FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 2 of 26
CONTENTS 1. Scope of Supply ...... 4
2. Operational ...... 5
3. Utilities Required demands ...... 6 3.1 Environmental Conditions Requested for Installation...... 6 3.2 Others ...... 6 4. Process Description...... 7 4.1 Saturated Steam Cycles...... 8 4.2 Air-over-steam cycles ...... 10 4.3 Programs Included in Delivery...... 11 4.4 Autoclave Performances ...... 12 5. Mechanical Construction...... 13 5.1 Pressure Vessel...... 13 5.1.1 Chamber...... 13 5.1.2 Jacket ...... 13 5.1.3 Doors...... 13 5.2 Insulation ...... 14 5.3 Machine Frame...... 14 5.4 Panels...... 14 6. Mechanical Components ...... 15 6.1 Pipes and Valves...... 15 6.2 Vacuum and Drain System...... 16 6.3 Incoming Air to Chamber...... 16 6.4 Internal plates heat exchangers cooling/drying system...... 17 6.5 Chamber’s Internal Circulation Fans ...... 17 6.6 Spray washing/rinsing System ...... 17 7. Electrical Components ...... 18 7.1 Required Connections ...... 18 7.2 Control System ...... 18 7.3 Panel and Indicators on loading side...... 18 7.4 Indicators on unloading side...... 18 7.5 Indicators in Service Area...... 19 7.6 Temperature and pressure transducers ...... 19 8. Extra features ...... 21
9. Documentation ...... 21 9.1 Installation Drawing, P&ID...... 21 9.2 Pressure Vessel Documentation ...... 21 9.3 Documents supplied on Completion...... 21 10. Standards & Codes ...... 23
11. Glossary...... 24
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Appendix 1 TN-102081– TH4 - Report of Pressure and Temperature Measurement
Appendix 2 SP-102190– TH4 – Extract from Functional Design Specification
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1. Scope of Supply
1.a The machine has to be in accordance with this specification that defines the main characteristics of the machine for STERILYO (FRANCE). However this specification is not intended to provide a complete list of all machine characteristics: some details or additional features can be omitted, but the non-mentioned characteristics cannot affect the compliance to the requirements declared in this document.
1.b The autoclave shall be complete in all respects, comply with current cGMP standards for clean, efficient, safe and secure operation, maintenance; it will comply with the current GAMP, having its control systems tested and verified to enable full process validation to be performed.
1.c FEDEGARI shall provide an autoclave system, fully piped, wired, instrumented and tested, consisting of the following as a minimum:
- Sterilizing chamber (pressure vessel with external jacket) - Facing loading/unloading side panels, with bio-seals on both sides - Two horizontally sliding doors - Thermal insulation with external sheathing - Pipes and valves - Frame for chamber and valves - Control devices and instrumentation - Thema4 process controller - No. 2 liquid ring vacuum pump systems for mechanical air removal, as described in section 6.2 - No. 1 intake air filter equipped with connections suitable to perform manually the WIT test - Washing/rinsing spray system - Electrical panel in technical area - Operating panel on loading side - Thermal paper printer, on loading side - Indicators at loading/unloading side, as described in section 7.3 and 7.4 - Indicators in service area, as described in section 7.5 - Temperature and pressure transducers, as described in section 7.6 - External trolley(s), as described in section 2 - Internal trolley(s), as described in section 2 - Drain cooler, as described in section 6.2 - Air/water separator on the general drain - Internal plates heat exchangers cooling/drying system - No. 2 fans for internal air circulation - Thema4 validation package (shared with NA1341AN and NA1342AN sterilizers) - Remote GUI license
1.d FEDEGARI will supply the documentation, as specified in Section 9 of this document, and the autoclave qualification documents, including all factory tests, pre-delivery tests and results and input into PQ.
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2. Operational
2.a Loading component processor/autoclave The autoclave is a two-door unit. It shall normally be loaded from SIDE 1 and unloaded into SIDE 2. The inversion of the loading/unloading flow is possible in some cases (for further details refer to Annex 2, SP-102190–TH4–Extract from Functional Design Specification, section 7 “Doors management”). The autoclave loading and unloading operations are completely manual. The autoclave is equipped with the following handling devices:
- no. 8 external trolleys type “A” in AISI 304, equipped with two swivelling wheels1 - no. 8 internal trolleys/pallets type “E” in AISI 3041, each suitable for loading 3 columns of 18 cassettes with one removable side.
The length of each trolley is 1/2 of the usable depth of the chamber. The internal trolleys are equipped with adjustable vertical angles to place the cassettes. The internal trolleys are properly designed to vertically place the removable sides of the cassettes in such a way that they can be easily washed. The bottom of the chamber is provided with two pairs of removable guide rails in AISI 304 to guide the loading trolley.
2.b Process configuration All cycles, except the Leak Rate Test, include:
- pre-treatment - sterilization at desired temperature - post-treatment
The pressure inside the chamber is measured by a precision absolute pressure transducer to properly control the steam supply to the chamber, in order both to ensure a repeatable sterilization process and not to damage the product. The process description is specified in Section 4.
2.c Safety & Interlocking The fully automatic sliding doors are provided with a containment cabinet that prevents access to the mechanisms. The control system interlocks shall prevent the autoclave doors from being opened if a potentially dangerous condition exists within the autoclave, and cycles from being initiated until the doors are closed and locked, thus isolating and sealing the chamber. The autoclave doors can never be opened while the chamber is under pressure and while a cycle is being executed (for emergency reasons a cycle can be aborted in controlled and safe conditions: see TH4 User’s Manual).
As an active protection for the operator, the doors can be closed only by a continuous pressure on closing button (if it is released, the door will automatically reverse its direction motion).
A safety thermometer (TESIC), connected to an independent chamber temperature probe (TE5) and equipped with independent digital display located on the loading side fascia panel, prevents the opening of the doors in case of too high temperature (minimum set level) in the chamber. If during the process the temperature in the chamber exceeds the safety temperature (maximum set level), TESIC locks any energy supply to the chamber by closing the steam inlet valve(s) and the compressed air inlet valve(s). The TESIC temperature set configuration is accessible only through password.
1 Interchangeable with NA1341AN and NA1342AN sterilizers.
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3. Utilities Required demands
3.a Details on the required and available utilities can be found on the installation drawing (FEDEGARI dwg. no. GA011575).
3.1 Environmental Conditions Requested for Installation
3.1.a Limit environmental conditions for the autoclave:
- Temperature, including maintenance area and electric panel: 5 ÷ 40 °C. - Relative humidity max.: 85%, T≤ 40 °C. - Powder concentration max.: 2 x 106 cu ft.
3.2 Others
3.2.a Heat radiation to loading side (door closed) 1,2 kW Heat radiation to unloading side (door closed) 1,2 kW Heat radiation to technical area 4,3 kW Weight (empty) 5500 kg Weight (hydrostatic test) 12300 kg
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4. Process Description
4.a Loading the product, selecting the cycle to be performed, closing and locking the doors: these operations precede the sterilization cycle in strict sense, as well as final door opening and unloading the product. These operations are not automatically performed by Thema4 process controller.
4.b A typical sterilization cycle always includes the following steps:
- Starting the cycle - Pre-conditioning - Heating up to the exposure temperature - Exposure/sterilizing - Post treatment - Atmospheric balance
Each cycle phase can be individually configured within the options of the supplied software. “Service” cycles as chamber tightness (or leak rate) test and chamber draining do not include heating or sterilization phases. For the details about the programmed cycles to be included in the delivery see Section 4.3.
4.c Pre- conditioning The pre-conditioning step may include pre-heating and/or air removal from the chamber and the product.
4.d Heating up to the exposure temperature The chamber and load are heated and pressurized to the required parameters by the heating medium relevant to the selected cycle.
4.e Exposure/sterilizing Exposure phase begins when all the process monitoring probes have reached the lower temperature threshold; this starts the counting of the exposure time. The chamber temperature is held within a selectable temperature range for a selectable period of time. Exposure duration control may be based on “time within temperature range”, with or without calculation of the F0 value summed up, or directly on “F0 target”. The physical parameters for sterilization (temperature range, duration, F0 target, excess of duration, maximum F0 spread, etc.) have to be defined according to load characteristics and probe positions. The success of the process is monitored by dedicated Pt100 probes. In any case, temperature probes are no longer considered if they are detected to be failed, i.e. if they return a measurement value outside the temperature range regarded as meaningful (-20 °C ÷ 160 °C). Dedicated alarms monitor the value of all designated probes over the sterilization period and record incidents such as power blackouts, as specified by programmable parameters.
4.f Post Treatment The purpose of the post treatment is to cool and/or to dry the product/equipment after sterilization.
4.g Atmospheric balance This step equilibrates the internal pressure of the chamber with the atmospheric pressure of the site, either by pressure release via VP4 valve or by vacuum break via VPX and VP3 valves.
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4.1 Saturated Steam Cycles
4.1.a General Saturated steam cycles require the evacuation of air from the chamber prior to the sterilization phase. The air removal from the chamber and, if necessary, from the load can be obtained by the methods described below, to be chosen according to the characteristics of the load to be processed. A one-to-one relationship exists between temperature and pressure of the pure saturated steam, so that the control of chamber pressure may be used to reach and maintain the temperature set. This control method has the advantage to use a physical parameter that has an uniform value inside the autoclave chamber, and is measured by a quick response instrument-in-the-field. The degree of control is precise and responsive enough to maintain a temperature distribution better than ±1,0 ºC both in empty and in loaded chambers, both throughout the load and over time. Heat is effectively transferred to the load as the steam in the chamber condenses on it, releasing its latent heat. Condense is continually drawn out of the chamber by the vacuum pump through a small valve (VP7). The removal of condensate causes the continuous demand of new steam, in order to keep the chamber pressure constant; it also helps to draw out any accumulation of non-condensable gases which may be entrained in the steam. During the phases that perform heating of the jacket, the jacket temperature is controlled by the temperature probe TE8 actuating the on/off inlet steam valve VP1.
4.1.b Air removal: dynamic vacuum (applicable to non-porous and not hollow loads) Vacuum is performed by vacuum pump down to a target value (0,06 ÷ 0,10 bar abs), through vacuum pump PV and full size valve VP6. At vacuum target, a bleed of steam is injected in chamber while the vacuum pump PV maintains a set vacuum value for a target time. Around 90% of air is evacuated during the first pull; the residual air is carried out, together with some steam, during the steam bleed. Initial vacuum rate may be reduced by using the vacuum pump PV7 coupled to the small size valve VP7 down to a programmable intermediate target.
4.1.c Air removal: steam/vacuum pulses (suitable to porous and hollow loads) Vacuum is performed by vacuum pump down to a target value (0,10 ÷ 0,12 bar abs), through vacuum pump PV and full size valve VP6. At vacuum target, steam is fed to the chamber while the vacuum pump PV7 maintains the suction through the reduced size valve VP7, up to a pressure target. At set value of pressure, vacuum is performed again through vacuum pump PV and full size valve VP6, down to a vacuum target. The vacuum rate down to a programmable intermediate target may be reduced by using the vacuum pump PV7 coupled to the small size valve VP7. This pulsing process may be repeated for a selectable number of times. The actual sequence of pulses can also consist out of initial sub-atmospheric pulses followed by final super-atmospheric ones. Around 90% of air is evacuated during the first pull; the subsequent repeated extraction of steam/air mixture, progressively poorer in air, assures complete air removal.
4.1.d Air removal: by gravity (suitable to loads that can be damaged by pressure differences or liquid loads in small sealed containers) The air displacement is performed by steam injection while the drainage valve VP4 is maintained open to allow the direct evacuation of air (mixed with steam). The phase is ended by reaching a target duration or a target drain temperature.
4.1.e Heating phase Steam is injected in chamber up to a target temperature. The steam injection valve is controlled by using as pressure set point the saturated steam pressure corresponding to the sterilization temperature.
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4.1.f Sterilization phase The temperature control is performed in the same way as during the heating phase, i.e. using as pressure set point the saturated steam pressure corresponding to the sterilization temperature. The phase is ended by reaching the exposure time target within sterilization temperature range, or the minimum F0 value calculated by the selected probes.
4.1.g Cooling phase with pressure control Steam inlet to chamber and jacket is switched off, and compressed air is fed to the chamber via VP3 valve, to remove the steam from the chamber in order to allow the cooling without excessive pressure drop. Next to steam removal, cooling water is fed to the internal plates heat exchangers. Cooling phase can be performed either by keeping the pressure constant or by progressively reducing it as a function of the temperature. The control of the chamber pressure is obtained by simultaneously modulating air inlet valve VP3 and vent valve VP4.
4.1.h Vacuum drying phase Steam inlet to chamber is switched off, but the jacket is heated to provide some drying energy to the load and to the chamber walls. Vacuum helps to speed the drying process by lowering the steam pressure in the chamber, thus allowing the evaporation of water surrounding the load, provided this is still warm enough. Vacuum is performed by vacuum pump PV down to a pressure target through full size valve VP6. Initially, the vacuum rate may be reduced by using the vacuum pump PV7 coupled to the small size valve VP7 down to a programmable intermediate target. Finally, target vacuum is maintained until a target time.
4.1.i Drying by vacuum/air pulses Steam inlet to chamber is switched off, but the jacket is heated to provide some drying energy to the load and to the chamber walls. The energy transfer for drying the product may be enhanced by air pulses to the chamber. Vacuum is performed by vacuum pump PV down to a target value (0,10 ÷ 0,12 bar abs), through full size valve VP6. At set vacuum, air is fed to the chamber up to a pressure target. At pressure target, air may be circulated until a target time; then vacuum is performed again through vacuum pump PV and full size valve VP6 down to a target value and vacuum target may be maintained until a target time. This pulsing process may be repeated for a selectable number of times. Finally, target vacuum may be maintained until a target time.
4.1.j Drying by air circulation The jacket is heated to provide some drying energy to the load and to the chamber walls. The energy transfer for drying the product is obtained by air circulation in the chamber. The pressure in the chamber may be either super-atmospheric (outlet via VP4 valve) or sub- atmospheric (outlet via VP6 or VP7 valves and vacuum pumps). Sub-atmospheric air circulation may used either compressed air fed by VP10 valve, or ambient air sucked by vacuum pump via VPX valve. Air circulation is maintained until a target time.
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4.2 Air-over-steam cycles1
4.2.a General It is well known that the internal pressure of a tight sealed container containing an homogeneous liquid is equal to the sum of:
- the steam pressure of the liquid at its actual temperature; - the initial pressure of the air inside the container, multiplied for the ratio of its actual absolute temperature and its initial (i.e. when the container was closed) absolute temperature, and divided for the ratio of the actual head space and the initial head space ("head space" is the difference between the internal volume of the container and the volume of the liquid contained in it); - the fugacity (i.e. the escaping pressure) of the gases initially solved by the liquid.
The ratio between the actual head space and the initial one obviously depends on the difference between the thermal expansion of the liquid and the thermal expansion of the container; it has a meaningful effect in the case of glass containers that are much filled, but it is negligible in case of plastic containers. This is the reason why it is practically impossible to sterilize by heat glass containers with a head space less than 10% unless they are sealed by a movable stopper. This constraint does not apply to plastic containers; on the other side, the mechanical strength of many plastic materials becomes often so small at the sterilization temperature that it is necessary to keep the difference constantly very small between the internal pressure of the container and the autoclave pressure. On the contrary, in case of rigid (i.e. glass) containers the same difference may be appreciably greater.
To ballast the pressure inside the autoclave chamber at almost the same level as the pressure inside the product, the air initially present in the chamber is not eliminated.
4.2.b Heating phase Due to the presence of both steam and air inside the autoclave chamber during the process, the chamber total pressure does not depend directly on the temperature; a one-to-one relationship only exists between the temperature and the partial pressure of the steam inside the chamber. Therefore, the chamber pressure can and must be independently controlled with a fixed or variable set point; this control is obtained by adding compressed air into the chamber or by pressure relief from it. At the end of the heating phase both the temperature set point and the pressure set point are attained. Steam is fed to the chamber to heat the chamber and the product up the set point temperature value. The steam feed valve is controlled by the “plant” probes TE9 or TE10. During the heating phase the control of the pressure in the autoclave chamber is performed by feeding compressed air via the valve VP3 and/or discharging overpressure via the pressure relief valve VP304. Various pressurization patterns are stored in the Thema4 controlled programs and may be configured by the User. The heating phase ends only when the minimum "product" temperature has overcome the programmed min. sterilization temperature threshold (e.g. the minimum sterilization temperature increased of a specific value which varies according to the particular typology of the sterilizer in use. In this case the value is equal to 0,2 °C).
4.2.c Sterilization phase The temperature control and pressure control are performed as during the heating phase. The phase is ended by reaching the exposure time target within sterilization temperature range, or the minimum F0 value calculated by the selected probes.
1 This section is written as standard for FEDEGARI though no air over steam cycles are foreseen for this particular sterilizer.
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4.2.d Cooling phase with pressure control See above, 4.1.g. The discharge of the excess pressure from the chamber may occur, alternatively or in addition, either via the bottom valve VP4 or via the side valve VP304, both of the modulating type.
4.3 Programs Included in Delivery
4.3.a Programmability limits Up to 9999 ready-for-use programs may be simultaneously stored for production. The autoclave will be delivered with the following cycles (each of which may be used as the basis of several production programs with different parameters), derived from the standard FEDEGARI cycles according to the Client’s requirement.
4.3.b 1.01 – Chamber vacuum leak rate test The cycle includes initial vacuum pull residual pressure targeted, stabilization phase time targeted, test phase time targeted, vacuum break phase.
4.3.c 1.03 – Chamber pressure leak rate test The cycle includes initial air pulse pressure targeted, stabilization phase time targeted, test phase time targeted, pressure release phase.
4.3.d 1.04 – Chamber spray washing The cycle includes spray washing of the product by purified water and final chamber drain. For a detailed description on how the spray system works see Section 6.6.
4.3.e 1.10.D2 – Pre-heating/Initial mixed vacuum/sterilization/drying vacuum/drying by air pulses To perform programs at temperature values between 102 °C and 138 °C, including pre-heating initial vacuum with timed steam injection and two sets of separately programmable pulsed steam/vacuum for air elimination, heating and sterilization, programmable vacuum drying, programmable hot air pulses. (See above: 4.1.b, 4.1.c (twice), 4.1.e, 4.1.f, 4.1.h, 4.1.i, 4.1.j)
4.3.f 1.13 – Initial vacuum pulses/sterilization/drying (for porous solids) To perform programs at temperature values between 102 °C and 138 °C, including initial pulsed steam/vacuum for air elimination, heating and sterilization, programmable vacuum drying. This cycle is typical for the loads that demand Bowie Dick Test or DART to check the suitability of the process. (See above: 4.1.c, 4.1.e, 4.1.f, 4.1.h)
4.3.g 1.55 – Initial vacuum pulses/sterilization/drying (for air filter sterilization) To perform programs at temperature values between 102 °C and 138 °C, including initial pulsed vacuum/steam for air elimination, heating and sterilization, optional vacuum drying. VPY valve is kept open during all the cycle, to connect air intake line with chamber for air removal, heating, sterilization and drying. Condense discharge valves VPZ and VPZ1 are kept open during heating and sterilization phase, provided that the chamber pressure is super-atmospheric. (See above 4.1.c, 4.1.e, 4.1.f, 4.1.h)
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4.4 Autoclave Performances
4.4.a The heating of the empty chamber up to 121°C will not exceed 15 minutes. The vacuum system is capable of evacuating the autoclave chamber to an ultimate pressure equal to or less than 60 mbar absolute in max. 12 min (starting from ambient pressure and feeding the vacuum pump liquid ring with water at a temperature that does not exceed 15°C).
The max. allowed sterilization temperature during pure saturated steam cycles is 138 °C.
4.4.b Throughout the holding time the temperature distribution in the chamber in empty conditions does not fluctuate or does not differ more than ±1,0 ºC with respect to the process sterilization temperature.
Throughout the holding time the temperatures measured in the autoclave chamber are maintained within the specified sterilization temperature band according to the proper set sterilization temperature.
4.4.c The autoclave is equipped with a vacuum system capable of pulling the vacuum to a pressure value greater than or equal to 60 mbar absolute and during the chamber leak test the rate of the pressure rise shall not exceed 80 mbar/h, in accordance with HTM 2010 and EN285, over a duration of test equal to 10 min. The test has to be performed after a stabilization phase. The vacuum leak rate test cycle can be performed including the chamber vent filter housing assembly.
4.4.d The expected sound level will not exceed the value of 70 dB(A) at 1 m from the perimeter of the machine (value calculated both considering one operative hour and the period of 8 hours).
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5. Mechanical Construction
5.1 Pressure Vessel
5.1.a The pressure vessel will be designed, manufactured and examined according to the German Construction Code AD-2000 MERKBLATT, in order to obtain the full compliance to the 97/23/EC PED Directive. The pressure vessel is mainly made up of three parts: the chamber, the jacket and the doors.
5.1.1 Chamber
5.1.1.a The chamber dimensions are 1300 x 1500 x 2000 mm (W x H x L), corresponding to an useful volume of 3900 litres. The loading level height is 500 mm.
5.1.1.b The chamber is cylindrical with inner surface ground and polished to high quality. The Ra value has to be better than 0,4 µm. All metal parts in the inner surfaces are made of stainless steel AISI 316 Ti.
5.1.1.c The design pressure for the chamber is 4 bar absolute overpressure and full vacuum. A test certificate will be provided for both the chamber and the pressure relief valve.
5.1.1.d The automatic valve VP4 for pressure discharge is installed on chamber drain line; PC4 micro-switch verifies the valve close position.
5.1.2 Jacket
5.1.2.a The jacket is made of pressed stainless steel AISI 316 Ti, welded around the chamber. The primary purposes of the jacket are to improve heat distribution in the chamber and to reduce condense.
5.1.2.b The design pressure for the jacket is 3,5 bar absolute overpressure. A test certificate will be provided for both the jacket and the pressure relief.
5.1.3 Doors
5.1.3.a The unit has to be a double door unit. The doors are made of AISI 316 Ti stainless steel and have to be of horizontal sliding type, opening and closing automatically by an electric motor. After a sterilization process the doors can be opened and closed repeatedly. The doors are interlocked to prevent the simultaneous doors opening that would compromise the integrity of the sterilized load, of the chamber and of the clean room. The opening of the door on the sterile side is allowed only when sterilization is achieved. Then the door on sterile side can be open and closed repeatedly, until the door on not sterile side remains closed.
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5.1.3.b Provisions are made to eliminate the risk for personnel and equipment to get jammed at door closing. Safety interlocks foreseen for door management are described in details at section 7 of TH4–Extract from Functional Design Specification SP-102190 in Annex 2.
5.1.3.c The doors have internally a smooth surface with a Ra value better than 0,4 µm. The doors’ gasket is made of solid silicone rubber, placed in a precision machine tapered groove around the chamber opening. The gasket tightens against the door when compressed air is pressed into the groove behind the gasket. Before the door is opened, pressure is released and the seal moves back due to its inherent elasticity. Thanks to a properly design and material, all mechanisms are lubricant free.
5.2 Insulation
5.2.a The chamber is insulated with artificial mineral wool fibre panel (asbestos, chlorides and crystalline silica free) whose thickness is 50 mm with aluminium cover sheathing.
5.2.b The door is insulated with 30 mm mineral wool and covered with AISI 304 stainless steel cover sheets. The external temperature cannot exceed 50 °C.
5.2.c The piping insulating sheets are made of polyamide that does not contain asbestos, chloride and crystalline silica. The lines provided with piping insulation are shown on the P&ID (Tag. P.P.: Personal Protection).
5.3 Machine Frame
5.3.a The pressure vessel is supported on a frame with adjustable feet, made of AISI 304 stainless steel.
5.3.b Most valves and other equipment are mounted on a separate frame. This frame is made of AISI 304 stainless steel and has adjustable feet.
5.4 Panels
5.4.a The fascia panel, the door panels and the lateral sides panels are made of AISI 304 stainless steel sheets, vertically brushed. The surface is satin finish to 0,3 µm Ra Scotch Brite. The autoclave is bio-sealed on both sides.
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6. Mechanical Components
6.1 Pipes and Valves
6.1.a All incoming media valves are to be pneumatically operated, sanitary design, made of AISI 316L with Teflon seats and glandless. Condense removal system comprises adjustable orifice drain valve (VP7) and permanent application of vacuum to drain throughout the process.
6.1.b The piping components installed on the machine will be in accordance with the following General Piping Specification:
Item Size Description Piping All sizes Material: ASTM A270 Type 316L Stainless Steel STD O.D. finish Internal Finishing with max. Ra = 0,8 µm (Ra value better than 0,4 µm for clean steam line, compressed air line and purified water line) Imperial size dimensions Nozzles All sizes To be applied to all nozzles welded on the Pressure Vessel. Material: 1.4404/1.4435 EN10216-5 Stainless Steel Tubing STD O.D. finish Internal Finishing with max. Ra = 0,8 µm Imperial size dimensions Joints All sizes Butt welded, Automatic Orbital Welding (as an alternative where not applicable: manual TIG welds) Clamps All sizes Cast type 304 stainless. The ferrules are sanitary design Tri-Clamp type, design and manufacturer according to FEDEGARI STD. Gaskets All sizes EPDM steam resistant material In-Line Valves All sizes and all types Body: hot rolled 316L stainless steel (ON/OFF, modulating, Internal finishing with max. Ra = 0,8 µm sampling installed on STD O.D. finish tubing) Connections: Tri-Clamp type, design and manufacturer according to FEDEGARI STD. Diaphragm: PTFE Lubricant free Thermostatic All sizes Body: hot rolled 316L Stainless Steel steam traps Connections: Tri-Clamp type, design and manufacturer according to FEDEGARI STD. Bimetallic Traps Type by GESTRA
Notes: 1 - Diaphragm valves are designed according to the following design conditions: pressure 6 bar g, temperature 160 °C. The design assures the sanitary design and the installation assures the proper drainage. 2 - All devices are tagged and fully traceable to the P&ID. 3 - All connections are Tri-clamp type connections designed and manufactured according to FEDEGARI STD..
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6.2 Vacuum and Drain System
6.2.a Full rate vacuum is performed by means of the water ring vacuum pump PV (mod. 2BV5 121-0KC90-6S by NASH ELMO) through VP6 valve while the reduced rate vacuum is performed by means of the smaller sized water ring vacuum pump PV7 (mod. 2BV2 060-0NC00-1S by NASH ELMO) through VP7 valve.
6.2.b The pumps have to be connected to an automatic feed and re-circulating water system. Softened water fills up a tank (TANK) and supplies the vacuum pump after having been cooled by a plates heat exchanger (RAFFR2) (mod. CB76-20H by ALFA LAVAL). The water that leaves the vacuum pumps is redirected into the tank thus forming a closed loop. The recovery tank is provided with an overflow and make-up.
6.2.c A drain cooling system is installed on the condensates discharge pipe and on the generic waste before leaving the machine. This system is constituted by a plates heat exchanger (RAFFR) (mod. CB27-24H by ALFA LAVAL) supplied with chilled water and regulated by a thermostat (TER). The system is used to reduce the temperature of condensates below 80 °C. Before leaving the machine the above stream is de-pressurized by separating the air from the liquid phase already present within the cyclone separator (SEP). The residual condensate stream is then conveyed to the main drain system, whose dimensions are designed in order to assure an appropriate evacuation.
6.3 Incoming Air to Chamber
6.3.a The air filter (FA) has to be installed for compressed or atmospheric air entering the autoclave chamber. Filter’s absolute removal rating is 0,2 µm in liquids, 0,003 µm in gases. Filter’s bacterial challenge: Brevundimonas (Pseudomonas) diminuta 107/cm2.
6.3.b The filter has to be housed in a filter-holder made of stainless steel (cartridge PALL type Emflon PFR mod. AB1PFR7PVH4, mod. housing AGT11G95EEH4 by PALL). The installation should be designed for automatic in-line steam sterilization. The sterilization and test cycle includes pre-heating, sterilization (set temp/time), cooling and drying. One Pt100 probe (TE7) indicates and records during air filter sterilization.
6.3.c The filter is equipped with the required connection manual valves (VM6 and VM16) for the execution of WIT test with manual mode and protection sheet.
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6.4 Internal plates heat exchangers cooling/drying system
6.4.a The internal plates heat exchangers cooling water re-circulation system is constituted by a recovery tank (TANK4), connected to a softened water line, a re-circulation pump (PA3, mod. CA70/33 by LOWARA) and a cooler (RAFFR4) (mod. CB27-50H by Alfa Laval), supplied with chilled water. The heat exchanger is of Cu-brazed type, with cover plates, plates and connections in AISI 316.
6.4.b The re-circulation pump and the cooling water feeding valve to RAFFR4 are activated in closed loop to the re-circulation tank (TANK4) both when the thermostat (TER2) is in high temperature condition and during the activation of the cooling system: the cooling water for the heat exchangers is fed through the valve VP308 and discharged through valve VP328 to the recovery TANK4. The cooling water is drained out of the heat exchangers by letting in compressed air through valve VP329. In case of low level the automatic make-up to the tank is assured, in case of minimum level (RL1W) the re-circulation pump is de-activated.
6.4.c The internal plates heat exchangers can be also fed with steam for drying purposes through VP306 valve.
6.5 Chamber’s Internal Circulation Fans
6.5.a The chamber is equipped with no. 2 air re-circulation fans. The motor is magnetically coupled to the fan through the chamber. The fans’ material is AISI 316 for the magnetic drive, while PVDF (Brand mane SOFEF PVDF in accordance with section 177.2510 – Polyvinylidane Fluoride Resins – Code of Federal Regulation, volume 21) for fans’ blades. During operation the fans force the fluid (air/steam) to circulate through heat exchangers opportunely placed within the chamber. In this way the fluid gets cooler and is led again through the load by means of a suitable aeraulic passage.
6.6 Spray washing/rinsing System
6.6.a The machine is equipped with internal nozzles installed on the two sides of the chamber (3 stripes of nozzles for each side, 42 nozzles on each stripe) to assure the washing and rinsing of the product inside the chamber. The stripes are activated in alternation (one stripe at a time with selectable time differences between activations). The rated flow-rate of each nozzle is equal to 1,6 l/min.
6.6.b The chamber is fed with purified water through VPW2 root valve. The six stripes of nozzles are activated by opening VPW2A, VPW2B, VPW2C, VPW2D, VPW2E and VPW2F valves in alternation. After the washing/rinsing process the purified water is drained out of the chamber and is routed to the cyclone separator (SEP) through VP16 valve. The flushing/draining of the purified water line is performed by letting in filtered air at atmospheric pressure through VP6T air intake valve and by simultaneously opening VPE1, VPE2 and VPE3 valves.
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 18 of 26
7. Electrical Components
7.1 Required Connections
7.1.a One power supply 400V - 3ph + PE - 50Hz (for autoclave and control system).
7.2 Control System
7.2.a See TH4 –User’s Manual. With reference to the General HW Configuration of the Control System, the one that will be foreseen for the specific machine is the following (see Section 1 of SP-102190):
1 – Side 1 Operator Panel (primary/S1): Digital Proface PC mod. PL6921-T42 with lateral floppy disk drive 2 – Side 2/technical area Panel PC: not included 3 – PLC remote I/O modules: Siemens ET200S 4 – Hub for Ethernet connection between operator panel and external connection: included 5 – UPS for blackout management: included 6 – Thermal Printer: included 7 – Side 2 door management module: included 8 – Remote Operator Station: not included 9 – Remote GUI license: included
7.2.b All messages and alarms visualized on the PC panel have to be in French.
7.3 Panel and Indicators on loading side
7.3.a Door control panel including emergency stop button, process controller key-switch, door OPEN/CLOSE buttons.
Additional available features are: 1) one light to indicate emergency button activation
7.3.b Sanitary pressure gauge for chamber pressure (MAVS). Pressure gauge for jacket pressure (MAI).
7.3.c Safety thermometer and independent temperature indicator (TE5 and TESIC).
7.4 Indicators on unloading side
7.4.a Door’s control display, emergency stop button, door OPEN/CLOSE buttons.
7.4.b Sanitary pressure gauge for chamber pressure (MAV1S).
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 19 of 26
7.5 Indicators in Service Area
7.5.a Manometers installed on the utility lines: - on the air feeding line for the internal heat exchangers (MA8).
Sanitary manometers installed: - on the compressed air feeding line for the chamber (MA3.1).
7.5.b Manometers installed on the pneumatic distribution lines: - on compressed air controls (MA6 and MA7) downstream the i/p converters (COP and COT) - on the line feeding the low-pressure valves (MA24) - on the line feeding the door seal controls (MA, MA1 and MA2).
7.6 Temperature and pressure transducers
7.6.a Temperature probes
Temperature probes may be fixed or flexible, designated as product, plant or display probes. All circuits have built in linearization (“autocalibration”). The temperature probes are connected with sanitary connection. Temperature probes are of the 4-wire Pt100 type (manufacturer FASINTERNATIONAL), Specification IEC/751 Class 0.1, with silicone rubber sheathing, duplex when applicable (see section 7.6.b). The theoretical measuring range of the temperature probes is –80 °C/+250 °C. Thema4 controller considers the probes to be failed if they return a measurement value outside the meaningful range (-20 °C ÷ 160 °C).
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 20 of 26
7.6.b The following list gives the location and use of each probe supplied by FEDEGARI and by Client. TE5 is not connected to the Thema4 but to a separate safety thermometer TESIC (mod. 2108i/AL/GN/VH/RF/RF, manufacturer EUROTHERM).
Probe ID Type Location Usage Fixed, product Coolest point for TE1 Chamber drain and display saturated steam cycles
TE2 Flexible, Load or chamber Load temperature or TE3 product or free space chamber temperature TE4 display
Safety interlock for door opening (fluid loads), Load or chamber independent TE5 Flexible, safety free space temperature check, independent over- temperature interlock Temperature control of TE7 Fixed, product Process air FA the inlet air Control of jacket TE8 Fixed, plant Jacket temperature by steam valve operation
Control of chamber TE9 Fixed, plant Chamber space temperature during air- TE10 steam cycles
7.6.c Each temperature probe can produce a digital and graphic recording on the Thema4 process controller.
7.6.d The process controller will detect probe failures (open or short circuit) and will ignore data from a failed probe. The process controller will generate an alarm and it will disable the failed probes. However the process will continue as long as at least one plant probe and at least one product probe remain functional; otherwise the process will be aborted with consequent alarms.
7.6.e Pressure transducers
Pressure transducers with separation diaphragm, 0 ÷ 5 bar absolute range, specification VDI/VDE 2184, accuracy +/-0,1% full scale (TP), manufacturer HAENNI mod. ED 701 R204R4A2510/9007/0120.
7.6.f The circuit has built-in linearization (“autocalibration”). The pressure transducers are connected with a sanitary connection. The following table gives the location and use of the transducers supplied.
Transducer ID Location Usage TP Chamber Control of chamber pressure by compressed air/vent valve operation and steam valve
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 21 of 26
8. Extra features
8.a As standard the autoclave includes:
- automatic SIP of sterile air filter and connections for in-line manual integrity testing - condensate level sensor and alarm - chamber validation ports (nozzles C28 and C29) with total capacity for at least 24 thermocouples.
8.b - No. 1 kit for introduction of validation probes provided with one tri-clamp connection (with blanking plates and safety clamps), suitable for the introduction of at least 12 thermocouples.
8.c Other non-standard features included in the scope of supply to be installed on machine are:
- Sanitary pressure switches on clean steam, compressed air and purified water lines (CPV, CPA and CPH2) - Pressure reducers on the compressed air feeding line for the internal heat exchangers, on the compressed air feeding line for the chamber (RA0 and RA1) - Safety valve on compressed air line - 1” ASME BPE compliant Tri-clamp adapters on compressed air line for chamber counter-pressure and on purified water line and 2 ½” ASME BPE compliant Tri-clamp adapter on clean steam line
9. Documentation
9.1 Installation Drawing, P&ID
9.1.a Installation DWG: no. 2 copies already sent and returned approved/commented by Client.
9.1.b P&ID: no. 2 copies will be issued for approval, 1 copy to be returned approved/commented within two working weeks.
9.1.c Certified construction DWG: sent approx 2 weeks after approval. As Built DWG: issued after FAT and delivered with autoclave, in both copies of Technical Manual.
9.2 Pressure Vessel Documentation
9.2.a Pressure vessel documents issued at FAT. Original and one copy.
9.3 Documents supplied on Completion
9.3.a 3 copies of Technical Manual in French, incorporating: - As built Installation drawing - P&ID with parts list - Wiring Diagram with parts list - Drawings of Fedegari supplied valves, devices - Data sheets for bought-in items e.g. vacuum pump
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 22 of 26
- EC Declaration of Conformity for critical instruments - Configuration data - User Manual for Thema4 operating system - Data sheets for each phase in the library supplied - Installation instructions - Sub-supplier information - Maintenance instructions - FDS (Functional Design Specification, issued for the specific machine) - Planned preventative maintenance schedule – daily/weekly/monthly/annual overhaul
9.3.b 3 copies of Operators Manual in French, including: - Recommended spare parts list
9.3.c Process Controller THEMA4 Validation Package including: - Validation Package Letter - Life cycle of Process Controller – GAMP4 Approach - Functional Design Specification - Configuration Manual – HW and SW Configuration - HW-SW Change Control - Libraries Configuration Manual - Change Control P/G Library - Validation Activities Planning - Risk Analysis – Methodology - Risk Analysis – Report
9.3.d Certificates - Welding log for clean steam line, compressed air line and purified water line tubing and 3.1B certificate - Roughness test certificate (for chamber) - Documentation on manometers’ supplier and manometers certificates - Calibration certificates
9.3.e - Data sheets on chamber safety valves calculations - Material declaration - Insulating material declaration - PED dossier copy
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 23 of 26
10. Standards & Codes
10.a The quality System of Fedegari Autoclavi SpA has been Certified compliant with the EN ISO 9001:2000.
The autoclave has to be CE marked and has to be in conformity with the following European Directives:
- Dir. 98/37/EC MD-Machinery Safety - Dir. 97/23/EC annex 3, category III PED-Pressure Equipment module H - Dir. 89/336/EC and amendments EMC-Electro Magnetic Compatibility - Dir. 73/23/EC and amendments LVD-Low voltage systems
10.b The pressure vessel code AD-2000 MERKBLATT (Germany). Build standard is to full cGMP standards. Control software is fully compliant with GAMP4 standard and 21 CFR Part 11. Documentation prepared in compliance to the applicable European Directive. Drawings – P&ID symbology – ANSI-ISA S5.1–1984 (DIN19227, DIN28004).
10.c The autoclave is constructed following the performance requirements, when applicable, specified in EN285 : 1996 Sterilization – Steam Sterilizers – Large Sterilizers (applicable parts) UK NHS Department Technical Health Memorandum HTM2010
10.d Conformity to others European Standards: EN 12100 – Safety of machinery EN 55011 – Industrial scientific and medical (ISM) radiofrequency equipment EN 60204-1 (IEC 204.1) Safety of machinery – Electrical equipment of machines. Part 1: General requirement EN 61000-4-2 (IEC 1000.4.2) Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques. Section 2: Electrostatic discharge immunity test EN 61000-4-4 (IEC 1000.4.4) Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques. Section 4: Electrical fast transient/burst immunity test
10.e The electrical system achieves a minimum protection degree equal to IP54.
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 24 of 26
11. Glossary
CFR : Code Federal Regulation DWG : Drawing FAT : Functional Acceptance Test FDS : Functional Design Specification GAMP : Good Automated Manufacturing Practice cGMP : Good Manufacturing Practice GUI : Graphical User Interface HTM : Health Technical Memorandum HW : Hard Ware NHS : National Health Service P&ID : Process & Instruments Diagram TH4 : FEDEGARI Process Controller Thema4 UPS : Uninterruptible Power Supply WIT : Water Intrusion Test
FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 25 of 26
Appendix 1 TN-102081– TH4 - Report of Pressure and Temperature Measurement
TN –102081-3 Report of Pressure and THEMA4 Temperature Measurement Pag. 2/7
CONTENTS 1. THEMA4 PRESSURE MEASUREMENT...... 3 1.1 “Pressure- Measurement- Chain”: Description and Relevant Errors ...... 3 A. Pressure Transducer ...... 3 B. I/O Module ...... 3 C. Process Controller ...... 3 2. THEMA4 TEMPERATURE MEASUREMENT...... 5 2.2 “Temperature-Measurement - Chain”: Description and Relevant Errors ...... 5 A. Temperature Probe...... 5 B. INOR Module ...... 5 C. I/O Module ...... 5 D. Process Controller ...... 5 References...... 7
TN –102081-3 Report of Pressure and THEMA4 Temperature Measurement Pag. 3/7
1. THEMA4 PRESSURE MEASUREMENT
1.1 “Pressure- Measurement- Chain”: Description and Relevant Errors
The Thema 4 “Pressure measurement chain” is composed by the following elements:
A. Pressure Transducer
Input: 0 – 5 bar abs Output: 4 – 20 mA Model: HAENNI, ED701/R20.4R4.A25.10/9007/0080 Maximum allowable total error: + 0,4% Input Range = +0,02 bar
Note: The evaluation of this error includes non-linearity, thermal drift, hysteresis and reproducibility errors and it is applicable for “media temperature” values from 25 to 125 °C. Each single Pressure Transducer is calibrated (with an interactive method) and certified by the manufacturer in compliance to the above specified precision.” PRESSURE TRANSDUCER
B. I/O Module 1
The performance of the I/O analog module is described according to the manufacturer.
ET200S ET200M Allen Bradley
6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1794-IF2XOF2I 1794 – IF4I Input : 4 – 20 mA Input : 4 – 20 mA Input : 4 – 20 mA Input : 4 – 20 mA Output: 0 – 27648 counts Output: 0 – 27648 counts Output: 0 – 61681 counts Output: 0 – 61681 counts +0.012 mA +0.011 mA +0.017 mA +0.017 mA +0.004 bar 2 +0.003 bar 2 +0.005 bar 2 +0.005 bar 2
I/O MODULE
C. Process Controller
The controller operates using data in Pa.
ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794 – IF4I Input : 0 – 27648 counts Input : 0 – 27648 counts Input : 0 – 61681 counts Input : 0 – 30840 counts Output: 0 – 500000 Pa Output: 0 – 500000 Pa Output: 0 – 500000 Pa Output: 0 – 500000 Pa < +0.001 bar 2 < +0.001 bar 2 <+ 0.001 bar 2 < + 0.001 bar 2
PC
1 I/O Modules according to the specific HW configuration of TH4 as specified on FDS section 7.2. 2 Max allowable total error TN –102081-3 Report of Pressure and THEMA4 Temperature Measurement Pag. 4/7
Total Accuracy of the Measurement-Chain
ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794-IF4I PRESSURE TRANSDUCER +0.020 bar +0.020 bar +0.020 bar +0.020 bar I/O MODULE +0.004 bar +0.003 bar +0.005 bar +0.005 bar PC negligible negligible negligible negligible TOTAL (ABSOLUTE) 3 +0.024 bar +0.023 bar +0.025 bar +0.025 bar
TOTAL (PONDERAL)4 + 0.020 bar + 0.020 bar + 0.021 bar + 0.021 bar
3 Absolute total error is equal to the sum of the allowable total errors 4 Ponderal total error is equal to the square root of the sum of the quadratic allowable total errors TN –102081-3 Report of Pressure and THEMA4 Temperature Measurement Pag. 5/7
2. THEMA4 TEMPERATURE MEASUREMENT
2.2 “Temperature-Measurement- Chain”: Description and Relevant Errors
The “Temperature Measurement Chain “ is composed by the elements described below.
A. Temperature Probe
Model: FAS INTERNATIONAL: PM600019 Sensor Type: Pt100, 4 wire Input: Temperature –20°C / +160°C Output: Resistance, as Temperature function, in compliance to IEC 751 (IPTS68)
Applied wiring: 4 wire, with full compensation of the cable length Maximum allowable error (Tolerance): as defined for Class 0,1 (IEC 751) = Pt 100 +[0,1 + (0,0017 x Unsigned Temperature value)]
B. INOR Module
Model: Inor IPAQ-L Input: -20°C / +160°C Output: 4 – 20 mA Accuracy: 0.1% Input Range = +0.18°C
INOR MODULE
C. I/O Module
The performance of the I/O analog module is described according to the manufacturer.
ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1794-IF2XOF2I 1794-IF4I Input : 4 – 20 mA Input : 4 – 20 mA Input : 4 – 20 mA Input : 4 – 20 mA Output: 0 – 27648 counts Output: 0 – 27648 counts Output: 0 – 61681 counts Output: 0 – 61681 counts + 0.012 mA + 0.011 mA + 0.017 mA + 0.017 mA
I/O MODULE + 0.14°C 5 + 0.12°C 5 + 0.19°C 5 + 0.19°C 5
D. Process Controller
The controller operates using data in cent of Celsius degree °C.
ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1794-IF2XOF2I 1794-IF4I Input : 0 – 27648 counts Input : 0 – 27648 counts Input : 0 – 61681 counts Input : 0 – 61681 counts Output: -20 – 160 °C Output: -20 – 160 °C Output: -20 – 160 °C Output: -20 – 160 °C < + 0.01 °C 5 < + 0.01 °C 5 < + 0.01 °C 5 < + 0.01 °C 5
PC
5 Max allowable total error TN –102081-3 Report of Pressure and THEMA4 Temperature Measurement Pag. 6/7
Total Accuracy of the Measurement-Chain for Some Meaningful Temperature Values
TEMP. 0°c ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794-IF4I PT100 ±0.1 °c ±0.1 °c ±0.1 °c ±0.1 °c INOR MODULE ±0.18 °c ±0.18 °c ±0.18 °c ±0.18 °c I/O MODULE ±0.14 °c ±0.12 °c ±0.19 °c ±0.19 °c PC negligible negligible negligible negligible TOTAL (ABSOLUTE) ±0.42 °c ±0.40 °c ±0.47 °c ±0.47 °c TOTAL (PONDERAL) ±0.25 °c ±0.24 °c ±0.28 °c ±0.28 °c TEMP. 65°c ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794-IF4I PT100 ±0.21 °c ±0.21 °c ±0.21 °c ±0.21 °c INOR MODULE ±0.18 °c ±0.18 °c ±0.18 °c ±0.18 °c I/O MODULE ±0.14 °c ±0.12 °c ±0.19 °c ±0.19 °c PC negligible negligible negligible negligible TOTAL (ABSOLUTE) ±0.53 °c ±0.51 °c ±0.58 °c ±0.58 °c TOTAL (PONDERAL) ±0.31 °c ±0.30 °c ±0.34 °c ±0.34 °c TEMP. 121°c ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794-IF4I PT100 ±0.31 °c ±0.31 °c ±0.31 °c ±0.31 °c INOR MODULE ±0.18 °c ±0.18 °c ±0.18 °c ±0.18 °c I/O MODULE ±0.14 °c ±0.12 °c ±0.19 °c ±0.19 °c PC negligible negligible negligible negligible TOTAL (ABSOLUTE) ±0.63 °c ±0.61 °c ±0.68 °c ±0.68 °c TOTAL (PONDERAL) ±0.38 °c ±0.37 °c ±0.40 °c ±0.40 °c TEMP. 140°c ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794-IF4I PT100 ±0.34 °c ±0.34 °c ±0.34 °c ±0.34 °c INOR MODULE ±0.18 °c ±0.18 °c ±0.18 °c ±0.18 °c I/O MODULE ±0.14 °c ±0.12 °c ±0.19 °c ±0.19 °c PC negligible negligible negligible negligible TOTAL (ABSOLUTE) ±0.66 °c ±0.64 °c ±0.71 °c ±0.71 °c TOTAL (PONDERAL) ±0.41 °c ±0.40 °c ±0.43 °c ±0.43 °c TEMP. 150°c ET200S ET200M Allen Bradley 6ES7 134-4MB00-0AB0 6ES7 331-7NF00-0AB0 1749-IF2XOF2I 1794-IF4I PT100 ±0.36 °c ±0.36 °c ±0.36 °c ±0.36 °c INOR MODULE ±0.18 °c ±0.18 °c ±0.18 °c ±0.18 °c I/O MODULE ±0.14 °c ±0.12 °c ±0.19 °c ±0.19 °c PC negligible negligible negligible negligible TOTAL (ABSOLUTE) ±0.68 °c ±0.66 °c ±0.73 °c ±0.73 °c TOTAL (PONDERAL) ±0.42 °c ±0.42 °c ±0.44 °c ±0.44 °c
TN –102081-3 Report of Pressure and THEMA4 Temperature Measurement Pag. 7/7
References 1. TN – 41712.2/MAR Pressure and Temperature Measurements on Process Controller THEMA 3 for Fedegari Autoclaves. 16.02.2000 2. TN – 98800.1/RPE Uncertainty Evaluation 14.07.2003 3. TN – 99488.1/RPE Taratura della catena di misura dei segnali di pressione e temperatura Controllore TH4 26.01.2004 FEDEGARI STERILIZER FOAF NA1343AN FUNCTIONAL DESIGN SPECIFICATION Doc. no. 147854-3 Page 26 of 26
Appendix 2 SP-102190– TH4 – Extract from Functional Design Specification
TH4-EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION SP-102190 -8
Control system:
THEMA4
EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION
ORIGINAL DOCUMENT: SP-95630v3
Function Abbreviation of Date Signature initials the name (dd/mm/yy) Written by IPR ARE
Revised by: IPR FAF 10/04/2006 FABIO FUSI
8 10/04/06 Implemented access levels table [RDB] 7 03/03/06 Added sect. 1.6 and implemented section 5.3 6 08/02/06 Implemented description of emergency shutdown management 5 11/07/05 Version comply to TH4-SP (D/O # 94296v6, MGH) 4 13/04/05 Version comply to TH4-SP (D/O # 94296v5, MGH) 3 05/11/04 Third emission 2 22/07/04 Second emission 1 29/03/04 First emission Version Date (dd/mm/yy) Description of the revision
Page 1 of 35 TH4-EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION SP-102190 -8
CONTENTS
0 INTRODUCTION 4
1 PHYSICAL DESCRIPTION OF THE CONTROL SYSTEM 5 1.1 HARDWARE ARCHITECTURE 6 1.1.1 SIDE 1 (PRIMARY) OPERATOR PANEL 6 1.1.2 SIDE 2 (SECONDARY) / SIDE 3 (TECHNICAL AREA) OPERATOR PANELS 6 1.1.3 PLC REMOTE I/O MODULES 7 1.1.4 HUB FOR ETHERNET CONNECTION BETWEEN OPERATOR PANELS AND/OR EXTERNAL CONNECTIONS 7 1.1.5 UPS FOR BLACKOUT MANAGEMENT 7 1.1.6 THERMAL PRINTER 7 1.1.7 SIDE 1/2 DOOR MANAGEMENT MODULES 7 1.1.8 REMOTE OPERATOR STATION 8 1.2 SHUTDOWN 9 1.2.1 SHUTDOWN IN SAFE CONDITION 9 1.2.2 EMERGENCY SHUTDOWN 9 1.2.3 RESTARTING AFTER EMERGENCY SHUTDOWN 10 1.2.4 EXTENDED SHUTDOWN 10 1.3 DATA STORAGE 10 1.4 BACKUP/RESTORE DATA 11 1.5 CONNECTION TO THE FIELD 11 1.6 MANUAL ABORT CYCLE 11
2 PROCESS MANAGEMENT 12 2.1 PHASE GROUPS – CYCLES - PROGRAMS 12 2.2 ALARMS – GENERAL INFORMATION 13 2.2.1 "KERNEL" ALARMS 13 2.2.2 “CONFIGURATION” ALARMS 13 2.3 "PHASE" ALARMS 14 2.4 CAUSES AND SOLUTIONS OF ALARMS 15
3 PASSWORDS 16 3.1 OPERATING PROCEDURES AND ACCESS LEVELS 16 3.2 ACTIVE CODE CONFIGURATION DISPLAY/PRINTOUT 17
4 LIST OF OPERATIONS 19 4.1 OPERATING MENUS 19 4.1.1 RUNS & OPERATIONS 19 4.1.2 PROGRAM MANAGEMENT 19 4.1.3 CYCLE MANAGEMENT 19
Page 2 of 35 TH4-EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION SP-102190 -8
4.1.4 SETUP & CONFIGURATION 20 4.1.5 DIAGNOSE & MAINTENANCE 21 4.1.6 LOG-IN & PASSWORDS 22 4.1.7 ALARM & DATA LOGGING 23 4.1.8 ON-LINE MANUALS 23 4.2 OPERATIONS THAT ARE DISABLED DURING A CYCLE 23
5 PROGRAM EXECUTION 24 5.1 TIME CALCULATION 24 5.2 PROCESS SUMMARY 24 5.3 PROCESS REPORT 24
6 PRINTOUT MANAGEMENT 28 6.1 ARCHIVED AND PRINTED DATA 28 6.2 “PROCESS REPORT” PRINTOUT 29 6.2.1 AUTOMATIC OR MANUAL PRINTOUT 29 6.2.2 REDUCED OR NORMAL PRINTOUT FORMAT 29
7 DOOR MANAGEMENT 30 7.1 DOORS CONFIGURATION 30 7.2 DOORS OPENING MANAGEMENT 31 7.2.1 PROCESS CONDITIONS FOR OPENING DOOR 31 7.2.2 SAFETY REQUIREMENTS FOR OPENING DOOR 32 7.3 CRITERIA FOR MOVING MOTORIZED DOORS 32 7.3.1 DOOR SYSTEM ALARMS 32 7.4 SAFETY REQUIREMENTS FOR THE INTRODUCTION OF PRESSURIZED FLUID IN CHAMBER 33
8 CALCULATION OF F0 34
9 GLOSSARY 35
Page 3 of 35 TH4-EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION SP-102190 -8
0 INTRODUCTION
The THEMA4 process controller manufactured by Fedegari Autoclavi SpA is an electronic system, based on commercial hardware, dedicated to the control of moist-heat, gas or dry-heat sterilization processes. The Thema4 software was developed in compliance with GAMP4. Access to the Thema4 process controller and password structure and management was developed in compliance with the “CFR 21 Part 11” directive.
Page 4 of 35 TH4-EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION SP-102190 -8
1 PHYSICAL DESCRIPTION OF THE CONTROL SYSTEM
1 The THEMA4 control system can be configured according to the following composition : 1 – Side 1 Operator Panel (primary /S1) 2 – Operator Panels for Side 2 (secondary /S2) / Side 3 (technical area /S3) 3 – PLC remote I/O modules 4 – Hub for Ethernet connection between operator panels and external connections 5 – UPS for blackout management 6 – Thermal printer 7 – Side 1/2 door management modules 8 – Remote operator station
These 8 main parts are interconnected as shown schematically here:
STERILIZER 6 5
Thermal printer UPS 2 Panel PC Side 2 Field Bus 1 Panel PC card Side 1 BUS Panel PC Technical Area 3 Operator Panel 1 PWR BUS D D AN AN IN OUT IN OUT Operator Panels 2/3
7 4-20mA/Pt100 4 Converter
FIELD: Sterilizer devices (Sensors and Ethernet HUB Actuators) Door module PLC remote I/O modules
8 Ethernet link (DDE, DDL,OPC) to external systems (SCADA, DCS, Recorder)
WINDOWS Printer Serial Line Link (Modbus) PC (WINDOWS) to external systems (SCADA, DCS) Remote operator station
1 The configuration foreseen for the specific project is detailed on the FDS (Section 7.2).
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1.1 HARDWARE ARCHITECTURE
1.1.1 SIDE 1 (PRIMARY) OPERATOR PANEL The Side 1 Operator Panel is the control unit of the system and the operator interface on side 1 of the sterilizer (always installed). This is the primary station of the sterilizer and is composed of two units: 1 Touchscreen Panel PC TH4_HW-PANEL 1 PCI Card for connection via Profibus field bus TH4_HW-I/O BOARD_P
Minimum requirements of side 1 Panel PC of THEMA4 system
The minimum requirements that the Panel PC must have are listed below.
Touch Driver for Pentium III 700MHz 1 HD ≥ 10GB Vx Works 128MB RAM
1 PCI slot for Profibus card
1 LPT port for Thermal Printer
1 RS232C COM for Modbus RS232 connection
1/2 RS232C COM for Door Board connection
1 Ethernet 10/100 MHz port
1 front-mounted Floppy Disk Drive (or side mounted) 1 PS2/Keyboard port for installation of SW and Backup/Restore operations
1 USB port for connection of backup/restore units
12.1-inch color TFT LCD SVGA 800x600 analog resistive touch-screen
1.1.2 SIDE 2 (SECONDARY) / SIDE 3 (TECHNICAL AREA) OPERATOR PANELS Side 2 (secondary) Operator Panels on the side of the sterilizer normally used for unloading and side 3 Operator Panel (technical area of the sterilizer) are two optional additional operator stations on board the machine. Both operator panels are composed of a single unit, which is the same one used for the Operator Panel on side 1: 1 Touchscreen Panel PC: TH4_HW-PANEL
Serial, parallel and USB ports are not used for these panel PCs. Moreover, the hard disk may be replaced with a FLASH Disk, since it stores no data but only the applications required for the installation and operation of the user interface.
Page 6 of 35 TH4-EXTRACT FROM FUNCTIONAL DESIGN SPECIFICATION SP-102190 -8
1.1.3 PLC REMOTE I/O MODULES The digital and analog signals that the control system exchanges with the devices (field) of the sterilizer (sensors and actuators) are acquired and sent by means of (Siemens or Allen Bradley) a set of Input/Output modules that are appropriately powered and communicate with side 1 Panel PC by means of a Profibus communications module. This set of modules is constituted by two units: