Facilities & Utilities CQV Capabilities
Kymanox experts work with you to define your needs and customize a plan for your Facilities & Utilities Commissioning, Qualification, and Validation (CQV).
01
End-to-End Experience
We are involved from early stages of design and construction to align with all groups and trades to ensure seamless transition from engineering turnover through commissioning, qualification, and into production.
Start Getting More Done!
02
Robust Qualification Packages
Using a combination of traditional validation methods and risk-based strategies, Kymanox works with each client to ensure robust qualification packages.
Start Getting More Done!
03
Partnership Model
We partner with client system owners and quality teams in qualification planning to ensure an appropriate level of testing is decided and executed, and that all documentation meets regulatory expectations.
Start Getting More Done!
04
Integrated Approach with a Project Management Focus
Kymanox ensures efficient and successful qualification by providing engineering and regulatory resources while using an integrated team approach including project management.
Start Getting More Done!
Meet our Facilities & Utilities CQV Experts
Faith Fraley
PRINCIPAL ENGINEER
Markets That Benefit from Our Facilities & Utilities CQV Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics and Cell & Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.
The Kymanox Difference
At Kymanox we are more than consultants. We are partners with our clients and create custom solutions that meet each client’s unique needs.
"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.
Proven Broad Expertise
Our diverse experience includes lyophilization cycles, cleaning and sterilization cycles, cannabis extraction, biological upstream and downstream manufacturing, medical devices and combination products.
Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
Frequently Asked Facilities & Utilities CQV Questions (FAQs)
What kinds of facilities and utilities can you qualify?
Kymanox has the expertise and experience to qualify a wide range of facilities and utilities, including: cleanrooms, clean utilities, Aseptic manufacturing equipment, custom manufacturing equipment and control systems, drug product packaging equipment, controlled storage equipment and facilities, computerized software systems, building management systems (BMS), and environmental monitoring systems (EMS).
What is the purpose of CQV?
Commissioning, Qualification, and Validation (CQV) is an essential area for the life science industry. Commissioning and qualification of systems that support the drug production process (facilities, utilities, and equipment) is critical to ensure patient safety, product quality, regulatory compliance, and business needs. Our SMEs will work together with you to ensure an efficient and successful CQV process from the early stages of user requirements to operations handover. Throughout the process, Kymanox will continuously educate your team to enable knowledge transfer and ensure sustainability. Whether you are a small start-up or commercial manufacturing company, Kymanox is ready to assist you with any of facility, utility, and equipment needs.
What is commissioning and how can I be successful?
The first part of CQV is commissioning. Commissioning is defined as a documented and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to end user, that results in a safe and functional environment and that meets established design requirements and stakeholder expectations. The keys to a successful commission and turnover of facilities/utilities are planning and an integrated team approach! At Kymanox, we work together with key stakeholders (system owner, quality assurance, project engineers, etc) to develop a commissioning plan, identify and execute key deliverables to ensure a seamless transition from commissioning/qualification to production.
How can I maintain the validated state of my facility/utilities?
After qualification, it is important to maintain the validated state throughout the life cycle of your equipment. There are many reasons why equipment/systems can no longer maintain a validated state (breakdowns, modifications, aging, regulatory updates, introduction of new product, etc). Therefore, the best place to start is with a strategic and comprehensive gap assessment prioritizing upgrades and replacements as needed. At Kymanox, we can assist you with a variety of solutions (performing periodic reviews, revalidation, establishing a robust change management system, etc) to ensure your facility maintains its validated state and meets regulatory compliance.
Read the Latest at Kymanox
Analytical Techniques For Addressing Viral Vector Purification Challenges
When producing gene therapies, circular plasmids containing therapeutic DNA , an outer capsid shell, and proteins required for virus assembly are inserted into host cells. Manufacturers often face difficulties creating consistency in gene therapy produ...
Rapid Microbiologic Methods Aid In The “Race To Release” Challenges Of Cell And Gene Therapy Manufacturing
Rapid Microbiologic Methods (RMM) is perfectly suited to cell-based manufacturing because it allows scientists to obtain results up to ten times faster than traditional culture-based microbiological analysis techniques and with less produ...
Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate Critical Tasks
Human Factors Engineering (HFE) is a risk-based discipline crucial to validating that a medical product and its user interface is safe and effective for the intended users and use environments. The HFE process aims to optimize the user interface for me...