Home

Manual

1. shield This will protect the product from any debris falling into it and minimise the effect of external air turbulence on the weigh pan The shield can be easily removed for cleaning Electrical Compliance The unit is in compliance with national and international statutory standards with respect to noise guarding of dangerous parts electrical standards and levels of protection hazardous areas An EC Certificate of Compliance is issued with each unit The electrical signal power continuity and earthing tests are dealt with in the Final Test Schedule Software Compliance with Regulatory Standards All Cl Precision Cl Electronics Systems Limited software has been programmed to the coding standards laid down in the Cl Quality Manual This manual has been based on the GAMP Good Automated Manufacturing Practice standards Where the Cl Quality Manual does not provide sufficient guidance for a particular area then the GAMP guide will be followed The operating software used in the SADE SP is not designed for long term storage of results All batch data is deleted prior to starting a new batch Long term storage of data and reports can be achieved with the SP Connect option please refer to the Options section of this document Module amp Machine Serial Numbers Cl keeps track of SADE SP units and their associated modules sub assemblies via a Machine Record Cl labels all SADE SP units with a unique Serial Number SADE SP modules and
2. machine and batch set up It also provides real time on screen monitoring of the batch being processed Cl Matrix 4 also has enhanced diagnostic features to allow monitoring of hardware components during operation Modes of Operation Sorting The Sorting mode will individually weigh and sort product into accept and reject categories providing sort and batch reports including statistical analysis of the sort Sampling As well as weight sorting the SADE SP unit offers a sampling mode of operation so can be used for the weighing and analysing of batch samples up to 1000 In sampling mode a list of the individual weights can be printed Limits The SADE SP provides the user with a comprehensive range of Limit types Min Max The user sets an upper and lower sort limits The values can be chosen or calculated as a percentage of the target weight This limit type is primarily associated with weight sorting A amp B 14 f PRECISION A amp B limits are set as a from the target weight and allows only a fixed percentage of samples to be between the A and B limit A amp B limits are primarily associated with sampling but can be used for weight sorting T1 T2 T3 These limits allow for three limit values and they are set as a from the target weight For example T1 5 T2 10 and T3 15 The user selects the limit points that they wish items to be rejected e g T3 These limits can be used for both weight sorting and sampling
3. up of dust we have incorporated several features The hopper tray insert is perforated so allows dust to fall into a dust collection pot under the hopper There is another dust collection pot located underneath the exit of the bowl feeder A puff of air is regularly passed over the optical detector to minimise the build up of dust Starting a new batch The SADE SP sorters are designed to be simple to set up and operate To start a new batch the user will be guided through the batch setup entering the required details The batch set up is saved and approved Once approved details cannot be altered The operator can then start sorting The SADE SP sorters offer a quick set up mode but also have a library that allows details of Products used regularly to be securely stored When setting up a new Batch using Library mode the operator has only to select the appropriate Product Code and enter the Batch Code All other details are automatically entered from the library settings WHITETAB oated tablet Zz 200 dias 19 E iii 210 E Mechanical Operation The tablets or capsules are manually loaded into the bulk hopper and the sorter set to run From the hopper product moves into the bowl via the hopper vibrator tray This flow is regulated by the proximity detector situated in the bowl feeder The bowl feeder vibrates the product around the bowl and by the use of deflector plates the items are positioned in line ready to drop into the pre weighin
4. 16 Security 16 User ID 16 User Passwords 16 User Access 16 Material Specification 16 Contact Parts 16 Non Contact Parts 16 Material Specification 16 Contact Part Sets 16 Construction Compliance with GMP Standards 17 Draught and Product Shield 17 Electrical Compliance 17 Software Compliance with Regulatory Standards 17 Traceability 17 Module amp Machine Serial Numbers 17 User Manual 17 Options 17 Technical amp Validation Documentation 17 Machine Technical Folder 17 Validation Support DVD Design and Functionality 18 IQ OQ template 18 Material Certification Folder 18 Spares Packs 18 Optional Data Output to a PC 19 SP Connect 19 SP Link 20 Testing 20 Pre delivery testing 20 Installation and Training 20 Installation Requirements 20 Installation Procedure 20 On Site Training 21 f i PRECISION kA Services Required 21 After Sales Support 22 Routine Service Schedule 22 Calibration Certificate 22 f PRECISION SADE SP Series Tablet Capsule Weight Sorters Introduction Cl SADE SP weight sorters are designed for use in pharmaceutical production quality control and research amp development departments for the accurate weight sorting of batches of tablets or capsules Each item is individually weighed and sorted into accept and reject categories SADE SP sorters are versatile units offering flexibility accuracy and quality They can handle both tablets and capsules of different shapes and sizes without the need for any
5. 16 stainless Electro polished 316 stainless steel or PEEK steel or PEEK steel or PEEK polyetheretherketone to FDA polyetheretherketone to FDA polyetheretherketone to FDA 21 CFR 177 2415 21 CFR 177 2415 21 CFR 177 2415 Description of equipment 1 x Control unit 1 x Control unit 1 x Control unit 4 x Sorting modules 2 x Sorting modules 1 x Sorting module 1 x Stand 1 x Stand 1 x Stand 1 x Hopper 2 x Hopper 1 x Hopper 1 x Hopper frame 2 x Hopper frame 1 x Hopper frame Stand can be raised on castors Stand can be raised on castors Stand can be raised on castors for mobility for mobility for mobility Data Output Connections RJ45 Ethernet RJ45 Ethernet RJ45 Ethernet 1x USB 1 x USB View amp Print Statistical Reports including sort Statistical Reports including sort Statistical Reports including sort Statistical Reports counts and statistics can be counts and statistics can be counts and statistics can be viewed and printed as required viewed and printed as required viewed and printed as required 1148Dx1364Wx1493H 942Dx1098Wx1459H 942Dx808Wx1461H x f PRECISION kea Description of the Equipment The SP User Interface and Control Unit The SP User interface consists of a wipe clean touch screen display The SP Weighing and Sorting Modules The weighing and sorting modules for the SADE SP Series include Bowl Feeder amp Bowl Vibrator The bowl feeder is cast in electro polished 316 stainless steel The low voltage
6. Fixed Quantity Sorting The SADE SP unit can be configured to sort a pre specified number of accepts Bin Counts The SADE SP can be set to stop sorting when the accept or reject containers reach a specified number to allow for emptying Statistical Results Statistical results can be produced for the Accepts only for the Accepts and Rejects Balance Head Cl MK6 Balance Head The SADE SP Sorters incorporate the MK6 balance head which is of Cl s own design and manufacture This is a highly accurate robust balance specifically designed for fast response dynamic weighing Calibration and Auto Zero Auto Zero The SADE SP sorters have an automatic zero function that is performed at the beginning of each batch or sort In addition the SADE SP monitors the zero periodically during operation and will automatically re zero if required Calibration The SADE SP sorters have been designed to offer easy and accurate calibration The operator is guided through the calibration process and a record of the calibration can be printed The system can be configured to prompt the operator to conduct calibration at regular intervals using one or two calibration weights The calibration status is included in the Batch or Sort report If a calibration is due or a calibration check has failed the unit cannot be operated until a successful calibration has been achieved A 1g F1 and 500mg F1 Calibration Weight are supplied with the unit An
7. a crossover cable and RJ45 connection Router SP Connect can be set up to run with a router One or multiple Cl units can be connected Network Server SP Connect can be set up to run across the network allowing multiple Matrix devices to connect to a PC with SP Connect via a server SP Link allows multiple units to be linked together to provide higher sorting capacities The additional units are set to SP Link mode and connected to the main SADE SP controller using an SP Link cable The main SADE SP will take over control of the additional weighing channels and provide a single consolidated record of the results of the sorting operation Each SADE can be returned to independent operation by simply deselecting SP Link mode and removing the SP Link cable This provides greater flexibility in sorting capacity and reduces the risk of downtime SP Link applies to SADE SP440 and SADE SP240 units Pre delivery testing The units are fully tested pre installation in accordance with our Final Test Schedule The Final Test Schedule and Final Test result sheet are supplied within the Machine Technical Folder Installation and Training Installation Requirements In order to meet the performance criteria outlined above then the equipment must be installed in an environment suitable for high accuracy weighing We will offer specific advice on this but generally the weighing unit must be located on solid foundations Air movement mechanical vib
8. bowl vibrator assembly ensures a smooth flow of product in the bowl Balance Head and Pan For increased accuracy and faster response CI use their compact MK6 balance head in the SP Series The stainless steel balance pan is of an aero dynamic design and easy to clean Optical Detectors The feed of the tablets or capsules from the bowl onto the weigh pan and the pre weighing feed gate are controlled by through beam optical detectors Auto adjust and auto clean functions help to keep the detectors free from the build up of dust The detectors do not need to be adjusted between products keeping operator adjustment to a minimum Micro Pneumatics The tablets or capsules are removed from the weigh pan by precision low pressure jets located within the sorting assembly The air jets require no operator adjustment and the air pressure is kept constant by a pressure controller Puff profiles automatically compensate for different target weights and empty capsule shells Chutes The sort exit chutes are of a rounded design and easy to clean Draught Shield The sorting platform is covered with a polycarbonate shield which is easily removed for cleaning and set up Mobile Stand SP440 SP240 and SP140 The control unit and the SP weighing and sorting platform are mounted on a sturdy stand which can be raised on castors for mobility The SP Bulk Hopper SP bulk hoppers allow for long periods of unattended sorting e g through the night Ea
9. ch hopper has a vibratory feed mechanism positioned at the base which provides a smooth and regular flow of product into the bowl feeder A proximity switch automatically regulates the flow into the bowl feeder The SP bulk hoppers for the SADE SP240 and SP140 have a two piece construction that makes handling for cleaning much easier and are supplied with lids The large hopper for the SP440 is also designed in sections for ease of handling for cleaning The SP140 has one 60 litre hopper The SP240 has two 60 litre hoppers The SP440 has one 150 litre hopper so can be filled from one single point Report Printer The SADE SP Sorters can be connected directly to a local or network standard PCL3 compatible printer using a USB connection A basic printer is supplied for installation purposes see Printing Options for more details 11 fi PRECISION Set up and Dismantling for Cleaning Operation Dismantling Care has been taken with the design and manufacture of the SADE SP sorters to allow for quick and efficient strip down for cleaning The unit can be easily dismantled with minimum use of tools Thumb screws are used in preference to small fixings and screws Set up The unit is simple to reassemble and set up for the next product The amount of operator adjustment needed between products is minimal Advice on dismantling and set up is provided by our Customer Support Engineer during installation Dust To help minimise the build
10. change parts and can be quickly dismantled for cleaning and easily set up for the next product The SADE SP units can send detailed statistical reports directly to a printer Alternatively weight data and reports can be transferred to a PC using our optional program SP Connect First introduced in 1986 and with over five hundred units supplied to many international companies across the world the Cl SADE weight sorter has established a reputation for solid robust and consistent operation The latest SADE SP units incorporate the unique and flexible design of the previous models but we have introduced major improvements to enhance the quality accuracy soeed and operation of the units The latest SP440 SP240 SP140 and SP B40 Benchtop models have new generation electronics and the new CI Matrix 4 touch screen operating system The improved user interface guides the operator intuitively through set up and operation The new display provides real time data on the batch being processed Cl Matrix 4 also has enhanced diagnostic features to allow monitoring of hardware components during operation This document provides information on the three floor standing units the SADE SP440 SADE SP240 and SADE SP140 For details on our SADE SP B40 Benchtop model please refer to the SP B40 Technical Description or please contact Cl Precision Applications r i PRECISION Production Areas Batch Reclamation Reclamation of weight acceptable product f
11. epartment and have qualified personnel available for full technical support Cl also offer Service and Calibration Visits or comprehensive Service Agreements details of which can be supplied on request This Service and Calibration Visit includes for one of our Customer Support Engineers to visit your site to service the SADE SP unit to our Routine Service Schedule and issue a traceable Calibration Certificate Routine Service Schedule Comprehensive examination of the unit Removal of parts for examination and test Withdraw balance head and remove cover and examine mechanism Check operation of control unit keyboard display etc Calibrate the unit and check linearity Perform repeatability test Calibration Certificate A traceable Calibration Certificate will be issued Training Our engineer can also offer training on aspects of the machine if required Topics can include e Set up e Operation e Dismantling for cleaning Calibration Any component parts required will be charged for at Cl list prices Distributed by Lab Unlimited Tallaght Business Park Whitestown Dublin 24 Ireland Tel 01 4523432 CARL STUART GROUP Fax 01 4523967 E mail info labunlimited com Web www labunlimited com
12. fy PRECISION 0 O z 0 D 0 a kes E 0 gt a 0 o i O Technical Description SADE SP tablet capsule weight sorter Models SADE SP440 SP240 amp SADE SP140 Distributed by Tallaght Business Park Whitestown Dublin 24 Lab Unlimited CARL STUART GROUP Fax 01 4523967 E mail info labunlimited com Web www labunlimited com gh iy f PRECISION Ti CONTENTS Page SADE SP Series Tablet Capsule Weight Sorters 5 Introduction 5 Applications 6 Production Areas 6 Batch Reclamation 6 Batch Recovery 6 Quality Control 6 Benefits 6 Research amp Development Clinical Trials 6 Uniformity of weight 6 Benefits 6 Features 7 SADE SP Series Models 9 SADE SP440 9 SADE SP240 9 SADE SP140 9 SADE SP B40 Benchtop 9 Specification Details 10 Description of the Equipment 11 The SP User Interface and Control Unit 11 The SP Weighing and Sorting Modules 11 The SP Bulk Hopper 11 Report Printer 11 Set up and Dismantling for Cleaning 12 Dismantling 12 Set up 12 Dust 12 Operation 12 Starting a new batch 12 Mechanical Operation 12 Statistics and Counts 13 Completion of Sort 13 Statistical Reports 13 Printing Options 14 Operating Software 14 Modes of Operation 14 Sorting 14 Sampling 14 Limits 14 Fixed Quantity Sorting 15 f i PRECISION a Bin Counts 15 Statistical Results 15 Balance Head 15 CI MK6 Balance Head 15 Calibration and Auto Zero 15 Auto Zero 15 Calibration 15 Alarm Conditions
13. g feed gate As each item falls into the pre weighing feed gate a detector beam is broken This triggers the bowl to stop vibrating ensuring that only one item falls into the gate If the balance pan is clear the feed gate opens to allow the item onto the pan for weighing The feed gate closes and the next item is fed into the gate whilst the item on the pan is being weighed Once the weighing cycle has completed the item is either blown into the accept 12 Statistical Reports f PRECISION container or blown in to the reject container Suitable containers will need to be provided and positioned appropriately Statistics and Counts The SADE SP calculates statistical information about the products being sorted This includes the mean weight SD CV range total number of items sorted number of accepts number of high rejects number of low rejects and miss feeds This information can be viewed on screen in real time during operation or printed A batch can be separated into multiple sort runs The statistics are maintained for each individual sort and the complete batch Completion of Sort When the sort is complete the user can terminate the sort and print reports Batch results have to be deleted before starting the next batch Batch and Sort reports can be printed using a suitable printer The information includes Date amp Time Operator Name Batch Code Product Name Target Weight Dosage Form Sort limits Accep
14. h the logged on user ID who performed the operation User Passwords With passwords enabled a password is required at log on User Access Access to functions within the program can be controlled by setting up users and configuring their access rights The SP sorter includes three preloaded users the Master a Supervisor and an Operator Only the Master can set up edit and delete users Material Specification Contact Part Sets Contact Parts All contact parts are manufactured in electro polished 316L stainless steel or in food grade PEEK polyetheretherketone to FDA 21 CFR 177 241 Non Contact Parts Non contact parts are in 304 stainless steel polycarbonate acetal hard anodised aluminium or other appropriate materials Stainless steel contact parts are engraved for identification Material Specification A Material Specification that lists the contact parts and the material they are manufactured from is supplied in the Technical Folder For Material Certification is also available Please refer to the Options section of this document Each SADE SP unit is supplied with one set of contact parts Additional sets can be supplied and save time by keeping the unit operational whilst the other set is cleaned 16 f PRECISION Construction Compliance with GMP Standards Traceability User Manual Options Draught and Product Shield For increased GMP compliance the weighing and sorting platform is covered by a polycarbonate
15. ifications FAT Specifications and results for both the SADE SP Series and the operating software together with up to date copies of the change control software release notes and software revision history IQ OQ template This option provides the customer with an IQ OQ template to the Cl standard The document is in MS Word format and can be used as a basis for customer s own OQ Material Certification Folder Spares Packs We can supply copies of certificates for the 316L stainless steel used in the manufacture of the contact parts to standard EN10202 3 1b The Material Certification folder contains e A check list for the SADE SP contact parts e Copies of the Material Certificates relevant to the SADE SP tablet capsule weight sorter contact parts Two spares pack options are available Full Spares Pack Includes the following e MK6 Balance Head inc fixing screws amp washers e Balance Pan e Fuse Pack e Set of bowl driver rubber feet and bowl driver vibration mounting rubbers e Down chute fixing knob bottom e Chute fixing knob front e Thickness blade amp thickness blade fixing knob e Diameter blade amp diameter blade fixing knob e Bowl top fixing bolt e Central pillar labyrinth e Transit bolt e Hopper slide gate thumb screw e Dust extraction insert thumb screw e Assortment of M4 and M3 bolts amp washers e Gate 18 0 PRECISION e Gate actuator e Gate cylinder e Gate cylinder elb
16. litres per hour Supply Voltage 110 230 VAC single phase Power Sockets Two 1 for SADE SP unit and 1 for the printer Frequency 50 60 Hz Product Small quantity of tablets or capsules Air Connection The unit is supplied with a length of 6mm outside diameter flexible pipe We ask for the customer to provide a fixing to attach this to their compressed air outlet The supplied air should not exceed 5 bar pressure Printer A basic printer will be supplied with the SADE SP unit for installation purposes Location of SADE SP weight sorter In order to meet the performance criteria outlined in our technical data sheets the SADE tablet capsule weight sorter much be installed in an environment suitable for high accuracy weighing The SADE must be located on solid foundations Air movement mechanical vibration temperature changes and humidity levels should be kept to a minimum SP Connect Data Output If the optional SP Connect program has been ordered then the customer is required to provide a PC which needs to be operating with Windows 2000 Windows XP Windows 7 and Vista 21 After Sales Support f PRECISION have a network connector for communication with the sorter have a CD drive to read the installation disk at least 50mb of available hard disk space 1 GB of system memory 128 MB of graphics memory minimum Installing the software will require administrator access rights We maintain a Customer Support D
17. m high throughput multichannel combinations See separate data sheet for details of SP Link combinations SADE SP140 The SP140 is the ideal unit for Research amp Development departments for the weight sorting of clinical trial or development batches It offers one weighing channel and is designed for 24 hour operation with long periods of unattended sorting using the SP Bulk Hopper It offers a sorting rate of up to 4500 per hour and 105 000 over the 24 hour period SADE SP B40 Benchtop The SADE SP Series includes a neat and compact Benchtop model the SP B40 For more detailed information about this unit please refer to the SADE SP B40 Benchtop Technical Description fi PRECISION a Specification Details Technical Details a SADE SP440 SADE SP240 SADE SP140 RES a Number of 4 2 1 weighing channels Sorting Rate Up to 22 000 per hour Up to 9 000 per hour Up to 4500 per hour Varies per product and weighing environment 24 hour operation Up to 500 000 per 24 hour Up to 210 000 per 24 hour Up to 105 000 per 24 hour SP Bulk Hopper Capacity 1 x 150 litres 2 x 60 litres 1 x 60 litres Product Size Tablets Ls24mm Ws lt 20mm Tablets Ls24mm Ws20mm Tablets L lt 24mm Ws lt 20mm Capsules 0 1 2 3 4 5 amp 00 Capsules 0 1 2 3 4 5 amp 00 Capsules 0 1 2 3 4 5 amp 00 Reproducibility User selectable Img to 3SD Img to 3SD 2mg to 3SD or 1mg to 3SD Contact Parts Electro polished 316 stainless Electro polished 3
18. option to purchase a full set of UKAS certified calibration weights can be provided on request A calibration certificate is supplied with each unit Calibration Checks The system allows a simple calibration check routine The system can be configured to require a calibration check at pre set intervals or before the start of each batch Calibration checks are made using a single weight that is normally different to those used in calibration A report of the calibration check can be printed If the calibration check fails then the unit stops sorting and prompts the operator to conduct calibration 15 Alarm Conditions Security f PRECISION There are visible and audible alarms which are triggered by the conditions including Balance Over under range e Zero Failure balance fails to zero Bowl time out bowl empty of product Feed gate errors Optical detector errors Printing errors e Air pressure out of range the air pressure within the unit is monitored digitally and an alarm is triggered if pressure is out of range e Calibration and calibration check errors e Calibration weight eject warning e Accept or Reject container count reached e Sort Limit reached The SADE SP unit provides a flexible range of security options for identifying operators and controlling access User ID With User ID s enabled each user can be provided with a user ID which must be entered to logon to the unit All reports are identified wit
19. ow and straight fitting e Polyurethane tube 2mm O D Mini Spares Pack We can also offer a mini Spares pack that includes a spare balance pan and various fixings e Balance Pan e Set of bowl driver feet and vibration mounting rubbers e Chute and Down Chute Fixing Knobs e Bowl Top Fixing Bolt e Fixing Knob for Thickness Blade or Diameter Blade e Thumb Screw for Hopper Slide Gate or Dust Extraction Insert e Various Fasteners e Gate Gate actuator e Gate cylinder e Gate cylinder elbow and straight fitting e Polyurethane tube 2mm O D Optional Data Output to a PC SP Connect SP Connect is an optional software program that enables you to transfer reports and data from your CI SP unit on to a PC With SP Connect enhanced colour reports are automatically saved as secure pdf files for ease of long term storage You can also export weight data including individual weights into an Excel spread sheet for further analysis CIE SORT REPORT Page 2 of 2 Unit name TESTO04 Created on 12 12 2007 15 06 29 Product code TEST1 Batch code 2 Product name TEST1 Batch started 12 12 2007 13 53 00 Sort No 2 Sort started 12 12 2007 14 27 24 Ni lt 448 75mg 163 DISTRIBUTION Histogram bandwidth 2 5mg FPP BPS GPP BF oP a wp BF 9 oP oF Fa oF FPP SLOPE PE LSP ESS KP RS 19 SP Link Testing f PRECISION Configuration Direct Connection The PC operating SP Connect can be connected directly to one Cl unit using
20. ows for SADE SP units to be connected for faster sorting rates f PRECISION SADE SP Series Models SADE SP440 The SADE SP440 combines four of our proven SADE SP sorting modules into one compact unit so will rapidly weight sort your batches of tablets or capsules into accept or reject categories The unit includes one control unit and one bulk hopper with single fill point so it is quick and easy to set up and use The bulk hopper has a capacity of 150 litres so the unit can operate for long periods without the need for operator intervention saving time and funds With a sorting rate of up to 20 22 000 per hour and its ability to work around the clock the SADE SP440 is capable of sorting up to 500 000 per 24 hour period As a new feature we have included two accuracy settings 2mg and 1mg so the user can select the accuracy required for the product they are sorting The SADE S440 ideal for the 100 weight sorting of batches for quality control SADE SP240 The SADE SP240 combines two sorting modules each fed by a 60 litre bulk hopper It weight sorts to an accuracy of 1mg and offers a sorting rate of 9000 per hour and up to 210 000 in a 24 hour period It can be used in Production areas for batch reclamation but is also suited for Research amp Development departments needing to weight sort large batches for clinical trials For increased sorting capacity and flexibility multiple SP240 units can be used with SP Link to for
21. ration temperature changes and humidity levels should be kept within reasonable levels Installation Procedure The SADE SP unit will be delivered to the customer s site via road or airfreight On notification of its arrival we arrange for one of our customer support engineers to visit unpack and assemble the unit and conduct the installation A Cl Installation Qualification procedure is followed A copy of the Installation Qualification Document and Test Results are supplied to the customer It is assumed that any Operational 20 Services Required f PRECISION Qualification procedures will be conducted by the customer An 1 Q OQ template document can be purchased as an optional item On Site Training During the Installation the engineer provides training on e Positioning the Unit e Operation Procedures e Cleaning Procedures Routine Maintenance The training is designed for operators and first line maintenance engineers SADE SP Sorters Training Certificates can be issued on request Installation and training is usually carried out in one working day This can be extended by request but additional days on site will be charged for at our normal rate SADE SP tablet amp capsule weight sorter Air Supply Clean dry compressed at 3 to 5 bar 43 to 73 Psi Air Pipe Dimensions 6mm outside diameter 4mm inside diameter Air Consumption SP140 approx 3 litres per hour SP240 approx 6 litres per hour SP440 approx 12
22. rom weight rejected batches Batch Recovery Recovery of product made during press run in run out times Quality Control 100 weight sorting of certain products for complete quality assurance Benefits e Save valuable product that may otherwise be discarded e Minimises wastage and the costs of discarding batches e Rapid return on investment the SADE SP can pay for itself in a short time Research amp Development Clinical Trials Uniformity of weight Due to their ability to handle tablets and capsules of lots of different shapes and sizes the SADE SP units are ideal for the weight sorting of development or clinical trial batches Benefits e Reclamation of good product from weight rejected batches e Ensures consistency of weight needed for clinical trial batches e Used for checking over encapsulation e Saves manual checking Features f PRECISION sorts both tablets and capsules With its unique design the SADE SP sorters are capable of sorting both tablets and capsules sorts different shapes and sizes SADE SP sorters are easily adjusted to handle products of different shapes and sizes no change parts No change parts are required for different shapes and sizes of product quick and easy clean down The units are designed to be quickly and easily dismantled cleaned and re set minimal operator adjustment The amount of operator adjustment between products is minimal 24 hour operation Bulk hoppe
23. rs allow for long periods of unattended sorting e g through the night accuracy Incorporating our own Cl MK6 weigh head the SADE SP sorters can provide high accuracy sorting consistent results The design of the new feed and sort mechanism provides improved precision handling and consistent sorting accuracy statistical reports Statistical data can be viewed on screen reports can be printed directly via USB printer or saved to a PC with SP Connect f PRECISION control software The new sophisticated Cl Matrix 4 simplifies batch set up and operation improved user interface New touch screen and improved user interface simplifies machine and batch set up real time display The new display shows real time weight data quality materials Contact parts 316L stainless steel or FDA approved PEEK material certification Copies of certificates for the material used for the manufacture of the contact parts can be provided mobile stand The solid stainless steel stand can be raised on castors for ease of mobility validation documentation Comprehensive validation support documentation is available and represents a saving in time and research for the customer data transfer With our SP Connect program reports are automatically saved to a PC for long term storage plus weight data can be exported for further analysis enhanced diagnostics Improved help messages minimises down time SP LINK SP Link all
24. sub assemblies associated with the unit are also labelled with unique numbers This information is recorded on the Machine Record Cl provides full traceability from parts received and manufactured through to delivery of the SP Units This information assists customer support and servicing Each SADE SP is supplied with a User Manual giving details of set up and normal operation of the unit The User Manual also provides detailed instructions on using the advanced features of the Cl Matrix 4 operating software including details of the Library Security System Print and Calibration setting options Technical amp Validation Documentation Cl can supply comprehensive Validation Support Documents for the SP Series The information contained in the optional documents represents a great saving in time and research for the customer Machine Technical Folder Each SP Series SADE can be supplied with a Machine Technical Folder containing machine specific information including the following documents e Technical Specification e Machine Build Record 17 f PRECISION e Machine Configuration Default Factory Settings e SP Parts List e Final Test Specification e Final Test Results e Calibration Certificate e Material Specification e Conformity Certificate e CE Certificate Validation Support DVD Design and Functionality This DVD has the generic design validation information for the model including full Functional Design Spec
25. ts Count Reject Count Rejects above target weight range Rejects below target weight range Total Counts Misfeeds Mean SD CV Target Based Histogram 13 f PRECISION If a local PCL printer is connected to the SADE SP sorter then a batch report showing the Statistical information and a basic histogram can be produced Other reports can be printed including calibration history product and method library details and system settings Auto print options can be set to automatically print reports e g at batch termination start of new sort calibration etc Printing Options A basic printer is supplied for installation purposes DeskJet PCL3 compatible The SADE SP unit can also be configured to work with a network printer PCL3 compatible via the network cable If required printouts can also be transferred on to an USB memory device and copied on to a PC In this way reports are produced in HTML format but are similar in appearance to the standard printouts The files can be manually renamed and converted into pdf format Using our SP Connect program enhanced colour reports can be transferred to a PC for storage and printing for more details on SP Connect please refer to the Options section of this document Operating Software The SADE SP sorters are now controlled by the new sophisticated Cl Matrix 4 operating system The new user interface via a full touch screen controller guides the operator intuitively through both

Manual

Contents

Download Pdf Manuals

Related Search

Related Contents