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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
Risk Assessment for the cleanroom garments in the Context of the GMP Annex 1 Revised version
Global Life Sciences Market Leader
Dupont de Nemours
Since the early dates of cleanroom technology personnel have been considered as one of the largest sources of contaminants, especially in the form of particles, dead particles as well as viable microorganisms.
One way to minimize the impact of humans to the air cleanliness of a cleanroom is to reduce or even totally remove humans from the environment. In most cases this is not possible, forcing us instead to reduce the number of persons in the cleanroom and at the same time equip them with specially designed cleanroom garments, acting as filters to minimize the impact of particles from humans on the quality of the cleanroom air.
The presentation covers:
• The development of cleanroom garments
• Draft GMP Annex 1 (2017) and the impact for cleanroom clothing
• Risk assessment reusable polyester and single-use Tyvek® IsoClean® cleanroom garments
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
Implementatie en gebruik van biocides in de farmaceutische industrie
KEY ACCOUNT MANAGER BENELUX LIFE SCIENCES
ECOLAB LIFE SCIENCES
De presentatie bespreekt een aantal criteria die je voor ogen houd bij het kiezen van een desinfectans.
Vaak wordt hierbij de wetgeving over het hoofd gezien en is het actueel om eerst te bekijken wat de mogelijkheden zijn in het Europa van morgen. De nieuwe versus oude biocide wetgeving komt aan bod en wat dit zal teweegbrengen.
De vereisten waar een regime voor reiniging/desinfectie aan moet voldoen en hoe je keuzes kunt maken.
Real-time Microbiological Air Sampling in Cleanrooms
Mr Simon Tebb
Senior Regional Sales Manager
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.
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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