their company t-shirt and finally wash and dry their hands
-these AHC zone staff enter through the entry side (i.e. the entrance is divided using a mobile barrier into two sides, one to serve for entry and another to serve for exit)
-the AHC zone is physically segregated from the low risk zones but has only strip curtains at the entrance
-only filling and packing process is carried out at the AHC zone, where the liquid product is hot filled at 75-80 deg C and only briefly exposed to the environment prior to capping
-there is no staff contact with product, but there is staff contact with exterior of the bottles when they conduct inspection of bottles for defects before the bottles are being fed to the filling machine
*Appreciate that you can kindly comment whether the above protective clothing controls are acceptable based on the context given, where risk of contamination from staff to the product is low.
*Thanking you in advance.
Hi Judy
This sounds very good to me!
Kassy
Is desiccated coconut an ambient high care product?
Hi Iemlda,
Although it can support the growth, coconut doesn’t seem to have an inherent issue with Salmonella.
Kassy