Engineering Services

Eagle Analytical provides engineering support services for healthcare, laboratory, and manufacturing facilities operating within controlled environments.

Our Engineering Department offers certification, calibration, qualification, and cleanroom design review services to help facilities maintain compliant operations and reliable environmental conditions.

Backed by a dedicated team of engineering professionals, Eagle Analytical is committed to providing responsive service, technical expertise, and dependable customer support.

Engineering Services

Eagle Analytical provides engineering support services for healthcare, laboratory, and manufacturing facilities operating within controlled environments.

Certification

Certification services for cleanrooms, primary engineering controls, and controlled environments to help support USP and ISO compliance requirements.

Calibration

Calibration services for critical laboratory and environmental monitoring equipment to support accuracy, consistency, and operational reliability.

Qualification

Qualification (IQ/OQ/PQ) services designed to verify equipment installation, operation, and performance under controlled conditions.

Cleanroom Design and Review

Consulting and review services focused on cleanroom layout, airflow design, pressure relationships, and USP compliance considerations.

Certification

Certification services for cleanrooms, primary engineering controls, and controlled environments to help support USP and ISO compliance requirements.

Calibration

Calibration services for critical laboratory and environmental monitoring equipment to support accuracy, consistency, and operational reliability.

Qualification

Qualification (IQ/OQ/PQ) services designed to verify equipment installation, operation, and performance under controlled conditions.

Cleanroom Design and Review

Consulting and review services focused on cleanroom layout, airflow design, pressure relationships, and USP compliance considerations.

Certification Services:

Cleanroom certifications to USP <797>, USP <800>, and CETA standards, which includes:
- HEPA filter integrity testing (leak test)
- Differential pressure measurement
- Air change per hour measurement and calculation
- Non-viable air sampling (particle counts)
- Viable air and surface sampling (environmental monitoring)
- Ambient temperature and relative humidity measurement
- Static air visualization study (smoke study)
Dynamic air visualization study (smoke study) with video and report
Laminar airflow workspace (LAFW) certification
Biological safety cabinet (BSC) certification
Powder containment hood certification

Start your Certification journey with Eagle →

Calibration Services:

Balances
Temperature Sensors and Thermometers
Relative Humidity Sensors
Differential Pressure Sensors (digital and magnehelic)
Controlled Temperature Units
Pipettes

Calibration services are performed under our A2LA (American Association for Laboratory Accreditation) accreditation, ensuring traceable and high-quality results.

Start your Calibration journey with Eagle →

Qualification Services:

Installation/Operational Qualification and Performance Qualification:
- Autoclave – Sterilization Cycle Validation
- Dry-Heat Oven – Depyrogenation Cycle Validation
- Incubators
- Refrigerators
- Freezers
- Stability Chambers

Start your Qualification journey with Eagle →

Cleanroom Design & Review

Eagle Analytical provides cleanroom design and review services for sterile and non-sterile environments, including hazardous and non-hazardous applications. Our team helps clients develop controlled environments that support compliance, operational efficiency, and long-term performance.

We provide guidance for:

• Sterile Hazardous Compounding Areas
• Sterile Non-Hazardous Compounding Areas
• Non-Sterile Hazardous Compounding Areas
• Non-Sterile Non-Hazardous Compounding Areas

Our services are performed in alignment with cGMP, ISO 14644, USP <795>, USP <797>, USP <800>, and industry best practices. We assist with facility layout, workflow, airflow considerations, and environmental controls to help optimize your space for both current operations and future growth.

Start your Cleanroom Design & Review journey with Eagle →

Discover Our Engineering Services:

Certification Services:

Cleanroom certifications to USP <797>, USP <800>, and CETA standards, which includes:
- HEPA filter integrity testing (leak test)
- Differential pressure measurement
- Air change per hour measurement and calculation
- Non-viable air sampling (particle counts)
- Viable air and surface sampling (environmental monitoring)
- Ambient temperature and relative humidity measurement
- Static air visualization study (smoke study)
Dynamic air visualization study (smoke study) with video and report
Laminar airflow workspace (LAFW) certification
Biological safety cabinet (BSC) certification
Powder containment hood certification

Start your Certification journey with Eagle →

Calibration Services:

Balances
Temperature Sensors and Thermometers
Relative Humidity Sensors
Differential Pressure Sensors (digital and magnehelic)
Controlled Temperature Units
Pipettes

Calibration services are performed under our A2LA (American Association for Laboratory Accreditation) accreditation, ensuring traceable and high-quality results.

Start your Calibration journey with Eagle →

Qualification Services:

Installation/Operational Qualification and Performance Qualification:
- Autoclave – Sterilization Cycle Validation
- Dry-Heat Oven – Depyrogenation Cycle Validation
- Incubators
- Refrigerators
- Freezers
- Stability Chambers

Start your Qualification journey with Eagle →

Cleanroom Design & Review

We provide guidance for:

• Sterile Hazardous Compounding Areas
• Sterile Non-Hazardous Compounding Areas
• Non-Sterile Hazardous Compounding Areas
• Non-Sterile Non-Hazardous Compounding Areas

Start your Cleanroom Design & Review journey with Eagle →

Engineering Support Backed by Laboratory Expertise

Eagle Analytical combines engineering support with microbiology and environmental monitoring expertise to provide a broader understanding of controlled environment operations.

By connecting engineering services with laboratory insight, we help facilities evaluate both environmental performance and contamination control considerations within critical compounding areas.

A Structured Approach to Engineering Support

Step 1: Assessment & planning

We evaluate facility requirements, equipment, environmental conditions, and regulatory expectations to determine project scope and service needs.

Step 2: Testing & Evaluation

Certification, qualification, calibration, or monitoring services are performed according to established procedures.

Step 3: Documentation

Results and observations are documented to support internal records and compliance programs.

Step 4: Ongoing Support

Our team remains available to support recurring services, follow-up evaluations, and operational questions.

Supporting a Wide Range of Facilities & Equipment

Facilities We Support:

◆ 503A Compounding Pharmacies

◆ 503B Outsourcing Facilities

◆ Hospital Pharmacies

◆ Research Laboratories

◆ Biotechnology Facilities

◆ Pharmaceutical Manufacturing Facilities

◆ Clean Manufacturing Areas

◆ Controlled Storage Environments

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Equipment We Support:

◆ Biological Safety Cabinets

◆ Laminar Flow Hoods

◆ Autoclaves

◆ Dry Heat Ovens

◆ Incubators

◆ Refrigerators & Freezers

◆ Environmental Monitoring Systems

◆ Differential Pressure Sensors

◆ Analytical Balances

◆ Pipettes

◆ Temperature and Relative Humidity Sensors

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Frequently asked questions

What information is needed to receive a quote?

To prepare an accurate quote, we typically request information about the facility, equipment, or services required.

Helpful details may include the facility type, equipment models and quantities, certification or qualification requirements, floor plans and room dimensions, location of the work, and any scheduling constraints.

How often should a cleanroom be certified?

To ensure regulatory compliance, cleanrooms should be certified every 6 months.

What is the difference between IQ, OQ, and PQ?

Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are stages of equipment qualification that demonstrate that critical equipment is properly installed, operates as intended, and performs consistently for its intended use.

IQ (Installation Qualification): verifies that equipment has been installed correctly and according to manufacturer and facility requirements.

OQ (Operational Qualification): confirms that the equipment operates within established parameters and functions as intended.

PQ (Performance Qualification): demonstrates that the equipment consistently performs as expected under actual or simulated operating conditions.

Do you provide calibration certificates and traceability documentation?

Yes. Calibration services include NIST-traceable documentation of measurement results, equipment identification, calibration dates, and applicable standards used during the calibration process. Calibration records are maintained to support traceability and quality system requirements.

What is included in cleanroom certification?

Certification services typically include airborne particle testing, airflow visualization, airflow velocity measurements, HEPA filter integrity testing, temperature and humidity assessment, and optional airflow visualization studies (a.k.a. smoke studies).

Upon completion, clients receive documentation of the testing performed, results obtained, and any observations or recommendations identified during the certification process.