盤式干燥器,瓶子干燥機(jī) 英文使用說明、操作手冊(cè)英文范本.doc

USER REQUIREMENT SPECIFICATION FOR BOTTLE DRYER ARTICLE 1 APPROVAL Raised By NameDesignationSignatureDate Reviewed By Reviewed By Approved By Revision History Sl NoRevision onDateHistory 10103 07 2013New ARTICLE 2 INTRODUCTION This URS cover the design manufacturer inspection testing and putting into the operation of Tray Dryers together with supporting document of the equipment to be used in a ORAL LIQUID manufacturing department This design must meet all cGMP guidelines and legislation 2 1 Purpose Purpose of specifies the user requirement for a Bottle Dryer 2 2 Scope This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor The equipment supplier or vendor will be abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions 2 3 General Description The Bottle Dryer will be operated within the Bottle Dryer room of the new building 2nd floor under Clean Class D ARTICLE 3 OVERVIEW Bottle dryer utilize the principle of passing the hot air at a high velocity through the chamber of trays that contains material Bottles to be dried The blower situated on the exhaust side of the dryer operates on negative pressure principle which create the induced draught and sucks in the fresh air in to the dryer 3 1 Use The Bottle Dryer will be used for drying of bottle to remove its water switches operator panel etc shall be in English language Optional Minimum protection class of control cabinets placed outside the clean room is IP54 Surface epoxy painted not required for plastic materials Machine should measure controlled automatically the following parameters 4 1 6 1 Temperature Control Built in Digital Temperature Controller Manufacturers name must be mentioned for controlling a Temperature b Drying time c Cooling time There should be proportional control valve Temperature should be within 200oC to 250oC 4 1 6 2 Process Time Indicator There should be a timer for indicating the process time 4 1 6 3 Pressure Gauge Machine should be equipped with differential pressure table 4 1 7Validation Port There should be validation port in different position for measurement of temperature 4 2 Utility Requirement Power Supply 380 415Volts Current Frequency 50 Hz Compressed air Pressure available 8 9 kg cm2 Consumption Max peak Mean Electricity 400V 6 6 3 Phase Electricity 230V Single phase 50 Hz Compressed Air with required pressure 4 3 Main Physical Data Room Size will be supply later Room Temperature 22 20 C Clean Class Class D Main Machine Maximum size installed mm L x W x H Note of any additional access requirements mm Maximum weight installed kg Minimum size of access openings for Transfer positioning mm Lx W x H Air inlet unit Maximum size installed mm L x W x H Note of any additional access requirements mm Maximum weight installed kg Minimum size of access openings for Transfer positioning mm Lx W x H Air outlet unit Maximum size installed mm L x W x H Note of any additional access requirements mm Maximum weight installed kg Minimum size of access openings for Transfer positioning mm Lx W x H Tray Dryer Tray size range Length min mmmax mm Width Height 4 4Material of Construction 4 4 1Main Chamber The main chamber should be S S 316L made in single piece welded construction for easy hygienic cleaning There should not be any flange joints in process chamber 4 4 3Seal Compliant with FDA Regulation eg PTFE Silicon or viton rubber 4 4 4Product Tray Product should be made of SS 316L Size Number of tray should be mentioned 4 4 5Heating Coil Electrical coil unit with copper tube aluminum fins 4 4 6Heat Insulation During normal operation no external part of the equipment should reach a temperature in excess of 550C Where parts are likely to attain a temperature in excess of 550C they should be insulated with proper insulating materials and clad For those parts in the pharmaceutical zone this cladding shall be in stainless steel AISI 304 Note No asbestos in any form shall be permitted for any purpose 4 4 7 Inlet Air chamber It should be made of S S 304 4 4 8 Duct Inlet Duct and out let duct should be made of S S 304 4 4 9 Others All parts of equipment in contact with the product shall be stainless steel AISI 316 L Surface that contact components in process materials or drug products shall not be reactive additive or absorptive Product contact surface shall have a surface better than Ra 0 5 micron All product contact lubricants shall be food grade All non contact MS parts must be cladded with AISI 304 4 5 Cleaning The design and construction of the equipment should be such that sharp angles and corners and other parts those are not easily accessible for cleaning are avoided All parts have to be designed in such a way that it can be dismantled easily for cleaning Machine should be modular design to have easy cleaning facility Supplier shall provide detail cleaning procedure validation method 4 6 Safety There should be standard safety facilities 4 6 1 Noise The noise levels at the work place for each machine operating at maximum speed must be below 75 dB A at operator work position the supplier shall state noise levels during normal operation of the equipment 4 6 2 Emergency Stop The system must have a local stop capability that shuts the system down in an orderly manner The E stop mechanism shall be located in easily accessible areas around the equipment No damage to the machine will occur due to emergency stop 4 6 3 Explosion Relief Vent There should be expansion flap incase of excessive pressure generation in the chamber Optional 4 6 4Earthing There should have positive earthing network to neutralize the plausible static charge at tentative points 4 6 5 Electrical All electrical equipment located in process areas should be rated to IP55 dust proof and protected against water jets unless specified otherwise and terminations within the machine made in sealed junction boxes Electrical equipment located in non process technical plant areas should be rated to IP41 minimum 4 6 6 Interlocking There should be process security for no batch failure by interlocking all the process key parameters There should be interlocking between Tray Dryer blower motor and exhaust damper 4 6 7 Locking Device There should be pneumatically operated safety locking device 4 6 8Utility failure When reconnected after an electric power failure the machine must not start automatically without operator input In a case of any other utility failure the machine should stop If a hardware failure occurs the complete machine must stop immediately in a safe way 4 6 9 Alarms Error messages shall be in plain text with fault code Optional Error messages shall be printed clearly A light on the machine shall indicate all alarms Emergency stop activated Pressure sensors out of range The process cannot complete the current task The current task shall be specified on the alarm report 4 6 10 Power failure Recovery On power failure the system shall fall into a safe state A safe state shall be defined as All motion stopped on the machine Reset required before machine to be restarted No damage to machine will occur and No product loss Re start based on last state before loss of power 4 7 Maintenance and Spare Parts Maintenance The machine shall be built with intention for quick and easy access for service and maintenance The supplier shall provide customer s personnel an adequate training for operation and maintenance of the control system The supplier shall provide lubrication list and recommended schedule The supplier shall provide a scheduled maintenance plan Spare parts Spare parts recommended for two years of normal operation List must be attached with the offer Special tools necessary for service and maintenance shall be stated as a separate post in the quotation and included in delivery The supplier shall provide a list of recommended spare parts of the control system ARTICLE 5 PLANS DOCUMENTS Supplier will prepare the DQ Design qualification and get approval from authorized representative of the client in advance The supplier shall provide at the time of the inspection visit acceptance trials 2 copies of the following documents all in English language Equipment completeness and compliance to the specifications and design Equipment operational compliance Proper IQ OQ protocol report execution All Mechanical Plans As built Drawings All Electrical Plans As built Drawings Instruction Manual for installation Copies or samples of any checklists used to record tests and checks Programme to detail the equipment supply and the following a Proposed issue dates of documents b Approval dates of documents c Key activities d The critical path The following manuals drawings to be available Soft Hard Copies English Version 2 2 Operational Manual 3 Service Manual 4 Routine maintenance schedule and change parts 5 Drawings of P I diagram 6 Wiring diagram 7 Equipment layout diagram 8 Control Panel Board Electrical Assembly drawing others necessary Certificates Material certificates for all metallic parts in contact with product Material certificates statements for all non metallic parts gaskets in contact with product Certificates and or measurement protocols for surface finish for all metallic parts in contact with product Calibration certificates of measuring apparatus with validity date signature with date ARTICLE 8 FACTORY ACCEPTANCE TEST MUST ARTICLE 9 SITE ACCEPTANCE TEST SAT COMMISSIONING VALIDATION AND TRAINING OF OWNER S PERSONNEL The supplier shall quote separately for the provision of competent English speaking Commissioning Engineer or Engineers on site to Supplier is responsible for machine installation supervises the installation of the equipment Supplier provide