Deaton Engineering

Pharmaceutical Engineering

Deaton Engineering Understands Good Manufacturing Practices (GMP)

The impact of long product development cycles, global competition, and current Good Manufacturing Practices presents a unique challenge to the pharmaceutical industry. When designing or changing a process, great care must be taken to balance international regulatory requirements with efficiency and cost. Managing these requirements makes pharmaceutical engineering a discipline unto itself.

Whether you are scaling up a new process or modifying an existing one, Deaton Engineering can help. Our risk-based approach to pharmaceutical engineering is a proven strategy for managing process design, development, and change. Deaton Engineering partners with you to determine the best solution to meet your goals.

Total quality management: define, design, build, validate, and improve.Our engineering teams are highly skilled and experienced with the latest technologies. We deliver innovative equipment and system solutions using nonproprietary technologies (including open standards whenever possible) to accelerate adoption and simplify validation. Deaton Engineering understands current GMP requirements and follows the proven Total Quality Approach to providing engineered solutions. This approach can deliver substantial improvements in productivity while maintaining the highest assurance of product and human safety.

Process & Facilities Optimization, Equipment Automation, and Regulatory Compliance

Machine Design & Process Automation

Deaton Engineering can design and build an individual piece of equipment or a complete manufacturing line to automate and improve your process. We use GAMP-compliant designs to create turnkey solutions that are reliable, cost-effective, and suitable for GMP validation. Deaton Engineering can also help identify, integrate, and validate your Process Analysis Technology (PAT) solutions.

Process Engineering, Facilities, and Safety

Deaton Engineering provides support services for production and utility systems in FDA-approved facilities. Our engineers can design, improve, or support the systems that run your operation -- including on-site construction management and start-up -- to help you every step of the way.

Risk-Based Validation Engineering and FDA Compliance

Our engineers provide turnkey validation services that cover the entire validation process. We can develop and execute qualification protocols for equipment, facility systems, and processes. Our documentation packages are extremely thorough and comply with regulatory requirements. Deaton Engineering can perform validations of automated control systems in accordance with 21 CFR Part 11.

Pharmaceutical Engineering Services

  • Process analysis technology (PAT)
  • FDA, GMP, cGMP compliance & design
  • Current good manufacturing practice (cGMP) (GMP)
  • Good automated manufacturing practice (GAMP)
  • Quality assurance & quality control
  • USP purified water, water for injection (WFI)
  • Design of experiments
  • Pharmaceutical consultants
  • Aseptic process & equipment design
  • Quality by design
  • Bioprocess engineering
  • Standard operating procedures (SOP)
  • User requirements specifications (URS)
  • Functional requirements specifications (FRS)
  • Software requirements specifications (SRS)
  • Installation qualifications (IQ)
  • Operational qualifications (OQ)
  • Performance qualifications (PQ)
  • 21 CFR Part 11
  • Process development & optimization
  • Clean and sanitary design practices
  • System design specifications
  • Measurement system analysis
  • Statistical process control
  • Automated process control systems (APCS)
  • On-site construction management
    and start-up support
  • System commissioning
  • Process and manufacturing equipment list
  • Process engineering services list
  • Facilities engineering services list
  • Validation engineering services list
  • FDA, regulatory and safety services list




FAQs:

What pharmaceutical engineering services does Deaton Engineering offer in Texas?

Deaton Engineering provides a comprehensive suite of pharmaceutical engineering services, including:

  • Process Analysis Technology (PAT): Implementing advanced monitoring and control systems to enhance process efficiency.
  • FDA, GMP, and cGMP Compliance & Design: Ensuring all processes and designs meet stringent regulatory standards.
  • Aseptic Process & Equipment Design: Developing sterile systems to maintain product integrity.
  • Validation Services: Conducting thorough qualifications such as IQ, OQ, and PQ to ensure system reliability.
  • Automated Process Control Systems (APCS): Designing and integrating automation solutions for consistent production quality.

These services are tailored to meet the unique needs of pharmaceutical companies operating in Texas. Deaton provides engineering and validation services across Texas, including in Austin, Dallas, Fort Worth, Waco, Houston, and San Antonio.

How does Deaton Engineering ensure compliance with Texas-specific pharmaceutical regulations?

Deaton Engineering stays abreast of both federal and Texas state regulations governing drug manufacturing and distribution. They ensure that all projects comply with guidelines set forth by the Texas Department of State Health Services (DSHS), including adherence to state-specific statutes and federal laws adopted by reference.

Texas Health and Human Services

Can Deaton Engineering assist with facility optimization and safety in Texas-based pharmaceutical plants?

Yes, Deaton Engineering offers support services for production and utility systems in FDA-approved facilities across Texas. Their engineers can design, improve, or support systems that run operations, including on-site construction management and start-up support, ensuring efficiency and safety standards compliance.

What is Deaton Engineering's approach to process automation for Texas pharmaceutical companies?

Deaton Engineering designs and builds individual equipment or complete manufacturing lines to automate and improve processes. They utilize GAMP-compliant designs to create turnkey solutions that are reliable, cost-effective, and suitable for GMP validation, catering to the specific needs of Texas pharmaceutical manufacturers.

How does Deaton Engineering support risk-based validation and FDA compliance in Texas?

Their engineers provide turnkey validation services covering the entire validation process. They develop and execute qualification protocols for equipment, facility systems, and processes, ensuring documentation complies with regulatory requirements. Additionally, they perform validations of automated control systems in accordance with 21 CFR Part 11, which is crucial for Texas companies seeking FDA compliance.

Does Deaton Engineering offer consulting services for Texas pharmaceutical companies?

Yes, they provide pharmaceutical consulting services, including process development and optimization, quality assurance and control, and the development of standard operating procedures (SOPs), all tailored to the needs of the Texas pharmaceutical industry.

How can Texas pharmaceutical companies initiate a project with Deaton Engineering?

Companies can contact Deaton Engineering through its website or by visiting its Georgetown, Texas, headquarters. It offers free consultations to discuss potential projects and provide estimates, facilitating collaboration with Texas-based pharmaceutical firms. Deaton provides engineering and validation services across Texas, including in Austin, Dallas, Fort Worth, Waco, Houston, and San Antonio.