Advance by Technology...

Transcription

1 Advance by Technology... Sophisticated engineering leads to unreached flexibility and performance. Our customers process demands solutions beyond the tablet press. Therefore, Pharma Technology offers peripheral devices as integrated solutions, which provides great customer benefits. As always, the new generations of vertical dedusters have been developed to achieve the highest possible flexibility, in conjunction with superior figures for output and dedusting quality.

2 STAND-ALONE DEDUSTER

3 PT PF SEGMENTABLE STAINLESS STEEL TABLETS DEDUSTER DUST-TIGHT SEGMENTABLE POLYMER TABLETS DEDUSTER DUST-TIGHT Stainless steel Modular Spiral Pharma Technology PT range consists in a segmented stainless steel tablet & capsule Deduster. Stackable 275 mm dedusting modules allow easy dismantling, cleaning, and validation. A self-regulating vibrating base with accelerometer, making it unnecessary to adjust gaps of springs on the unit s base when changing the deduster s tower height, or when transitioning from one product to another. This universal spiral can handle any size of tablets or capsules at a very high speed. An innovative vacuum in conjunction with an air jet technology allows a higher dedusting performance. 5 different conveying heights are available from 500 mm to 1500 mm. A modular axle permits side dismantling of the segments. Optional deburring modules are available on request. PT iseries generation includes dust tight cover features to reduce operator exposure to the product and the quantity of dust contamination in the production room. The unit exists in Hi-containment and Washable version. Like the original PharmaFlex range of Dedusters, each of the PF Deduster s spiral segments can be removed individually for easier cleaning and fast changeover. This modular system also allows for adjustable height gain. Additional segments can be added in increments of 5 to increase the machine s height and extend its shaft. This unit allows to dedust tablets from 4 mm to 25 mm at a Hi-Speed. 5 different conveying heights are available from 500 mm to 1500mm. Enlarged circumferential dust extraction channel and central air jet on the tablets improve dedusting efficiency. A self-regulating vibrating base with accelerometer, making it unnecessary to adjust gaps of springs on the unit s base when changing the deduster s tower height or when transitioning from one product to another. Clear spiral segments for the complete tower, providing direct sightlines to the tablets throughout the process. Optional deburring modules are available. This dust tight technology allows a higher dedusting efficiency thanks to an innovative dust extraction in conjunction with an air jet system. Polymer Modular Spiral

4 A NEW GENERATION OF MODULAR MACHINE

5 The iseries frame is a new generation of modular frame that allows to run a Pharma Technology and Pharma Flex deduster on the same vibrating base thanks to a universal vibration sensor. The fully modular and upgradable system can be extended to several options such as the following examples : Standard «C» Containment Pharma Flex deduster with metal check «C» Containment Pharma Technology deduster with a 2-Parameters IPC tester (weight & thickness) «HC» Hi-Containment Pharma Flex deduster with Hepa filter and pressure decay «WIP / WOL» Hi-Containment washable Pharma Technology deduster with Alpha-Beta valve

6 iseries DEDUSTER METAL CHECK DUST-TIGHT

7 PFC iseries C PTC iseries C SEGMENTABLE POLYMER TABLETS DEDUSTER DUST-TIGHT SEGMENTABLE STAINLESS STEEL TABLETS DEDUSTER DUST-TIGHT METAL DETECTOR METAL DETECTOR Rotating dust extraction chute support PTC & PFC iseries Dust-Tight The combined unit always includes a stainless steel or polymer version of our deduster combined with metal detector. Autocheck for metal detector Several metal detector brands are available to suit your requirement such as LOCK, CEIA or SAFELINE. Dust extraction chute support left A unique patented metal check system Flex Connect ensures a completely closed Dust Tight transfer from the deduster to the drum without using any tri-clamp solution. A clever system enables to introduce test samples inside the metal check head without any contact between the product and the operator. The control of the metal check parameters is monitored through an integration of original software of the metal check supplier inside the central machine HMI. Thanks to a sophisticated engineering, this Dust-Tight base unit can be easily transformed into an Hi-containment and washable execution. Metal check software emulation Test Samples inserting device

8 iseries DEDUSTER METAL CHECK HI-CONTAINMENT

9 PTC iseries HC PFC iseries HC SEGMENTABLE STAINLESS STEEL TABLETS DEDUSTER HI-CONTAINMENT SEGMENTABLE POLYMER TABLETS DEDUSTER HI-CONTAINMENT METAL DETECTOR METAL DETECTOR Test Samples inserting device PTC & PFC iseries Hi-Containment When manufacturing or planing to manufacture highly potent drugs, a Hi-Containment unit is requested to protect the operator and its environment. Hepa filter on air inlet PT Cover Sealing Our PTC iseries & PFC iseries machines ensures an OEL 5 Hi-Containment level. A unique patented metal check system Flex Connect guarantees a completely closed Dust Tight transfer from the deduster to the drum without using any tri-clamp solution. Auto-Check for metal detector A clever system allows to introduce test samples inside the metal check head without any contact between the product and the operator. Display pressure decay A pressure decay system permits to verify that the unit is perfectly tight before starting manufacturing. This self test system will vacuum the entire unit and verifies that there is no leakage in the entire system. A continuous pressure monitoring verifies that the inside of the equipment is always under a negative pressure that avoids dust particules to escape in the production room. In case of limit achievement, the system will automatically change the valves status to create a fail-safe situation for the operator. PF Sealing

10 iseries DEDUSTER METAL CHECK WASHABLE

11 PTC iseries WIP/WOL PFC iseries WIP/WOL SEGMENTABLE POLYMER TABLETS DEDUSTER WASHABLE SEGMENTABLE STAINLESS STEEL TABLETS DEDUSTER WASHABLE METAL DETECTOR METAL DETECTOR PTC & PFC iseries Washable WIP/WOL Mobile Washing Station HC Hi-Containment stainless steel or polymer systems are modularly upgradable to a washable solution. During the flooding of the deduster, vibration is used to remove sticking powder from the surfaces. Washable system does exist in two versions: - WIP = Washing In Line - WOL = Washing Off Line WIP/WOL Valves Concept The WIP version is foreseen to be washed in the production room linked with the tablet press or capsules filling machine. The connectivity remains connected and closed between the production and the washing process. The WOL version should be disconnected in an Hi-Containment way from the production machine to be washed in a separated washing room. In this case, since the WOL trolley remains in the washing room, it can handle several machines, creating a cost-saving and efficient solution for the company. We have the expertise to offer you a complete end-of-the-line concept with all the required Hi-Containment connectivities. Hi-Containment Valves Polymer Washable Spiral

12 iseries DEDUSTER METAL CHECK WEIGHT-THICKNESS IPC TABLET TESTER

13 PTC iseries IPC PFC iseries IPC SEGMENTABLE STAINLESS STEEL TABLETS DEDUSTER DUST-TIGHT SEGMENTABLE POLYMER TABLETS DEDUSTER DUST-TIGHT METAL DETECTOR METAL DETECTOR WEIGHT & THICKNESS TABLET TESTER WEIGHT & THICKNESS TABLET TESTER PTC & PFC iseries IPC Our iseries have the capability to integrate a 2-parameters tablets tester that allows to take automatically samples from your production and to monitor continuously weight and thickness. Automated Sampling system Thickness control The results of the testing can be used to regulate your tablet press in a OEM configuration. The Stand-Alone version allows to monitor simpler or older tablet press that do not have the loop of regulation and may benefit from stand-alone tester allowing to generate alarms in case of product specifications violation and create automatically quality batch report. This system offers an excellent price/efficient ratio. Pharmacopea s standards are included in the product book. Software is written following CFR 21 part 11 guidance including several users level and password protection. Data can be collected on a USB stick in a safe way. Weight control IPC Tester

14 A DVANCE BY TECHNOLOGY DEDUSTER METAL CHECK 4-PARAMETERS IPC TABLET TESTER

15 AIO PTC with IPC Tester AIO PFC with IPC Tester SEGMENTABLE STAINLESS STEEL TABLETS DEDUSTER SEGMENTABLE POLYMER TABLETS DEDUSTER METAL DETECTOR METAL DETECTOR 4-PARAMETERS IPC TESTER 4-PARAMETERS IPC TESTER Oblong centering device Central utilities connectivity The flexible and modular Tablet Testing System AIO measures automatically the weight, thickness, diameter and hardness of the tablets, oblong tablets, capsules and similar products. Display tester It offers the following features and benefits : Dust tight industrial design New weighcell - less sensitive to the production environment This new AIO generation of vertical dedusters made in polymer or stainless steel was developed to achieve the highest possible flexibility, in conjunction with superior figures for a better output and dedusting quality. Metal check and 4-parameters IPC tablet control tester are available. That new concept increases the performance of your tableting machine, directly monitoring and controlling manufacturing with less operator supervision need. This will ensure an 100% control of your manufacturing. Tester can be installed without any cable on the unit thanks to a Plug-In concept. This dust tight tester contains a new scale generation that eliminates most of the manufacturing interference. Plug and Play tester on the AIO deduster - No cable Fully automatic operation or manual mode Reliable and quick measurement Control of your production with or without a tablet press HMI Tablet samples transfer by vacuum - no dust in the tester Innovative solutions for tablet handling and orientation Easy cleaning / validation / calibration Round, oval, square and rectangular shapes can be tested. For oval shaped tablets, the proven Oblong Centering System can be adapted, this option is also retrofittable. Display batch tracking

16 Fully compatible results with UTS & Checkmaster devices Diameter Weight Thickness Hardness The AIO provided via a tablet press manufacturer can be integrated in the HMI of the production machine : The AIO provided as a stand-alone unit can release datas, statistics, T1 & T2 alarms, and/ or stop the press through the AIO HMI : This allows to regulate automatically the tablet press This allows the operator to adjust the tablet press accordingly AIO 12 stations tablets collector

17 CAPSULES DEDUSTER POLISHER METAL DETECTOR WEIGHT-LENGTH IPC TABLET TESTER

18 Q-CAPS CAPSULES DEDUSTER POLISHER METAL DETECTOR 2-PARAMETERS IPC TESTER Weight & Length Tester The Q-Caps is a new generation of capsules polisher that includes an efficient dedusting & polishing result. The system is based on a free pre-set discontinuous polishing timer that enables the highest efficiency of polishing. When the polishing timer is over, batches are transfered into a receiving hopper prior to metal check and diverter system. A de-ionisation technology is used to reduce any electrostatic charging of the capsules. The system may include an integrated sampling device with an IPC capsule tester to measure the weight and the length of the samples. The modular vertical construction enables an evolutive system on a very short wheel base frame. Sophisticated engineering allows to upgrade easily this machine to the highest Hi-Containment and/or washable unit. This unit may increase your quality and productivity. Q-Caps Polishing Hopper

19 CAPSULES DEDUSTER METAL DETECTOR EMPTY CAPSULES ELIMINATOR

20 PTGV PTG VERTICAL CAPSULE DEDUSTER CAPSULES DEDUSTER STAND-ALONE The PTGV MD dedusters are equipped with a metal particles detector Lock, Safeline or Ceia. This permits reaching an optimal accuracy such as a spherical 316L stainless steel part of 0,4 mm in the products. A high speed rejection mechanism instantly rejects non-conform products. The construction of this specific frame saves space into the production room and reduces the retention areas. The PTGV ECE is a combination of a vertical brush deduster and an Empty Capsules s Eliminator. It will guarantee you of a 100% production without empty capsules. In addition, the circuit of tablets is totally closed between the inlet of the deduster and the outlet of the metal detector. This unit could also be combined with any kind of metal detectors as per attached pictures. The PTG and PTG V ranges are mainly used for dedusting and polishing capsules. A polyamide/nylon rotative auger achieves a polishing in a 316L stainless steel tube. On the overall uphill conveying length suction stitchings allow powder excess to be removed. This ascending device with adjustable length from 800 mm to 1800 mm can be equipped with a removal system for empty or opened capsules. Optional possibilities such as metal detector combination are available. Another development called PTGR allows to cool capsules filled with warm liquids. All these units are completely dismountable without tooling and cleanable with ultrasonic wave bath. PTGV Stand-Alone PTGV with Metal Check PTGV with Metal Check & ECE

21 EXTERNAL LUBRICATION SYSTEM

22 PHARMA SPRAY EXTERNAL LUBRICATION SYSTEM A unique external lubrication system that sprays dry lubricant continuously onto tablet press punch tips and die walls. Pharma Spray delivers a consistent, verifiable amount of dry lubricant onto the tablet outer surface over time. Excess lubricant is eliminated by vacuum suction directly on the spray nozzle, then collected in a double bag discharge system. Pharma Spray has several innovatively-designed features, including a compact double-sided nozzle that fits most rotary tablet presses for optimal coverage of most tool sizes, and a backup line with a pressure sensor built into each nozzle allowing automated switching between lines that, in doing so, helps avoid costly interruptions due a potential blockage. For recipe storage, the system is equipped with a touch screen industrial PC with audit trail recording, compliant with FDA 21CFR part 11 requirements. Pharma Spray helps reducing the amount of dry lubricant in the compression blend whilst applying an optimized amount of lubricant to the upper punch face, die wall and lower punch face. Excess lubricant is directly vacuumed, next to the nozzle, allowing for consistent amounts of lubricant to be applied to tablets throughout a lengthy batch and from one batch to another. The amount applied can therefore be validated. Dosing system Consistent amount of Magnesium is sprayed onto the tablet surface (validatable). Target lubricant content sprayed on tablets below 0.1% w/w Control of vacuum side airflow is much more efficient than just control of spray rate. Excess lubricant is removed by vacuum and does not contaminate the inside of the tablet press. (allowing longer cleaning intervals) Spraying nozzle Easy access to clean the lines For existing hygroscopic or effervescent formulations the system helps reducing the die wall friction at the ejection stage, the lower punch face friction at the take off stage and helps prevent logo picking or stickiness issues. This provides the added benefit of reducing wear on and extending life of tooling and ejection cams. High precision volumetric spray rate derived from high precision feeder. Necessary for effervescent/hygroscopic formulations Enables elimination or reduction of lubricant addition Extends life of punches, dies and ejection cams This solubility enhancement has been in great demand for new drugs that often have poorly soluble APIs (esp. with biotech drugs). Added benefits for NEW products: Removes final blending stage from process Improves dissolution rate The minimal quantity of lubricant sprayed externally onto the tablets can be accurately measured and validated as below the threshold for listing as an ingredient in the formulation under US Pharmacopiea requirements. For new formulations, the system helps eliminate the need for dry lubricant in the blend, thus eliminating an extra step in the manufacturing process and greatly enhancing the solubility of the tablet.

23 BLISTER LINE FEEDER

24 BLF BLISTER LINE FEEDER WITH BROKEN TABLETS SORTING DEVICE Using the dedusting technology of the Pharma Technology or Pharma Flex deduster, the new BLF equipment allows you to feed automatically blister line from a reasonable height product hopper. This system allows raising the tablets and capsules to the blister line hopper minimizing dust emission in the packaging area. It permits also to sort small broken tablet parts from good tablets. It will help to reduce jam situation in the blister line feeding system and reduce significantly the down-time of your blister line. It can as well be used for tablets bottle filling line. Up to 97% of broken tablets can be sorted out allowing a huge performance increase of the packaging machine. The spiral EDM concept allows realizing quick change-over time. BLF sorting device close-up

25 ACCESSORIES

26 D4 EPS EURO PALLET SYSTEM DIVERTER Buffering concept for diverter Our model PTC+ EPS enables to distribute the production into different containers on a counter basis. The distributor is highly flexible. It considers the interchangeable amount of containers to be filled, as well as the adjustement to the products dropping height. The drum loading center is available in a Dust-Tight concept. The PTC+ EPS unit allows less contact with the product inside the production room, which reduces bi-cross contamination between operators and products. The U frame of the complete unit incorporates hydrolic cylinders for height adjustment. This frame saves space on the ground. The diverter D4 enables to distribute the tablets into different containers on a counting or weighing basis. The distributor is highly flexible. It considers the interchangeable amount of containers to be filled, as well as the adjustement to the products dropping height. The diverter D4 allows less interference from the operators inside the production room, which reduces bi-cross contamination between operators and products. This system can be connected to a stand-alone deduster PT or a combined unit with deduster and metal check PTC. A modification of the programm can also permit to feed automatically and on a regular basis an IPC testing equipment or a sampling collector for laboratory trials.

27 BUFFER QUARANTINE BUFFERING HOPPER A quarantine buffering hopper can be installed between the tablet press and a large container on our AIO or iseries machines. A sampling gate delivers samples from the quarantine hopper to the tester. This sequence happens at least once in the buffer. Tester will approve the quality of the products. If the product is conformed to the specs, they are released in the good product container by an automatic valve mechanism. If the products are not conformed, user will get an alarm and the small buffered quantity of products will be rejected. An individual report as well as a batch report can be exported in.xls format and/or in.pdf format on a USB stick to be analyzed on a computer and be printed. Software is made following the CFR21 part 11 guidance. AIO tester with buffering concept and tablets tester This solution allows to ensures the quality of your products. Quarantine buffering hopper

28 CLIP & CUT FLEX CONNECT EASY & SAFE OEL5 SAMPLING EASY & SAFE DUST-TIGHT CONNECTION Easy to re-open The Clip & Cut concept is an alternative to the Heat, Seal & Cut concept on continuous liner application. Dust-Tight Connectivity It consists in a way to disconnect products from an equipment in a C containment or in a HC Hi Containment way. It can be used to take samples, rejected products, etc... The Clip & Cut allows re-opening a bag without tooling, as well as re-connection with Bag In / Bag Out concept to the drain in washable application. Flex Connect allows, quick and easy connection between process equipment. It also avoids using sealing tools. Its flexibility allows for misaligned equipment, thermal expansion, and vibration. This system can be used for tablets, capsules, or powder transfers. A patented design permits to avoid any product jam in the funnel. The FDA approved silicone pipe withstands vibration between pipes and equipment. Flex Connect product can be used in Hi-Containment and washable situation with additional quick release collars. Samples are inside the continuous liner bag A double clip allows disconnection by collapsing the liner The liner film retracts in the clips when cutting The tight bag can be easily removed Flex Connect is often use to create a dust tight connectivity between two production machines, to easy assembly in dust tightness and washable metal detector, and can be used for a tablet press between powder hopper and die feeder.

29 NOTES International Sales & Service network Fully equipped FAT room 3D Engineering Service Efficient after-sales Service

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