Cleanroom Challenges in Ongoing Operations

Objective

In this conference track, we will present the expectations of regulatory authorities regarding the materials used, as well as provide insights into the requirements for qualifying such materials. Whether single-use or reusable, experienced speakers will introduce the properties, usability, and limitations of various consumables such as clothing, wipes, gloves, disinfectants, mops, etc., and will show you criteria that will assist you in selection and qualification.

Registration

Register as a congress delegate for just 690 EUR/day!
This special offer is only valid until 31 December 2024!

Background

In the production of pharmaceuticals, medical devices, cosmetics, or other products with high hygiene and quality demands, not only the "big" investments such as cleanroom planning and construction, design of production lines, ventilation systems, etc., play an important role, but often the pitfalls of quality assurance lie in the "small" materials, often referred to as "cent items" that are frequently used in daily routines. Gloves to protect products and/or personnel, wipes to clean surfaces, clothing—whether disposable or reusable—to reduce the human contamination source as a risk factor, or disinfectants to avoid or reduce contamination.

However, careful selection, qualification, and, if necessary, GMP-compliant preparation of these products and materials are of crucial importance. Clear specifications for materials regarding their purpose and location are essential. Guidelines such as VDI 2083, Sheet 9.2, or ISO 14644, Sheet 18 may provide users and decision-makers with references for their selection and definition processes.

Target Audience

The conference track is aimed at all those who deal with the following topics:

  • Selection and qualification of single-use materials within quality assurance
  • Purchasing and procurement of such materials
  • Users of consumables in cleanrooms
  • Personnel responsible for contamination control or contamination control strategies
  • Employees of suppliers of consumable materials
  • Staff from regulatory authorities

Detailed Programme

Cleanroom Garments – Clothing Basics, Barrier Functions and more
Jörg Mesenich, Mesenich Consulting
Gabi Schmeer-Lioe, German Institutes for Textile and Fibre Research Denkendorf (DITF)

Qualification Study for Cleanroom Garments
Carsten Moschner, CMC3

Consumables and Cleanroom – Expectations and Experiences of an Inspector
Dr Daniel Müller, Local Government Baden-Württemberg, Germany

Disposables – Face Masks and the Like – whatProtection do they really provide?
Monika Lamprecht, Lamprecht C&C

Cleanroom Wipes – What is Cleanroom-Compatible really?
Carsten Moschner, CMC3

Mopping Systems and the associated Systems
Margarete Witt-Mäckel, Witt Hygienemanagement

Cleanroom Gloves – the Balancing Act between Cleanroom Suitability and Personnel Protection
Monika Lamprecht, Lamprecht C&C
Robert Sevdas, Dastex

Facility Monitoring with Single-Use active viable Sampling in the daily Practice of a Contract Developer and Manufacturer – Complete and simple Solution
Dr Thomas Müller, Recipharm
Ivan Spiro, PMS

Pitfalls in microbiological Cleanroom Monitoring: Common Sources of Error in Qualification and Ongoing Monitoring
Melissa Schühlein, Labor LS
Melanie Braun, Labor LS

Live Demos

  • Facility Monitoring Systems
  • Continuous and rapid Monitoring of Bacteria in
    pharmaceutical Grade Water

Case Study: Disinfectants and their Effectiveness on various Surfaces
Dr Hans-Joachim Anders, Novartis Pharma

Navigating the Challenges of implementing New Annex 1 in Non-Sterile Manufacturing
Martina Gjorgjevska, The ForceCT
Apostol Todorovski, Sinceritas

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