3rd Annual HPAPIs: Containment & Handling Summit 2023 - uventia

3rd Annual HPAPIs: Containment & Handling Summit 2023

3rd Annual HPAPIs Containment & Handling
Event Details


Highly potent active pharmaceutical ingredients, or HPAPIs, are potent compounds that could effectively treat serious and life-threatening diseases such as cancer. Because of their high potency, these substances eventually put the workers in the production facility at risk. While exceptional product quality is required, additional measures must be taken to ensure operator safety.

At our online meeting, leading figures from the industry, occupational toxicologists and containment specialists will review the most recent developments affecting the handling of HPAPIs. The discussion will center on the safe and effective processing of potent APIs, process development and scale-up, occupational health hazards, toxicological assessment, improvements in isolators and facilities to minimize exposure risk, containment and cleaning validation practices, and risk management for cross-contamination.

In the end, managing HPAPI safely and effectively necessitates a thorough evaluation of a number of factors. This September, keep a look out for any new developments in HPAPI production and processing.


  • Verification and monitoring of containment performance.
  • Achieving containment performance targets in practice - a five year review of air sampling data.
  • In this presentation, you will learn more about risk-based approach throughout hpapi manufacturing to ensure occupational safety.
  • Quantitative measurement of risk in cleaning using ASTM standards.
  • Cleaning process development for HPAPIs and final dosage forms.
  • Lessons learnt from cross contamination/gradient study across pharmaceutical formulation sites.
  • Managing HPAPI risks using a relational risk analysis approach.
  • Lessons learnt from containment validation globally.
  • Implementation of complaint and regulatory observation proven cleaning validation program at potent compound contract facilities.
  • Exposure limits and bands for HPAPIs and the importance of a qualified expert.
  • How to optimize the manufacturing of OEB4 APIs and intermediates: SEQENS value proposition for the oncology market.
  • Human factors supporting human performance.
  • Garment selection criteria for the safe handling of HPAPI.
  • Achieving industrial hygiene standards of care in pharmaceutical R&D and manufacturing.
  • Considerations for optimizing a multi-product, shared facility for HPAPI OSD products.
  • HPAPIs and their unique challenges.
  • Development of lab/pilot scale continuous separation technologies for high potent API processing.
  • Risk assessments in potent HPAPI projects.


CxO, VPs, Directors, Heads, Managers of

  • HPAPI Manufacturing/ API Manufacturing/ Compounds Manufacturing
  • Occupational Toxicology/ Industrial Hygiene / EHS
  • Process Engineering/ Process Development/ Process Scale Up
  • Containment/ Cross Contamination/ Cleaning Validation
  • Cleanroom/ Facility Design/ Isolators
  • Risk Management/ Quality Assurance/ Quality Control
  • Analytical Development/ Analytical Methods
  • CMO/ CDMO/ Outsourcing

[Agenda] 3rd Annual HPAPIs: Containment & Handling Summit 2023

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

Speaking Companies

Previous Events
2nd HPAPI Handling & Manufacturing
[•REC] - €345
September 29, 2022
HPAPI Handling-Manufacturing Summit
[•REC] - €345
September 29, 2021

● AbbVie Inc. ● AGC Pharma Chemicals Europe ● Anthem Biosciences Pvt. Ltd. ● ATLAS ● AUSTAR Pharmaceutical Equipment (Shijiazhuang) ● Avan Bahman Chemi ● Axplora ● Beximco Pharmaceuticals Limited ● Catalent Pharma Solutions ● Center for Pharmaceutical Cleaning Innovation ● Cerbios Pharma SA ● Chatham Consulting Ltd. ● Consultant ● CONTINUUS Pharmaceuticals, Inc. ● Cooey Health ● Dottikon Exclusive Synthesis AG ● DuPont de Nemours ● Ecolab Deutschland GmbH ● Eli Lilly Kinsale Limited ● EUROAPI ● Euroapi Hungary Kft. ● Exyte, Inc. ● Figen Yilmaz Egitim ve Danismanlik Ltd. Sti ● GSK Vaccines srl ● HPAPI Project Services Limited ● Inke S.A. ● International Safety Systems Inc. ● International Safety Systems Inc. ● Lek Pharmaceuticals d.d. ● LOTTE Biologics USA, LLC ● MINAKEM ● Novartis, Advanced Accelerator Applications ● Occupational Health Management, PLLC ● Pharmadagio Limited ● Pharmascience Inc. ● SafeBridge Europe ● Saneca Pharmaceuticals a.s. ● Scale up Solutions; LLC ● SEQENS ● Thermo Fisher Scientific ● Umicore ● Valsource, Inc ● Vasista Pharma chem Pvt Ltd ● VTI Life Sciences, Inc. ● Wuxi biologics ● Yuria-pharm LLC

● LaboratóRio Edol - Produtos FarmacêUticos S.A. ● Hameln Rds S.R.O. ● HAS Healthcare Advanced Synthesis SA ● Research Center Pharmaceutical Engineering GmbH ● Esteve Quimica, S.A. ● Sterling Pharma Solutions Ltd ● Douglas Pharmaceuticals Ltd ● Sanofi ● Wildlife Pharmaceuticals (Pty) Ltd ● Merck KGaA ● Toxiconsultant S.L ● Gedeon Richter Plc. ● Shaoxing Hantai Pharmaceutical Co., Ltd. ● Lamda Laboratories SA ● Hellenic Breweries Of Atalanti S.A. ● Maprimed S.A. ● Glatt Pharmaceutical Services GmbH ● SEQENS ● SANOFİ ILAC SAN. TIC. A.Ş. ● Evotec ● Sanovel Pharmaceutical ● Teva Pharmaceuticals Inc ● PharmaLex India Pvt. Ltd. ● Pharmascience Inc. ● Dr Abidi Pharmaceutical ● EUROAPI ● Ferring Pharmaceuticals ● Angelini Pharma ● Hammersmtih Medicines Research ● Cehtra ● Delpharm Reims ● Recordati S.P.A. ● Delpharm Poznan ●HPAPI Project Services Limited ● Halozyme ● Scale Up Solutions; LLC ● SafeBridge Europe ● Lonza ● BSP Pharmaceuticals S.P.A. ● CPCI™ ● Piramal Pharma Solutions

● A/S Grindeks ● Abdi Ibrahim Global Pharm ● AdhexPharma ● AGC Pharma Chemicals Europe, S.L.U. ● Apotex Inc. ● AstraZeneca ● Aurobindo Pharma Limited ● Bayer AG ● BioDuro-Sundia Corporation ● Biotage GB Ltd ● Biovac ● Boehringer Ingelheim ● Boehringer Ingelheim Pharma GmbH & Co. KG ● Bristol-Myers Squibb ● Cambrex Corporation ● Catalent ● Cipla Ltd. ● Cristália Prod. Quim. e Farm. LTDA ● Custom Pharma Services ● Eurofins Amatsigroup ● FAREVA Mirabel ● Farmabios SPA ● FPS Food and Pharma Systems srl ● Fresenius Kabi ● Gedeon Richter Plc. ● Glatt India Engineering Pvt Ltd ● HPAPI Project Services Limited ● Johnson&Johnson ● Kindeva Drug Delivery ● Labesfal-Laboratórios Almiro S. A. ● Merck KGaA ● MSD Ballydine ● Novo Nordisk ● Nuvisan Pharma Services ● Oakwood Laboratories, LLC. ● Olon S.p.A ● Oncomed Manufacturing a.s. ● Organon Pharma BV ● Pharmascience Inc. ● Pharmascience Inc. ● PharmaZell GmbH ● Polpharma SA ● Quay Pharmaceuticals ● RCPE GmbH ● SafeBridge Europe ● Sai Life Sciences Limited ● Sandoz GmbH ● Saneca Pharmaceuticals a.s. ● Sanofi ● Sanofi Chimie ● Sanofi-Aventis ZRT ● Scale up Solutions ● Siegfried Evionnaz SA ● STADA Arzneimittel AG ● Symeres ● Vanessa Research

Speaker Board
Jayen Diyora
Principal Validation Engineer
Ronan Rocle
Marketing Manager – Innovative Technologies
Igor Gorsky
Principal Process Validation Consultant
Valsource, Inc
Rachel De Luca
Site Director, Le Mans
Bertrand Cottineau
Head of R&D, Le Mans site
Martin Kohan
Managing Toxicologist
SafeBridge Europe
Mark Witcher
SME – Biopharma Operations
Exyte, Inc.
Eric White
EHS Manager – Occupational Hygiene & Ergonomics
AbbVie Inc.
Steve Marnach
EMEA Training Specialist & Pharma Specialist
DuPont de Nemours
Nancy McClellan
Industrial Hygiene Consultant and Expert
Occupational Health Management, PLLC
Prasanth Kondragunta
Associate Director
International Safety Systems
Julie Avery
CIEHF, Chatham Consulting Ltd.
Wei Wu
Associate Director, Engineering
CONTINUUS Pharmaceuticals
Ankit Sharma
Associate Director
International Safety Systems
Mike Perry
Pharmadagio Limited
Tara Dennis
Occupational Hygiene Manager
SafeBridge, Europe
Justin Mason-Home
HPAPI Project Services Limited
Rich Arnett
Manager, Industrial Hygiene & Toxicology
Pharmascience Inc.
Jack Brown
Scale up Solutions; LLC
Thomas Altmann
Principal Global Technical Consultant – Life Sciences
Ecolab Deutschland GmbH

Summit Agenda

◆  Why do we need to assess containment performance.

◆  Guidance on carrying out a containment performance assessment.

◆  Interpreting results.

SafeBridge Europe, UK

◆  A review of air sampling containment performance data drawn from several thousand data points. The data was collected over a period of five years from a variety of pharmaceutical potent compound settings.

◆  Graphical presentation and comparison of personal and static data against various performance targets reveals the overall success of common containment solutions.

◆  Discussion of technical, operational and human factors which frequently impact containment performance achieved in practice, along with some general observations of the data relative to pass criteria thresholds arising from both current and previous versions of EN689.

Pharmadagio Limited, UK

◆  What are the risks related to HPAPI production and when can they occur?

◆  What information is required to assess the risks?

◆  How to reduce the risks at each stage: during development/ manufacturing?

◆  How can process design contribute to safer handling of HPAPIs?

◆  How does facility design contribute to safer handling of HPAPIs, and why is it not sufficient?

◆  How to ensure risk control over time?

Axplora, FR

◆  Discussion of the importance of ASTM Pharmaceutical Standards.

◆  ASTM Cleaning Standards, ICH Q9 and the FDA’s Process Validation GUidance.

◆  How Risk in Cleaning can be quantitatively measured using Toxicity, Process Capability and Detectability Scales.

◆  The Shirokizawa Matrix and how it can be used for risk-based selection of analytical methods and for developing a risk-based cleaning control strategy.


◆  Cleaning process development studies.

◆  Solubility considerations for lab testing.

◆  Cleanability and excipients.

◆  Cleaning validation requirements for detergents.

Ecolab Deutschland GmbH, DE

◆  Lessons learned from 500+ API monitoring results from Cross Contamination studies carried across Formulation sites will be discussed.

◆  Methods of conducting the Cross-contamination study, Identifying potential routes of contamination and results from the swab and air samples.

◆  Key recommendations related to management of ventilation systems and work practices to minimize the cross-contamination will be shared.

International Safety Systems Inc., IE

◆  Relational Risk Analysis (ReRA) supports both event and system based risk analyses for managing a wide variety of HPAPI risks.

◆  ReRA provide a foundation for both a simple inuitive risk analysis while also supporting comprehensive risk management exercises.

◆  ReRA provides an excellent understanding how risks impact HPAPI operations and safety.

Exyte, Inc., USA

◆  Lessons learned from 5000+ surrogate monitoring results from Factory Acceptance and Site Acceptance Tests for various particulate containment equipment will be discussed.

◆  Particulate containment surrogate result profiles based on statistical analysis of the results for various containment equipment will be shared.

◆  Key elements of planning for Factory Acceptance Test and Site Acceptance Test will be shared.

International Safety Systems Inc., USA

◆  What are HPAPIs.

◆  Occupational Exposure Limits (OELs) and Bands (OEBs).

◆  Permitted Daily Exposures (PDEs).

◆  Profile of a Qualified Expert.

SafeBridge Europe, UK

◆  SEQENS made significant investment in its sites to increase its capacity of potent APIs and intermediates.

◆  Case studies on how to optimize the handling of HPAPI based on adapting the manufacturing process or route of synthesis.

◆  Seqens value proposition for the oncology market.

Seqens, FR

◆  Cognitive overload – how does it feel? (Game – Control Panel) on mobile phones – no downloading needed).

◆  Using HF tools to ask better questions to understand work as done vs work as imagined. Adaptations people make in everyday work.

◆  Tbc – example from industry.

Chatham Consulting Ltd., UK

◆  The role of PPE in the containment strategy.

◆  Risk assessment.

◆  Understanding permeation & penetration.

◆  Which garments to use in grade A-D pharmaceutical cleanrooms?

DuPont de Nemours, LU

◆  Facility Planning & Optimization.

◆  Scaling up from lab-scale to GMP production.

◆  Understanding what kind of controls are required.

Pharmascience Inc., CA

HPAPIs by nature offer some unique challenges not only for their toxicity or potency but as well due to the limitations of raw materials (in most cases) and handling limitations. Typical potent compounds are studied at much smaller scale and the knowledge about the chemistry is limited to a smaller number of people since the chemistry has to be executed in a unique setting. Given these challenges, planning and experimental execution become more important. This requires that communication throughout the development is critical to effectively use the time and resources. We  will discuss several examples and how they were addressed.

Scale up Solutions; LLC, USA

◆  Integrated continuous manufacturing (ICM) of pharmaceuticals.

◆  Continuous separation process development for high potent lab/pilot plant.

◆  Rotary filter and drum dryer machinery deign with CIP capability.

CONTINUUS Pharmaceuticals, USA

◆  RA in HPAPI Projects versus Other Industries.

◆  Risk Assessment Techniques.

◆  Qualitative versus Quantitative Risk Assessment.

◆  Confidence in Risk Assessments and Sources of Support.

HPAPI Project Services Limited, UK

Event Details