2
FA - CIM FLEXIBLE AUTOMATION AND COMPUTER INTEGRATED MANAGEMENT Focuses on automated manufacturing and materials handling using computers to design and manufacture products in process and quality control. FA-CIM takes individual islands of manufacturing automation and link them together to achieve the ultimate efficiency of an organization manufacturing resource. FA-CIM supervise all Granulation Line: from dispensing to coaters. A Closed-Loop Feed back system where process manufacturing phases are integrated, rationalized and coordinated to deal effectively and efficiently with real-time analysis, planning and monitor of the whole process. FA-CIM improves the product quality, repeatability, the flexibility and it reduces the process time, flow time, lead time and production cost. A bar code system allows to check materials flow track. A full batch report can be printed. WIP CIP SYSTEM An Universal Movable Skid is designed to clean efficiently and rapidly all machinery and components in the granulation line. Stainless steel framework on wheels including: connection clamps, piping, sanitary valves, filters, high sanitary pressure pump, heated tank for purified water, detergent and emptying pump. Drying unit. Two motorized washing arm with 4 ways direction orbital washing nozzle to be fitted inside all machinery of granulation guarantee a perfect cleaning. PLC System to memorize and control up to 20 different washing recipes. Manual or automatic washing and drying System for IBC Nicobin. PHD - Process Handling Design One supplier for a fully integrated powder handling and processing line to supply a result: the best quality product, your product. Nicomac has a strong commitment to continuous technology innovation and excellence to be your expert for solid dosage departments. Each product has different characteristics, each project has different requirements and Nicomac will design for you a customized lay-out and the suitable machinery on the basis of your product, your needs and your production plans. Nicomac supplies a complete system and an integrated concept to fit your requirements. Nicomac will be your partner for turnkey projects where the goal is quality, efficiency, performance, output on the basis of your company requirements and your needs. A complete integrated production line can be designed following Total Containment System Standards. Flame proof design on request. All product contact parts are made in stainless steel SS 316 other materials and outer surfaces are made in Stainless Steel SS 304. Turnkey project - Process development - Material handling and product flow concept consulting with high performance machinery, First Class CleanRoom Materials, High quality, cGMP compliant, High functionality, Ergonomic customized designs, efficient high performance material flow. Easy to validate efficient cleaning process for the entire line. Pneumatic conveying system, different product flow can be chosen on the basis of features and the number of products to be handled. QUALITY WITHOUT COMPROMISE A lot of of reliable, state of the art technology machinery are working in FDA approved pharma industries. First Class durable quality components, quality assurance proce- dures for incoming and outgoing materials as per ISO 9001 SOP. Nicomac Highly Qualified, personnel for start-up, validation operation and after sales services. LAB SERVICES - DOCUMENTATION - VALIDATION Nicomac have a very modern LAB equipped with all modern machinery for research, formulation development and process trials. Experienced, professional personnel are available to support you to get the best process performances. In a Nicomac Clean Room Lab, a complete Nicomac Granulation Line with the most modern technology is available: 10 kg. Batch High speed Mixer - FDB processor - Universal blender - 10 and 50 litres capacity Solid wall Coating pan - Tablet press - Capsule Filling Machine. Nicomac can supply the validation service for the entire line starting from Dispensing System. With Log book with calibrated weight. IQ OQ PQ documentation with performed test for each single machine of the granulation line. Process and formulation consultancy at customer’s site to develop, improve and set formulation. NICOMAC SRL via Curiel, 12 - 20060 Liscate (MI) Phone +39 02 95 42 04 1 Fax +39 02 95 42 04 44 www.nicomac.com E-mail: [email protected] NICOMAC INC 80 Oak Street Norwood, NJ 07648 Phone +201 768 9501 Fax +201 768 9504 E-mail: [email protected] NICOMAC FAR EAST 502325 Hyderabad - India Phone +91 40 30914113 Fax +91 08458-279790 E-mail: [email protected] PHD - Process Handling Design GRANULATION LINE NICOMAC GRANULATOR LINE CUSTOMER COMPUTER INTEGRATED MANAGEMENT

COMPUTER INTEGRATED MANAGEMENT QUALITY ......FA - CIM FLEXIBLE AUTOMATION AND COMPUTER INTEGRATED MANAGEMENT Focuses on automated manufacturing and materials handling using computers

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Page 1: COMPUTER INTEGRATED MANAGEMENT QUALITY ......FA - CIM FLEXIBLE AUTOMATION AND COMPUTER INTEGRATED MANAGEMENT Focuses on automated manufacturing and materials handling using computers

FA - CIM FLEXIBLE AUTOMATION AND COMPUTER INTEGRATED MANAGEMENT Focuses on automated manufacturing and materials handling using computers to design andmanufacture products in process and quality control. FA-CIM takes individual islands of manufacturingautomation and link them together to achieve the ultimate efficiency of an organization manufacturingresource. FA-CIM supervise all Granulation Line: from dispensing to coaters. A Closed-Loop Feed backsystem where process manufacturing phases are integrated, rationalized and coordinated to dealeffectively and efficiently with real-time analysis, planning and monitor of the whole process. FA-CIMimproves the product quality, repeatability, the flexibility and it reduces the process time, flow time,lead time and production cost. A bar code system allows to check materials flow track. A full batchreport can be printed.

WIP CIP SYSTEMAn Universal Movable Skid is designed to cleanefficiently and rapidly all machinery andcomponents in the granulation line. Stainless steelframework on wheels including: connection clamps,piping, sanitary valves, filters, high sanitarypressure pump, heated tank for purified water,detergent and emptying pump. Drying unit. Twomotorized washing arm with 4 ways direction orbitalwashing nozzle to be fitted inside all machinery ofgranulation guarantee a perfect cleaning. PLCSystem to memorize and control up to 20 differentwashing recipes. Manual or automatic washing anddrying System for IBC Nicobin.

PHD - Process Handling Design

One supplier for a fully integrated powder handling and processing line tosupply a result: the best quality product, your product. Nicomac has a strongcommitment to continuous technology innovation and excellence to be yourexpert for solid dosage departments. Each product has differentcharacteristics, each project has different requirements and Nicomac willdesign for you a customized lay-out and the suitable machinery on the basisof your product, your needs and your production plans.

Nicomac supplies a complete system and anintegrated concept to fit your requirements.

Nicomac will be your partner for turnkey projectswhere the goal is quality, efficiency, performance,output on the basis of your company requirementsand your needs. A complete integrated production line can be designedfollowing Total Containment System Standards. Flameproof design on request. All product contact parts aremade in stainless steel SS 316 other materials andouter surfaces are made in Stainless Steel SS 304.

Turnkey project - Process development -Material handling and product flow conceptconsulting with high performance machinery,First Class CleanRoom Materials, High quality,cGMP compliant, High functionality, Ergonomiccustomized designs, efficient high performancematerial flow. Easy to validate efficientcleaning process for the entire line.

Pneumatic conveying system, different productflow can be chosen on the basis of features andthe number of products to be handled.

QUALITY WITHOUT COMPROMISE

A lot of of reliable, state of the art technologymachinery are working inFDA approved pharmaindustries. First Classdurable quality components,quality assurance proce-dures for incoming andoutgoing materials as perISO 9001 SOP. Nicomac Highly Qualified,personnel for start-up,validation operation andafter sales services.

LAB SERVICES - DOCUMENTATION - VALIDATION

Nicomac have a very modern LAB equipped with all modern machinery for research,formulation development and process trials. Experienced, professional personnel areavailable to support you to get the best process performances. In a Nicomac CleanRoom Lab, a complete Nicomac Granulation Line with the most modern technology isavailable: 10 kg. Batch High speed Mixer - FDB processor - Universal blender - 10 and 50litres capacity Solid wall Coating pan - Tablet press - Capsule Filling Machine.

Nicomac can supply the validation service for the entire line starting from DispensingSystem. With Log book with calibrated weight. IQ OQ PQ documentation with performedtest for each single machine of the granulation line. Process and formulationconsultancy at customer’s site to develop, improve and set formulation.

NICOMAC SRLvia Curiel, 12 - 20060 Liscate (MI) Phone +39 02 95 42 04 1Fax +39 02 95 42 04 44www.nicomac.comE-mail: [email protected]

NICOMAC INC80 Oak StreetNorwood, NJ 07648Phone +201 768 9501Fax +201 768 9504E-mail: [email protected]

NICOMAC FAR EAST 502325 Hyderabad - India Phone +91 40 30914113Fax +91 08458-279790 E-mail: [email protected]

PHD - Process Handling Design

GRANULATION LINEReport date: 03/06/2004 23:23:59

Batch n. Time begin Time end Time begin Time end Time begin Time end Time begin Time end Time begin Time end Time begin Time end Time begin T ime endBatch 2003-01 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-02 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-03 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-04 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-05 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-06 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-07 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-08 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-09 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-10 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-11 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-12 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-13 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-14 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-15 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-16 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-17 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-18 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-19 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-20 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-21 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-22 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-23 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-24 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-25 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-26 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-27 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-28 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-29 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-30 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-31 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-32 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-33 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-34 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-35 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-36 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-37 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-38 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-39 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-40 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-41 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-42 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-43 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-44 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-45 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-46 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32Batch 2003-47 03/06/2004 11.15.32 04/06/2004 11.15.32 05/06/2004 11.15.32 06/06/2004 11.15.32 07/06/2004 11.15.32 08/06/2004 11.15.32 09/06/2004 11.15.32 10/06/2004 11.15.32 11/06/2004 11.15.32 12/06/2004 11.15.32 13/06/2004 11.15.32 14/06/2004 11.15.32 15/06/2004 11.15.32 16/06/2004 11.15.32

Fluid bed dryier Dry calibrator Double cone mixer

NICOMAC GRANULATOR LINECUSTOMER

Vibrating siever Oscillating granulator High speed mixer Wet calibrator

COMPUTER INTEGRATED MANAGEMENT

Page 2: COMPUTER INTEGRATED MANAGEMENT QUALITY ......FA - CIM FLEXIBLE AUTOMATION AND COMPUTER INTEGRATED MANAGEMENT Focuses on automated manufacturing and materials handling using computers

DISPENSING Dispensing room: stainless steel or NicomacUnique high pressure laminate phenolicimpregnated panels structure with laminar flowto protect the operator and the product. Userfriendly system to manage up to 100 recipes,each one with15 different components. Summaryof weighing sequence. Different Scales frommilligrams to 150 kg weighing. Bar code readersystem. Printer with batch documentation andtracking system.

SIEVING - MILLING& CALIBRATIONCrushing, Separation, Clas-sifying, Sizing of dry and wetpowder and granules.Oscillating Reducer - VibroSifter - Multi\Cone MillCalibrator - Compact design,safe seal, easy dismantlingand cleaning.

HIGH SPEED MIXER - HIGH SHEARMIXING - RAPID MIXER Homogeneous mixing of dry & wet powders,deaglomeration of wet mass and fastdispersion of binding agent. Dust free, highfree flowing dosing properties, highuniformity of granule size. AC frequencycontrol for bottom driven Impeller Mixer with3 or 4 blades with exclusive scrape sidedesign and Chopper positioned to help the

product discharge. Steam Jacketed Bowl.The cleaning validation of Impeller is ensuredby a simple lifting operation - Binder pump -Automatic discharge in MultiCone-MillCalibrator - End point control of wet massby Torque Value to achieve better repeatability and accuracy of the process.Integrated WIP CIP system. PLC control with 100 Automatic recipes - Real time batch data monitoring and records. RS-232 communication port provided.

PNEUMATIC CONVEYINGSYSTEMVacuum transport of powders, granulesand other free flowing solids in a gentle,safe, closed system. Sequential timebased air blasted filter cleaning system.Washable filter. Filter Assembly and FineCollection port are with toggle clamp,which reduces the cleaning changeovertime. Silencer at suction and discharge

port to reduce the noise level. Vacuumsource is equipped with a suction airfilter to prevent the contamination withexternal particles. Vacuum Safety Valve.Vacuum Gauge and isolator valve on theVacuum power source for ease ofmaintenance. Control Panel will bemanufactured in stainless steel 304having dust proof construction. Controlpanel is sequential time based havingautomatic operation cycle. AC drive.

HORIZONTAL PROCESS LAYOUT VERTICAL PROCESS LAYOUT VERTICAL process lay-out on different levelsProduct flowing mainly downwards through several levels driven by gravity. The single process steps are either directly linked together or are interconnectedby the use of a NicoBin IBC with docking station.

FLUED BED

DOCKING SYSTEMLow dust, bridge free, safe, reliable, high quality manualand automatic docking system for charging anddischarging powder and granules. Active valve withpneumatic actuators.Systems to prevent segregation and product breakageduring discharge and to ensure even flow of stickyproduct. Connecting product chutes designed according toroom and equipment lay-out.

IBC INTERMEDIATE BULK CONTAINER NicoBin, practical, flexible , high finishing container can besupplied in different shape: round, rectangular and square,in different sizes. Track identification using barcodesystem.

CAPSULE FILLING MACHINEHigh Speed Automatic Capsule Filling Machine from 3000to 90.000 capsules/hour The control panel of the machineis supplied with Programmable Logic Control (PLC)system. All powder contact parts are in stainless steel 316. The designed output of the machine depends upon fillweight, powder characteristic and capsule size. The mainbody of the machine is fabricated in stainless steel 304quality plate and frame. cGMP. High quality with highfinishing and High output. Empty Capsule Sorter withElevator - Filled Capsule Sorter -Capsule PolishingMachine - Unfilled Capsule Separator

FDB NICOBED FLUID BED DRYER AND PROCESSORDust free, fast, gentle, uniform, effective drying. A special effective air flow duringfluidizations allows to pass through the entire surface of every single particle. Great drying efficiency for a perfect and uniform granule. NicoBed dryer/granulator series are manufactured for overpressure integrity usinga unique sealing system for operator safety and product containment.FDB PROCESSOR an automatic and accurate spraying system is available for TOPand BOTTOM spray: chamber has a port to insert spray arm, solution vessel,stainless steel anticlogging gun and peristaltic pump.Filter locking and lifting system for easy cleaning and dismantling. Solid flow meter.Sensor monitoring the powder content passing through the filter. Compressionseals are used among the components of the machine tower to completely seal thesystem. PLC Control system with touch screen Monitor. 100 Automatic recipes.

FDB NICOBED

COATERS NCSNicomatic Coating System is the mostadvanced, flexible and sophisticatedcoating equipment for the Pharma-ceutical industry all over the world. Asolid wall drum for high yield, topquality final product, easy cleaning,fast process for any kind of core andany type of process. World leaderCoaters, for pellets and powder dosingsystem. Nicomac developed manypatented system such as thermojacket,magnetic unloading system, 3D baffles,powder dosing system, no cloggingspray guns. Useful capacity from 10 to2300 litres! High flexibility and hightechnology. Perforated drum Coatingpans are also available on request.

Horizontal process lay-out on one levelManual or gravity system can be used for product flow. Pneumatic conveying system as well as mobile and stationery lifting and discharging system can be used. Soliddosage form lay-out may have different philosophy and/or configuration depending on how the link between the main process steps and product handling operations.

BLENDER IBC Tumbler - Double Cone - V type -Octagonal type - Drum Blender. Nicomaccan supply the best blender for any type ofproduct and any type of process. AllNicomac blenders can be easily integratedinto the process line. Dry Blending of freeuniform flowing powders/ granules toachieve homogeneity in a shortest timeprocess and easy cleaning. All systemsare safe with variable speed, for a perfect,

uniform and gentle mixing. IBC Blender isthe most efficient and best method ofhandling, blending, and transferring anyless-than-3000-liter batch powder product.The products are blended by continuouslyrotating the bin. The cage blender has apowered clamping cage which assuresthe operator safety. Different inclinationcan be set for an asymmetric flow ofpowder or granules in the bin duringtumbling. Universal clamping for differentsize and shape IBC.

LIFTING - DISCHARGING -TRANSPORT SYSTEM Stationery lifting and dischar-ging device. Rotating TiltingLifting stainless steel column.The Nicobin IBC can be movedby a manual pallet truck forklift,or by a battery powered stainlesssteel forklift.

WEIGHING SYSTEMNicomac are able to offer manualor automatic weighing station.

TABLET PRESSHigh tech, high reliable and high capacity tablet press can be supplied by Nicomac. From 8 to 81 stations,motorized control for auto operation of tablet parameter such as depth of fill setting pre-compression andmain compression, force sensing for main compression, pre - compression and ejection setting, SCADA15” Touch screen Industrial PC - PLC control system, Auto Weight Checker, force feeder, cleanness andcleanability, cGMP CE standard, fast and easy change over parts, stainless steel turret, metal detector,deduster and all options for single, double, triple layer tablets.

HIGH SPEED MIXER

PERFORATED DRUM COATERNicomac can also supply a wide range ofhigh tech perforated drum coating equip-ment with PC-PLC control system.