Validation of Equipment and Facilities
Controlled environments and safe operations with transparency and regulatory compliance
Validation of equipment, facilities, and cleanrooms is essential for ensuring product quality, controlled environments, and minimized contamination risks. We support organizations in validating, qualifying, and maintaining production and laboratory environments that meet regulatory requirements and operate reliably over time.
Challenges
Common challenges
Control over the environment, data, and processes is crucial to ensuring quality
Validating equipment and facilities involves ensuring that environments, processes, and data meet regulatory requirements and operate reliably. Challenges often arise due to poor data quality, insufficient documentation, and difficulties in maintaining control over the environment and changes over time.
Lack of reliable data on particulate and microbiological levels
Outdated cleaning protocols and inadequate documentation
Uncertainty regarding when and how cleanroom requalification should be carried out
Nonconformities detected during an inspection—not during routine operations
Deficiencies in hygienic design and environmental monitoring programs
Lack of relevant expertise and resources
We Offer
Practical Validation of Equipment and Facilities
Controlled environments that prevent contamination and ensure quality over time
We support organizations in validating equipment, facilities, and cleanrooms in accordance with regulatory requirements—such as GMP—to ensure that production operates stably and meets defined quality attributes. This work includes technical testing, documentation, and practical evaluation of processes to ensure functionality under actual operating conditions. By analyzing and monitoring critical parameters—such as ventilation, pressure, temperature, and environmental conditions—we help reduce the risk of contamination, ensure compliance, and create production environments that are reliable over the long term.Validation of cleanrooms
Ensures that cleanrooms meet classification and regulatory requirements, such as those under GMP.
Testing for Particles and Microorganisms
Identification and control of contamination risks in production environments.
Environmental Monitoring Program
Design and implementation of programs for the continuous monitoring of environmental and production conditions.
Cleanroom Reclassification
Planning and implementation of retrofitting to ensure long-term compliance and performance.
Value We Create
Prevents contamination during production (particles and microorganisms)
Ensures that cleanrooms and environments meet regulatory requirements and classifications
Ensures traceability and control through documentation at all critical control points
Increases confidence ahead of audits and inspections through assured compliance
Ensures consistent, long-term product quality over time
Customer cases
Here's How We Overcame Past Challenges
GMP-certified cleanroom for ATMP production
Problem: In order to begin production, the company needed to certify its cleanroom in accordance with GMP and meet extensive regulatory requirements. At the same time, it lacked established processes for aseptic work and validation in preparation for the application.
Solution: We led the entire qualification process for the cleanroom in accordance with relevant regulations and conducted validation of cleaning and aseptic processes. At the same time, we developed SOPs and work procedures to ensure that the organization was ready for a GMP audit.
Result: A fully compliant cleanroom and robust processes enabled the company to obtain a GMP license and begin production. The customer gained a secure and regulatory-compliant foundation that reduces risk and paves the way for continued growth.
Validation of cleanrooms
Ensures that cleanrooms meet classification and regulatory requirements, such as those under GMP.
Testing for Particles and Microorganisms
Identification and control of contamination risks in production environments.
Environmental Monitoring Program
Design and implementation of programs for the continuous monitoring of environmental and production conditions.
Cleanroom Reclassification
Planning and implementation of retrofitting to ensure long-term compliance and performance.
Common challenges
-> Lack of reliable data on particle and microbiological levels
-> Outdated cleaning protocols and inadequate documentation
-> Uncertainty regarding when and how cleanroom re-certification will be carried out
-> Nonconformities detected during an inspection—not during routine operations
-> Deficiencies in hygienic design and environmental control programs
-> Lack of relevant expertise and resources
Features and benefits
-> Prevents contamination during production (particles and microorganisms)
-> Ensures that cleanrooms and environments meet regulatory requirements and classifications
-> Ensures traceability and control through documentation at all critical control points
-> Increases confidence ahead of audits and inspections through assured compliance
-> Ensures consistent, long-term product quality over time
CONTACT
Talk to someone who knows your area
Marleen Dekker Scaffolding
Head of Unit Pharma and Biotech
Marleen Dekker Scaffolding
Head of Unit Pharma and Biotech
Karin Tördahl
Acting. Head of Unit Pharma and Biotech
Karin Tördahl
Acting. Head of Unit Pharma and Biotech