Dynamic Engineering Inc - Services

 Pharmaceutical Products & Services

Diversified Services

Dynamic Engineering offers a full range of services from project conception through validation, start-up, and ongoing operations. Consulting services are also available. As a single source services company, Dynamic Engineering is capable of providing Clients the services they need for their specific project requirements.

Pharmaceutical and Biological Design Expertise

Dynamic Engineering functions primarily in pharmaceuticals and biologics contributing to over 75% of our services. We have a proven track record that is evident by our repeat pharmaceutical and biological Clients. A sampling of our expertise includes:

• Sterile formulation
• Sterile fill and finish experience of vials, ampoules, bottles, syringe, blow fill and seal
• Lyophilization
• GMP unit operations and pharmaceutical equipment design and water processing – USP PW, WFI
• Sanitary vessel, heat exchanger, and piping design
• Solid dosage capsule filling, blending, milling, tableting
• Fluid bed coaters, powder granulators
• Bio Seed Reactors, Fermenters
• Barrier isolation Rapid Transfer Port design
• Facility design of Bio Level 1 – 3
• HVAC design of US 209D Class 100-100,000/ISO 5-8

Capabilities

Conception

• Estimates
• Feasibility studies
• Master Plans
• Permitting
• Project Financing
• Scope Definition
• Site Study

Validation

• Installation Qualification
• Operational Qualification
• Performance Qualifications
• Process Validation
• Cleaning Validation
• Computer Validation,
  21CFR11
• Validation Master Plans

Start-Up

• Automation Services
• Debugging
• Engineering Support
• Initial Production
• Maintenance Training
• Operator Training
• Pre-commissioning
• Supervision
• Systems Checkout
• Technical Services

Design

• Computer-Aided Design
• Construction Planning/Reviews
• Full Service Detailed Engineering
• Estimating and Cost Control
• Planning and Scheduling
• Procurement
• Safety Planning
• Systems Integration

Construction

• As-Built Drawings
• Construction Engineering
• Contractor Management
• Material Control
• Quality Control
• Safety Programs
• Security

Consulting

• Control Systems Design and
  Implementation
• Statistical Process Control
• Quality Systems Development
• Maintenance Management
  Systems
• Calibration Systems
  Development
• Energy Audits
• Equipment and
  Utility De-bottlenecking
• Operator and Maintenance
  Manuals and SOPs
• Specifications Development
• Plant Retrofits
• Unit Operations Upgrading

Validation, Regulatory and Process Technology Experience

Dynamic Engineering has significant validation experience in pharmaceutical and biological manufacturing facilities. Our people have prepared Site Validation Master Plans, Project Master Plans, Installation Qualifications, Operational Qualifications, Performance Qualifications, Process Validation, Cleaning Validation, and Computer Validation protocols. Our staff includes seasoned personnel with direct operating experience and regulatory compliance experience with both the FDA and MCA. As a direct result, we have developed compliant engineering, validation, calibration and maintenance.

Validation should begin early in the design process starting with the Design Qualification protocols. It is most important to integrate validation activities early in design rather than as an after thought. Significant design issues must be reviewed, understood and accepted by the Quality Department as well as Manufacturing and Engineering before progressing too far into detail design.

Our experienced Process Technology personnel are able to assist you to identify critical process parameters and manufacturing limitations. We can lead and manage your drug delivery project for new product launches. We can establish engineering limits through process efficiency studies, design experiments for pre-validation engineering
investigations, write the process validation protocols and oversee the work.

Quality Systems

Dynamic Engineering’s Quality Plan

Dynamic Engineering maintains an internal quality plan of written procedures that communicates throughout the organization our written procedures and practices, which we apply to all projects to maintain a structured quality philosophy.

Dynamic Engineering also develops and implements a formal quality plan for all projects. The quality plan ensures that the project deliverables conform to both the Client and Dynamic Engineering requirements. The quality plan serves to document understanding and agreement of construction plans and requirements necessary to maintain cCMP conditions within an operating manufacturing unit. The quality plan also identifies the required validation deliverables necessary to execute the validation protocols.

Quality Plan Implementation

Implementation of the quality plan comprises periodic formal reviews, on-going informal reviews, review of applicable regulatory publications, and review of current practices within the pharmaceutical industry.

Our Quality Coordinator is responsible for ensuring adherence to the quality plan. This person will participate in periodic formal reviews and support the design process. The quality coordinator has the authority, independent of project and engineering management, to monitor the project impartially. Some of these oversight management responsibilities include:

• Insure each discipline has in place, and is adhering to, its own department interdiscipline checking procedure
• Establish and administer the interdiscipline checking procedure
• Participate in weekly design review meetings for quality assurance purposes
• Review all critical project design documents for compliance with project design criteria
• Assure that each discipline performs their work in conformance with the latest cGMP checklist
• Assure that all key project personnel have been GMP trained, have copies and understand the regulatory guidelines

Quality Reviews

The Quality Coordinator and all lead design personnel will perform a formal review. The purpose of this review is to ensure that the project is in compliance with the engineering, quality and regulatory project requirements. Each design discipline will perform an internal review of their deliverables before issuing for “Client Approval” in accordance with Design Engineering, Inc. procedures.

Our staff has Owner/Operator experience to compliment our engineering credentials. As a result, we have a keen sensitivity to insure operability and maintainability. We’ve walked in your shoes and understand your operability, reliability and regulatory requirements.

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	Dynamic Engineering Inc
	215 Broadus Sturgis MI 49091-1384 USA
Tel.	+1 269 651 4055
Fax	+1 269 651 6590