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Formazione >> Webinar e Formazione Online >> Workshop: Extractables & Leachables and Container Closure Integrity Testing

Workshop: Extractables & Leachables and Container Closure Integrity Testing

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A journey through the evaluation and testing of packaging, devices and process items

DATE: 27th, September 2022 | Hr 8.30am - 05.00 pm

VENUE: Hotel Van Der Valk Gent - Akkerhage 10 9000 Gent, Belgium

OFFICIAL LANGUAGE: English

FEE: €180 excl. VAT

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Workshop Overview

The workshop will provide an overview on the assessment and tests needed to be in compliance with the up-to-date regulations and guidances. Starting with the testing on the materials of constructions (plastic pellets, foils, films) and components (stoppers,glass,) we will see the rational behind the choice of the testing, following specific chapters of the US and EP Pharmacopoeias.

We will move then to the required testing when these materials and semi-finished product became a Primary Packaging, a Medical Device or a Single/Multiple Use System used in the product manufacturing. This testing embraces the Extractables & Leachables assessment, which evaluates the safety of the materials in terms of potential toxic compounds releasing, and the Container Closure Intergrity Testing (CCIT) which has the aim to evaluate the capability of the chosen closure system to preserve the product chemical properties and to avoid contaminations.

In the last years the requests by regulatory authorities and notified bodies become more and more demanding about this testing.

In the workshop it will be explained how to manage the risk assessment for these two complex field of the analytical chemistry, and the related Design of the Experiments based
on the items’ shape, use and, in case of the closure systems, on the chemical/physical properties of the product contained. Several case studies and hands on will help to fix the
key concepts of the decisional workflows.

Agenda

Welcome: 8:30-9:00

Compendial testing:
The compendial testing on the material of construction and components (USP <661>; <381>; <660>; EP <3.1.X> and <3.2.X> series)

E&L - Extractables studies:
• The extractables & leachables testing - Guidelines and regulatory requirements (USP<1663> <1664>; ISO 10993-18; USP <665> <1665>)
• When and how to set up an extractable study and the desing of the experiment.
   Critical evaluation of the packaging system, process components and medical devices and
   their differences in the analytical approaches.
• Setting up an extractables study (Design of Experiment):
  - Selection of extraction conditions
  - Selection of extractive solvents
  - Selection of analytical techniques (HS/GC/MS-GC/MS HPLC/MS/UV-ICP/OES-ICP/MS Ion
    Chromatography)
• Definition of the Analytical Evaluation Threshold

Coffee Break (10:15 -10:30)

E&L - Toxicological evaluation:
• Maximum Daily Intake (MDI)
• Threshold of Toxicological Concern (TTC)
• Different approaches to the interpretation of data of known and unknown compounds
• Tolerable Intake (TI) / Tolerable Exposure (TE)
• NOAEL-LOAEL: Definition and selection criteria
• Uncertainty factors
• In silico predictions

E&L - Leachables studies: 
• When and how to set up a leachablee study
• The approach on known and unknown extractables
• Targeted & non-targeted leachable screening
• Method development and validation
• Leachables studies stability plan
• Q&A

Lunch 12:00-13:00

E&L – Case studies Leachables studies
Hands on session- working groups for the DoE E&L on: primary packaging - medical devices - combination products - Single Use Systems; and discussion of the results

CCIT - Overview:
• CCI definition and regulation (USP 1207)
• CCIT definition and approaches
• Probabilistic vs Deterministic approach (Differences, advantages and drawbacks)

CCIT- Method development and validation:
• The need for method validations
• Validation phases, key elements and parameters

Coffee Break (15:00 – 15:15)

CCIT - Methods in detail
• CCIT along the product life cycle
• Tracer liquid (dye ingress)
• Microbial Ingress Test
• High Voltage Leak Detection
• Laser-based Gas Headspace Analysis
• Tracer gas detection (vacuum mode)
• Mass extraction
• Vacuum/Pressure decay

CCIT - Case studies
• High Voltage Leak Detection
• Vacuum decay for larger volumes
• Microbial Ingress Test

Q&A
Closing 17:00
Network drink (17:00-18:00)

Speakers

Simone Carrara
Simone holds a Biotechnology degree from the University of Milan and has a vast experience as bio-analytical researcher, through LC/MS method development for Pharmacokinetics analysis and ADMET profiling. In his previous role as Project Leader he has successfully managed different projects including analytical method development and validation with LC/MS-GC/MS, and drug product impurities characterization. In the last 7 years he has been focusing on extractables & leachables studies to support drugmanufacturing companies to fulfill regulatory requirements. He is currently the E&L Business Unit Manager, in Eurofins BioPharma Product Testing in Italy.

Tommaso Tancredi Alessandro Taroni
Project Leader at Eurofins BioPharma Products Testing divisione E&L and packaging testing. 

Daniele Lioi
HAS Consultant, Senior Consultant, Eurofins Medical Device Testing Italy