Services Provided by Steyer Consulting Engineering Resources LLC

Steyer Consulting Engineering Resources LLC is an established independent engineering consulting firm delivering Senior Principal-level expertise in Aseptic Process Development; Contamination Control Strategy; cGMP Remediation; & Architecture, Engineering, & Construction (A/E/C) Oversight for regulated process development & optimization within pharmaceutical, biotechnology, & medical-device organizations.

Services include, but are not limited to: Aseptic Process Development & Optimization; Remediation & Architecture, Engineering & Construction (A/E/C) Oversight; Contamination Control Strategy & Gap Assessment; Quality Risk Management (QRM) & Data-based Risk Assessments; Process Validation & Technology Transfer; Cleanroom & Facility Design Verification; & Pre-Approval Inspection Readiness. See the full range of services below.

Selected Engineering Consulting Services by Technical Area

Available for corp-to-corp engagements; contact to discuss scope.

Core Aseptic Process, Compliance & Manufacturing-Readiness Services

Aseptic Facility & Equipment Design Verification, Optimization & Remediation Services

Delivers aseptic facility & equipment design verification, design optimization, performance qualification, validation, & remediation services for sterile-manufacturing operations. Provides aseptic facility & equipment design; aseptic transfer; airflow visualization; aseptic process simulation; facility, utility, process, & equipment integration; aseptic equipment qualification; & personnel training to strengthen operational readiness & contamination-control implementation.

Contamination Control Strategy & Gap Assessment Services

Develops, evaluates, & remediates contamination control strategies (CCS) for aseptic manufacturing by integrating quality risk management (QRM) with facility, utility, equipment, process, material, & personnel controls; cleaning & disinfection; sterilization; aseptic process simulation; airflow visualization; aseptic transfer; barrier systems; control-strategy governance; & environmental monitoring. Performs CCS gap assessments, data-based risk assessments, control mapping, & implementation planning aligned with EU GMP Annex 1, ISO 13408, & PDA Technical Report No. 90 principles to mitigate microbial, endotoxin, & particulate contamination risks.

Risk Assessment & Risk Management Services

Develops data-based risk assessments & provides quality risk management support through risk traceability matrices, pFMEA, FMECA, dFMEA, HAZOP, HACCP, fault-tree analysis, hazard analysis, risk-control definition, risk-control implementation verification, periodic review, & performance monitoring. Applies ICH Q9(R1), ISO 14971, & ISO/TR 24971 principles to support risk-based development, validation, remediation, & design decisions.

Process Validation, Process Performance Qualification, & Process Optimization Services

Develops master validation plans & process-validation strategies integrating process characterization, process performance qualification (PPQ), continued process monitoring, & improvement planning using design of experiments, measurement system analysis, gauge R&R, statistical process control, multivariate analysis, & process modeling. Establishes critical quality attributes, critical process parameters, sampling plans, acceptance criteria, protocol & report requirements, & risk-based decision frameworks supporting aseptic process development, remediation, scale-up, & technology transfer.

Technology Transfer, CMC Documentation, & Manufacturing Readiness Services

Guides technology-transfer, scale-up, & manufacturing-readiness programs for aseptic, biologics, small-molecule, & medical-device manufacturing processes. Defines transfer strategies, knowledge-transfer requirements, analytical-method-transfer requirements, process-comparability requirements, critical quality attributes (CQAs), critical process parameters (CPPs), CMC documentation & development-report requirements, batch-record inputs, sampling plans, acceptance criteria, equipment & utility readiness, qualification requirements, & implementation actions supporting controlled transition from development, pilot-scale, or clinical-manufacturing operations into commercial-scale manufacturing.

Pre-Approval & Regulatory Inspection Readiness Services

Guides Pre-Approval Inspection (PAI) readiness, quality management system remediation, & cGMP oversight for pharmaceutical, biotechnology, & medical device organizations undertaking greenfield & brownfield capital projects from concept development through design, construction, commissioning, qualification, & operational handover. Performs technical & documentation gap assessments, risk assessments, design verification, traceability reviews, Master Validation Plan development, controlled-document review, CAPA-effectiveness evaluations, personnel training, & cross-functional readiness activities that align Engineering, Quality, Validation, Manufacturing, Regulatory, & A/E/C workstreams to prioritize deficiencies, direct remediation, & strengthen inspection readiness & technically complete project turnover.

Facility, Capital Project & Engineering Execution Services

Remediation & Architecture, Engineering & Construction (A/E/C) Oversight Services

Guides clients through architecture, engineering & construction (A/E/C) oversight for new construction, expansion, modernization, & remediation projects involving aseptic facilities, cleanrooms, utilities, process systems, & equipment. Reviews Engineering Basis of Design (EBOD), User Requirements Specifications (URS), layouts, personnel & material flows, HVAC pressure cascades, cleanability, maintainability, & commissioning & qualification planning to support alignment with 21 CFR Parts 210 & 211, EU GMP Annex 1, ISO 14644, & applicable building & life-safety codes.

Cleanroom Design & Design Verification Services

Provides cleanroom design & design verification for ISO Class 5 aseptic processing environments & associated ISO Class 6, ISO Class 7, & ISO Class 8 cleanrooms, or EU GMP Grade A, Grade B, Grade C, & Grade D cleanrooms, as applicable. Guides projects from Engineering Basis of Design (EBOD) & User Requirements Specifications (URS) through detailed design, construction turnover, commissioning, qualification, & operational readiness, applying ISO 14644 standards to facility layouts, room classifications, personnel & material flows, HVAC pressure cascades, airflow-visualization studies, utility interfaces, cleanability, & maintainability.

Critical Utility Systems Engineering Services

Provides critical utility-system engineering, design verification, & qualification support for pharmaceutical, biotechnology, & medical-device facilities. Develops & reviews water for injection (WFI), purified water, clean steam, clean compressed air, process-gas, vacuum, CIP, SIP, temperature-control, & associated distribution systems through Engineering Basis of Design (EBOD), User Requirements Specifications (URS), P&IDs, equipment specifications, capacity assessments, sampling strategies, commissioning, qualification, & operational handover. Aligns utility requirements with process demand, equipment interfaces, facility layouts, construction turnover, FAT, SAT, IQ/OQ/PQ, change control, as-built documentation, & lifecycle-maintenance planning to strengthen engineering traceability & operational readiness.

Piping & Instrument Diagram (P&ID) Development & Review Services

Develops, reviews, & remediates Piping & Instrumentation Diagrams (P&IDs) for aseptic processes, process utilities, equipment, & facility systems. Evaluates process-flow paths, piping, valves, instruments, control loops, alarms, interlocks, sampling points, clean-in-place & steam-in-place interfaces, & equipment connections. Aligns P&IDs with Engineering Basis of Design (EBOD), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), control narratives, equipment specifications, FAT, SAT, IQ/OQ, change control, CAD updates, & final as-built records to strengthen engineering traceability, qualification readiness, & operational handover.

Engineering Calculations & Process Modeling Services

Performs mass & energy balances; heat-transfer, fluid-flow, & pressure-drop analysis; pump, pipe, heat-exchanger, & utility-demand calculations for aseptic, biochemical, API, & sterile-manufacturing processes. Applies dynamic process & control-loop analyses, statistical engineering, simulation, & process modeling to define process conditions, equipment capacity, utility requirements, operating ranges, & design alternatives supporting process development, scale-up, facility design, feasibility studies, & remediation. Evaluates CIP, SIP, WFI, purified water, clean dry air, vacuum, process-gas, & temperature-control systems supporting aseptic process equipment.

Commissioning, Qualification, & Validation Lifecycle Management Services

Guides commissioning, qualification, & validation (CQV) lifecycle management for greenfield, brownfield, expansion, modernization, & remediation projects supporting aseptic, biologics, small-molecule, & medical-device manufacturing. Establishes lifecycle strategies, master validation plans, qualification plans, traceability matrices, & execution pathways linking design inputs, design verification, FAT/SAT, construction turnover, commissioning, qualification, deviation management, change control, as-built documentation, final acceptance, & operational handover.

Specialized Sterility Assurance, Cleaning & Product-Contact Services

Cleaning Method Development & Cleaning Validation Services

Guides cleaning validation programs from initial equipment & cleaning-process assessment through method development, protocol execution, deviation evaluation, remediation, & continued-verification planning for clean-in-place, clean-out-of-place, & out-of-place cleaning. Authors cleaning validation master plans, risk assessments, PDE/HBEL-based residue-limit derivations, sampling rationales, detergent & soil residue-limit calculations & justifications, matrix-based equipment-grouping strategies, material-recovery-study assessments, cleaning validation protocols, & reports consistent with APIC Cleaning Validation Guidance, PDA Technical Report No. 29, & project-specific quality-system requirements.

Environmental Monitoring Performance Qualification Services

Develops & remediates Environmental Monitoring Performance Qualification (EMPQ) programs through gap assessments, risk assessments, viable microbial & nonviable particle assessments, EMPQ protocols & reports, environmental-monitoring maps, sampling-location rationales, data-trending plans, deviation investigations, & corrective-action recommendations. Supports EMPQ assessments & personnel training for ISO Class 5 aseptic areas, associated ISO Class 6, ISO Class 7, & ISO Class 8 cleanrooms, controlled environments, & EU GMP Grade A, Grade B, Grade C, & Grade D cleanrooms, as applicable, by applying PDA Technical Report No. 13 principles to align monitoring activities with facility, process, & contamination-control risks.

Sterilization Strategy Development Services

Provides sterilization development & sterility-assurance support for pharmaceutical, biotechnology, & medical-device products, components, single-use systems, & final packaging systems. Evaluates gamma irradiation, e-beam irradiation, ethylene oxide, steam sterilization, & vaporized hydrogen peroxide surface-decontamination approaches through material-compatibility assessment, bioburden evaluation, process definition, dose or cycle development, mapping, & validation planning. Applies standards & guidance including ISO 11137, ISO 11135, ISO 17665-1 for steam sterilization, EN 285, ISO 22441 for vaporized hydrogen peroxide, ISO 11737, ISO 10993, AAMI TIR17, & ISO 14937.

Single-Use Systems & Extractables/Leachables Strategy Services

Guides single-use system integration for upstream, downstream, aseptic processing, bulk drug substance, & fill/finish operations. Evaluates product-contact materials, system configuration, closed-processing strategy, aseptic connectors, system & connection integrity, operating conditions, equipment interfaces, supplier technical controls, & lifecycle change control supporting process validation, technology transfer, scale-up, & manufacturing readiness.

Authors single-use-system design-verification documentation, extractables & leachables assessments, supplier technical questionnaires, URS & FRS inputs, change-control evaluations, & controlled documentation informed by USP <665>, USP <1665>, applicable FDA guidance, & ICH Q3E principles.

Available for corp-to-corp engagements; contact to discuss scope.