Procedures & Guidelines Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations FSQ-588013-0101 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Table of contents Introduction Grounds and Buildings Production phases Production area requirements Design for sanitation Facilities Water supply Chemical storage Sewage and liquid waste Waste Sanitary waste Hand washing facilities Toilets Equipment and Product transfer Pre-processing area requirements Storage facilities Processing area requirements .9 Optimise equipment placement Productive work environments Filling room requirements 10 High infection risk areas 10 Room ventilation 11 Floors 13 Drains and gutters 13 Walls 13 Ceiling 13 Doorways 14 Lighting 14 Associated equipment 14 Product Handling & Storage 14 Utilities 15 City Water 15 Chilled water 15 Steam 16 Compressed air 16 Electricity 16 Acknowledgement .17 FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Introduction This document contains an overview of a hygienic production facility It is the responsibility of the Production department to ensure that production procedures are observed meticulously and that maintenance routines and Good Manufacturing Practices are followed and carried out according to predetermined schedules Grounds and Buildings The grounds around a production building should be kept in a sanitary condition This includes: • storing equipment properly, removing litter, cutting weeds and grass that may attract pests • maintaining roads, yards and parking lots so they don’t become sources of contamination • draining wet areas that may cause contamination or harbour pests • protecting outdoor storage or processing vessels from contamination using special coverings, proper ground maintenance, pest elimination, regular inspection and/or other special operating procedures Waste treatment and disposal systems should be designed so that they not contaminate product or product contact areas All production areas should be constructed so that they can be easily cleaned and repaired This includes: • providing enough space to properly place and operate equipment and store materials in a sanitary manner • reducing the potential for contamination of product or product-contact surfaces; use location, partitions, special use times or enclosures to separate productcontact areas from contaminated areas • designing cleanable and maintainable floors, walls and ceilings with adequate aisle space to allow operators to perform duties without contaminating the product; condensate from pipes must not contaminate food or food-contact surfaces • providing adequate lighting in hand-washing areas, locker rooms, toilets, storage, production and packaging areas • providing adequate ventilation in production areas to minimise odours and vapours and to prevent airborne contamination of food-contact areas • preventing entry of pests, using screens or other means FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Production phases In a production facility, the production area may include the following functions: • Pre-processing • Processing • Filling & Packaging • Product Handling and Storage FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Production area requirements This section discusses the requirements for a successful production area It describes general requirements for the entire production area and more specific requirements for each phase of production Be sure to follow all local regulations or nationally mandated practices Design for sanitation • Use cleanable materials with smooth surfaces • Route traffic from areas of higher hygiene to areas of lower hygiene • Avoid hard-to-clean architectural features such as corner “notches” or structural members that collect dust or other contaminants • Optimise floor cleaning by avoiding unnecessary door sills, stairs, elevations, or cavities in floors • Slope floors to efficiently route water away from processing areas • Install floor surfaces suitable to the environment including: – water, chemical and temperature resistance – concrete floors should be coated to prevent deterioration from acid or other corrosive materials – use glazed dairy floor tile with reinforced, acid resistant joints on floors exposed to thermal shocks; seamless flooring can develop cracks; install membranes under tile to protect subfloor from leaks or chemical damage • Locate floor drains so they can be easily accessed and cleaned • Provide ventilation for a sanitary environment: – provide clean sources of air, temperature and humidity controlled to prevent condensation – provide enough air changes per hour to maintain a stable clean air quality – maintain positive air pressures to protect against contamination from outside air – control air flows between processing areas to protect against cross contamination Note! Layout, installation, and construction details will influence the overall quality level of the finished product Where at all possible, consideration should be given to this at the planning stage It is easier, less expensive, and more effective to build the correct production facility from the beginning than to change an existing one For this purpose, reference is made to the IDF document No: 324 1997, Hygienic Design and Maintenance of Dairy Buildings and Services FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Facilities Water supply The water supply must have adequate capacity, temperature, and pressure to handle normal production functions; water contacting the product or product-contact surfaces must be safe and sanitary Piping systems carrying water for product or production processes must not have any back-flow or cross-connection to waste or sewage plumbing The plumbing must be designed to carry water in sufficient quantities to all parts of the production facility, as required by each process Chemical storage The chemical storage areas must be properly labelled so that toxic cleaning compounds and sanitising agents are identified and stored to protect against contamination of product, product contact surfaces, or packaging materials Sewage and liquid waste Plumbing must be designed to properly drain sewage, liquid waste and filling machine discharge away from the product processing and packaging areas Plumbing should not become a source of contamination to the water supply, productcontact areas or the product itself The sewage disposal system must be designed to meet the needs of the process Waste Waste receptacles should be constructed and maintained to prevent product contamination and emptied promptly to minimise possible contamination of product, product-contact areas, or harboring of pests Sanitary waste Sanitary waste should be kept separate from industrial or process waste FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Hand washing facilities Hand washing facilities must be convenient and available to all employees and have running water at a suitable temperature, with the following available: • Established procedures for hand washing and sanitising • Sanitising and cleaning preparations • Disposable towel services • Hand cleaning equipment or plumbing fixtures designed to minimise the recontamination of hands • Understandable and accessible signage instructing employees to wash or sanitise their hands Toilets Toilets must be sanitary and accessible facilities designed according to local regulations and must be available to all employees They must also be: • kept in sanitary condition • kept in good repair • have self-closing doors • designed to prevent exposure to product or product-contact areas FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Equipment and Product transfer These include general requirements for equipment Requirements related to specific production phases are listed in the sections following • All product-contact equipment and tools must be cleanable and be properly cleaned and stored All product and non-product contact surfaces should be cleaned and sanitised as often as is necessary to protect against contamination Follow all cleaning instructions provided by equipment suppliers Non-productcontact equipment must also be cleanable • Seams on all product-contact surfaces should be preferably avoided or must be smooth to minimise the accumulation of food particles, soil or the growth of micro-organisms • Holding, conveying and manufacturing systems must be kept sanitary • Cold storage compartments must have temperature measuring and control devices to ensure that product is always stored at the proper temperature • All control or measuring devices must be kept accurate and maintained • Compressed air or other gases used in or near product must be treated to prevent the product from being contaminated • Connections and piping between pieces of equipment should be permanent Rubber or plastic hoses should be avoided Unnecessary changes in elevation should be avoided so that traps are not created • All product transfer pipes should be installed in such a way that fluid is allowed to drain • Avoid “dead ends” If they occur in the installation, the ratio of length-todiameter should not be more than 1,5:1 • All dead ends should be cleanable and steam sterilisable Piping should be as straightforward as possible FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Pre-processing area requirements General building requirements concerning sanitation and maintenance, as outlined above, apply to this area of the production facility as well Storage facilities Storage tanks should be designed and located in such a way as to prevent damage to raw product as it is transferred to the processing area Storage tanks must be equipped with the proper controls, CIP and refrigeration devices to maintain and stabilise raw product quality Storage equipment should be designed to allow for efficient monitoring or testing of microbial activity Processing area requirements As with the pre-processing area, general building requirements concerning sanitation and maintenance apply to processing areas also The specific design of a processing system will often dictate its own facility requirements However, following are some points that can apply to processing areas in general Optimise equipment placement • Locate equipment or process functions to optimise the flow of product - linear flows can help to reduce product agitation or damage • Isolate processing functions from sources of contamination • Arrange equipment to reduce spread of contaminants Productive work environments • When possible, provide natural light and overviews of the processing facility • When possible, locate processing areas on one level to minimize isolation of employees and promote communication by allowing for spontaneous contacts and views into other work areas • Isolate noise or protect against noise, according to local regulations FSQ-588013-0101 Page of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Filling room requirements When packaging food products, it is of utmost importance that the packaging machine be placed in a working environment compatible with the machine’s hygienic design and function By ensuring that the highest environmental standards are maintained, you can minimise the risk of product recontamination High infection risk areas The degree to which the environment of the filling room is controlled strongly impacts the quality and the shelf life of the product Areas that are considered as high infection areas include: • rooms where processing equipment for sour milk products or milk powder processing equipment is installed • rooms where bottle washing equipment is installed • rooms with strong air currents • rooms with traffic to and from other areas of the production facility • rooms with high humidity, such as the room where the processor is installed, or any area where steam or hot water is discharged during pre-sterilisation and/or production • areas where unnecessary activities, especially those that produce dust, are performed • inadequate filtration for HVAC systems and/or poor air quality control The filling room should be located so as to avoid contamination from the above sources FSQ-588013-0101 Page 10 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Room ventilation Over-pressure The packaging machine should be installed in a room with an “overpressure” of filtered air Normally, the concentration of airborne bacteria is higher than average where food products are stored and processed.To protect the product from infection by these bacteria, the in-flux of non-filtered air through doorways and other openings must be prevented This is accomplished through over-pressure Over-pressure is achieved by bringing more filtered air into the filling room than the exhaust system can expel This excess pressure will cause air to flow out of the filling room through the cracks around doors and other openings, preventing infiltration by airborne bacteria Air intake and exhaust Carefully select the location of the air source Avoid dusty areas, or areas where there is a high concentration of exhaust gas, sewage vapour or other contaminants When designing the over-pressure condition, consider • the type of air filtration will affect intake and exhaust dimensions • the size of the exhaust must be smaller than the intake • air conditioning will affect inlet and exhaust • locate the air inlet to the filling room at the rear of the filling machine; inlet height to the filling room should be between 0.3 m and 0.5 m above floor level • air inlet to the filling room should be horizontally distributed along the wall • locate exhaust outlets high up on the wall in front of the filling machine opposite the inlet • all air handling components must be cleanable and corrosion resistant under the same conditions encountered in the environment of intended use Air exchanges When determining the capacity of the air intake and exhaust systems, you must consider how many “air exchanges” will be required to ensure a fresh supply of air in the filling room To calculate the average volume of the room, calculate the area of the floor next multiply this area by three meters (9.8 ft) Three meters is known as the “sojourn height” and is used to provide a consistent way of comparing filling rooms (the actual height of the room is not used) The “air exchange rate” is the number of times the ventilation system can move the calculated volume of air in an hour FSQ-588013-0101 Page 11 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Temperature, humidity and air quality Incoming air must be filtered, and its temperature and humidity controlled The following table lists recommended ventilation data for a filling room Air temperature 15° to 30° C (60° to 85° F) Humidity 30% to 70% Air speed 0.2 - 0.3 m/sec (8 - 12 in/sec) Over-pressure 2-4 mm water column (5/64” - 10/64”) Sojourn height m (10 ft) Note: For all practical purposes, the sojourn height is sufficient to calculate volume of air movement and is normally the working space for personnel Filtration* ASHRAE 52-76 20% DustSpot Arrested contaminants: 10 microns Note: ASHRAE 52-76 describes a testing method for air cleaning devices only This method is known to all qualified air conditioning and ventilation suppliers Air exchanges 10 - 15 /hr 20/hr under exceptional climatic or polluted conditions (* The above specifications should be regarded as a minimum requirement A stricter requirement for the incoming air quality should be based upon customer product quality demands and the technology installed.) FSQ-588013-0101 Page 12 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Floors The following guidelines should be followed with respect to the filling room floor: • The floor should be finished in non-slip and acid/alkali resistant tiles or equivalent finish e.g epoxy coating All floor/wall corners should be rounded for easy cleaning • The floor should have a descending grade of 1.5% from the magazine end to the discharge end of the machine • The floor tiles should be of sufficient strength to carry the point loads of the machine Broken or cracked tiles can provide an excellent breeding area for bacteria Drains and gutters Drains are a potential source of infection in the filling room All waste and contamination washed from machines during cleaning must flow through gutters to the drains To minimise the contamination risk, flow gutters and drains must be accessible and easy to clean For this reason, the machine must not be located over a drain or a flow gutter Floor drainage is best accommodated by an open gully along the front of the room, passing out of the room, and then directly into a hygienic drain Hygienic drains should be used exclusively in the production hall The drains should not be constructed of materials that can corrode Use tiled or stainless steel gullies, plastic, stone, or ceramic drain pipes Walls The filling room walls should be tiled to a height of 1–2 m (3.3 - 6.5 ft) The tiles should be acid/alkali resistant Above the tile-line, the wall should be finished with an easy-to-clean surface (for example, glass panelling in aluminium frames) All window-sills should be sloped for easy cleaning and to prevent their use as storage shelves Ceiling Since ceilings are not easily accessible, a very smooth, impervious finish should be used to facilitate cleaning with a long-handled brush or mop If any ceiling ductwork or exhaust hoods are installed, they should be designed for easy cleaning FSQ-588013-0101 Page 13 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Doorways The number of doorways should be kept to a minimum Hygienic access control for staff should be implemented Lighting Production staff must have a clear view for operating the machine and controlling the packages • Use as much light as possible from surrounding rooms and through ceilings • Avoid lighting that emits a pronounced frequency flicker • Reduce dark zones and avoid dazzling and reflective systems • All lights should be easily accessible for maintenance and cleaning and must be safely screened against any glass fragmentation of bulbs Associated equipment Associated equipment such as chillers, processing equipment, and electrical cabinets should not be installed in the filling room Product Handling & Storage • Maintenance of chilled chain after filling (Pasteurised and ESL applications) • Cold store and distribution (Pasteurised and ESL applications) • First in first out system for product storage • Product access and tracking system recommended for QC/QA purposes (To be expanded) FSQ-588013-0101 Page 14 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Utilities Utilities needs to be of highest quality, and installed in such way, that the hygienic level not be downgraded by soiling or re-contamination City Water The city water used in filling machines must be free of impurities, rust and minerals that can damage or leave deposits on components In addition, it must be of potable quality To minimise corrosion, avoid lime deposits, and to minimise the chance of bacterial contamination, city water used in the packaging machine should: • have a low content of organic substances • have a lime content no greater than CaCO3 3-5 DH, 50ppm • have low chlorine content Excessive chlorine can lead to corrosion even on stainless steel Cl2 less than or equal to 0.2 mg/L Cl less than 30mg/L • have pH of 7.5 – 8.5 • be free of disease generating components, both particulate and chemical as well as filtered to a maximum particle size Note! The above specifications are to be regarded as general More stringent specifications and/or local legislation should be adopted in preference Chilled water For the secondary (or closed) water system in the packaging machine, use clean distilled (type III) or de-ionised water Treatment with a microbicide is recommended to avoid microbial growth and associated blockage of narrow pipelines and corrosion • Best cooling effect is attained if the packaging machine cooling water system is connected to the plant-chilled water system • The chilled water must be free of impurities, rust and minerals that can deposits in the cooling water system FSQ-588013-0101 Page 15 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Steam Steam supplied to the packaging machine must be of culinary quality This means that the steam is considered safe for use in food preparation The water source must be potable and acceptable to local regulatory agencies The steam should be free of entrained contaminants and relatively free of water in liquid form If the steam main which delivers steam to the packaging machine and all surfaces with which processed product comes into contact is not culinary grade, then additional equipment needs to be installed upstream of the machine To achieve culinary grade steam, a cyclone and active carbon filter or equivalent must be installed upstream of the applicable equipment This will remove impurities and odours • A steam trap must be installed before each steam inlet to the machine, preventing the build-up of condensate in the line • Steam supplied to the packaging machine must be filtered and free of condensate • Consumption is low, but a constant pressure must be maintained • Pressure variation must be kept to a minimum, avoid sudden exhaust elsewhere in the steam system that might starve the supply to the packaging machine Compressed air The air must be dry, clean and oil free The customer should provide an external 50 micron filter on the supply line upstream from the compressor A coalescing filter should be located in the air pipeline downstream from the compressor The water separator must be drained according to a maintenance schedule • To prevent condensation inside of valves and cylinders, the temperature of the air supplied to the machine should be C less than the ambient temperature • The air pressure must be at least bar during production This pressure can be read on the pressure gauge on the machine Electricity The electricity to the packaging machine must be stable and a very low voltage variation to be accepted +/- 10% for the incoming voltage to the packaging machine FSQ-588013-0101 Page 16 of 17 Guideline for the Hygienic Production of Liquid Food Part 1- Site Recommendations Acknowledgement The following documents have been used as source of information: • Guidelines for Good Manufacturing Practices Low-Acid, Ultra Pasteurised Extended Shelf-life products (Doc no: GMP 586085-102) • Installation Manual Tetra Rex TR/16 (Doc no: IM 586146-0101) • IDF document no: 324 1997, Hygienic Design and Maintenance of Dairy Buildings and Services FSQ-588013-0101 Page 17 of 17