Cleanroom society providing
Knowledge, Networking & Training
Cleaning and disinfection programs part of a lifecycle approach
Walid EL Azab
Industrial pharmacist –Qualified Person
The presentation seeks to show how cleaning and disinfection program should be part of a lifecycle approach. In this regard, the presentation presents and analyze the different regulatory requirements related cleaning and disinfection program. A deep dive into the analysis of the different regulatory requirements regarding cleaning and disinfection programs, including disinfectant rotation along with a sporicidal agent and rinse program will be discussed. The understanding of the different regulatory requirements will along with the historical environmental monitoring data, product impact analysis, the microbial risk assessment results, disinfectant qualification results support the development and decision making to scientifically justify the cleaning and disinfection program chosen by the manufacturers. Finally, the presentation will share case studies to explain the selection and the number of disinfecting agents to be used, the frequency of application, and the rotation of (one or more) disinfectants along with a sporicidal agent and an efficient rinse program while being compliant with the different regulatory requirements. Finally, the presentation will share good practices and common mistakes observed during the past years auditing pharmaceutical companies.
Key take home:
1. understand the regulatory requirement for cleaning and disinfection program (including rotation)
2. be able to be beyond compliance regarding cleaning and disinfection program and rinse program
3. Lessons learned from various case studies to develop robust the cleaning and disinfection program
Modern PTFE membrane based HEPA-ULPA filters for improved energy savings and risk reduction.
The presentations is about:
• ePTFE & eFRM membrane media (origin and structure)
• superior mechanical stability & chemical resistance
• ultra-low pressure drop
• introducing PAO tolerant eFRM that can be leak tested by photometers
• energy savings & risk reduction
Dr.-Ing. Marc Schmidt
Director Research & Development Europe
Cleanroom garments for chemical and biological risks (PPE)
Materials and Product Development Engineer
Dupont de Nemours Protective Apparel
End users operating in cleanrooms and controlled environments within Life Sciences, Pharmacy and Healthcare industries are facing multiple risks coming from the operator and the process.
This document provides an evaluation of different protective cleanroom garments based on the type of hazard people and process are exposed.
Presented aspects such as cleanliness, fabric performance, barrier level, protection against biological risks, garment lifecycle are valuable data in order to assist end users in the task.
There are many different coveralls commercially available, and although they are qualified, there are very wide ranging performance difference for products.
Case studies of recurrent microbial contamination: benefit of EM data review and periodic audit of practices
Walid EL Azab
Industrial pharmacist –Qualified Person
“Control of microbiological contamination” is still one of the top 10 observations by FDA and EMA auditors. The goal of the presentation is to explain why microbial contamination control is often inadequate based on years of performing audits and benchmarking of several pharmaceutical companies. The presentation is based on case studies on recurring microbial contamination due to ineffective investigation and trending of data gathered during routine monitoring. To identify the root causes and resolve recurring microbial contamination deviation not only investigation in the field is important but also using historical Environmental Monitoring (EM) data review and periodic audit of the practices are key. The presentation will share how adequate risk based monitoring plan, regular audits of the cleaning and disinfection practices and historical data review can help to design an effective cleaning and disinfection program.
At the end of the presentation the attendees will be able to understand:
* Common mistakes leading to recurrent microbial contamination.
* How to use the data available to support the root cause investigation and resolve recurring issues.
* The benefit of cross-functional team for the investigation success
* How effective data analysis can avoid recurring microbial contamination and confirm the robustness of the contamination control procedure in place.
Cleanroom energy reduction – possibilities for now and in the near future
Cleanrooms are critical for product quality in many manufacturing processes.
However, they are also very energy intensive and costly to operate.
Where cost of goods is important in a competitive global market, many organizations are searching for ways to minimize the operational costs of these facilities and also meet sustainability objectives.
In this presentation, Keith will share his experience of working with global life science manufacturers to help them reduce costs and deliver on sustainability targets.
He will cover some top tips and give pointers to useful sources of information and guidance.
He will also share a vision of the future, that EECO2 are helping to make a reality, where cleanrooms can respond dynamically to the contamination challenges, maintaining and monitoring real-time quality compliance.
Keith Beattie, BEng, MSc, CEng MIET,
Chartered Energy Manager MEI
Life Science Lead
EECO2 - Energy Efficiency Consultancy Limited
Clean areas used for aseptic manufacturing of sterile medicinal products are subject to standards and guidelines to ensure quality of production, minimize the risks of particulate and microbiological contamination.
In recent years, proper monitoring plan with risk based approach become a part of many standard and regulations such as new ISO 14644-2:2015 and ICH Harmonized Guideline ICHQ9 Quality Risk Management.
However it is also obvious that there is a lack of Good Application Practices for proper monitoring plans based on risk assessment.
Cleanroom Technologies Society of Turkey
Impact radioprotectie op ventilatie-installaties in GMP-omgeving
ir. Pieter Sturbois
De lezing gaat over de impact van radioprotectie op de ventilatie-installatie in een GMP-omgeving.
Het onderwerp wordt geïllustreerd aan de hand van een installatie opgebouwd in UZ Leuven.
In het project werden de productielabo’s voor nucleaire geneeskunde omgebouwd en uitgebreid.
Het programma omvat laboratoria voor commerciële productie van FDG en conventionele radiofarmacie met bijhorende administratieve en technische ruimtes.
De productieruimtes zijn cleanrooms geclassificeerd volgens de EU GMP (Good Manufacturing Practice) Annex I.
Bij de uitwerking van het project wordt ook grote aandacht besteed aan radioprotectie en het minimaliseren van de lozing naar de buitenomgeving
The digitalization of cleanroom textile management contribution to change behavior
Product Manager West-Europe
Real-time Microbiological Air Sampling in Cleanrooms
Traditional microbiological sampling methods have many challenges in today’s cleanroom production environments and the regulations are starting to move to recommending other methods.
We will take a detailed look at the new real-time (alternative) micro methods (AMM) based on Fluoresence and where they can be used.
Mr Simon Tebb
Senior Regional Sales Manager
In this seminar we are explaining you the possibilities of digitalization within cleanroom textile management.
It is surprising to see that within a highly regulated industry many things are being done offline. This makes it difficult to oversee and ensure compliance to the high standards.
Elis Connected Cleanroom has been developed in cooperation with our customers to improve SOP compliance and time efficiency for our operators By using UHF technology or Barcode scanning.
Challenges such as: How can you easily track & trace your cleanroom textile, stock management, insight in SOP compliance, garment change behavior of your employees, increased transparency on usage of your own facility and comprehensive data to monitor?
All the data collected is translated into a sophisticated overview that reflects your SOP KPIs. This will create more transparency through the lifecycle of cleanroom apparel and other systems. With the ability to collect data and make decisions based on insights by using data analytics your cleanroom becomes fully integrated into the operations.
CONNECTED OR NOT CONNECTED, THAT’S NOT THE QUESTION ANYMORE!
Overzicht ISO en CEN normen op het gebied van cleanrooms, luchtreinheid en oppervlaktereinheid met betrekking tot deeltjes, mico-organismen, chemische stoffen en nanodeeltjes en bijbehorende meetmethoden.
Het realiseren en beheren van cleanrooms en clean zones met aandacht voor energie management.
Nieuwe normen voor het bepalen van de emissie van deeltjes en chemische stoffen door materialen, verbruiksartikelen en apparatuur.
Operationele normen over reiniging en toepassing van deeltjesdepositie snelheid en de nieuwe Europese norm voor bio-contaminatie EN17141.
ISO/TC209, ICCCS, CTCB-I, VCCN
BCW is een onafhankelijke cleanroom vereniging met als doel, informatie verstrekken rond het bouwen en uitbaten van cleanrooms volgens nationale en internationale normen, standaarden en goede praktijken.
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