SIMVal ApS
Home
Menu
  • Services
  • Validation Equipment
  • About Us
  • Knowledge Hub
SIMVal ApS
Home
Menu
  • Services
  • Validation Equipment
  • About Us
  • Knowledge Hub
Mere
  • Home
  • Menu
    • Services
    • Validation Equipment
    • About Us
    • Knowledge Hub
  • Home
  • Menu
    • Services
    • Validation Equipment
    • About Us
    • Knowledge Hub

Services

Qualification and Validation

Qualification and Validation

Qualification and Validation

We are expert in commissioning, qualifications and validation. Let our team help you with your next validation and qualification.

Learn More

Temperature Calibration

Qualification and Validation

Qualification and Validation

We can help you with NIST-traceable temperature calibrations according to your companies SOPs or our own calibration procedures.

Learn More

Validation Equipment

Qualification and Validation

Project Management & Execution

All our validation equipment is qualified and of the highest quality and standard manufactured by Kaye. Rent our equipment for your next project. 

Learn more

Project Management & Execution

HVAC Optimization, Cleanroom Rebuild & CFD Simulation

Project Management & Execution

 At SIMVal, we offer efficient and reliable project management and execution services tailored to the life science and pharmaceutical industries. 

Learn more

Engineering and Energy Optimization

HVAC Optimization, Cleanroom Rebuild & CFD Simulation

HVAC Optimization, Cleanroom Rebuild & CFD Simulation

 At SIMVal, we offer engineering consultancy with a strong focus on rebuild and expansion projects.

Learn more

HVAC Optimization, Cleanroom Rebuild & CFD Simulation

HVAC Optimization, Cleanroom Rebuild & CFD Simulation

HVAC Optimization, Cleanroom Rebuild & CFD Simulation

 SIMVal provides expert consultancy in HVAC optimization and cleanroom rebuilds with the utilization of advanced CFD simulations. 

Learn more

Qualification and Validation

Let our experts help you stay in compliance

Our team of experts will work with you to help you through your next validation or qualification project. By choosing us, you are ensured that we will help you with the highest quality, accuracy and flexibility.  We can help fulfill complex requirements within the life science and pharmaceutical industry.

Services

Let us help you with:

  • Project Management
  • Validation Planning
  • Change Request
  • Validation Staffing
  • IQ / OQ / PQ Validation and Qualification Protocol Generation and Writing
  • IQ / OQ / PQ Validation and Qualification Report Generation and Writing
  • Factory Acceptance Testing Services (FAT Testing)
  • Site Acceptance Testing Services (SAT Testing)

We are experts in

  • Installation Qualification (IQ / IV)
  • Operational Qualification (OQ / OV)
  • Performance Qualification (PQ / PV)
  • Requalification (RQ / RV)

Temperature Calibration

NIST-Traceable Calibration in our Laboratory

We deliver our equipment with highly accurate NIST-traceable certificate performed in our own laboratory or DANAK certificate by third party in the range:

Temperature: -196°C to 420°C

NIST-Traceable Calibration On Site

We can perform temperature calibrations of any temperature measuring equipement according to our own QMS system or your QMS system. You will receive a highly accurate NIST-traceable certificate. 

Temperature: -196°C to 400°C

Calibration Staffing

Our team has many years of experience with calibrations of:

  • Temperature
  • Pressure
  • Humidity
  • Gas
  • Flow

We can help you with calibration staffing no matter if it is for short or long-term.

Project Management & Execution

At SIMVal, we offer efficient and reliable project management and execution services tailored to the life science and pharmaceutical industries. Our team ensures that projects are planned meticulously, executed efficiently, and completed in compliance with industry standards.

Our Services Include:

Project Planning & Coordination: Developing detailed project plans,  timelines, and resource allocations to ensure smooth execution.

  • Execution Oversight: Managing day-to-day operations, coordinating with stakeholders, and ensuring adherence to project objectives.
  • Quality Assurance: Implementing quality control measures to maintain compliance with GMP and other regulatory requirements. 
  • Risk Management: Identifying potential risks and developing mitigation strategies to prevent project delays or compliance issues.
  • Communication Management: Facilitating clear and consistent communication among all      project stakeholders.

With our expertise, SIMVal ensures that your projects are delivered on time, within budget, and to the highest quality standards.

Engineering and Energy Optimization

At SIMVal, we offer engineering consultancy with a strong focus on rebuild and expansion projects within the pharmaceutical and life science industries. Whether upgrading existing facilities or scaling up operations, we help you navigate technical complexity while maintaining regulatory compliance and operational continuity. 

Our services include:

  

  • Rebuild & Retrofit Projects – Planning and executing modifications to existing facilities with minimal disruption to ongoing operations.
  • Expansion Planning – Designing and managing facility expansions to support increased capacity or new production lines.
  • Utility & Infrastructure Upgrades – Assessing and optimizing utilities to meet the demands of expanded or modernized operations.
  • GMP Compliance in Modifications – Ensuring all changes meet current GMP standards and support future regulatory inspections.
  • Interdisciplinary Coordination – Integrating process, facility, and equipment design with project timelines and stakeholder input.

SIMVal brings the technical insight and practical experience needed to ensure your rebuild or expansion project is executed efficiently, safely, and in full compliance with industry requirements.

HVAC, Cleanroom Rebuild & CFD Simulation

SIMVal provides expert consultancy in HVAC optimization and cleanroom rebuilds for the pharmaceutical and life science industries. Our services ensure controlled environments meet strict GMP and ISO standards—whether you're upgrading legacy systems or expanding capacity.

Using advanced CFD (Computational Fluid Dynamics) simulations, we deliver precise insight into airflow patterns and environmental control, enabling data-driven design and validation. 

Our services include:

  

  • Cleanroom HVAC Rebuilds – Redesigning and upgrading HVAC systems for classified cleanroom environments, with minimal disruption to operations.
  • Airflow Optimization – Ensuring correct air change rates, pressure cascades, and zoning to maintain contamination control and meet classification requirements.
  • CFD Simulation – Modelling airflow, temperature, and particle movement to optimize system performance and support troubleshooting.
  • Capacity & Compliance Assessments – Verifying that HVAC systems support  current and future operational demands while aligning with GMP and ISO 14644 requirements.
  • Commissioning & Requalification Support – Supporting full system validation, including documentation, testing, and regulatory readiness.

Whether you're facing a facility upgrade or cleanroom expansion, SIMVal ensures your HVAC systems deliver performance, compliance, and long-term reliability.

Email: info@SIMVal.dk   /   Phone: +45 51 52 42 68   /   Lyngby Hovedgade 98, 2800 Kongens Lyngby, Danmark   /   CVR: DK44775964

Copyright © 2024 SIMVal A/S  - All Rights Reserved.


Dette website anvender cookies.

Vi bruger cookies til at analysere websitetrafik og optimere din websiteoplevelse. Når du accepterer vores brug af cookies, bliver dine data vist med alle andres brugerdata.

AfvisAcceptér