ASEPTIC FILLING SOLUTIONS

Transcription

1 ASEPTIC FILLING SOLUTIONS

2 Ultimate flexibility for clinical-scale aseptic filling For over 50 years the Watson-Marlow Pumps Group has led the world in peristaltic filling innovation, the technology of choice for high purity fluid handling in the pharmaceutical, biotech and diagnostics industries. PRECISION For Flexicon customers it is vital that our systems work with high precision. Not only do we satisfy that demand; we deliver exactly what has been ordered on time, every time. Today s industry also requires safe operation with minimum risk to process, product and personnel. We accomplish this through our unique peristaltic filling systems, providing validated processes from clinical trials to production. EFFICIENCY Our customers can produce small and medium sized batches securely and profitably. Flexicon s equipment is reliable, easy to operate and requires minimal maintenance at long intervals. We offer first class after-sales service and full documentation for all our products. In performance as well as quality, we deliver what we say we will. Our range of filling and capping equipment provides solutions with the precision, efficiency and flexibility that customers have come to know and trust. Peristaltic filling the solution for high purity and low risk A peristaltic pump s low shear action is created by compressing a tube. Inside the single-use tube the fluid is driven forward by rollers while the tube s recovery behind each roller draws in more fluid. The pump is perfect for moving fluid aseptically because the fluid stays within the tube. Unlike piston pumps there are no seals, valves or moving parts in its path to lead to contamination. Flexicon peristaltic fillers are recognised by production managers for high quality, reliability and performance. Our equipment simplifies validation, improves yield and reduces expensive downtime. FLEXIBILITY Our fillers are easily and quickly adjustable for a huge range of fill volumes, fluids, capacities, bottles and caps. We can customise products to your exact requirements and you can visit our plant to assure yourself that our performance matches our promise. We offer a short response time from initial contact to delivery. Flexicon offers a range of products that grow with you, from stand-alone units for hand filling, through semiautomatic systems, to fully automatic filling, stoppering and capping machines. The fully automatic systems are customised to fit any glass vial, plastic bottle, test tube, eye-dropper or non-self-standing microtube. A tabletop dispenser can be connected to a bottle handling unit, if the need for automation arises. This reduces validation costs and limits extra investment as demand for production capacity increases. The added benefit of such easy up-scaling is that only a minimum of operator training is needed. We are the only global supplier of peristaltic filling equipment with our own tubing production facility, therefore ensuring full control of the complete solution, reducing risk, providing consistent performance and saving customers time and money. 2 3

3 Aseptic liquid filling and capping equipment Flexicon - flexibility to grow with your changing needs Flexicon offers a range of products that grow with your business, from stand-alone units for hand filling, through semi-automatic systems, to fully automatic filling, stoppering and capping machines. The fully automatic systems are customised to fit any glass vial, plastic bottle, test tube, eye-dropper or non-self standing microtube. Tabletop units Semi-automatic systems Fully-automatic systems Solutions for integration or retrofit Fillers Filling Wide range of systems for automation of filling, stoppering, capping and weight check OEM peristaltic fillers and controllers Cappers Filling and capping Customised monobloc systems Trolley solutions for piston pump replacement Single-use sterility throughout. Flexicon Accusil and asepticsu single-use fluid path technology makes validation and scale-up easy Lab - R&D Clinical I Clinical II Clinical III Small Production Full Production High Speed Sterile, single-use fluid path - asepticsu (pages 6-7) Tabletop Dispensing Systems - PF6, 520Di, PF22 (pages 8-9) Tabletop Screw and Crimp Cappers - FS and FC (pages 10-11) Vial/Bottle Handling - FlexFeed15 and FlexFeed20 (pages 12-13) Filling/Screw Capping - FlexFeed30 (pages 14-15) Filling and Stoppering - FP50 (pages 16-17) Filling, Stoppering and Capping - FPC50 (pages 18-19) FPC50 for integration into an Isolator - FPC50ISO (pages 18-19) Fully Automatic Monobloc - FMB210 (pages 20-21) Master Controllers, Trolleys and Pumps/Fillers - OEM Solutions (pages 22-23) 4 5

4 Your answer for aseptic filling single-use fluid path and Accusil platinum-cured silicone tubing for sterility throughout Single-use technology asepticsu asepticsu is a sterile, single-use fluid path perfected for aseptic filling by Flexicon, the world leader in peristaltic filling systems for over 25 years. The combination of asepticsu and Flexicon peristaltic technology lowers your risk in high purity, high accuracy filling applications. Flexicon peristaltic filling units with asepticsu singleuse technology deliver rapid product changeover, no line-cleaning, no cross-contamination and simplified validation. Huge validation savings and faster to market Contamination risks are eliminated Prevents costly overfilling Small batch production is easy and efficient Simplified inventory management Simplify your cleaning validation Imagine a USP Class VI fluid path that is fully traceable from end-to-end, is simple to validate, and you have asepticsu. From the bag, to the tubing through the pump, to the filling nozzle on your machine, asepticsu provides an entire wet end, which is fully assembled and lot traceable. And best yet, its single-use design eliminates costly cleaning validation. Filling equipment and single-use fluid paths from just one supplier makes validation easy and prevents costly overfilling Accusil precision tubing prevents costly overfilling Accusil tubing provides perfect filling accuracy, fill speed, minimum foaming and no dripping between fills for volumes from less than 0,2ml to more than 250ml. This prevents costly overfilling and eliminates production stops due to spillage between the fills. For full details on Accusil tubing, see page 23 asepticsu TM enhances a complete filling system, such as the FPC50W shown here Accusil with laser-etched lot number, part number and use-by-date 6 7

5 Tabletop dispensing The simplest filling set-up with accuracy, flexibility and reliability Flexicon tabletop fillers are designed for use in cleanrooms for production processes complying with cgmp. Setting up a filling regime for vials, bottles, test tubes or other containers is achieved by loading the peristaltic filler tube and entering the parameters required using the intuitive keypad. The pump maintains a closed fluid path from the bulk product container to the end of the filling nozzle. Change the path and the pump is clean, sterile and ready for the next batch. You can control the filler with a foot switch or integrate it into an automatic bottle handling system. No cross-contamination Accuracy: ±0.5% and no costly overfilling No foaming, splashing or dripping between fills One-minute set-up and changeover Unmatched filling flexibility over a very wide range of fill volumes, from less than 0.2ml to more than 250ml from the same pumphead Designed with the operator in mind higher productivity and less risk of human error A complete solution from just one supplier makes validation easy and prevents costly overfilling Flexicon peristaltic pumpheads and Accusil platinum-cured silicone tubing provide excellent dispensing accuracy Flexicon s unique peristaltic pumphead enables product changeover in less than one minute Filling time (sec) PF6 - capacity diagram (based on water) Filling time (sec) PF22 - capacity diagram (based on water) PF22 for less than 5ml to more than 5000ml Filling volume (ml) Filling volume (ml) 8 9

6 Tabletop screw and crimp capping Cappers ensure consistent quality crimps and torque When there is need to increase productivity, while minimising operator fatigue and repetitive strain injury, our cappers can be added to your current process. Features offered by both crimp and screw cappers are: Consistent quality closure Cap up to 1,000 units/hour Fast changeovers Deciding which capper is right for the process depends on the capping needs. Each capper has specific benefits. Screw cappers No tools needed for changeover Handles caps up to 65mm and bottle sizes up to 100mm in diameter Adjustable closing torque Crimp cappers High quality aluminium overseal Low particle release Easy to mount crimp heads and bottle tools in standard or customised sizes are available Collection of used compressed air A range of format parts is available to handle different types and sizes of caps, bottles and vials Max. Cap Size Max. Bottle Size Capper Name Diameter Height Diameter Height Air Supply FC10 Screw 50mm 40mm 55mm 180mm 6 bar 85 l/min FC32 Screw 65mm 40mm 100mm 240mm 6 bar 85 l/min FS10 Crimp 8-20mm DIN standard 55mm 180mm 35 l/min. free air FS32 Crimp 13-32mm DIN standard 95mm 240mm 50 l/min. free air Screw capper FC10 Crimp capper FS10 Crimp capper FS32 If space is at a premium in your current setting, take a look at the small foot print offered by our cappers. FS10 FS32 FC10 FC32 Dimensions in mm/inch 10 11

7 Automatic filling and tabletop vial/bottle handling system FlexFeed 15 and 20 automatic filling systems As the need for more automation grows Flexicon s product line meets the needs of flexible production of small batches in contract filling and diagnostics operations where there are many different sizes of bottles. The speed at which the vials/bottles are presented at the filling needle is fully adjustable, allowing light vials or bottles to be filled. Customised solutions can be designed to handle bottles with special shapes. The FlexFeed15 and FlexFeed20, used in conjunction with one of our crimp or screw capping machines, provides a simple and very flexible means of production and customers can achieve a fast return on investment. 12mm to 50mm (FF15) / 67mm (FF20) diameter bottles without any format parts Complete changeover in less than five minutes Prevents repetitive strain injuries Small foot print and designed for cleanroom environments Unique cost of ownership Ideal for contract filling where there are many different sized bottles/vials Go from manual to automatic filling and get a fast return on investment FlexFeed15 FlexFeed20 The 520Di dispensing pump can also be used with the FlexFeed 15 and 20 vial/bottle handling systems Dimensions in mm/inch 12 13

8 Semi automatic filling and capping system FlexFeed30 filling and capping system for small batches For a higher productivity, a more consistent screw capping and no more repetitive strain injuries, the FlexFeed30 is the answer for contract manufacturers and diagnostic companies. Fills bottles from 12mm to 50mm in diameter Reduced production costs and increased productivity Consistent cap torque prevents leakage of liquid Up to 1,200 units/hour Protects operators from repetitive strain injuries Complete cap and bottle change in less than five minutes Fills bottles from 12mm to 50mm in diameter Small batch production - easy and efficient Filling is done automatically, cap is placed manually and capping torque is applied automatically A 520Di/L pump can also be used with the FlexFeed30 filling and capping system Dimensions in mm/inch 14 15

9 Fully automatic filling and stoppering FP50 automates two key features: vial filling and stoppering Automating the key steps of aseptic filling cuts the risk of operator error and related contamination. The FP50 peristaltic filling system also eliminates the costs and risk issues of volumetric filling pumps. The FP50 is a tabletop filling system used for biopharmaceutical research and development departments during clinical trial phases, or for contract manufacturing companies where it will increase flexibility and save costs. Up to 25 units/minute Filling accuracy better than ±0.5% From less than 0,2ml to 100ml fills of 2R to 100H vials Full or partial stoppering Quick and simple format changes Universal format parts reduce costs Small footprint for LAF bench or RABS installations Increase your flexibility when filling smaller batches - just one machine will fill all your vials Fills from less than 0.2ml up to 100ml. Maximum 25 vials per minute Stoppering with 13mm and 20mm stoppers requires no additional format parts A customised FP50 is built into an isolator so that the fluid and the filled vials are completely contained. Dimensions in mm/inch 16 17

10 Fully automatic filling, stoppering and capping FPC50 offers superior filling technology with optional 100% in-line check weighing The FPC50 provides a ready-to-use and easy-to-validate filling, stoppering and capping system for flexible small batch pharma production. It is a modular system which offers options for 100% inline check-weighing and usage under a standard LAF or a RABS. The FPC50 can also be customised for integration into an isolator with easy access to all areas of the machine through glove ports. The universal format parts of the FPC50 allow for filling of a wide range of vials, stoppers and caps. The peristaltic filling system eliminates having product-dedicated or volumededicated pumps in stock. We have an excellent record in providing short and reliable delivery times and performing seamless FAT, IQ and OQ tests, avoiding costly project delays. High accuracy filling for less than 0.2ml up to 100ml with no splashing, dripping or foaming Fast and easy changeover between batches with very limited product waste at start-up Universal format parts reduce costs and increase flexibility Up to 25 units/minute Batch report after each production run and full audit trail First class documentation and test protocols for FAT, SAT, IQ and OQ Software designed and qualified according to GAMP5 Optional software to support 21 CFR Part 11 Master controller can be situated outside an LAF hood or RABS unit Universal format parts allow filling, stoppering and capping of a wide range of vials FPC50 crimping head for minimum air turbulence and fast changeover between caps A filling machine and single-use fluid path from one supplier makes validation easy and prevents costly overfilling Dimensions in mm/inch 18 19

11 Fully automatic filling, stoppering and capping FMB210 for medium sized batches with easy setup and changeover The FMB210 is perfect for fully automated filling and capping for aseptic drug, ophthalmic and diagnostic applications. It can handle a wide range of container and closure types. A unique tool platform allows simple, fast and accurate format changes where multiple products need to be processed on a single filler. It can be configured for a choice of infeed and outfeed options or other peripherals. Ophthalmic and diagnostics: filling, dropper insert and precise screw capping better than ±10 Ncm (±0.9 lbs/inch) Aseptic filling of injectable drugs: filling, stoppering and crimp capping Roller closing of caps for consistent high quality crimps Compact design means a small footprint that fits inside small cleanrooms Up to 75 units/minute: depending on type of cap, vial size and fill volume Completely closed peristaltic filling system ensuring no cross-contamination A filling machine and single-use fluid path from one supplier makes validation easy and prevents costly overfilling Handles a wide range of containers and closure types The sensor for the FMB210 s no-vial-nofill feature Modular design allows for customised infeed, outfeed and capping technology 20 An FMB210 fed by a bottle unscrambler unit top, and bottom, an FMB210 installed within a laminar air flow cabinet Dimensions in mm/inch 21

12 Flexible, production-scale filling OEM system components to complete your filling line Accusil TM platinum-cured silicone tubing for accurate dispensing Many filling machine manufacturers have already successfully incorporated Flexicon solutions into their filling lines, thereby adding value to their product and increased satisfaction from their clients. Full flexibility in fill volumes Prevent spillage between fills, foaming and splashing Fast changeover High filling accuracy reduces production costs Global support and high quality filling accessories OEM applications include: Existing filling lines where piston pumps need to be replaced New high capacity filling lines for the biopharm industry Master controllers Master controllers, such as the MC100 and the MC12, can control up to 16 pumps on a filling line. We supply stand-alone controllers, panel mounts and controllers for communication with filling line systems via PROFIBUS or DeviceNet. The MC100 receives filling data through an industrial fieldbus, calculates operating values for the fillers then transmits those through a FlexNet protocol to the fillers. Parallel Production Set-Up Accusil precision tubing prevents costly overfilling Accurate and consistent dispensing requires having the right tubing inside the right pump. Accusil is manufactured in our state-of-the-art extrusion facility to the highest quality, with a consistent wall thickness and a specific hardness for optimal tubing restitution. Accusil fulfills biopharmaceutical requirements and is ideal for single-use filling Full biopharmaceutical compliance with USP Class VI, Ph. Eur. 6.8 Chapter 3.1.9, ISO and FDA CFR Reduce your costs and increase your productivity with Accusil Excellent filling accuracy on PF6 and PD12 peristaltic pumps Peristaltic filling technology provides fast and easy changeover between liquids to be filled Cross-contamination between liquids to be filled is prevented Enhanced safety as contact between liquid and operator can be avoided Tubing sizes for fill volumes from less than 0.2ml up to more than 250ml Fast delivery service Filling lines for bottles with an awkward shape for the diagnostics industry Dynamic Recalibration Set-Up Validation pack available 100% traceability with laser-etched part number, lot number and use-by date Lot specific certificate of conformance in each box and accessible online Manufactured in an ISO Class 7 environment at state-of-the art tubing production facility Accessories Flexicon also offers filling nozzles and other accessories which can ensure aseptic filling with the highest possible accuracy. Replace hard to validate piston fillers with Flexicon single-use technology Double-bagged for protection against contamination Post-cured after extrusion for superior purity Fully sterilisable by gamma radiation, autoclave or ethylene oxide Animal Derived Content Free MC12 control unit with multiple PD12 fillers Trolley solutions are supplied for integration into new or existing filling lines fitted with up to sixteen peristaltic fillers The unit fulfils all the usual requirements and can be extended to include several filling stations, an electronic bottom-up fill system, a printer, a direct link to a balance for dynamic recalibration and more. The PD12 filler is available in several versions as a stand-alone unit or for panel mounting. Panel mount versions can be ordered for vertical or horizontal integration and with a pump head in either anodized aluminium or in stainless steel. We are the only global supplier of peristaltic filling equipment with our own tubing production facility, therefore ensuring full control of the complete solution, reducing risk, ensuring consistent performance and saving customers time and money

13 home profile technology products product guide distributors news contact brochures download WORLD LEADERS IN ASEPTIC PERISTALTIC FILLING NEW PRODUCT - RABS for FPC50 Watson-Marlow Flexicon is very proud to present our brand new product for FPC50 - RABS (Restricted Access Barrier System) PRECISION For Watson-Marlow Flexicon customers it is vital that our machines work with high precision. Not only do we satisfy that demand; we deliver exactly what has been ordered on time, every time. Today s industry also requires safe operation with minimum risk to process, product and personnel. We accomplish this through our unique peristaltic filling systems. FLEXIBILITY Our fillers are easily and quickly adjustable for a huge has range joined of the fill volumes, Watson- Flexicon Marlow fluids, capacities Groupand caps. We can customize products to your exact requirements 11th of February and you can 2008 visit Flexicon our plant the joined to assure Watson-Marlow yourself that our and performance is now part of the matches world s our largest promise. group We of offer a short response time from initial contact to delivery. EFFICIENCY Our customers can produce small and medium sized batches securely and profitably. Watson-Marlow s Flexicon equipment is reliable, easy to operate and requires minimal maintenance at long intervals. We offer first class aftersales service and full documentation for all our products. In performance as well as quality, we deliver what we say we will. A Spirax-Sarco Engineering Company Watson-Marlow Pumps Group has six world-class factories supported by direct sales operations in 23 countries and distributors in more than 50 countries. For contact details visit our website: Watson-Marlow Bredel Alitea Flexicon MasoSine Watson-Marlow Bredel Flexicon MasoSine ASEPTIC FILLING AND CAPPING SOLUTIONS NEWS Ultimate flexibility for aseptic filling Med pegetekster FPC50 - Aseptic filling, stoppering and capping... more Flexicon online Learn more about Flexicon by downloading detailed brochures and viewing videos of our full range of aseptic liquid filling solutions. The information in this document is believed to be correct, but Watson-Marlow Flexicon A/S accepts no liability for any errors it contains, and reserves the right to alter specifications without notice. WARNING: These products are not designed for use in, and should not be used for, patient-connected applications. asepticsu and Accusil are registered trademarks HB0332 Issue Issue 3