Designing A Solid Phase Peptide Synthesis Reactor Facility

Transcription

DESIGNING A SYNTHESISREACTOR FACILITYMike ClucasGroup Head Process EngineeringDPS

THE PROJECTFRAMING THE DESIGN

A qualified, commercial scale fully automated SynthesisFacility The facility is based on using a modified Neutsche Filter /Dryer as a chemical synthesis reactor This project has delivered a successful novel approach forcommercial scale manufacture of the product in a safe, fullyautomated multiproduct facilityConnectingPharmaceuticalKnowledgeispe.org

Project INDUSTRIALISEKnowledgeispe.org

THE SAFETY DRIVERNEW SYNTHESIS PLANT

Facility SafetyA Basis Of Safety ApproachHaving safety as a design driver Preliminary Hazard Analysis (PHA) HAZOP Containment Ergonomics ATEX Report and Drawings LOPA SILConnectingPharmaceuticalKnowledgeispe.org

Basis of SafetyCHEMICALStep 1HAZARDABCDEStep 2Reagent AFlammableReagent BCorrosiveReagent CStep 3Acute Toxicity, Irritant, SensitiserAcute ToxicityFSensitiser, Mutagen, Carcinogen,Reproductive ToxinGConnectingPharmaceuticalKnowledgeispe.org

ChemicalOpen andmanual solventtransfersABCHard Pipedautomatedtransfers fromTank FarmDFOpen solventdrum pumpingPPE & RPEGHContained drumboothHard piped fixedIBC’sAutomated transfersIOpen reagentdispensingPPE & RPEReagent AReagent BContained reagentaddition systemReagent C8ConnectingPharmaceuticalKnowledgeispe.org

Powder Sampling & Liquid HandlingNew SynthesisNew SynthesisAutomated& containedvesselsamplerContainedpowdertransfers ConnectingPharmaceuticalAutomated solvent transfer systemSophisticated instrumentation foraccurate & repeatable transfersFully contained chargingKnowledge9ispe.org

Facility SafetyA Basis Of Safety ApproachHaving safety as a design driver Fully Contained Charging, Bulk solvent and Liquid Waste Handling, Vent Header Design Recipe Controlled Vacuum swing Inertion and Collected, Abated Venting. Contained Potent Dispensing and Charging Fully contained, long term technically sealed solvent transfer and collection systems. Fully ATEX, PED and FM Global Compliance Relief Sizing to g

THE INDUSTRIALISATION DRIVERNEW SYNTHESIS PLANT

Basis of DesignDesign of aSynthesis FacilitySafeProcess1 week batchcycle timeMultiproductand l280lbatch reactorConsistent andincreased yieldKnowledgeispe.org

Early DesignPDF’s, MassBalance and BatchCycle calculationEngagementwith FacilityteamProof of Concept –Key ech Transferand VendorTrialsEquipmentSelection-Neutsche FilterKnowledgeispe.org

THE REACTORNEW SYNTHESIS PLANT

New SynthesisExisting SynthesisControlledagitationPressure ratedhastelloy vesselwith pressurecontrolControlledheating & cooling40 um filterbase ConnectingAutomated productdischargeOperations take place in single vesselAutomated CIP cycleAutomated filter base loweringNo lifting or manual handling requiredPharmaceuticalKnowledgeispe.org

Reactor OCESSKnowledgeispe.org

Reactor ceuticalFLEXIBILITYKnowledgeINNOVATIONispe.org

THE NEW FACILITY

ConnectingPharmaceuticalKnowledgeispe.org19

Thank YouStephen Judd , Lead Process EngineerMike Clucas, Group Head Process Engineeringwww.dpsgroupglobal.com

A qualified, commercial scale fully automated Synthesis Facility The facility is based on using a modified Neutsche Filter / Dryer as a chemical synthesis reactor This project has delivered a successful novel approach for commercial scale manufacture of the product in a safe, fully automated multiproduct facility