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GMP for Critical
Environments

Our Commitment to Life Sciences Compliance
At GDI Ainsworth, we combine industry-leading GMP Manufacturing Facilities cleaning and contamination control expertise with technical services capabilities to deliver fully integrated solutions for regulated environments.
Through stringent contamination control programs and adherence to cGMP protocols, our teams of trained professionals ensure the integrity of your production environment.
Click to Review GDI’s Statement of Qualifications

Our Life Sciences Center of Excellence

Our GMP Center of Excellence delivers industry-leading contamination control and technical expertise to keep your facilities safe, efficient, and audit-ready.
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GMP Academy

GDI Ainsworth’s GMP Academy offers comprehensive training for both frontline staff and management on clean room behaviour and contamination control guidelines.

Our academy also develops and administers a cutting-edge Learning Management System (LMS) to streamline and enhance the training process.

GMP Academy
Certifications

Every GMP employee is trained and certified through our GMP Academy before working in a controlled environment.

  • Management Excellence: Leaders are additionally certified by the Bio Pharma Institute.
  • Industry Alignment: All certifications are designed to meet cGMP, ISO, and industry-specific regulatory expectations.
Certifications
Quality Control and Quality Assurance

Our GMP Quality Program is built to maintain the highest operational and compliance standards at all times.

  • SOP Development, Support & Review: Facility-specific documentation to ensure consistent, auditable performance.
  • Supplier Qualification & Regulatory Support: Advisory services to streamline approval processes.
  • Performance Monitoring: GMP Campaign tracks KPIs, documentation accuracy, and workforce retention.
  • Corrective Action Planning: Custom solutions to prevent deviations and improve audit outcomes.
  • Internal Audits & Event Management: Comprehensive audits, deviation reviews, OOS investigations, change control oversight, and CAPA implementation.
Quality Control and Quality Assurance

The GDI Ainsworth Advantage

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Comprehensive Services

Cleaning, contamination control, and integrated facility services tailored for life sciences and manufacturing.

Deep Expertise:

Decades of experience applying industry-specific protocols and cutting-edge technology.

Advanced Training:

Continuous development in contamination and particle control through the GMP Academy.

State-of-the-Art Technology:

Technicians equipped with tools like FotoFinish, FotoFeedback, and GDI Inspect for verifiable results.

Regulatory Compliance:

ISO 9001, ISO 14001, CIMS, and cGMP-aligned processes for inspection readiness.

Customized Solutions:

Every program is built around your unique environment, workflow, and compliance needs.

GMP Cleaning Services

We offer a broad array of GMP contamination control services designed to maintain the integrity of your controlled environments:

Cleanroom Cleaning

Customized cleaning protocols for maintaining sterile environments, including:
  • Aseptic cleaning
  • GMP cleaning customized to your facility's needs and guidelines
  • Prequalification cleaning services
  • SOP & Protocol development support
  • Remediation cleaning
  • Post-construction detail cleaning

Cleanroom Post Construction Cleaning:

Before your cleanroom goes operational, GDI Ainsworth removes all dust, debris, and construction residue that could compromise the qualification of your GMP environment.
Our multi-stage cleaning process includes surface disinfection to ensure compliance with ISO standards and client specifications.

Contamination Control

We implement strict contamination and particle control programs tailored to current Good Manufacturing Practice (cGMP) requirements. This includes:
  • Controlled entry and gowning procedures.
  • Zoning and workflow design to minimize cross-contamination risk.
  • Use of validated cleaning agents and disinfection procedures.

Waste Handling and Disposal

Our team safely collects, transports, and disposes of non-hazardous waste in compliance with environmental and safety regulations. This includes sealed transfer procedures, segregation of waste streams, and documented disposal to protect personnel, products, and the environment.

Vivarium Cleaning and Disinfection

Specialized teams clean and disinfect vivarium facility surfaces with precision, ensuring compliance with biosafety and animal welfare standards. Services include washing empty cages, surface cleaning and general waste removal, high-touch surface disinfection, and use of species-appropriate, non-toxic cleaning agents.

GMP Logistics Services

We support your operations with coordinated GMP logistics, from materials movement and staging to cleanroom consumables management. Our services keep workflows uninterrupted while maintaining contamination control and regulatory compliance, utilizing the ALCOA principles to ensure data integrity.

Safety Inspections

Regular inspection and verification of critical safety systems help prevent incidents and maintain compliance. We inspect:
  • Eye wash and safety shower stations flushing
  • Fire extinguisher inspection

Meet Our Team

Life Sciences Division Team and GMP Subject Matter Experts

Ted Kyranos
Vice President of Operations - North America, Life Sciences Division
Mabia Tavares
Vice President of Business Development/GMP SME – North America, Life Sciences Division
Katie Harlow
Compliance Director – North America, Life Sciences Division
Yogi Kale
Senior Vice President of Operations, Northwest
Jonathan Sauze
CSP | VP Risk & Safety BSG North America
Mike Cadotte
V.P. Quality Assurance – Business Services Group – US
Savanah Balkam
Business Development Manager/ Lab Operations SME
Ted Kyranos – Head of GMP Vertical Vice President of Operations - North America, Life Sciences Division
Ted Kyranos is a distinguished leader in Life Sciences operations, bringing a wealth of expertise to his role as Vice President of Operations, Life Sciences at GDI Ainsworth. With a robust background in GMP cleaning and disinfection, health and safety device inspections, contract administration, vendor management, people management, and regulatory oversight, Ted’s career is a testament to his unwavering commitment to excellence.
Ted’s extensive experience and technical proficiency in GMP and Contamination Cleaning have positioned him as a key player in driving GDI Ainsworth’s ambitious growth in the Life Sciences sector. His leadership and deep industry knowledge are instrumental in maintaining the highest standards of operational excellence.
Mabia Tavares is a master of excellence in the field of Good Manufacturing Practices (GMP) and contamination control. As a distinguished GxP Subject Matter Expert (SME) with a profound background in cGxP facilities services management, compliance, and training, her career is a testament to unwavering dedication and expertise.
With extensive experience across the Biopharmaceutical and Semiconductor industries, Mabia has honed her skills in the crucial areas of GMP, Client and Contract Management, Life Science contamination control programs, and ensuring GMP/ISO compliance. Her ability to manage multidisciplinary project teams and her proficiency in languages, including Portuguese and Spanish, further exemplify her versatile skill set.
Experienced Life Sciences Compliance/quality professional with an emphasis on medical device, biopharmaceutical, and Semiconductor manufacturing industries. Solution-driven with expertise in aseptic manufacture, critical process improvement, deviation closure and CAPA implementation with expertise in the following areas: Contamination Control for sterile Manufacturing, Controlled Environments. Annex 1, (ISO-1644, EN ISO 14698/EN ISO 17141, ISO 17025, IEST RP CC001/CC0012, ANSI/AAMI ISO11737), Medical Devices (ISO 9001, ISO 13485, ISO 14971), Pharmaceuticals (21CFR Part 210, 211), GLP (21CFR, Part 58).
Yogi Kale is a seasoned professional with 33 years of rich, international experience in facilities management and the hospitality sector, currently serving as the Senior Vice President at GDI Ainsworth. With a deep-rooted passion for clean-tech innovation and operational excellence, Yogi leads the Western Region in organic growth, fiscal performance, customer retention, and enhancing employee experiences. His expertise extends across Integrated Facility Management (IFM), Environmental, Social, and Governance (ESG), Good Manufacturing Practice (GMP), and other compliance standards.

Yogi has played a pivotal role in elevating GMP cleaning services to meet stringent regulatory standards, crucial for industries such as pharmaceuticals, food, and semiconductor manufacturing. He has managed data center cleaning protocols and the development of cleaning standards compliant with FDA regulations. 

A strong advocate for continuous improvement and ethical integrity, Yogi drives business growth and client satisfaction through innovative technology platforms, strategic planning, and fostering multicultural relationships. Under his leadership, clients experience elevated standards of cleanliness and sustainability, ensuring GDI Ainsworth remains at the forefront of the facility services industry.

Jonathan Sauze has 16 years of combined hands-on and managerial experience in Health, Safety, Security, Environmental, Quality, and Risk Management in manufacturing, transportation, and facility services. Jonathan is a Certified Safety Professional (CSP) and Lead Auditor for ISO 45001:2018 and ISO 14001:2015. Areas of expertise include Environmental & Safety Management, Program/Project Management, Inspections & Auditing, OSHA/ISO Standards & Compliance, Root Cause Analysis, Behaviour-Based Safety, Safety Management Systems, Continuous Improvement, Risk Assessment, Hazardous Waste Management, Partnership Management, Strategy Planning, and Claim Management. 

As VP of Risk & Safety for GDI Ainsworth US, Jonathan leads the development and execution of H&S initiatives in partnership with the field operation team to promote a workplace safety culture. This includes developing, implementing, and coordinating H&S programs and policies to ensure corporate goals attainment as well as compliance with all applicable regulations.
Mike Cadotte has 30 years of experience with GDI Ainsworth and is a systems process professional who developed, installed, and has maintained our organization’s various quality certifications, including ISO 9001, ISO 14001, and CIMS standards. Mike’s dedication to process control and total quality management has been a decades-long pursuit.
Mike oversees all quality programs for the US and leads GDI Ainsworth’s global ESG effort as well. Mike has developed subject matter expert team initiatives that include the GxP-Life Sciences Subject Matter Expert Team with the direct intent to not only maintain solid process, procedure, and quality service delivery controls in that vertical but also continue to build, learn, and grow our understanding of GxP-Life Sciences so as to continually maintain the highest level of excellence in the industry.

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Trust GDI with Your GMP and Controlled Environment

Choosing GDI Ainsworth means partnering with a team that is not just proficient in GMP standards but is also committed to elevating the standards of cleanliness and compliance in your facilities.
Trust our experts to guide your operations to excellence in GMP compliance and contamination control. Contact us today.

Trust in GDI to guide your operations to excellence
In GMP Compliance and Contamination Control

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Proven Leadership in GMP Cleaning and Contamination Control
 

  • GDI Leadership: Developed GxP contamination control programs for top organizations such as Catalent, Takeda, and Thermo Fisher. 
  • Project Execution: Spearheaded the facility start-up at a new $180M viral vector manufacturing facility, demonstrating exceptional project leadership and execution skills. 

Staying at the Forefront of Industry Standards 

  • Commitment to Excellence: GDI stays current with the latest GMP regulations, cleaning techniques, and industry standards. 
  • Professional Engagement: Active involvement in organizations like PDA, ISPE, LULAC, Interfex, and MassBio. 
  • Certifications: Maintains Bio Pharma Institute certification for GMP cleaning, ensuring adherence to the latest FDA guidelines and industry innovations. 

Philosophy on Training and Mentoring 

  • Training Excellence: Developed a robust GMP academy training program, providing essential knowledge to new employees and ensuring their effective contribution. 
  • Mentorship: Emphasizes the importance of comprehensive training and ongoing mentorship under the guidance of subject matter experts, fostering a culture of high standards in quality and safety. 

Mastering Challenges with Innovative Solutions 

  • Innovative Training Solutions: Established a GMP academy to address hiring and training challenges in regions lacking qualified personnel, enhancing GMP and GDP practices significantly across GDI. 

FAQs

What sets GDI's GMP cleaning services apart?

GDI combines expertise, technology, and customized service delivery to meet the specific needs of regulated industries, ensuring compliance with GMP standards.
Our technicians are trained in cGMP protocols, utilizing the latest in cleaning technology and practices to maintain your production environment’s integrity.
Yes, GDI’s services are tailored to meet the specific requirements of various industries, including pharmaceuticals, biotechnology, medical devices, and semiconductor manufacturing.
Life Sciences Industries
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Pharmaceuticals
Pharmaceuticals
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GMP-Medical Devices
Medical Devices
Medical Devices
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Biotech
Biotech
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Vivarium
Vivarium
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