NCS Pharmaceuticals has experience in engineering design, commissioning and   validation in a wide variety of different facilities, systems, processes and  equipment. This experience includes, but is not limited to the following: Facilities Compounding/Formulation                                 Environmental Rooms Aseptic Suites                                                        Containment Areas Laboratories Controlled Substances                Medical Devices Barrier Technology Utilities/Services Purified Water                                                        Process Chillers Water for Injection                                                 HVAC               Sterile Air                                                                Vacuum Compressed Air                                                   Clean Steam Plant Air                                                                   Plant Steam Nitrogen                                                                  Emergency Power Dust Collection                                                      Sterilize in Place Waste Neutralization                                            Clean in Place Systems/Computer Validation Computer Hardware                                            Label Control Computer Software                                              Automatic Inspection Automated Warehouse                                       LIMS Programmable Logic Controllers                    SAP                                     Distributed Control Systems                              Decontamination System Parenterals Steam Sterilization                                             Environmental Monitoring Depyrogenation Ovens/Tunnels                      Terminal Sterilization       Aseptic Filling/Processing                                Stoppering/Crimping     Stopper Washing/Sterilizing                             Lyophilizers Radiation Sterilization                                        Sterile Filtration     Ethylene Oxide Sterilization                              Laminar Flow Hoods Form/Fill/Seal Machines                                   Inspection Stations Glassware Washers/Dryers Oral Solid Dosage Forms Blenders                                                              Tablet Coaters High Shear Mixers                                              Tablet Printers Fluid Bed Granulators                                       Capsule Printers Milling Equipment                                               Dryers Check Weighers                                                 Centrifuges Tablet Presses                                                   Microwave Drying Biotechnology Master Cell Banks                                            Ultrafiltration Media Preparation                                            Chromatography Buffer Preparation                                            Biosafety Cabinets Fermentation                                                     Deactivation Harvesting                                                          Neutralization Separation                                                         Sterilization Bulk Pharmaceuticals Reactors                                                            Tank Farms Centrifuges                                                        Solvent Recovery Distillation  Columns                                       Vessels/Agitators Crystallizers                                                       Filtration Extruders                                                            Drying Packaging Unscramblers                                                   Neck Banders Fillers                                                                  Accumulation Tables Pluggers                                                            Cartoners      Cappers                                                             Shrink Wrappers Tamper Evident Features                               Overwrappers     Labelers                                                             Case Sealers Batch/Date/Bar Coders                                   Palletizers Blister Packers                                                  Cottoners PROJECTS: API: We provided engineering design (estimates, vendor selections, specs, drawings-PFDs/P&IDs, bid evaluation, etc.), commissioning and validation services for active pharmaceutical ingredients (API) manufacturers. We managed the process validation, cleaning validation, and equipment/utility qualification for API manufacturers. Supported the clients with cleaning validation acceptance criteria and company-wide master plans and policies. Prepared and executed cleaning validation protocols and final reports. Responsible for the cleaning validation activities of reaction trains, centrifuges, tray dryers, rotary dryers, mills and blende.rs. Led a multi-discipline team to evaluate and improve all aspects of the cleaning validation program including residue limits, cleaning processes, documentation, and analytical methods validation. Prepared and executed equipment qualification (IQ/OQ) protocols and final reports for rotary vacuum dryers, vacuum tray dryers, stills, reactors, condensers, distillation columns, mills, blenders, hydrogenators, HVAC systems, BMS, softwall enclosures, crystallizers, and centrifuges. Prepared and executed process validation protocols and reports for crystallization, drying, milling and blending operations for API’s and their intermediates. Developed, Computerized Systems Master Validation Policy. Assessed FDA compliance status of computerized systems, ranging from analytical systems in the QC laboratory and SCADA, DCS, and HVAC systems, to databases, maintenance management, and QA information systems. Developed validation plans, assessment scripts, specifications, procedures, manuals, schedules, and budgetary estimates. Assembled life cycle documentation, reverse-engineered, and enhanced SCADA system for product dryers to provide compliance with 21 CFR Part 11 by implementing a SQL Server based audit trail, electronic signatures, and a custom batch reporting system. Installed dryer system upgrade, wrote test scripts, and cataloged changes in a report for change control closeout. Developed prototype for a Part 11 compliant client-server solution to manage training records, coordinate with legacy personnel record management system, and eventually automate employee and HR notification of training requirements via e-mail. Prepared SOPs for cleaning validation, process validation, equipment qualification, master planning, and computer validation. Solid Dosage: Provided engineering design, commissioning and validation services for solid dosage facilities. Generated/executed protocols and final reports for Quadro Comil, Stokes Granulator, AMF Mixer, PK Blenders, Ribbon Blender, Stokes Vacuum Dryer, Williams Tablet Conveyer, H&K Encapsulator, Mocon Vericaps, Pro-Quip Inspection Belt, Key Capsule Polisher, Metal Detector, Stokes Sugar Coating Pan, Coating Solution Tank, and PIAB Pneumatic Tablet Transfer System. Mammalian Production: Provided detailed design for cell culture pilot plant. Involved with start-up and commissioning, and validation of automated centrifuge with CIP/SIP, clean gas systems, plant control system, plant/clean steam, USP Purified Water, WFI, cooling tower water, and plant/process chillers. Prepared validation turnover packages, generated/executed validation protocols and reports for cooling tower water, reverse osmosis water, WFI, USP Purified Water, HVAC clean gases, plant control systems, ultrafiltration skids, depth filter housings, CIP skids, B. Braun bioreactors, buffer tanks, media tanks, chromatography skids, column packing, autoclave, glass washer, centrifuges, pumps, filters, cold rooms, freezers, refrigerators, and incubators. Clinical Production: Provided services to the clinical manufacturing facilities. Directly involved with start-up and commissioning of process control system, HVAC, UPS, clean compressed air, plant/clean steam, USP Purified Water, plant/process chillers, process tanks, incubators, shakers, fume hoods, biosafety hoods, laminar flow hoods, and bio-waste system. Prepared validation turnover packages, generated/executed validation protocols and reports for process control system, HVAC, clean compressed air, clean steam, USP Purified Water, incubators, and process tanks. Cell Culture: Provided services in design, commissioning and validation for the bioreactors projects. Prepared validation master plan for project. Prepared and executed equipment qualification (IQ/OQ) protocols. Contract Packaging and  Contract Manufacturer: Developed cleaning validation and packaging validation programs including preparation of the validation master plans, preparation of SOPs, and development of the validation protocols. Did audit including the areas of cleaning validation, process and packaging validation, process equipment, HVAC, filling machines, control systems, and utility systems, and laboratory systems qualification. Provided design, start-up, commissioning and validation for contract research organization and contract manufacturers. Supported the installation of packaging equipment for the manufacture of an insulin metering system. Performed start-up, commissioning, and validation (IQ/OQ) activities for EAM Fillter/Capper, Chromatography Systems, EAM Cartridge Assembly Machine, Comas Plunger/Insert Assembly Machine, Cazzoli Gross Washer with Siliconization, Cazzoli Stopper Washer, Receiving Vessels, and Formulation Vessels, Lab Equipments, etc. Developed and executed depyrogenation protocols. Prepared SOPs.