TASA Omega Hygienic Design

TABLE OF CONTENTS
1. INTRODUCTION ........................................................................................ 4 2. GENERAL PRINCIPLES ........................................................................... 4
2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.2.6 4.2.7 4.2.8 4.3 4.3.1 4.3.2 4.3.3 Product contact surfaces .................................................................................................. 4 Surface roughness ........................................................................................................... 4 Cleaning and draining ..................................................................................................... 4 Dead-legs ......................................................................................................................... 4 Inspection for cleanliness ................................................................................................ 4 Drain outlets .................................................................................................................... 4 Instrument probes ............................................................................................................ 5 Insulation ......................................................................................................................... 5 Equipment support structure shall be sealed to the building ........................................... 5 Working space ................................................................................................................. 5 Buildings design and pest ................................................................................................ 5 Buildings, design and cross contamination ..................................................................... 5 Design of buildings ......................................................................................................... 5 Fork-lifts .......................................................................................................................... 5 Slope to drain .................................................................................................................. 5 Overhead structures and fittings ...................................................................................... 6 Open grid flooring ........................................................................................................... 6 Suspended ceilings .......................................................................................................... 6 Stairs, structures and platforms ....................................................................................... 6 Personnel rooms .............................................................................................................. 6 Hand washing .................................................................................................................. 6 Ventilation ....................................................................................................................... 6 Exterior and interior of equipment and pipelines ............................................................ 6 Product Contact Materials ............................................................................................... 7 Secondary contact materials ............................................................................................ 8 Stainless steels ................................................................................................................. 8 Plastics ............................................................................................................................. 9 Elastomers ....................................................................................................................... 9 Adhesives ........................................................................................................................ 9 Lubricants ........................................................................................................................ 9 Signal transfer liquids...................................................................................................... 9 Coatings ........................................................................................................................... 9 Prohibited materials......................................................................................................... 9 Non-contact materials ..................................................................................................... 9 Walls and floors .............................................................................................................. 9 Paints and coatings ........................................................................................................ 10 Prohibited materials....................................................................................................... 10 Internal .......................................................................................................................... 10 External ......................................................................................................................... 10 Crevices ......................................................................................................................... 10 Dead-legs ....................................................................................................................... 11

3. LAYOUT ....................................................................................................... 5

4. MATERIALS OF CONSTRUCTION ....................................................... 6

SURFACE FINISHES, CREVICES & DEADLEGS ............................. 10

5.1 5.2 5.3 5.4

MECHANICAL EQUIPMENT ................................................................ 11

6.1 6.2 6.3 6.4 6.5 6.6

Self draining .................................................................................................................. 11 Cleaning ........................................................................................................................ 11 Shaft sealing .................................................................................................................. 12 Screw Threads ............................................................................................................... 12 Leak detection ............................................................................................................... 12 Replacement parts ......................................................................................................... 12 Product contact surfaces/visual inspection .................................................................... 12 Internal corners .............................................................................................................. 12 Inlets and outlets............................................................................................................ 12 Internal fittings .............................................................................................................. 12 Vessels self draining...................................................................................................... 13 Surface finishes ............................................................................................................. 13 Lids and man lids .......................................................................................................... 13 Screw threads inside vessel ........................................................................................... 13 Shaft seals ...................................................................................................................... 13 Exterior and non product contact surfaces .................................................................... 13 Feet ................................................................................................................................ 13 Design and cleaning duties ............................................................................................ 13 Contamination during fabrication ................................................................................. 13 Pipes .............................................................................................................................. 14 Couplings ...................................................................................................................... 14 Hard Tees ................................................................................................................... 14 Swept Tees .................................................................................................................... 14 Reducers ........................................................................................................................ 14 Flange construction ....................................................................................................... 14 General requirements .................................................................................................... 14 Diaphragm valves .......................................................................................................... 15 Ball Valves .................................................................................................................... 15 Butterfly valves ............................................................................................................. 15 Plug valves .................................................................................................................... 15 Control valves ............................................................................................................... 15 CIP valves ..................................................................................................................... 16 Other accessories ........................................................................................................... 16 Welding ......................................................................................................................... 16 Bending ......................................................................................................................... 16 Piping layout ................................................................................................................. 16 Supports ......................................................................................................................... 17

TANKS & VESSELS ................................................................................. 12

7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 7.13

PIPING ........................................................................................................ 14
8.1 8.2 8.3 8.4 8.5 8.6

VALVES ...................................................................................................... 14
9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 10.1 10.2 10.3 10.4

10 PIPING INSTALLATION ........................................................................ 16

11 TYPICAL DRAWINGS............................................................................. 18

1. INTRODUCTION
This document gives the design philosophy for the design aspects for the engineering and construction of the manufacturing facility for API and Food Additives. Facilities shall be constructed to meet the requirements of Good Manufacturing Practice for Food Additives.

2. GENERAL PRINCIPLES
In the design and installation of equipment and facilities, the following basic requirements must be met. ASME Bioprocessing Equipment Standard BPE-2009 is defined as a guiding document, and has been normative for preparing this document. Where the requirements of this Hygienic Design Philosophy cannot be followed for any reason, a DEVIATION REQUEST must be raised for approval. Approved Deviation Requests should be retained for filing with project documentation. 2.1 Product contact surfaces All product contact surfaces must be inert and resistant to the process and cleaning fluids over the full range of operating pressures and temperatures. For further details see Section 4. 2.2 Surface roughness Product contact surfaces must satisfy maximum roughness requirements as specified in Section 5. 2.3 Cleaning and draining All equipment and piping must be self-draining and easily cleanable. See Sections 3.14, 6.1and 10. 2.4 Dead-legs The number and length of dead-legs in piping systems shall be minimised. See Section 5.4 2.5 Inspection for cleanliness All surfaces in contact with product must be either easily accessible for visual inspection for cleanliness, or it must be demonstrated that routine cleaning procedures are effective and eliminate the possibility of contamination. If CIP (Cleaning In Place) techniques are used, it must be demonstrated that the results achieved are satisfactory. This can be verified by dismantling and inspection, and verified by visual inspection.. Cleanliness of surfaces in contact with product shall be proven by visual inspection. 2.6 Drain outlets Drain outlets on equipment and vessels shall be configured to prevent the possibility of contaminants being sucked back into the process. A minimum gap or 'air break' of 2 pipe diameters shall be provided between the equipment and drain.

2.7 Instrument probes Instrument probes in contact with product shall as far as possible follow the principles outlined above and in Sections 4, 5, 6, 7 and 8. 2.8 Insulation In critical areas, i.e. where product is exposed, the insulation of piping and equipment should be minimised. Where it is necessary to use insulation in such areas, it must be enclosed in stainless steel cladding or aluminium cladding ( depending on cost) , preferably fully welded to prevent the occurrence of crevices. Where valves and couplings are covered by insulation, provision shall be made for access for maintenance and to detect leaks. Non absorbent insulation surfaces must be used. Utility piping shall us the best , cleanest cladding possible. 2.9 Equipment support structure shall be sealed to the building Equipment and support structures shall be sealed to the building (floor, walls, columns, ceiling) in such a way that no pockets or gaps exist in which dirt may accumulate. Alternatively, adequate clearance shall be provided between equipment and the civil construction to allow cleaning and inspection of all surfaces.

3. LAYOUT
3.1 Working space Adequate working, space shall be provided to allow for satisfactory performance of all operations including maintenance and easy adequate cleaning. 3.2 Buildings design and pest The buildings and facilities shall be designed to prevent the entrance and harbouring of pests and the entry of environmental contamination such as smoke, dust, etc. 3.3 Buildings, design and cross contamination The buildings and facilities shall be designed to provide separation, by partition, location or other effective means, between those operations, which may cause cross-contamination. 3.4 Design of buildings Buildings and facilities shall be designed to facilitate production operations by means of a regulated flow in the process from the arrival of the raw material at the premises to the finished product, and shall provide for appropriate temperature conditions for the process and the product. 3.5 Fork-lifts Fork-lift trucks operating within the process buildings shall not travel on contaminated thoroughfares. Change points shall be designed so that 'dirty' forklifts discharge their load on a platform to be picked up by 'clean' forklifts from the other side. 3.6 Slope to drain Floors in production areas shall slope sufficiently (3:100) for liquids to drain to trapped outlets. This is not applicable to storage areas.

3.7 Overhead structures and fittings In critical handling, areas all overhead structures and fittings shall be installed in such a manner as to avoid contamination directly or indirectly of product and raw materials by condensation and drip, and shall not hamper cleaning operations. They shall be insulated where appropriate and be so designed and finished as to prevent the accumulation of dirt and minimise condensation, mould development and flaking. They shall be easy to clean. 3.8 Open grid flooring Open grid flooring shall only be used where equipment and materials located below will not be affected by dirt, liquid spills and cleaning from the floor above. For zoning purposes, areas above and below such floors will be treated as the same area. Outside areas can use grid flooring. 3.9 Suspended ceilings In critical areas, suspended ceilings shall be considered to reduce the accumulation of dirt. Piping shall be routed above ceilings where practicable. An example of this area will be the drum filling room. 3.10 Stairs, structures and platforms Stairs and auxiliary structures such as platforms, ladders, etc. shall be easily cleanable and so situated and constructed as not to cause contamination. Particular attention shall be paid to the clean ability of supports of open grid platforms. 3.11 Personnel rooms Living quarters, toilets, and changing rooms shall be completely separated from and shall not open directly on to product handling areas. 3.12 Hand washing Adequate and conveniently located facilities for hand washing and drying shall be provided whenever the process demands. 3.13 Ventilation Adequate ventilation shall be provided to prevent excessive build-up of heat, condensation, and dust and to remove contaminated air. The direction of the airflow shall never be from a dirty area to a clean area. 3.14Windows Windows shall be flush with the inside of the walls (no window frame for collection of dirt) 3.15Exterior and interior of equipment and pipelines The exterior and interior of all equipment and pipelines in the factory must be self-draining, and easily cleanable. Adequate clearance shall be provided around all items to allow access for cleaning, particularly below items that are not scaled to the floor.

4. MATERIALS OF CONSTRUCTION
Materials used for construction must fulfil certain specific requirements.

Product contact materials must be inert to the process fluids as well as to detergents and anti-microbial chemicals under all conditions of use. They must be corrosion resistant and mechanically stable, so that the original surface finish is unaffected. Materials used in secondary contact areas (ie those which may be contacted by waste product and require cleaning to prevent contamination) must be corrosion resistant and inert to cleaning chemicals. Non-contact materials shall be mechanically stable, smoothly finished and easily cleaned. 4.1 Product Contact Materials 4.1.1 Stainless Steels The following grades of stainless steel (or their equivalents) are acceptable: - AISI 316 (machined parts) - AISI 316L, 316 Ti (welded parts) - AISI 317L, 317 Ti (welded parts, higher corrosion resistance) - AISI 410, 409, 329 and Uddeholm 904L, Sandvik 2205, Avesta 254 SMO and Incoloy 825 may also be used. Any other grades shall be used only with the express distinct permission by [XXXX] 4.1.2 Plastics Plastics must comply with the following: - Current EU Guidelines on the use of plastics in contact with food, in particular Directives 75/318/EEC, and 90/128/EEC. - The USA Code of Federal Regulations of the FDA (CFR 21, parts 170 - 199), latest edition. In addition to their corrosion resistant properties, clean ability is an important factor in selecting the proper plastic material. The following plastics are easy to clean, and may be used in contact with the product: Polypropylene (PP) High density Polyethylene (HDPE)

The selection of any other plastics requires approval by [XXXX] prior to their application. Reinforcements in plastics shall not come in contact with the product.

4.1.3 Elastomers Only certain types of elastomer may be used for seals, gaskets, and joint rings contacting the product. For this plant the choices are limited to those compatible with the product: PTFE PVDF Fluor elastomer (FKM, Viton)*

Or for hot oil systems the gaskets recommends by the manufacturer to handle the heat requirements.

* applicable for high temperature applications (up to 260C) Materials used for reinforcement must not be allowed to contact the product. The compression of elastomers must be controlled. Excessive compression of the elastomer will cause damage and may cause the elastomer to extrude into the product zone. Therefore an elastomer seal must be physically limited to the correct compression by metal to metal contact within the joint, taking into account thermal expansion due to temperature variations. Manufacturers will make recommendations as to the torque that each gasket can have on the flange. 4.1.4 Adhesives Where adhesives must be used for keeping gaskets in place (ie in plate heat exchangers), these shall always comply with the recommendations of the equipment supplier. This is required to ensure that the adhesive will not lead to localised corrosion attack of the stainless steel of the equipment. Compatibility of all adhesives with process conditions and materials must be checked with Quality Assurance and approved before use. 4.1.5 Coatings No coatings are permitted on product contact surfaces. 4.1.6 Prohibited materials The following materials shall not be used in contact with the product: Zinc Lead Cadmium Antimony Asbestos Plastics containing free phenol, formaldehyde or plasticisers (PVC) Wood Copper Brass Bronze

4.2 Secondary contact materials 4.2.1 Stainless steels All the grades above are acceptable, in addition: AISI 304 AISI 304 L, 321 (as above for welded parts

4.2.2 Plastics In addition to the above list, PVC may be used where necessary as covering for electrical cables. Where possible, PVC insulated electrical cables shall be protected from contact with the product by other materials more applicable with the product. 4.2.3 Elastomers See section 4.1.3 for information on suitable adhesives. 4.2.4 Adhesives See section 4.1.4 for information on suitable adhesives. 4.2.5 Lubricants Where there is a risk they may come in contact with the product, greases and lubricating oils shall comply with the FDA regulations, especially with 21 CFR 178.3570. This chapter specifies which components are allowed in oils and greases used as protective anti-corrosion film, as release agent on gaskets and seals of tank closures, or as a lubricant where there is exposure of the lubricated parts to product or in-process fluids. 4.2.6 Signal transfer liquids Liquids used for signal transfer may come into contact with the process fluids if a membrane leaks. Therefore these liquids shall comply with the above FDA regulations. Silicone oil or glycerine are often used for this purpose, however vegetable oils are the preferred medium for this plant. 4.2.7 Coatings Coatings that may crack, blister or flake should be avoided on secondary contact surfaces. 4.2.8 Prohibited materials The following, materials shall not be used in secondary contact situations: Lead Cadmium Antimony Asbestos Plastics containing free phenol, formaldehyde or plasticisers PVC (but see above) Wood

4.3 Non-contact materials 4.3.1 Walls and floors All wall and floor finishes in process areas shall be suitable for washing down, ie smooth, no shedding, impervious to moisture and resistant to all substances used in manufacture and cleaning. Joints shall be fully scaled or constructed so as to minimise crevices.

4.3.2 Paints and coatings All paints, lacquers and varnishes applied to walls, ceilings etc should conform to the following: - Good quality /resistant to flaking when properly applied to well prepared surfaces - Free from lead, arsenic, antimony, cadmium, chromium, barium or mercury - Not containing toxic solvents or substances injurious to health that may be leached out by condensation of vapours. Any paints containing fungicides should be clearly identified and used in a particular location only upon approval by Quality Assurance 4.3.3 Prohibited materials The following materials shall not be used anywhere in the plant: Lead Cadmium Antimony Asbestos

SURFACE FINISHES, CREVICES & DEADLEGS

5.1 Internal Large product contact surfaces of equipment shall have an internal surface finish of <0.8 m Ra (for definition of Ra, see ISO 4287). A roughness >1.2 m Ra is acceptable for small areas (e.g. inaccessible welds). (Note: cold rolled steel is normally 0.2 - 0.5 m Ra, and therefore does not require polishing). Roughness values <1.2 m Ra are acceptable inside proprietary items such as pumps, provided that these are otherwise of acceptable hygienic design and a smoother finish is not readily available. See also Section 6 and 7. The inside surface of product contact pipes shall have a roughness <0.8 m Ra. Where agreed by Quality Assurance, longitudinal seam welded pipes may be specified, in which case the maximum internal seam roughness may be <2.0 m Ra. 5.2 External Surface roughness must be such that manual cleaning can be easily performed. Sharp corners, edges, dead spaces or crevices must be avoided. Inside buildings and particularly in Secondary Contact situations, attention shall be paid to pipe and cable supports to ensure they are easy to clean. Exposed screw threads shall be avoided. See also Section 10.4. 5.3 Crevices Product contact surfaces must be free from crevices, therefore: The use of O-rings in contact with the product is not allowed in process equipment and piping systems. The only exception is in constructions where the O-ring is deformed to provide a seal at the product contact surface. Figure 1 shows an example of the acceptable use of O-rings.

Avoid metal to metal joints in contact with the product, other than welding (metal to metal contact may allow the ingress of bacteria), if it is not a coupling with AAAapproval. Avoid misalignment of pipe connections (see Section 11, Illustrations). If seals/gaskets are used, their design must be such that no crevice exists where soil residues may be trapped and bacteria can accumulate and multiply. Avoid contact of product with screw threads and crevices (see Section 11, Illustrations). Sharp corners are not allowed. The minimum radius of corners is 3 mm. Hose clamps connecting flexible and rigid materials must be as close as possible to the product side to minimise entrapment of product between the rigid and flexible surfaces.

5.4 Dead-legs Dead-legs must be as short as possible. Dead-legs are defined as any branch out of the process fluid flow. Target length of such branches shall be less than 2 branch pipe diameters, but must not exceed 4 pipe diameters from the wall of the main pipe. For insertion of probes, instead of a regular Tee piece a swept Tee or a bend can be used. If dead-legs are unavoidable, special care must be taken in the design and proper installation. Special provisions for CIP shall be provided. This must be discussed and agreed in advance with Quality Assurance To enable CIP, the cleaning fluid flow must be directed towards the dead end, which must be as short as possible. If liquid is used to inactivate micro-organisms in the process line, there shall be no upward pointing dead legs as they would trap air and thus prevent the microbiocidal liquid from reaching all surfaces.

MECHANICAL EQUIPMENT
There is inevitably a conflict between moving/rotating equipment and the best process design. Mechanical equipment should be selected to comply as far as possible with the following guidelines: 5.5 Self draining Where possible, pumps etc should be oriented such that any fluid remaining after use will self drain. If this is not feasible, then consideration shall be given to the addition of suitable drain valves. 5.6 Cleaning All process fluid spaces should be mechanically swept by the action of the equipment, or sufficient turbulence generated to ensure efficient cleaning. Internal surfaces should be smooth with no abrupt changes in cross-section or sharp corners.

5.7 Shaft sealing Seals used to contain process fluids shall be separate from those used to contain lubricants etc. Lip ring shaft seals can be used for gearboxes etc provided there is no direct contact with the product. Single mechanical seals are widely used for scaling process fluids. Attention should be paid to assure continuous overpressure from the process side. Double mechanical seals are acceptable in cases where the process fluid provides inadequate lubrication and/or cooling. Fluids used for seal cooling shall be compatible with, and where possible at a lower pressure than that on the process side of the seal.

5.8 Screw Threads There shall be no exposed screw threads inside product contact areas. Deviations will have to be presented to and approved by Quality Assurance. Cap nuts shall be used where possible. 5.9 Leak detection Any leakage of joints, seals etc. shall be directed to the outside of equipment, where it shall be immediately self evident, and the source easily identified. 5.10 Replacement parts Parts requiring periodic replacement shall be easily replaceable and designed so that they cannot be wrongly assembled. Joints and seals shall be designed so that leak proof assembly is easily achieved with the correct components and without recourse to sealing compounds.

6 TANKS & VESSELS

6.1 Product contact surfaces/visual inspection All product contact surfaces shall be accessible for cleaning and visual inspection. Where necessary, this may be by means of dismantling. 6.2 Internal corners All internal corners shall have a radius of minimum 50 mm where possible. 6.3 Inlets and outlets All inlets and outlets shall be flush to the inside of the vessel. Side connections should be avoided where possible. Where vessels are subject to CIP, care should be taken to ensure that the spray ball(s) can reach to the end of connections, except where the connection is part of a CIP route. 6.4 Internal fittings Internal fittings, which may create difficulties when cleaning, shall be minimised. Where internal fittings are required, their arrangement shall be co-ordinated with spray ball(s) to ensure that no masking of internal surfaces occurs.

6.5 Vessels self draining Vessels shall be self draining. All surfaces should slope towards the drain connection(s). Pockets and depressions, whether by design or by the flexing of unsupported surfaces, shall be avoided. 6.6 Surface finishes Surface finishes shall be in accordance with Section 5. All welds shall be ground and/or polished to visually match the surrounding surface. 6.7 Lids and man lids Lids and man lids shall use simple hinges where possible. It is essential that the action of opening lids or man lids does not allow contamination to enter the vessel. The design shall avoid the creation of internal pockets. Stand-offs shall be minimised to aid cleaning. 6.8 Screw threads inside vessel There shall be no exposed screw threads internal to a vessel. On the outside, exposed screw threads shall be minimised. Cap nuts shall be used where possible. 6.9 Shaft seals Shaft seals for agitators etc. shall follow the principles described in Section 6.3). Agitators shall either be top entry, or bottom mounted magnetic drive type. Deviations have to be presented to and approved by Quality Assurance. 6.10 Exterior and non product contact surfaces Exterior and non product contact surfaces shall be readily cleanable and arranged to prevent the harbouring of dirt, bacteria or pests. Legs made from hollow stock shall be completely sealed. Ties and braces shall be minimised and avoid acute angles and crevices. Where it is necessary to have stiffening, bars on the top of a tank, they shall be of the stand-off type, or continuously welded. 6.11 Feet Where stainless steel legs meet the floor, they shall be designed so that the floor and surrounding area is easily cleaned. The area meeting the floor shall be curved so it is easy to clean. 6.12 Design and cleaning duties Design conditions must take into account both production and cleaning duties. Particular attention should be placed on conditions at the end of CIP, where atmospheric collapse may create a vacuum in a normally atmospheric vessel. 6.13 Contamination during fabrication During, fabrication, all possible sources of surface contamination must be removed. After flame cutting the surface should be removed by grinding to prevent slag inclusion. All stainless steel welds shall be continuous, using MIG or TIG methods. Filler wires must be compatible with the parent metal. All joints should be butt welded where possible. If fillet welds are used, they should be given generous radii. Where it is necessary to use carbon steel brackets or supports, these must not be welded directly to a stainless steel vessel; stainless steel backing plates must be used.

PIPING

7.1 Pipes Pipes and fittings/accessories to be used have to be in accordance to the standard DIN 11850 serial (SS6). (Pipes: DIN 11866, Fittings: DIN 11865, Connections: DIN 11864). Deviations from this will have to be discussed and approved by Quality Assurance Ref. Piping Specification, Document number P52-001. 7.2 Couplings The number of couplings shall be minimised, continuously welded pipe assemblies being used wherever possible. Where couplings are necessary, for example to allow dismantling for cleaning, or maintenance, Screw fittings to DIN 11864-1 are to be used. These couplings comprise a metal to metal mating surface to avoid distortion or over compression of the gasket. There may be reasons to use other coupling as, such as Clamp fittings to ISO 2852. These shall be agreed in advance by Quality Assurance 7.3 Hard Tees Although factory made tees require more welding compared to site welded tees, the factory made T pieces are to be preferred. Where site welded tees are to be used, the pipe neck shall be inspected for hair cracks after it is drawn out. 7.4 Swept Tees Swept Tees can be used where minimum dead-legs are required, for example for the mounting of instrument probes (see Section 5). 7.5 Reducers Changes of cross sectional area shall be effected by a smooth taper without abrupt changes or sharp edges. They shall be oriented such that they are self draining and welded to the adjacent pipe where possible. 7.6 Flange construction Where the pipe couplings specified in 8.1 are unsuitable, the flanged joint type illustrated in Section 11 (or any equivalent alternatives supplied by specialised vendors) may be used. The use of these kinds of joints shall be agreed by Quality Assurance The spigot on the face of the flange serves to: - locate the two mating flanges together accurately and prevent the occurrence of a "step" - provide defined compression of the gasket. - provide a bacteria tight joint at the product side due to the 5 angle on the spigot face. The gasket shall be made from approved elastomer with a smooth outer surface, and a hardness of 70 shore.

8 VALVES
8.1 General requirements Within the limits of each valve type, the flow passage shall be smooth with no abrupt changes in cross section.

The design shall allow easy dismantling for maintenance and cleaning. It shall be inherently self draining. Any leakage shall be immediately self evident, and the source easily identified. The valve mechanism shall be completely isolated from the process fluid. Seats shall be designed to make an effective seal where shut-off is required, and shall not hinder self draining. Seats shall give a smooth contour to the bore. Where soft seats are used, they shall be so retained that they are not easily displaced by pressure or vacuum. In particular, seats shall be designed to resist wear and allow regular maintenance in order to preserve their performance characteristics. Manual valves shall be clockwise closing, and their open or closed state shall be readily apparent. 8.2 Diaphragm valves Internal diameter shall be equal to that of the pipe applied. Tapering internal diameters are not permitted. The membrane shall be selected for compatibility with the product, cleaning agents and operating temperatures. The bonnet shall be provided with leak detection to show leaking of membrane. Note: The construction of the sealing bridge (weir) can cause an obstruction in horizontal pipes so that they are not fully drained. To make the system capable of being drained, such valves shall be installed an angle as recommended by the manufacturer (typically with the valve stem 15 to horizontal). Some designs may leave a small residual space in the valve. 8.3 Ball Valves Because of the dead space around the ball and between the seals, it is not considered easy to assure the cleanliness of ball valves. They may only be used in contact with the product where no suitable alternative is available, subject to the approval of Quality Assurance in each instance. 8.4 Butterfly valves Butterfly valves of hygienic design have to be approved by Quality Assurance before use. 8.5 Plug valves Valves that regulate the flow by means of a plug, attached to a moving shaft shall be designed to eliminate contamination caused by the shaft moving into and out of the process fluid flow. The shaft seal may be affected by a diaphragm or bellows, which may be combined with the scat. Such seals must be easy to clean, and any leakage clearly evident outside the valve. 8.6 Control valves Control valves shall have a fixed, not a soft seat. A bellows or membrane seal shall be used for shaft sealing, as for plug valves. Care should be taken to ensure that the valve will permit an adequate flow during cleaning operations.

8.7 CIP valves For combining Cleaning In Place systems with the process plant, special valves may be used to serve as a barrier between the cleaning system and the process system. These valves shall have leak detection between the valve seal of the cleaning component and the valve seal of the process component. The operating shaft must not come into contact with the product. 8.8 Other accessories To prevent risks of contamination, accessories like safety relief valves, non return valves and restriction orifices shall be mounted beyond the product contact parts where possible. Where they have to be situated in product contact pipelines suitable designs meeting the requirements of this philosophy as far as possible shall be used, subject to the approval of Quality Assurance in each instance.

9 PIPING INSTALLATION
9.1 Welding The preferred fusion method is automatic orbital welding, ensuring a protective gas both at the inside and outside of the welding surface (TIG welding). If carried out properly, no post welding treatment such as grinding and polishing is necessary. Samples of welds must be approved by Quality Assurance. Manual welding is also acceptable when performed by properly skilled and qualified welders. The specifications of the two pipes to be joined must be as similar as possible. It is important to note that not only may outer diameters vary within a general classification by 10% (depending upon type of tube and standard), but that tube manufacturers may produce a wide range of standard sizes which can be quite similar. If the inside diameters of the pipes are not the same, it may be possible to expand the smaller size up to the larger. Specialised expanding tools available for this purpose must be used. Careful preparation of pipe ends is essential to a good quality weld. Ends must be cut square using, specialised cutting equipment. No grinding of the inside pipe surface is permitted. All manual welds, and at least 10% of orbital welds must be internally inspected with an endoscope. Identification of inspected welds must take place. The CONTRACTOR shall submit inspection protocols. Welds must exactly fill the gap between pipe ends and fittings. No under penetration or excessive over penetration and/or surface weld defects are allowed. 9.2 Bending Bending, of small diameter pipe has the advantage that fewer welds are required. Specialised equipment shall be used. Bending radius shall be minimal 3 times the nominal diameter and the wall shall be completely smooth without flattening etc. Samples of pipe bends made in this way must be approved by Quality Assurance 9.3 Piping layout To ensure that pipelines self drains, horizontal pipe runs shall be inclined to a specified slope towards drain points. A slope of 1:100 will be adequate for piping local to equipment, and special bends and tees will not be required. The slope may be increased to 1:30 for long runs of small diameter pipe to ensure that sagging or distortion does not lead to reverse slopes. The required slope shall be clearly marked on all drawings.

9.4 Supports Supports for piping or equipment must be fabricated and installed such that no pockets of water or soil can remain on the surface or within the supports. The preferred option is to use rectangular tubing with fully welded ends.

10 TYPICAL DRAWINGS
FIGURE 1

HYGIENIC RISK

CORRECT

O-ring

Misalignment

O-ring

FIGURE 2

Gasket and gap

Misalignment

Gasket and no gap

No misalignment

FIGURE 3
Gasket

Product side

Product side

Gasket