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Thema4 Process Controller - No FEDEGARI STERILIZER FOAF NA1343AN Doc. no. 147854-3 FUNCTIONAL DESIGN SPECIFICATION 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 FEDEGARI STERILIZER FOAF NA1343AN Doc. no. 147854-3 FUNCTIONAL DESIGN SPECIFICATION Page 3 of 26 Appendix 1 TN-102081– TH4 - Report of Pressure and Temperature Measurement Appendix 2 SP-102190– TH4 – Extract from Functional Design Specification FEDEGARI STERILIZER FOAF NA1343AN Doc. no. 147854-3 FUNCTIONAL DESIGN SPECIFICATION Page 4 of 26 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. FEDEGARI STERILIZER FOAF NA1343AN Doc. no. 147854-3 FUNCTIONAL DESIGN SPECIFICATION Page 5 of 26 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
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