Cleaning and Sterilisation processes

25-26 APRIL 2023 • COPENHAGEN, DENMARK

Speakers and summary of presentations

Click a speaker name for bio and abstract.

Sponsored by
Novatek International

Sponsored by
Steris Life Sciences

Mark Thompson, Managing Director, MTL Projects Ltd
– KEYNOTE SPEAKER →

• New Product Development; Defining and justifying the approach to sterilisation
• Top 10 inspection findings associated with Sterilization and Depyrogenation

Laurent Merli, Sterile Manufacturing & Nuclear
Medicine Drug Expert, Theraxel-Point Forty Five →

• Why a robust cleaning process before is essential for the success of the Sterilisation one?!

Mohammad Ovais, Pharmaceutical Consultant →
• Monitoring and trending of cleaning data

Walid El Azab, Industrial Pharmacist & Qualified Person,
Steris →

• Case studies on common cleaning mistakes and enablers for cleaning improvement
• Workshop – Sterilization and Annex 1 – the elements to consider in CCS for sterilization processes

Susan B. Cleary, Director of Product Development, Novatek International →
• Risk-Based Cleaning Validation, Carry Over and Process Automation

Dr. Andreas Flückiger, Occupational Toxicology and Containment in the Pharmaceutical Industry  →
• Improving quality of Health Based Exposure Limits (HBELs). Current best practices based on guidance by EMA, PIC/S and ASTM Standard E-3219

Ioanna-Maria Gerostathi, Quality &Validation Professional  →
• Workshop – Statistical Analysis in Recovery Studies

Tony Christensen & Juha Mattila →
• Workshop – Sterilization and Annex 1 – the elements to consider in CCS for sterilization processes

Igor Gorsky, Principal Process Validation Consultant,
Valsource →

• Use of statistics including treatment of censored data in Lifecycle Cleaning Validation as prescribed by ASTM E3106

Solenn Brajeul Janvier, RP Pierre Fabre Group →
Development and validation of an analytical method for cleaning validation: Tips & Tricks

Joe Cagnassola, Associate Director Validation,
Boehringer-Ingelheim →

• Creating a robust Cleaning Protocol and Report

Mark Thompson
Managing Director, MTL Projects Ltd – KEYNOTE SPEAKER

Mark Thompson is a Chartered Engineer with 30 years of experience in the Life Science industries. Starting his career in 1989 with Eli Lilly, after 12 years with ‘big pharma’ in a variety of Project and CQV Management roles Mark moved to provide Consultancy and Training to the industry.

Mark Thompson Lifesciences Ltd provide consultancy and training all over the world to hundreds of organisations, delivering training to thousands of people. This has included delivering training courses for regulatory inspectors from China, Saudi, UK, Ireland, Italy, Denmark and the Netherlands.

MTL Projects Ltd is a team of engineers who provide CQV services primarily to Sterile Product Manufacture.

PRESENTATIONS:

New Product Development; Defining and justifying the approach to sterilization

MTL Projects get involved in some early-stage product development studies including pre-clinical development of new products and combination products. This lecture will present the approach to determining the most appropriate and regulatory compliant sterilization technology, balancing regulatory expectations with product and component limits.

Top 10 inspection findings associated with Sterilization and Depyrogenation Processes
Mark Thompson Lifesciences Ltd work internationally providing regulatory support and troubleshooting guidance. This provides an international view on regular inspection findings associated with Sterilization and Depyrogenation. We have also delivered training to and written inspection guidelines for some of the worlds inspectorates so have a unique insight into the current common deficiencies identified. These are presented here together with strategies for robust compliance.

Laurent Merli
Sterile Manufacturing & Nuclear
Medicine Drug Expert,
Theraxel-Point Forty Five

After a Master degree at University of Liège (Belgium) with a thesis in the Organic Chemistry Department,
Laurent Merli got a PhD in chemistry at the same university with a thesis in the Radiochemistry
Department (analytical study of radioactive material).
With around 20 years of experience first as employee (almost 13 years) and currently as freelance consultant (almost 8 years), He gained a lot of experience through 17 different jobs / missions in touch with 10 pharmaceutical or radiopharmaceutical industries; his field of expertise is the facility, utilities, and equipment qualification and the process validation with all the needed transversal skills (project management, QA, QC, training, etc.)

PRESENTATION:

Why a robust cleaning process before is essential for the success of the Sterilisation one?!
This lecture will present the new Annex 1 and the reinforcement of the regulatories for cleaning in various situations, to do sterile medicinal drugs and its impact on sterilization.
Keywords: Endotoxins, drying process, Barrier Technologies, CIP/SIP cycle.

Mohammad Ovais
Pharmaceutical Consultant

Mohammad Ovais is a pharmaceutical scientist with more than 15 years of experience working in pharmaceuticals, active pharmaceutical ingredients (APIs), and biologicals industries.

Over the course of his career, he has worked in R&D, validation, and Quality Assurance. His technical expertise covers many areas of pharmaceutical manufacturing including life cycle management of product and processes, Quality Risk Management, technology transfer, and cleaning validation. He has over 10 years of hands-on experience in validating cleaning processes and has (co-)authored more than 15 articles on the subject. He is one of the co-authors of ASTM standards E3106, E3263, G121, G122 and PDA’s Technical Report 29 (work in progress). He provides regular training and consulting services in process and cleaning validation.

Ovais is currently a member of the Board of Directors of The Center for Pharmaceutical Cleaning Innovation (a not-for-profit research organization) and is a Participating member of ASTM International.

He holds a Master of Pharmacy degree from Hamdard University (India).

PRESENTATION:

Monitoring and trending of cleaning data
Trending of data is important to evaluate the performance of a process and to ensure that the validated state of a process is maintained during its lifecycle. Data trending can detect process drifts and identify unexpected process variability. It can also be used for predicting a future event. However, data trending is a very unfamiliar concept to most of the cleaning validation scientists. This presentation aims to give scientists involved in the validation of cleaning processes an introduction to data trending and describes how it can be applied to evaluate the performance of cleaning processes.

Walid El Azab
Industrial Pharmacist & Qualified Person, Steris

Walid El Azab is an Industrial Pharmacist and a Qualified Person (QP). He is a Senior Manager Technical Services for the Life Sciences Division of Steris Corporation.  He currently provides technical support related to cleaning, disinfectants, sterility assurance, and process validation. He also leads workshops to improve inspection readiness and contamination control levels.

His areas of expertise include both upstream and downstream pharmaceutical operation and validation in non-sterile and sterile processes. Walid has held various positions, including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, lead auditor, and QP. Walid’s responsibilities and experience have also included project management, handling deviations and complaints, releasing raw materials, drug products, and investigational medicinal products (IMP), conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA, SFDA, ANVISA…) audits and develop strategy approach for process, cleaning, and system gap analysis.

Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium, and is a certified Lean Six Sigma green belt. Walid is a lecturer at the University of Liège and Brussels (Medicine faculty in Belgium).

He is an active member of the PDA, ISPE, ECA, and A3P associations with numerous published articles and book chapters on contamination control. He is also active with the A3P GIC working groups on sterilization and derouging and passivation, GMP Annex 1, and Contamination Control strategy. He leads the UPIP-VAPI EU GMP Annex 1 (guidance for sterile manufacturing) working group, and he is also part of the ECA task force regarding the revision of the EU GMP Annex 1. Also, he lead the ECA task force on contamination control strategy. He was a planning committee member of the Annual PDA Conference on Pharmaceutical Microbiology, and of the European Biomanufacturing (1st to 4th). He is also an Editorial and sub-art committee member of the PDA Letter. Finally, Walid is a board member of the Belgium Qualified Person (UPIP-VAPI) association and co-founder of the Belgium QP academy.

PRESENTATIONS:

Case studies on common cleaning mistakes and enablers for cleaning improvement

hrough examples, the presentation discusses elements to consider for improvements, such as laboratory studies from designing cleaning cycles and on-site observations. By using case studies, the presentation shares some common mistakes, and how data analysis was used to confirm that the improvements made had increased the cleaning. Key take-aways:

  • Understand the elements to consider for cleaning improvement. 
  • Learn from common mistakes as enablers for improvement.
  • Understand basic statistics to analyze retrospectively and prospect potential cleaning performance through case studies.

WORKSHOP – Sterilization and Annex 1 – the elements to consider in CCS for sterilization processes

The workshop aims to design a control strategy for the sterilization processes as part of the CCS. 
At the end of the workshop, the attendees should be able to design a sterilization CCS dashboard. 

Therefore, during the workshop, a process map will be presented to the attendees to develop the sterilization process risk assessment and define the measures and controls to be implemented. Then, based on the elements set, determine the critical controls that should be part of their CCS. 

Susan B. Cleary
Director of Product Development, Novatek international

Susan B. Cleary, B.Cs, EMBA, is the Director of Product Development at Novatek International. Susan has more than 20 years of experience in designing, developing, and implementing large scale quality management and contamination control systems. 

Susan works with pharmaceutical, biotech, and medical device companies and specializes in data integrity and regulatory compliance and is highly experienced with streamlining quality processes and digitizing data for GMP systems.

PRESENTATION:

Risk-Based Cleaning Validation, Carry Over and Process Automation

Understand Risks in a cleaning validation program and how automation can address these risks.

  • Awareness of the regulations for cleaning validation.
  • Identify risks in the cleaning validation program.
  • The importance of managing master data and understanding the correlation between master data sets.
  • Define risk ranges and risk criteria to use to determine potent vs non-potent products.
  • Gain Insight into the equations to calculate and select the Maximum Safe Carry (MSC).
  • Understand the change process and avoid information silos through electronic means.
  • Trending and process control metrics for results and safety margins.
Dr. Andreas Flückiger Occupational Toxicology and Containment in the Pharmaceutical Industry

Certified in internal medicine, Dr. Andreas Flückiger was the global head of occupational health for the Roche Group for over 32 years.

In this function, he was also responsible for setting Roche’s Health Based Exposure limits and authored or reviewed and finally approved the rationales for well over 1000 such limits.

He is a member of the Society of Toxicology and honorary member of various professional associations. Official assignments in the field of toxicology have included longstanding memberships of the Scientific Committee of Ecetoc (European Centre for Ecotoxicology and Toxicology of Chemicals) and the Swiss Governmental Advisory Board on Air Quality.

Andreas now works as a part-time consultant.

PRESENTATION:

Improving quality of Health Based Exposure Limits (HBELs). Current best practices based on guidance by EMA, PIC/S and ASTM Standard E-3219

This presentation will describe current best practices for setting HBELs. HBELs include Permitted Daily Exposures (PDEs) as they are needed to establish science-based cleaning standards for shared equipment and Occupational Exposure Limits (OELs) which help determine the required degree of process containment. Such limits are needed for APIs but may also be required for other molecules such as cleaning agents and synthesis intermediates.

Formal regulatory guidance for setting PDEs was issued by EMA in 2014 and adopted by PIC/S in 2018. As it is not very detailed, this guidance may lead to divergent limit values. This is particularly true if the guidance is interpreted by inexperienced experts, a fact that is independent of their formal professional qualification, e.g. as toxicologists.

In an effort to improve the quality of HBELs, a team of experts in toxicology and cleaning validation drafted more detailed guidance for setting such limits. It was published as ASTM Standards E-3219 in 2020 and updated in 2022.

This presentation will focus on the key steps of setting such limits: (1) Hazard characterization, (2) Identification of the critical effect(s) including dose-response assessment, (3) determination of one or several Points of Departure (PoD)s for the calculation of HBELs, (4) Application of PoD-specific Adjustment Factors (AFs), and (5) Calculation of HBELs including justification for the preference given to a particular derivation rationale if more than one was developed.

Tony Christensen
CEO / Owner
of Scantago A/S

Tony Christensen

Juha Mattila
Director, Sterlization Technologies at STERIS life Sciences Steris

Juha Mattila

Tony Christensen has practical and theroretical experience with the following technologies: 

  • High purity utility systems within pharmaceutical and biopharmaceutical industry 
  • Lyophilization of drug products, operation and trouble shooting of equipment 
  • Cleaning validation of biopharmaceutical process systems 
  • Qualification and validation of utility and process equipment 
  • Training within the field of pharmaceutical water system, lyophilization, Qualification and Validation 
  • Wash and sterilization – advance trouble shooting on moist heat sterilizations processes.

Specialties: Lyophilization technology, Clean utility systems, Wash and Sterilization, Qualification and Validation.

Juha Mattila, holds a Masters in Engineering.
He works as Director, Sterilization Technologies. His tasks include: Global technology leadership and
product management & marketing team lead for STERIS Life Sciences portfolio of Steam and VHP
(Vaporized Hydrogen Peroxide) industrial sterilization, VHP material transfer decontamination equipment technologies and WFI distillation and Pure Steam generator systems for GMP pharmaceutical manufacturing and research applications. Product portfolio strategic management, product line management, new product development process lead, international standards development group work, industry engagement, technology education and Customer application project support.

PRESENTATION:

Workshop – Sterilization and Annex 1 – the elements to consider in CCS for sterilization processes
The workshop aims to design a control strategy for the sterilization processes as part of the CCS.
At the end of the workshop, the attendees should be able to design a sterilization CCS dashboard.

Therefore, during the workshop, a process map will be presented to the attendees to develop the sterilization process risk assessment and define the measures and controls to be implemented. Then, based on the elements set, determine the critical controls that should be part of their CCS.

Ioanna-Maria Gerostathi
Quality & Validation Professional

Ioanna-Maria Gerostathi works as a Qualification and Validation professional in Life Sciences.

Ioanna-Maria has worked in various roles in Quality Assurance, Validation and Engineering and hands-on experience in cleaning validation, equipment, facilities and utilities qualification. She has set sampling plans and trained teams in sampling activities for cleaning validation. Her academic background is in chemical engineering.

PRESENTATION:

Workshop – Statistical Analysis in Recovery Studies
Recovery studies are probably the only kind of studies that can link the quantity of residues recovered by analysts while sampling to the actual quantity of residues on equipment surfaces. In this presentation we will discuss representative case studies of recovery analysis and how we can make the most out of our results via statistical analysis. We will explore how to assess our data through statistic tools and hypothesis testing and how we can create prediction models for our residues through simple linear regression. In our workshop we will demonstrate practical hands-on statistical analysis with tools utilized in machine learning.

Igor Gorsky
Principal Process Validation Consultant, Valsource

Igor Gorsky has been a pharmaceutical industry global expert for over 40 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire. He is currently holding a position of Principal Consultant at Valsource. Igor’s over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. 

He published numerous articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he had been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops, PDA Brazil and other forums. He is also very active with PDA co-leading several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He is leading PDA Water Interest Group. He also is a voting member of ASTM E55, Workgroup 15778 Committee Team drafting a Standard for Cleaning Validation. He serves on Board of Directors for IVT and CPCI.

Igor Gorsky is an author of a book on Principals of Parenteral Solution Validation and Pharmaceutical Scale-Up. He holds a BS degree in Mechanical/Electrical Engineering Technology from Rochester Institute of Technology.

PRESENTATION:

Use of statistics including treatment of censored data in Lifecycle Cleaning Validation as prescribed by ASTM E3106
Cleaning Validation is a process that needs to be developed, qualified and monitored similarly to Manufacturing Process. What is Censored Data and how to treat it. Stage 1 Development of Cleaning Processes statistics. Stage 2 Qualification of Cleaning processes statistics (Control charts, Hypothesis testing, Capability Analysis). Statistical sampling – why we need to use it.

Solenn Brajeul Janvier
RP Pierre Fabre Group

Solenn Janvier is a pharmacist and holds a PhD in organic synthesis.

She has worked for the Pharmaceutical Industry for more than 15 years in chemical development, analytical development and Quality Control.

Solenn has also worked on Cleaning Validation Analysis for more than 7 years. She has taken part in the A3P group “Cleaning Validation” for 6 years.

She has worked for Pierre Fabre Group in Gien (France) since January 2020, where she is heading the Quality Control Laboratory (85 people).

PRESENTATION:

Development and validation of an analytical method for cleaning validation: Tips & Tricks
Abstract coming soon

Kenneth Farrugia
Operations Manager, Mint Health Ltd

Kenneth Farrugia is a Subject Matter Expert in Cleaning Validation and the prevention of cross-contamination. He is a versatile and highly innovative individual with a passion to lead and work with people at all levels.

Assuming an array of roles within the pharmaceutical sector, and engaging in the most challenging projects, Kenneth has attained invaluable experience in the holistic management of pharmaceutical business operations.

Kenneth is currently the Operations Manager for Mint Health Ltd., a young pharmaceutical distribution company with great potential to excel, while at the same time offering consulting services to the pharmaceutical industry on sustainable quality management. Kenneth is currently pursuing an MBA with focus on Operational Excellence through maximizing human potential..

PRESENTATION:

Sustainable Cleaning Validation

The presentation will provide a practical approach for managing the risks associated with cleaning validation with the aim of generating a practical and applicable classification leading to a guided sustainable mitigation and control strategy.  In the light of current financial pressures impacting the pharmaceutical industry, a case study based on a real event will be presented, showing how a holistic risk assessment strategy can result in financial security, whilst maintaining confidence in the quality of the product received by the patient.

Joe Cagnassola
Associate Director Validation, Boehringer-Ingelheim

Joe Cagnassola currently holds the position of Associate Director Validation with Boehringer-Ingelheim. In this position, Joe participates in the validation of cleaning, sterilization, equipment and processes qualifications.
He is active in performing qualifications protocols, writing Master Plans and remediation and optimization efforts of process related activities. During his career, Joe has held validation position of increasing responsibility with Cardinal, Mallinckrodt, Pfizer, Alcon, and BI.

Joe has professional interests in ASQ. He obtained his Certified Quality Engineer and Auditor Certifications and has been trained in Six Sigma and Lean.
His work supporting various quality initiatives has provided him a unique experience and insight into the challenges in today’s fast paced pharma environment. Joe earned his Bachelor of Science in Biology from Arizona State University.

PRESENTATION:

The key to success in any cleaning program is having a cleaning protocol and report that captures the critical steps and provides audit ready documentation. Understanding the cleaning process/program helps the users write polished documentation that stands up to the scrutiny of auditors. This presentation will go step by step through the inception of the cleaning project through the completion of the report. Understanding the process flow will help expedite the Validation time and ensure compliance to internal and external requirements.

Learning Goals for this presentation include:

  • User Requirements
  • Pre-Requisites to get started writing
  • Understanding the Writing Process
  • Execution and Report Writing


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